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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-00712 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| s14-01925 | |||
| AALL1231 | Other Identifier | Children's Oncology Group | |
| AALL1231 | Other Identifier | CTEP | |
| U10CA098543 | U.S. NIH Grant/Contract | View source | |
| U10CA180886 | U.S. NIH Grant/Contract | View source |
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This randomized phase III trial compares how well combination chemotherapy works when given with or without bortezomib in treating patients with newly diagnosed T-cell acute lymphoblastic leukemia or stage II-IV T-cell lymphoblastic lymphoma. Bortezomib may help reduce the number of leukemia or lymphoma cells by blocking some of the enzymes needed for cell growth. It may also help chemotherapy work better by making cancer cells more sensitive to the drugs. It is not yet known if giving standard chemotherapy with or without bortezomib is more effective in treating newly diagnosed T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma.
PRIMARY OBJECTIVES:
I. To compare event-free survival (EFS) in patients with newly diagnosed T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LLy) who are randomized to a modified augmented Berlin-Frankfurt-Munster (ABFM) backbone versus bortezomib plus the modified ABFM backbone.
SECONDARY OBJECTIVES:
I. To determine the safety and feasibility of modifying standard therapy for T-ALL and T-LLy based on the results of UKALL 2003, which includes a dexamethasone-based induction, additional doses of pegaspargase (PEG-ASP) during induction and delayed intensification (DI), and dexamethasone pulses during maintenance therapy.
II. To determine if prophylactic (presymptomatic) cranial radiation therapy (CRT) can be safely and effectively eliminated in the 85-90% of T-ALL patients classified as standard or intermediate risk.
III. To determine the proportion of end of consolidation (EOC) minimal residual disease (MRD) >= 0.1% T-ALL patients who become MRD negative (undetectable by flow cytometry) after intensification of chemotherapy, using three high risk (HR) BFM blocks, and to compare EFS between the patients who become MRD negative after the three HR BFM blocks and continue on chemotherapy with those who continue to have detectable MRD and are eligible for other treatment strategies, including hematopoietic stem cell transplant (HSCT).
IV. To compare the EFS between very high risk (induction failure) T-LLy patients treated with HR BFM intensification blocks who have partial or complete response (PR or CR) with those who do not respond (NR).
CORRELATIVE OBJECTIVES:
I. To investigate the prognostic significance of day 29 bone marrow (BM) MRD in T-LLy patients.
II. To determine if protein expression patterns can predict bortezomib response and drug resistance in T-ALL.
III. To analyze and target relevant signaling pathways in T-ALL blasts, focusing on early T cell precursor (ETP) acute lymphoblastic leukemia (ALL).
OUTLINE: Patients are randomized to 1 of 2 treatment arms. Patients are risk assigned based on data from end of induction and/or consolidation therapy; this then modifies the subsequent therapy received.
T-ALL Risk Group Definitions:
Standard Risk (SR): CNS1*, lumbar puncture prior to steroid therapy (not steroid pretreated), Day 29 (end of induction) bone marrow M1, Day 29 bone marrow minimal residual disease (MRD) <=0.01%, no testicular leukemia at diagnosis.
Intermediate Risk (IR): Not SR or VHR.
Very High Risk (VHR): M3 marrow at Day 29 and/or end of consolidation (EOC) MRD >=0.1%.
*CNS2 and CNS3 cannot be SR and are assigned to IR or VHR based on marrow response.
T-LL Risk Group Definitions:
Standard Risk (SR): CNS1*, MRD at diagnosis <1% in bone marrow, lumbar puncture prior to steroid therapy (not steroid pretreated), Day 29 (end of induction) complete response (CR) or partial response (PR).
Intermediate Risk (IR): Not SR or VHR.
Very High Risk (VHR): Stable Disease (SD)/No response (NR) at Day 29 (End of Induction).
*CNS2 and CNS3 cannot be SR and are assigned to IR or VHR based on radiographic response.
ARM A INDUCTION: Patients receive cytarabine intrathecally (IT) at time of diagnostic lumbar puncture (if within 72 hours from start of protocol therapy) OR day 1; vincristine sulfate intravenously (IV) over 1 minute on days 1, 8, 15, and 22; dexamethasone orally (PO) twice daily (BID) on days 1-28 (no taper); daunorubicin hydrochloride IV over 1-15 minutes on days 1, 8, 15, and 22; pegaspargase IV over 1-2 hours on days 4 and 18; and methotrexate IT on days 8 and 29 (and on days 15 and 22 for central nervous system 3 involvement [CNS3] T-ALL patients).
ARM A CONSOLIDATION: Beginning on day 36 from Induction, patients receive methotrexate IT on days 1, 8, 15, and 22 (days 1 and 8 only for CNS3 T-ALL or CNS3 T-LLy patients); cyclophosphamide IV over 30-60 minutes on days 1 and 29; cytarabine IV over 1-30 minutes or subcutaneously (SC) on days 1-4, 8-11, 29-32, and 36-39; mercaptopurine PO once daily (QD) on days 1-14 and 29-42; pegaspargase IV over 1-2 hours on days 15 and 43; and vincristine sulfate IV on days 15, 22, 43, and 50. Patients with persistent testicular disease undergo radiation therapy.
Patients are then assigned to subsequent therapy according to risk assignment. Patients with standard risk (SR) disease receive Interim Maintenance with Capizzi methotrexate (CMTX); patients with intermediate risk (IR) disease receive Interim Maintenance with high-dose methotrexate (HDMTX), Delayed Intensification, and then Interim Maintenance with CMTX; and patients with very high risk (VHR) disease receive 3 HR Intensification Blocks, Delayed Intensification, and then Interim Maintenance with CMTX.
ARM A CMTX INTERIM MAINTENANCE: Patients receive vincristine sulfate IV over 1 minute on days 1, 11, 21, 31, and 41; methotrexate IV over 2-5 minutes (undiluted) or 10-15 minutes (diluted) on days 1, 11, 21, 31, and 41; pegaspargase IV over 1-2 hours on days 2 and 22; and methotrexate IT on days 1 and 31. The next course (based on risk assignment) begins on day 57 or when blood counts recover (whichever occurs later).
ARM A DELAYED INTENSIFICATION: Patients receive vincristine sulfate IV over 1 minute on days 1, 8, 15, 43, and 50; dexamethasone PO BID or IV on days 1-7 and 15-21; doxorubicin hydrochloride IV over 15 minutes on days, 1, 8, and 15; pegaspargase IV over 1-2 hours on days 4, 18, and 43; methotrexate IT on days 1, 29, and 36; cyclophosphamide IV over 30-60 minutes on day 29; cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39; and thioguanine PO on days 29-42. The next course (based on risk assignment) begins on day 64 or when blood counts recover (whichever occurs later).
ARM A HDMTX INTERIM MAINTENANCE: Patients receive high-dose methotrexate IV over 24 hours on days 1, 15, 29, and 43; leucovorin calcium IV or PO on days 3-4, 17-18, 31-32, and 45-46; vincristine sulfate IV on days 1, 15, 29, and 43; mercaptopurine PO QD on days 1-56; and methotrexate IT on days 1 and 29. The next course (based on randomization assignment) begins on day 57 or when blood counts recover (whichever occurs later).
