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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
| Massachusetts General Hospital | OTHER |
| Queen Elizabeth II Health Sciences Centre | OTHER |
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The purpose of this study is to determine the safety and optimal dosing of L-asparaginase in adult patients with acute lymphoblastic leukemia (ALL) between the ages of 18 and 50 years.
This study has four treatment phases: 1) induction, 2) central nervous system therapy, 3) intensification, and 4) continuation.
The induction phase lasts one month and eight drugs are used during this phase of treatment. The drugs are administered as follows:
A bone marrow aspirate and biopsy will be obtained on day 15 and day 29 of induction therapy. If on day 29, the patients' bone marrow and peripheral blood counts are not in complete remission, then the patient may receive vincristine on days 29, 36 and 43. Bone marrow biopsy will be repeated weekly until complete remission is documented. If the patient does not achieve complete remission by day 49, they will be removed from the study.
Central nervous system (CNS) therapy begins immediately after the end of the induction therapy. This phase of treatment should last 3 weeks. Treatment includes a series of spinal taps with the instillation of anti-leukemia drugs. Four spinal taps will be performed over a two week period. Anti-leukemia drugs will also be given orally. The drugs given are as follows: Vincristine; on day 1: Doxorubicin; on day 1: 6-mercaptopurine (6-MP); on days 1-14: Intra-thecal Methotrexate/Cytarabine; 4 times over 2 weeks.
Radiation therapy (RT) will be delivered in 10 daily treatments during the CNS phase of therapy.
The intensification phase begins as soon as the CNS phase ends and lasts approximately 30 weeks. It consists of cycles of chemotherapy repeated every 3 weeks, along with asparaginase administered weekly. The drugs given are as follows: Vincristine; day 1: Dexamethasone; days 1-5: 6-MP; days 1-14: Doxorubicin; day 1: Asparaginase; weekly: Methotrexate; weekly: Intra-thecal Hydrocortisone/Methotrexate/cytarabine; every 18 weeks.
The continuation phase of treatment begins after the intensification phase. It consists of cycles of chemotherapy repeated every three weeks and will last until the patient is in remission for two years. The drugs given are: Vincristine; day 1 : Prednisone or Dexamethasone; days 1-5: 6-MP; days 1-14: Methotrexate; weekly: Intra-thecal Methotrexate/Cytarabine/Hydrocortisone: every 18 weeks.
During this study, blood tests will be performed at the start of therapy, at day 29 post induction and at the time of each intra-thecal therapy (every 18 weeks).
Bone marrow biopsy/aspirate will be done days 15 and 29 of induction, then every 6 months until completion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Only Arm for this study | Other | Only Arm for this study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prednisone | Drug | Induction Phase: Given orally on days 1-28 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Asparaginase Completion Rate | Feasibility based on the rate of asparaginase completion defined as the percentage of patients who, after having achieved a complete remission after induction therapy, complete all 30 doses of asparaginase as part of intensification therapy. Complete remission is defined as peripheral blood without lymphoblasts, a bone marrow with <5% lymphoblasts, an antigen-presenting cell (APC) > 1000/mm3, platelets > 100,000/mm3, and no evidence of extramedullary leukemia. | Assessed at the end of the 30-week post-induction treatment period or when the participant comes off treatment, whichever occurs first. |
| Measure | Description | Time Frame |
|---|---|---|
| 4-year Disease-Free Survival | Disease-Free Survival (DFS) based on the Kaplan-Meier method is defined as the time from achieving a complete remission to the first of disease recurrence or death, censored at time of last disease assessment. 4-year DFS is the percent probability of patients remaining alive, relapse-free and without occurrence of second malignant neoplasm 4 years from complete remission. Disease relapse is defined as >25% lymphoblasts identified morphologically in bone marrow aspirate/biopsy, or identification of lymphoblasts in marrow (any percentage) identified to be leukemic by flow cytometry, cytogenetics, fluorescent in situ hybridization (FISH), immunohistochemistry, or other tests. Appearance of leukemic cells at any extramedullary site (a single, unequivocal lymphoblast in the cerebrospinal fluid (CSF) may qualify as CNS leukemia) also qualifies if confirmed by the PI. |
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Inclusion Criteria:
Patients must have pathologically documented acute lymphoblastic leukemia, excluding mature B-cell ALL.
No prior therapy for leukemia with the following exceptions:
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
Between the ages of 18 to 50 years.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel J. DeAngelo, MD, PhD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States | ||
| Massachusetts General Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Induction, CNS, and Intensification With Pharmacokinetically Individualized Doses of L-asparaginase | prednisone: Induction Phase: Orally days 1-28 doxorubicin: Induction Phase: Intravenously days 1 and 2 CNS Therapy: Intravenously day 1 Intensification: Given day 1 of each cycle vincristine: Induction: Intravenously days 1, 8, 15, and 22. If complete remission not achieved, will be given on days 29, 36 and 43. CNS Therapy: Intravenously day 1. Intensification: Intravenously day 1 of each cycle. Continuation: Intravenously day 1 of each cycle methotrexate: Induction: Intravenously day 3. CNS Therapy: Intrathecally 4x over two weeks Intensification: Intrathecally every 18 weeks Continuation: Intravenously weekly and intrathecally every 18 weeks asparaginase: Induction: Given into the muscle on day 5 dexamethasone: Intensification: Orally days 1-5 of each cycle cranial radiation: 10 daily treatments during CNS phase leucovorin: Induction: Intravenously/orally 36 hours after methotrexate cytarabine: Induction: Intrathecally days 1, 15, 29 CNS Therapy: Intrathecally 4x over 2 weeks Intensification: Intrathecally every 18 weeks Continuation: Intrathecally every 18 weeks hydrocortisone: Induction: Intrathecally days 15 and 29. Intensification: Intrathecally every 18 weeks. Continuation: Intrathecally every 18 weeks. 6-mercaptopurine (6-MP): CNS Therapy: Orally days 1-14. Intensification: Orally on days 1-14. Continuation: Orally on days 1-14. e. coli