ARM A INTENSIFICATION BLOCK I: Patients receive dexamethasone IV or PO BID on days 1-5; high-dose methotrexate IV over 24 hours on day 1; leucovorin calcium IV or PO on days 3-4; vincristine sulfate IV on days 1 and 6; cyclophosphamide IV over 1-6 hours on days 2-4; high-dose cytarabine IV over 3 hours every 12 hours on day 5; pegaspargase IV over 1-2 hours on day 6; and triple IT therapy comprising methotrexate IT, hydrocortisone IT, and cytarabine IT on day 1. The next course (Intensification Block II) begins on day 22 or when blood counts recover (whichever occurs later).
ARM A INTENSIFICATION BLOCK II: Patients receive dexamethasone PO BID or IV on days 1-5; high-dose methotrexate IV over 24 hours on day 1; leucovorin calcium PO or IV on days 3-4; vincristine sulfate IV on days 1 and 6; ifosfamide IV over 1 hour every 12 hours on days 2-4; daunorubicin hydrochloride IV over 30 minutes on day 5; pegaspargase IV over 1-2 hours on day 6; and triple IT therapy on day 1 as in Intensification Block I. The next course (Intensification Block III) begins on day 22 or when blood counts recover (whichever occurs later).
ARM A INTENSIFICATION BLOCK III: Patients receive dexamethasone PO BID or IV on days 1-5; high-dose cytarabine IV over 3 hours every 12 hours on days 1-2; etoposide IV over 1-2 hours every 12 hours on days 3-5; pegaspargase IV over 1-2 hours on day 6; and triple IT therapy on day 5 as in Intensification Block I. The next course (based on randomization) begins on day 22 or when blood counts recover (whichever occurs later).
ARM A MAINTENANCE THERAPY: All patients receive vincristine sulfate IV over 1 minute on days 1, 29, and 57; dexamethasone PO BID or IV on days 1-5, 29-33, and 57-61; mercaptopurine PO on days 1-84; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78 (omit day 29 for SR patients during the first 4 cycles); methotrexate IT on day 1 (and day 29 during the first 4 cycles for SR patients and during the first 2 cycles for IR patients). Patients with CNS1-3VHR and CNS2 VHR, and CNS3 IR disease also undergo cranial radiation therapy during the first 4 weeks (cycle 1). Treatment in female patients with T-ALL and patients with T-LLY repeats every 12 weeks for up to 2 years from the start of Interim Maintenance (week 119). Treatment in male patients with T-ALL repeats every 12 weeks for up to 3 years from the start of Interim Maintenance (week 171).
ARM B INDUCTION: Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11(1.3 mg/m^2 per dose); and cytarabine, vincristine sulfate, dexamethasone, daunorubicin hydrochloride, pegaspargase, and methotrexate as in Induction Arm A.
ARM B CONSOLIDATION: Beginning on day 36 from Induction, patients receive methotrexate IT on days 1, 8, 15, and 22 (days 1 and 8 only for CNS3 T-ALL or CNS3 T-LLy patients); cyclophosphamide IV over 30-60 minutes on days 1 and 29; cytarabine IV over 1-30 minutes or subcutaneously (SC) on days 1-4, 8-11, 29-32, and 36-39; mercaptopurine PO once daily (QD) on days 1-14 and 29-42; pegaspargase IV over 1-2 hours on days 15 and 43; and vincristine sulfate IV on days 15, 22, 43, and 50. Patients with persistent testicular disease undergo radiation therapy.
Patients are then assigned to subsequent therapy according to risk assignment. Patients with standard risk (SR) disease receive Interim Maintenance with Capizzi methotrexate (CMTX); patients with intermediate risk (IR) disease receive Interim Maintenance with high-dose methotrexate (HDMTX), Delayed Intensification, and then Interim Maintenance with CMTX; and patients with very high risk (VHR) disease receive 3 HR Intensification Blocks, Delayed Intensification, and then Interim Maintenance with CMTX.
ARM B CMTX INTERIM MAINTENANCE: Patients receive vincristine sulfate IV over 1 minute on days 1, 11, 21, 31, and 41; methotrexate IV over 2-5 minutes (undiluted) or 10-15 minutes (diluted) on days 1, 11, 21, 31, and 41; pegaspargase IV over 1-2 hours on days 2 and 22; and methotrexate IT on days 1 and 31. The next course (based on risk assignment) begins on day 57 or when blood counts recover (whichever occurs later).
ARM B DELAYED INTENSIFICATION: Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 15, and 18 (1.3 mg/m^2 per dose); and vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, methotrexate, cyclophosphamide, cytarabine, and thioguanine as in Delayed Intensification Arm A. The next course (based on risk assignment) begins on day 64 or when blood counts recover (whichever occurs later).
ARM B HDMTX INTERIM MAINTENANCE: Patients receive high-dose methotrexate IV over 24 hours on days 1, 15, 29, and 43; leucovorin calcium IV or PO on days 3-4, 17-18, 31-32, and 45-46; vincristine sulfate IV on days 1, 15, 29, and 43; mercaptopurine PO QD on days 1-56; and methotrexate IT on days 1 and 29. The next course (based on randomization assignment) begins on day 57 or when blood counts recover (whichever occurs later).
ARM B INTENSIFICATION BLOCK I: Patients receive dexamethasone IV or PO BID on days 1-5; high-dose methotrexate IV over 24 hours on day 1; leucovorin calcium IV or PO on days 3-4; vincristine sulfate IV on days 1 and 6; cyclophosphamide IV over 1-6 hours on days 2-4; high-dose cytarabine IV over 3 hours every 12 hours on day 5; pegaspargase IV over 1-2 hours on day 6; and triple IT therapy comprising methotrexate IT, hydrocortisone IT, and cytarabine IT on day 1. The next course (Intensification Block II) begins on day 22 or when blood counts recover (whichever occurs later).
ARM B INTENSIFICATION BLOCK II: Patients receive dexamethasone PO BID or IV on days 1-5; high-dose methotrexate IV over 24 hours on day 1; leucovorin calcium PO or IV on days 3-4; vincristine sulfate IV on days 1 and 6; ifosfamide IV over 1 hour every 12 hours on days 2-4; daunorubicin hydrochloride IV over 30 minutes on day 5; pegaspargase IV over 1-2 hours on day 6; and triple IT therapy on day 1 as in Intensification Block I. The next course (Intensification Block III) begins on day 22 or when blood counts recover (whichever occurs later).
ARM B INTENSIFICATION BLOCK III: Patients receive dexamethasone PO BID or IV on days 1-5; high-dose cytarabine IV over 3 hours every 12 hours on days 1-2; etoposide IV over 1-2 hours every 12 hours on days 3-5; pegaspargase IV over 1-2 hours on day 6; and triple IT therapy on day 5 as in Intensification Block I. The next course (based on randomization) begins on day 22 or when blood counts recover (whichever occurs later).
ARM B MAINTENANCE THERAPY: All patients receive vincristine sulfate IV over 1 minute on days 1, 29, and 57; dexamethasone PO BID or IV on days 1-5, 29-33, and 57-61; mercaptopurine PO on days 1-84; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78 (omit day 29 for SR patients during the first 4 cycles); methotrexate IT on day 1 (and day 29 during the first 4 cycles for SR patients and during the first 2 cycles for IR patients). Patients with CNS1-3VHR and CNS2 VHR, and CNS3 IR disease also undergo cranial radiation therapy during the first 4 weeks (cycle 1). Treatment in female patients with T-ALL and patients with T-LLY repeats every 12 weeks for up to 2 years from the start of Interim Maintenance (week 119). Treatment in male patients with T-ALL repeats every 12 weeks for up to 3 years from the start of Interim Maintenance (week 171).
All treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically for up to 10 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (combination chemotherapy) | Active Comparator | Patients receive combination chemotherapy without bortezomib. See Detailed Description. |
|
| Arm B (combination chemotherapy, bortezomib) | Experimental | Patients receive combination chemotherapy with bortezomib (4 doses at 1.3 mg/m^2 during Induction and 4 doses at 1.3 mg/m^2 during Delayed Intensification). See Detailed Description. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bortezomib | Drug | Given IV |
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| Measure | Description | Time Frame |
|---|---|---|
| Event-free Survival (EFS) for Modified Augmented Berlin-Frankfurt-Munster Backbone With or Without Bortezomib in All Randomized Patients | EFS is calculated as time from randomization at study entry to first event (induction failure, induction death, relapse, second malignancy, remission death) or date of last contact. Three-year EFS rates will be calculated for both groups. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity Rates Associated With Modified Standard Therapy, Including Dexamethasone and Additional Pegaspargase | Percentage of patients who experienced Grade 3 or higher Toxicity Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | 3 years from start of therapy by patient |
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Inclusion Criteria:
T-ALL: T-ALL patients must be enrolled on AALL08B1 or Project:EveryChild (APEC14B1, if open for the classification of ALL patients) prior to treatment and enrollment on AALL1231
All patients must be > 1 and < 31 years of age
Patients must have newly diagnosed T-lymphoblastic leukemia (T-ALL) or T-lymphoblastic lymphoma (T-LLy) stages II-IV
All patients and/or their parents or legal guardians must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
Exclusion Criteria:
Patients must not have received any cytotoxic chemotherapy for either the current diagnosis of T-ALL, T-L-Ly or for any cancer diagnosis prior to the initiation of protocol therapy on AALL1231, with the exception of:
Steroid pretreatment: prednisone or methylprednisolone for =< 120 hours (5 days) in the 7 days prior to initiating induction chemotherapy or for =< 336 hours (14 days) in the 28 days prior to initiating induction chemotherapy; prior exposure to ANY steroids that occurred > 28 days before the initiation of protocol therapy does not affect eligibility; the dose of prednisone or methylprednisolone does not affect eligibility
Intrathecal cytarabine (the CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment) system chemotherapy must begin with 72 hours of this IT therapy; or
Pretreatment with hydroxyurea; or
600 cGy of chest irradiation, if medically necessary
Pre-existing >= grade 2 sensory or motor peripheral neurotoxicity
Uncontrolled seizure disorder
Diagnosis of Down syndrome (Trisomy 21)
Patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs; a pregnancy test is required for female patients of childbearing potential
Lactating females who plan to breastfeed
Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
Patient has hypersensitivity to bortezomib, boron, or mannitol
Serious medical or psychiatric illness likely to interfere with participation in this clinical study
Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and within 30 days of any dose of bortezomib
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| Name | Affiliation | Role |
|---|---|---|
| David T Teachey | Children's Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Alabama | Birmingham | Alabama | 35233 | United States | ||
| USA Health Strada Patient Care Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38457359 | Derived | Hayashi RJ, Hermiston ML, Wood BL, Teachey DT, Devidas M, Chen Z, Annett RD, Asselin BL, August K, Cho S, Dunsmore KP, Freedman JL, Galardy PJ, Harker-Murray P, Horton TM, Jaju A, Lam A, Messinger YH, Miles RR, Okada M, Patel S, Schafer ES, Schechter T, Shimano KA, Singh N, Steele A, Sulis ML, Vargas SL, Winter SS, Wood C, Zweidler-McKay PA, Loh ML, Hunger SP, Raetz EA, Bollard CM, Allen CE. MRD at the end of induction and EFS in T-cell lymphoblastic lymphoma: Children's Oncology Group trial AALL1231. Blood. 2024 May 16;143(20):2053-2058. doi: 10.1182/blood.2023021184. | |
| 36603187 |
| Label | URL |
|---|---|
| Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A (Combination Chemotherapy): T-ALL | Patients receive combination chemotherapy without bortezomib. |
| FG001 | Arm B (Combination Chemotherapy, Bortezomib): T-ALL | Patients received combination therapy with bortezomib (4 doses at 1.3mg/m2 during Induction and 4 doses at 1.3mg/m2 during Delayed Intensification) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 29, 2019 |
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| Cyclophosphamide | Drug | Given IV |
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| Cytarabine | Drug | Given IT, IV, or SC |
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| Daunorubicin | Drug | Given IV |
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| Daunorubicin Hydrochloride | Drug | Given IV |
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| Dexamethasone | Drug | Given PO or IV |
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| Doxorubicin | Drug | Given IV |
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| Doxorubicin Hydrochloride | Drug | Given IV |
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| Etoposide | Drug | Given IV |
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| Hydrocortisone Sodium Succinate | Drug | Given IT |
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| Ifosfamide | Drug | Given IV |
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| Leucovorin Calcium | Drug | Given PO or IV |
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| Mercaptopurine | Drug | Give PO |
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| Methotrexate | Drug | Given IT, IV, or PO |
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| Pegaspargase | Drug | Given IV |
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| Radiation Therapy | Radiation | Undergo radiation therapy |
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| Thioguanine | Drug | Given PO |
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| Vincristine | Drug | Given IV |
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| Vincristine Sulfate | Drug | Given IV |
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| EFS for Standard (SR) and Intermediate Risk (IR) T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no Cranial Radiation Therapy [CRT]) and Similar Patients on AALL0434 (Received CRT) |
EFS is calculated as time from randomization at study entry to first event (induction failure, induction death, relapse, second malignancy, remission death) or date of last contact. |
| 3 years |
| Cumulative Incidence Rates of Isolated Central Nervous System (CNS) Relapse for SR and IR T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no CRT) and Similar Patients on AALL0434 (Receive CRT) | Cumulative incidence of isolated CNS relapse adjusting for competing risks using the method of: Gray R, A class of K-sample tests for comparing the cumulative incidence of a competing risk. Ann Stat 1141:1154, 1988 | 3 years |
| EFS for Very High Risk (VHR) T-ALL Patients Treated With High Risk (HR) Berlin-Frankfurt-Munster (BFM) Intensification Blocks Who Become Minimal Residual Disease (MRD) Negative and Those Who Remain MRD Positive at the End of HR Block 3 | EFS will be calculated as time from the end of the three high-risk blocks of therapy to first event (relapse, second malignancy, remission death) or date of last contact. | 3 years |
| EFS for Very High Risk (VHR) T-LLy Patients Treated With HR Berlin-Frankfurt-Munster (BFM) Intensification Blocks Who Have Complete or Partial Remission and Those Who do Not Respond | EFS for very high risk (VHR) T-LLy patients treated with HR Berlin-Frankfurt-Munster (BFM) intensification blocks who have complete or partial remission and those who do not respond | 3 years |
| Mobile |
| Alabama |
| 36604 |
| United States |
| Providence Alaska Medical Center | Anchorage | Alaska | 99508 | United States |
| Banner Children's at Desert | Mesa | Arizona | 85202 | United States |
| Phoenix Childrens Hospital | Phoenix | Arizona | 85016 | United States |
| Banner University Medical Center - Tucson | Tucson | Arizona | 85719 | United States |
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202-3591 | United States |
| Kaiser Permanente Downey Medical Center | Downey | California | 90242 | United States |
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | United States |
| Loma Linda University Medical Center | Loma Linda | California | 92354 | United States |
| Miller Children's and Women's Hospital Long Beach | Long Beach | California | 90806 | United States |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Valley Children's Hospital | Madera | California | 93636 | United States |
| UCSF Benioff Children's Hospital Oakland | Oakland | California | 94609 | United States |
| Kaiser Permanente-Oakland | Oakland | California | 94611 | United States |
| Children's Hospital of Orange County | Orange | California | 92868 | United States |
| Lucile Packard Children's Hospital Stanford University | Palo Alto | California | 94304 | United States |
| Sutter Medical Center Sacramento | Sacramento | California | 95816 | United States |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 | United States |
| Rady Children's Hospital - San Diego | San Diego | California | 92123 | United States |
| Naval Medical Center -San Diego | San Diego | California | 92134 | United States |
| UCSF Medical Center-Mission Bay | San Francisco | California | 94158 | United States |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Torrance | California | 90502 | United States |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center | Denver | Colorado | 80218 | United States |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | United States |
| Yale University | New Haven | Connecticut | 06520 | United States |
| Alfred I duPont Hospital for Children | Wilmington | Delaware | 19803 | United States |
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| Broward Health Medical Center | Fort Lauderdale | Florida | 33316 | United States |
| Golisano Children's Hospital of Southwest Florida | Fort Myers | Florida | 33908 | United States |
| UF Health Cancer Institute - Gainesville | Gainesville | Florida | 32610 | United States |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital | Hollywood | Florida | 33021 | United States |
| Nemours Children's Clinic-Jacksonville | Jacksonville | Florida | 32207 | United States |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | 33136 | United States |
| Nicklaus Children's Hospital | Miami | Florida | 33155 | United States |
| Miami Cancer Institute | Miami | Florida | 33176 | United States |
| AdventHealth Orlando | Orlando | Florida | 32803 | United States |
| Arnold Palmer Hospital for Children | Orlando | Florida | 32806 | United States |
| Nemours Children's Hospital | Orlando | Florida | 32827 | United States |
| Nemours Children's Clinic - Pensacola | Pensacola | Florida | 32504 | United States |
| Johns Hopkins All Children's Hospital | St. Petersburg | Florida | 33701 | United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Saint Joseph's Hospital/Children's Hospital-Tampa | Tampa | Florida | 33607 | United States |
| Saint Mary's Medical Center | West Palm Beach | Florida | 33407 | United States |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital | Atlanta | Georgia | 30329 | United States |
| Augusta University Medical Center | Augusta | Georgia | 30912 | United States |
| Memorial Health University Medical Center | Savannah | Georgia | 31404 | United States |
| Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | 96826 | United States |
| Saint Luke's Cancer Institute - Boise | Boise | Idaho | 83712 | United States |
| Lurie Children's Hospital-Chicago | Chicago | Illinois | 60611 | United States |
| University of Illinois | Chicago | Illinois | 60612 | United States |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Advocate Children's Hospital-Oak Lawn | Oak Lawn | Illinois | 60453 | United States |
| Advocate Children's Hospital-Park Ridge | Park Ridge | Illinois | 60068 | United States |
| OSF Children's Hospital of Illinois | Peoria | Illinois | 61637 | United States |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62702 | United States |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
| Ascension Saint Vincent Indianapolis Hospital | Indianapolis | Indiana | 46260 | United States |
| Blank Children's Hospital | Des Moines | Iowa | 50309 | United States |
| University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa | 52242 | United States |
| University of Kentucky/Markey Cancer Center | Lexington | Kentucky | 40536 | United States |
| Norton Children's Hospital | Louisville | Kentucky | 40202 | United States |
| Children's Hospital New Orleans | New Orleans | Louisiana | 70118 | United States |
| Ochsner Medical Center Jefferson | New Orleans | Louisiana | 70121 | United States |
| Eastern Maine Medical Center | Bangor | Maine | 04401 | United States |
| Maine Children's Cancer Program | Scarborough | Maine | 04074 | United States |
| University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland | 21201 | United States |
| Sinai Hospital of Baltimore | Baltimore | Maryland | 21215 | United States |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | United States |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889-5600 | United States |
| Tufts Children's Hospital | Boston | Massachusetts | 02111 | United States |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | United States |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | United States |
| UMass Memorial Medical Center - University Campus | Worcester | Massachusetts | 01655 | United States |
| C S Mott Children's Hospital | Ann Arbor | Michigan | 48109 | United States |
| Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Henry Ford Health Saint John Hospital | Detroit | Michigan | 48236 | United States |
| Michigan State University | East Lansing | Michigan | 48823 | United States |
| Hurley Medical Center | Flint | Michigan | 48503 | United States |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital | Grand Rapids | Michigan | 49503 | United States |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital | Grand Rapids | Michigan | 49503 | United States |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007 | United States |
| Corewell Health Children's | Royal Oak | Michigan | 48073 | United States |
| Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis | Minnesota | 55404 | United States |
| University of Minnesota/Masonic Cancer Center | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| University of Missouri Children's Hospital | Columbia | Missouri | 65212 | United States |
| Children's Mercy Hospitals and Clinics | Kansas City | Missouri | 64108 | United States |
| Cardinal Glennon Children's Medical Center | St Louis | Missouri | 63104 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Mercy Hospital Saint Louis | St Louis | Missouri | 63141 | United States |
| Children's Hospital and Medical Center of Omaha | Omaha | Nebraska | 68114 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| University Medical Center of Southern Nevada | Las Vegas | Nevada | 89102 | United States |
| Sunrise Hospital and Medical Center | Las Vegas | Nevada | 89109 | United States |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation | Las Vegas | Nevada | 89135 | United States |
| Summerlin Hospital Medical Center | Las Vegas | Nevada | 89144 | United States |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center | Lebanon | New Hampshire | 03756 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Morristown Medical Center | Morristown | New Jersey | 07960 | United States |
| Saint Peter's University Hospital | New Brunswick | New Jersey | 08901 | United States |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08903 | United States |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | United States |
| Saint Joseph's Regional Medical Center | Paterson | New Jersey | 07503 | United States |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87106 | United States |
| Albany Medical Center | Albany | New York | 12208 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| NYU Langone Hospital - Long Island | Mineola | New York | 11501 | United States |
| The Steven and Alexandra Cohen Children's Medical Center of New York | New Hyde Park | New York | 11040 | United States |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York | 10016 | United States |
| Mount Sinai Hospital | New York | New York | 10029 | United States |
| NYP/Weill Cornell Medical Center | New York | New York | 10065 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | United States |
| State University of New York Upstate Medical University | Syracuse | New York | 13210 | United States |
| Montefiore Medical Center - Moses Campus | The Bronx | New York | 10467 | United States |
| New York Medical College | Valhalla | New York | 10595 | United States |
| Mission Hospital | Asheville | North Carolina | 28801 | United States |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | United States |
| Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina | 28203 | United States |
| Novant Health Presbyterian Medical Center | Charlotte | North Carolina | 28204 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| East Carolina University | Greenville | North Carolina | 27834 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| Sanford Broadway Medical Center | Fargo | North Dakota | 58122 | United States |
| Children's Hospital Medical Center of Akron | Akron | Ohio | 44308 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Rainbow Babies and Childrens Hospital | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| Dayton Children's Hospital | Dayton | Ohio | 45404 | United States |
| ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital | Toledo | Ohio | 43606 | United States |
| Mercy Children's Hospital | Toledo | Ohio | 43608 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Legacy Emanuel Children's Hospital | Portland | Oregon | 97227 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Lehigh Valley Hospital-Cedar Crest | Allentown | Pennsylvania | 18103 | United States |
| Lehigh Valley Hospital - Muhlenberg | Bethlehem | Pennsylvania | 18017 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| Penn State Children's Hospital | Hershey | Pennsylvania | 17033 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Saint Christopher's Hospital for Children | Philadelphia | Pennsylvania | 19134 | United States |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Prisma Health Richland Hospital | Columbia | South Carolina | 29203 | United States |
| BI-LO Charities Children's Cancer Center | Greenville | South Carolina | 29605 | United States |
| Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | 57117-5134 | United States |
| T C Thompson Children's Hospital | Chattanooga | Tennessee | 37403 | United States |
| East Tennessee Childrens Hospital | Knoxville | Tennessee | 37916 | United States |
| The Children's Hospital at TriStar Centennial | Nashville | Tennessee | 37203 | United States |
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
| Dell Children's Medical Center of Central Texas | Austin | Texas | 78723 | United States |
| Driscoll Children's Hospital | Corpus Christi | Texas | 78411 | United States |
| Medical City Dallas Hospital | Dallas | Texas | 75230 | United States |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | United States |
| El Paso Children's Hospital | El Paso | Texas | 79905 | United States |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | United States |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center | Houston | Texas | 77030 | United States |
| UT MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Covenant Children's Hospital | Lubbock | Texas | 79410 | United States |
| UMC Cancer Center / UMC Health System | Lubbock | Texas | 79415 | United States |
| Children's Hospital of San Antonio | San Antonio | Texas | 78207 | United States |
| Methodist Children's Hospital of South Texas | San Antonio | Texas | 78229 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| Primary Children's Hospital | Salt Lake City | Utah | 84113 | United States |
| University of Vermont and State Agricultural College | Burlington | Vermont | 05405 | United States |
| University of Virginia Cancer Center | Charlottesville | Virginia | 22908 | United States |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | United States |
| Children's Hospital of The King's Daughters | Norfolk | Virginia | 23507 | United States |
| Naval Medical Center - Portsmouth | Portsmouth | Virginia | 23708-2197 | United States |
| VCU Massey Comprehensive Cancer Center | Richmond | Virginia | 23298 | United States |
| Carilion Children's | Roanoke | Virginia | 24014 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| Providence Sacred Heart Medical Center and Children's Hospital | Spokane | Washington | 99204 | United States |
| Mary Bridge Children's Hospital and Health Center | Tacoma | Washington | 98405 | United States |
| Madigan Army Medical Center | Tacoma | Washington | 98431 | United States |
| West Virginia University Charleston Division | Charleston | West Virginia | 25304 | United States |
| West Virginia University Healthcare | Morgantown | West Virginia | 26506 | United States |
| Saint Vincent Hospital Cancer Center Green Bay | Green Bay | Wisconsin | 54301 | United States |
| University of Wisconsin Carbone Cancer Center - University Hospital | Madison | Wisconsin | 53792 | United States |
| Marshfield Medical Center-Marshfield | Marshfield | Wisconsin | 54449 | United States |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| John Hunter Children's Hospital | Hunter Regional Mail Centre | New South Wales | 2310 | Australia |
| The Children's Hospital at Westmead | Westmead | New South Wales | 2145 | Australia |
| Queensland Children's Hospital | South Brisbane | Queensland | 4101 | Australia |
| Women's and Children's Hospital-Adelaide | North Adelaide | South Australia | 5006 | Australia |
| Monash Medical Center-Clayton Campus | Clayton | Victoria | 3168 | Australia |
| Royal Children's Hospital | Parkville | Victoria | 3052 | Australia |
| Princess Margaret Hospital for Children | Perth | Western Australia | 6008 | Australia |
| Perth Children's Hospital | Perth | Western Australia | 6009 | Australia |
| Alberta Children's Hospital | Calgary | Alberta | T3B 6A8 | Canada |
| University of Alberta Hospital | Edmonton | Alberta | T6G 2B7 | Canada |
| British Columbia Children's Hospital | Vancouver | British Columbia | V6H 3V4 | Canada |
| CancerCare Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada |
| Janeway Child Health Centre | St. John's | Newfoundland and Labrador | A1B 3V6 | Canada |
| IWK Health Centre | Halifax | Nova Scotia | B3K 6R8 | Canada |
| McMaster Children's Hospital at Hamilton Health Sciences | Hamilton | Ontario | L8N 3Z5 | Canada |
| Kingston Health Sciences Centre | Kingston | Ontario | K7L 2V7 | Canada |
| Children's Hospital | London | Ontario | N6A 5W9 | Canada |
| Children's Hospital of Eastern Ontario | Ottawa | Ontario | K1H 8L1 | Canada |
| Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| The Montreal Children's Hospital of the MUHC | Montreal | Quebec | H3H 1P3 | Canada |
| Centre Hospitalier Universitaire Sainte-Justine | Montreal | Quebec | H3T 1C5 | Canada |
| Saskatoon Cancer Centre | Saskatoon | Saskatchewan | S7N 4H4 | Canada |
| Starship Children's Hospital | Grafton | Auckland | 1145 | New Zealand |
| Christchurch Hospital | Christchurch | 8011 | New Zealand |
| Derived |
| Gossai NP, Devidas M, Chen Z, Wood BL, Zweidler-McKay PA, Rabin KR, Loh ML, Raetz EA, Winick NJ, Burke MJ, Carroll AJ, Esiashvili N, Heerema NA, Carroll WL, Hunger SP, Dunsmore KP, Winter SS, Teachey DT. Central nervous system status is prognostic in T-cell acute lymphoblastic leukemia: a Children's Oncology Group report. Blood. 2023 Apr 13;141(15):1802-1811. doi: 10.1182/blood.2022018653. |
| 35271306 | Derived | Teachey DT, Devidas M, Wood BL, Chen Z, Hayashi RJ, Hermiston ML, Annett RD, Archer JH, Asselin BL, August KJ, Cho SY, Dunsmore KP, Fisher BT, Freedman JL, Galardy PJ, Harker-Murray P, Horton TM, Jaju AI, Lam A, Messinger YH, Miles RR, Okada M, Patel SI, Schafer ES, Schechter T, Singh N, Steele AC, Sulis ML, Vargas SL, Winter SS, Wood C, Zweidler-McKay P, Bollard CM, Loh ML, Hunger SP, Raetz EA. Children's Oncology Group Trial AALL1231: A Phase III Clinical Trial Testing Bortezomib in Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia and Lymphoma. J Clin Oncol. 2022 Jul 1;40(19):2106-2118. doi: 10.1200/JCO.21.02678. Epub 2022 Mar 10. |
| FG002 | Arm A (Combination Chemotherapy): T-LLy | Patients receive combination chemotherapy without bortezomib. |
| FG003 | Arm B (Combination Chemotherapy, Bortezomib): T-LLy | Patients received combination therapy with bortezomib (4 doses at 1.3mg/m2 during Induction and 4 doses at 1.3mg/m2 during Delayed Intensification) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm A (Combination Chemotherapy): T-ALL | Patients receive combination chemotherapy without bortezomib. |
| BG001 | Arm B (Combination Chemotherapy, Bortezomib): T-ALL | Patients received combination therapy with bortezomib (4 doses at 1.3mg/m2 during Induction and 4 doses at 1.3mg/m2 during Delayed Intensification) |
| BG002 | Arm A (Combination Chemotherapy): T-LLy | Patients receive combination chemotherapy without bortezomib. |
| BG003 | Arm B (Combination Chemotherapy, Bortezomib): T-LLy | Patients received combination therapy with bortezomib (4 doses at 1.3mg/m2 during Induction and 4 doses at 1.3mg/m2 during Delayed Intensification) |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Event-free Survival (EFS) for Modified Augmented Berlin-Frankfurt-Munster Backbone With or Without Bortezomib in All Randomized Patients | EFS is calculated as time from randomization at study entry to first event (induction failure, induction death, relapse, second malignancy, remission death) or date of last contact. Three-year EFS rates will be calculated for both groups. | As pre-specified in the protocol, this analysis includes all eligible patients (T-ALL+T-LLy) enrolled on the study. Arms were combined for this analysis as pre-specified in the protocol. | Posted | Number | 95% Confidence Interval | Percentage of participants | 3 years |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Toxicity Rates Associated With Modified Standard Therapy, Including Dexamethasone and Additional Pegaspargase | Percentage of patients who experienced Grade 3 or higher Toxicity Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | As pre-specified in the protocol, this analysis includes all eligible patients (T-ALL+T-LLy) enrolled on the study. | Posted | Number | 95% Confidence Interval | Percentage of participants | 3 years from start of therapy by patient |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | EFS for Standard (SR) and Intermediate Risk (IR) T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no Cranial Radiation Therapy [CRT]) and Similar Patients on AALL0434 (Received CRT) | EFS is calculated as time from randomization at study entry to first event (induction failure, induction death, relapse, second malignancy, remission death) or date of last contact. | T-ALL patients on AALL1231 who did not receive CRT or bortezomib: IR (exclude CNS3) and SR T-ALL (exclude those who met AALL0434 [NCT00408005] Low Risk definition). T-ALL on AALL0434 [NCT00408005] (who received CRT, no nelarabine) excluding Low Risk, CNS3, M3 Day 29, and EOC MRD >0.1% | Posted | Number | 95% Confidence Interval | Percentage of participants | 3 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cumulative Incidence Rates of Isolated Central Nervous System (CNS) Relapse for SR and IR T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no CRT) and Similar Patients on AALL0434 (Receive CRT) | Cumulative incidence of isolated CNS relapse adjusting for competing risks using the method of: Gray R, A class of K-sample tests for comparing the cumulative incidence of a competing risk. Ann Stat 1141:1154, 1988 | T-ALL patients on AALL1231 who did not receive CRT or bortezomib: IR (exclude CNS3) and SR T-ALL (exclude those who met AALL0434 [NCT00408005] Low Risk definition). T-ALL on AALL0434 [NCT00408005](who received CRT, no nelarabine) excluding Low Risk, CNS3, M3 Day 29, and EOC MRD >0.1% | Posted | Number | 95% Confidence Interval | Percentage of participants | 3 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | EFS for Very High Risk (VHR) T-ALL Patients Treated With High Risk (HR) Berlin-Frankfurt-Munster (BFM) Intensification Blocks Who Become Minimal Residual Disease (MRD) Negative and Those Who Remain MRD Positive at the End of HR Block 3 | EFS will be calculated as time from the end of the three high-risk blocks of therapy to first event (relapse, second malignancy, remission death) or date of last contact. | VHR T-ALL patients who had EOC MRD >= 0.1%, completed the three high-risk blocks of therapy, and had MRD assessment done after the three high-risk blocks. MRD was not performed in T-LLy patients at end of the VHR blocks. MRD is not used in T-LLy to measure disease response. This outcome measure was pre-specified to only be assessed in the T-ALL patients. | Posted | Number | 95% Confidence Interval | Percentage of participants | 3 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | EFS for Very High Risk (VHR) T-LLy Patients Treated With HR Berlin-Frankfurt-Munster (BFM) Intensification Blocks Who Have Complete or Partial Remission and Those Who do Not Respond | EFS for very high risk (VHR) T-LLy patients treated with HR Berlin-Frankfurt-Munster (BFM) intensification blocks who have complete or partial remission and those who do not respond | VHR T-LL patients who completed the three high-risk blocks of therapy. The T-LLy VHR patients are included in the table, but there were not enough patients to do any formal analysis, eg there was only one patient (n=1) on the study with T-LLy who had radiographic disease assessment after the intensification blocks. | Posted | Number | 95% Confidence Interval | Percentage of participants | 3 years |
|
|
3 years from start of therapy by patient
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A (Combination Chemotherapy): T-ALL | Patients receive combination chemotherapy without bortezomib. | 38 | 308 | 56 | 308 | 231 | 308 |
| EG001 | Arm B (Combination Chemotherapy, Bortezomib): T-ALL | Patients received combination therapy with bortezomib (4 doses at 1.3mg/m2 during Induction and 4 doses at 1.3mg/m2 during Delayed Intensification) | 38 | 307 | 153 | 307 | 217 | 307 |
| EG002 | Arm A (Combination Chemotherapy): T-LLy | Patients receive combination chemotherapy without bortezomib. | 23 | 108 | 25 | 108 | 86 | 108 |
| EG003 | Arm B (Combination Chemotherapy, Bortezomib): T-LLy | Patients received combination therapy with bortezomib (4 doses at 1.3mg/m2 during Induction and 4 doses at 1.3mg/m2 during Delayed Intensification) | 9 | 101 | 60 | 101 | 74 | 101 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCv4 | Systematic Assessment |
| |
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | CTCv4 | Systematic Assessment |
| |
| Bone marrow hypocellular | Blood and lymphatic system disorders | CTCv4 | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | CTCv4 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCv4 | Systematic Assessment |
| |
| Hemolysis | Blood and lymphatic system disorders | CTCv4 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | CTCv4 | Systematic Assessment |
| |
| Heart failure | Cardiac disorders | CTCv4 | Systematic Assessment |
| |
| Left ventricular systolic dysfunction | Cardiac disorders | CTCv4 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | CTCv4 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | CTCv4 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCv4 | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | CTCv4 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | CTCv4 | Systematic Assessment |
| |
| Endocrine disorders - Other, specify | Endocrine disorders | CTCv4 | Systematic Assessment |
| |
| Eye disorders - Other, specify | Eye disorders | CTCv4 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Anal ulcer | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Colonic perforation | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Duodenal perforation | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Esophageal hemorrhage | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Gastric hemorrhage | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Pancreatic hemorrhage | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Rectal mucositis | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Rectal pain | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Rectal ulcer | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Small intestinal mucositis | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Typhlitis | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Death NOS | General disorders | CTCv4 | Systematic Assessment |
| |
| Edema face | General disorders | CTCv4 | Systematic Assessment |
| |
| Edema limbs | General disorders | CTCv4 | Systematic Assessment |
| |
| Fatigue | General disorders | CTCv4 | Systematic Assessment |
| |
| Fever | General disorders | CTCv4 | Systematic Assessment |
| |
| General disorders and administration site conditions - Other, specify | General disorders | CTCv4 | Systematic Assessment |
| |
| Hypothermia | General disorders | CTCv4 | Systematic Assessment |
| |
| Infusion related reaction | General disorders | CTCv4 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | CTCv4 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | CTCv4 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | CTCv4 | Systematic Assessment |
| |
| Hepatobiliary disorders - Other, specify | Hepatobiliary disorders | CTCv4 | Systematic Assessment |
| |
| Portal hypertension | Hepatobiliary disorders | CTCv4 | Systematic Assessment |
| |
| Allergic reaction | Immune system disorders | CTCv4 | Systematic Assessment |
| |
| Anaphylaxis | Immune system disorders | CTCv4 | Systematic Assessment |
| |
| Autoimmune disorder | Immune system disorders | CTCv4 | Systematic Assessment |
| |
| Anorectal infection | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Bone infection | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Bronchial infection | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Catheter related infection | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Eye infection | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Hepatic infection | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Hepatitis viral | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Infections and infestations - Other, specify | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Meningitis | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Mucosal infection | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Papulopustular rash | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Splenic infection | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | CTCv4 | Systematic Assessment |
| |
| Injury, poisoning and procedural complications - Other, specify | Injury, poisoning and procedural complications | CTCv4 | Systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | CTCv4 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | CTCv4 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | CTCv4 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCv4 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCv4 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCv4 | Systematic Assessment |
| |
| CPK increased | Investigations | CTCv4 | Systematic Assessment |
| |
| Cholesterol high | Investigations | CTCv4 | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCv4 | Systematic Assessment |
| |
| Electrocardiogram QT corrected interval prolonged | Investigations | CTCv4 | Systematic Assessment |
| |
| Fibrinogen decreased | Investigations | CTCv4 | Systematic Assessment |
| |
| GGT increased | Investigations | CTCv4 | Systematic Assessment |
| |
| INR increased | Investigations | CTCv4 | Systematic Assessment |
| |
| Investigations - Other, specify | Investigations | CTCv4 | Systematic Assessment |
| |
| Lipase increased | Investigations | CTCv4 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCv4 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCv4 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCv4 | Systematic Assessment |
| |
| Serum amylase increased | Investigations | CTCv4 | Systematic Assessment |
| |
| Urine output decreased | Investigations | CTCv4 | Systematic Assessment |
| |
| Weight gain | Investigations | CTCv4 | Systematic Assessment |
| |
| Weight loss | Investigations | CTCv4 | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCv4 | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | CTCv4 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCv4 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCv4 | Systematic Assessment |
| |
| Glucose intolerance | Metabolism and nutrition disorders | CTCv4 | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCv4 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCv4 | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCv4 | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCv4 | Systematic Assessment |
| |
| Hypertriglyceridemia | Metabolism and nutrition disorders | CTCv4 | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCv4 | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCv4 | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCv4 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCv4 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCv4 | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCv4 | Systematic Assessment |
| |
| Metabolism and nutrition disorders - Other, specify | Metabolism and nutrition disorders | CTCv4 | Systematic Assessment |
| |
| Tumor lysis syndrome | Metabolism and nutrition disorders | CTCv4 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | CTCv4 | Systematic Assessment |
| |
| Avascular necrosis | Musculoskeletal and connective tissue disorders | CTCv4 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCv4 | Systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCv4 | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCv4 | Systematic Assessment |
| |
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCv4 | Systematic Assessment |
| |
| Muscle weakness upper limb | Musculoskeletal and connective tissue disorders | CTCv4 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCv4 | Systematic Assessment |
| |
| Leukemia secondary to oncology chemotherapy | Musculoskeletal and connective tissue disorders | CTCv4 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Musculoskeletal and connective tissue disorders | CTCv4 | Systematic Assessment |
| |
| Treatment related secondary malignancy | Musculoskeletal and connective tissue disorders | CTCv4 | Systematic Assessment |
| |
| Aphonia | Nervous system disorders | CTCv4 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | CTCv4 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCv4 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | CTCv4 | Systematic Assessment |
| |
| Dysphasia | Nervous system disorders | CTCv4 | Systematic Assessment |
| |
| Edema cerebral | Nervous system disorders | CTCv4 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | CTCv4 | Systematic Assessment |
| |
| Facial nerve disorder | Nervous system disorders | CTCv4 | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCv4 | Systematic Assessment |
| |
| Intracranial hemorrhage | Nervous system disorders | CTCv4 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | CTCv4 | Systematic Assessment |
| |
| Leukoencephalopathy | Nervous system disorders | CTCv4 | Systematic Assessment |
| |
| Movements involuntary | Nervous system disorders | CTCv4 | Systematic Assessment |
| |
| Nervous system disorders - Other, specify | Nervous system disorders | CTCv4 | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCv4 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTCv4 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCv4 | Systematic Assessment |
| |
| Reversible posterior leukoencephalopathy syndrome | Nervous system disorders | CTCv4 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCv4 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | CTCv4 | Systematic Assessment |
| |
| Stroke | Nervous system disorders | CTCv4 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCv4 | Systematic Assessment |
| |
| Transient ischemic attacks | Nervous system disorders | CTCv4 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCv4 | Systematic Assessment |
| |
| Vasovagal reaction | Nervous system disorders | CTCv4 | Systematic Assessment |
| |
| Pregnancy, puerperium and perinatal conditions - Other, specify | Pregnancy, puerperium and perinatal conditions | CTCv4 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | CTCv4 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCv4 | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCv4 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | CTCv4 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCv4 | Systematic Assessment |
| |
| Psychiatric disorders - Other, specify | Psychiatric disorders | CTCv4 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | CTCv4 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | CTCv4 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | CTCv4 | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCv4 | Systematic Assessment |
| |
| Renal and urinary disorders - Other, specify | Renal and urinary disorders | CTCv4 | Systematic Assessment |
| |
| Renal calculi | Renal and urinary disorders | CTCv4 | Systematic Assessment |
| |
| Genital edema | Reproductive system and breast disorders | CTCv4 | Systematic Assessment |
| |
| Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | CTCv4 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCv4 | Systematic Assessment |
| |
| Bronchopulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCv4 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCv4 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCv4 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCv4 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCv4 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCv4 | Systematic Assessment |
| |
| Pharyngeal mucositis | Respiratory, thoracic and mediastinal disorders | CTCv4 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCv4 | Systematic Assessment |
| |
| Pleural hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCv4 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | CTCv4 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCv4 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCv4 | Systematic Assessment |
| |
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | CTCv4 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCv4 | Systematic Assessment |
| |
| Pruritus | Respiratory, thoracic and mediastinal disorders | CTCv4 | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | CTCv4 | Systematic Assessment |
| |
| Skin ulceration | Skin and subcutaneous tissue disorders | CTCv4 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | CTCv4 | Systematic Assessment |
| |
| Surgical and medical procedures - Other, specify | Surgical and medical procedures | CTCv4 | Systematic Assessment |
| |
| Capillary leak syndrome | Vascular disorders | CTCv4 | Systematic Assessment |
| |
| Hematoma | Vascular disorders | CTCv4 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCv4 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCv4 | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCv4 | Systematic Assessment |
| |
| Vascular disorders - Other, specify | Vascular disorders | CTCv4 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCv4 | Systematic Assessment |
| |
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | CTCv4 | Systematic Assessment |
| |
| Bone marrow hypocellular | Blood and lymphatic system disorders | CTCv4 | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | CTCv4 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCv4 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | CTCv4 | Systematic Assessment |
| |
| Left ventricular systolic dysfunction | Cardiac disorders | CTCv4 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | CTCv4 | Systematic Assessment |
| |
| Pericardial tamponade | Cardiac disorders | CTCv4 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | CTCv4 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCv4 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | CTCv4 | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | CTCv4 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | CTCv4 | Systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCv4 | Systematic Assessment |
| |
| Optic nerve disorder | Eye disorders | CTCv4 | Systematic Assessment |
| |
| Photophobia | Eye disorders | CTCv4 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Anal mucositis | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Anal pain | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Colonic perforation | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Gastric hemorrhage | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Rectal mucositis | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Rectal pain | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Retroperitoneal hemorrhage | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Small intestinal mucositis | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Typhlitis | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCv4 | Systematic Assessment |
| |
| Death NOS | General disorders | CTCv4 | Systematic Assessment |
| |
| Edema face | General disorders | CTCv4 | Systematic Assessment |
| |
| Edema limbs | General disorders | CTCv4 | Systematic Assessment |
| |
| Facial pain | General disorders | CTCv4 | Systematic Assessment |
| |
| Fever | General disorders | CTCv4 | Systematic Assessment |
| |
| Flu like symptoms | General disorders | CTCv4 | Systematic Assessment |
| |
| General disorders and administration site conditions - Other, specify | General disorders | CTCv4 | Systematic Assessment |
| |
| Hypothermia | General disorders | CTCv4 | Systematic Assessment |
| |
| Infusion related reaction | General disorders | CTCv4 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | CTCv4 | Systematic Assessment |
| |
| Pain | General disorders | CTCv4 | Systematic Assessment |
| |
| Sudden death NOS | General disorders | CTCv4 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | CTCv4 | Systematic Assessment |
| |
| Gallbladder pain | Hepatobiliary disorders | CTCv4 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | CTCv4 | Systematic Assessment |
| |
| Portal vein thrombosis | Hepatobiliary disorders | CTCv4 | Systematic Assessment |
| |
| Allergic reaction | Immune system disorders | CTCv4 | Systematic Assessment |
| |
| Anaphylaxis | Immune system disorders | CTCv4 | Systematic Assessment |
| |
| Immune system disorders - Other, specify | Immune system disorders | CTCv4 | Systematic Assessment |
| |
| Anorectal infection | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Bladder infection | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Bone infection | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Catheter related infection | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Endocarditis infective | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Infections and infestations - Other, specify | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Infective myositis | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Meningitis | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Mucosal infection | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Periorbital infection | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Small intestine infection | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | CTCv4 | Systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | CTCv4 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | CTCv4 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCv4 | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCv4 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCv4 | Systematic Assessment |
| |
| Blood antidiuretic hormone abnormal | Investigations | CTCv4 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCv4 | Systematic Assessment |
| |
| Cholesterol high | Investigations | CTCv4 | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCv4 | Systematic Assessment |
| |
| Fibrinogen decreased | Investigations | CTCv4 | Systematic Assessment |
| |
| GGT increased | Investigations | CTCv4 | Systematic Assessment |
| |
| Investigations - Other, specify | Investigations | CTCv4 | Systematic Assessment |
| |
| Lipase increased | Investigations | CTCv4 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCv4 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCv4 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCv4 | Systematic Assessment |
| |
| Serum amylase increased | Investigations | CTCv4 | Systematic Assessment |
| |
| Urine output decreased | Investigations | CTCv4 | Systematic Assessment |
| |
| Weight gain | Investigations | CTCv4 | Systematic Assessment |
| |
| Weight loss | Investigations | CTCv4 | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCv4 | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | CTCv4 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCv4 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCv4 | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCv4 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCv4 | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCv4 | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCv4 | Systematic Assessment |
| |
| Hypertriglyceridemia | Metabolism and nutrition disorders | CTCv4 | Systematic Assessment |
| |
| Hyperuricemia | Metabolism and nutrition disorders | CTCv4 | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCv4 | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCv4 | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCv4 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCv4 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCv4 | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCv4 | Systematic Assessment |
| |
| Metabolism and nutrition disorders - Other, specify | Metabolism and nutrition disorders | CTCv4 | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | CTCv4 | Systematic Assessment |
| |
| Tumor lysis syndrome | Metabolism and nutrition disorders | CTCv4 | Systematic Assessment |
| |
| Avascular necrosis | Musculoskeletal and connective tissue disorders | CTCv4 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCv4 | Systematic Assessment |
| |
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCv4 | Systematic Assessment |
| |
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | CTCv4 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCv4 | Systematic Assessment |
| |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCv4 | Systematic Assessment |
| |
| Cerebrospinal fluid leakage | Nervous system disorders | CTCv4 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | CTCv4 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | CTCv4 | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCv4 | Systematic Assessment |
| |
| Intracranial hemorrhage | Nervous system disorders | CTCv4 | Systematic Assessment |
| |
| Leukoencephalopathy | Nervous system disorders | CTCv4 | Systematic Assessment |
| |
| Nervous system disorders - Other, specify | Nervous system disorders | CTCv4 | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCv4 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTCv4 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCv4 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | CTCv4 | Systematic Assessment |
| |
| Reversible posterior leukoencephalopathy syndrome | Nervous system disorders | CTCv4 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCv4 | Systematic Assessment |
| |
| Stroke | Nervous system disorders | CTCv4 | Systematic Assessment |
| |
| Transient ischemic attacks | Nervous system disorders | CTCv4 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCv4 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | CTCv4 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | CTCv4 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCv4 | Systematic Assessment |
| |
| Psychosis | Psychiatric disorders | CTCv4 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | CTCv4 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | CTCv4 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | CTCv4 | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCv4 | Systematic Assessment |
| |
| Renal calculi | Renal and urinary disorders | CTCv4 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCv4 | Systematic Assessment |
| |
| Bronchopulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCv4 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCv4 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCv4 | Systematic Assessment |
| |
| Laryngeal mucositis | Respiratory, thoracic and mediastinal disorders | CTCv4 | Systematic Assessment |
| |
| Laryngospasm | Respiratory, thoracic and mediastinal disorders | CTCv4 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCv4 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | CTCv4 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCv4 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCv4 | Systematic Assessment |
| |
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | CTCv4 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCv4 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCv4 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCv4 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCv4 | Systematic Assessment |
| |
| Superficial thrombophlebitis | Vascular disorders | CTCv4 | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCv4 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Results Reporting Coordinator | Children's Oncology Group | 16264470064 | resultsreportingcoordinator@childrensoncologygroup.org |
| Jun 17, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| D003520 | Cyclophosphamide |
| D003561 | Cytarabine |
| D003630 | Daunorubicin |
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| C059464 | auricularum |
| C018038 | dexamethasone acetate |
| C004180 | dexamethasone 21-phosphate |
| D004317 | Doxorubicin |
| D005047 | Etoposide |
| D006854 | Hydrocortisone |
| C007133 | hydrocortisone hemisuccinate |
| D007069 | Ifosfamide |
| D002955 | Leucovorin |
| D015122 | Mercaptopurine |
| C488629 | azathiopurine |
| D008727 | Methotrexate |
| C015342 | merphos |
| C042705 | pegaspargase |
| D011878 | Radiotherapy |
| D011827 | Radiation |
| D013866 | Thioguanine |
| D014750 | Vincristine |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |
| D010078 | Oxazines |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D013438 | Sulfhydryl Compounds |
| D011687 | Purines |
| D000630 | Aminopterin |
| D013812 | Therapeutics |
| D055585 | Physical Phenomena |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D054836 | Indolizidines |
| D007212 | Indolizines |
Not provided
Not provided
| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Canada |
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| Australia |
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| New Zealand |
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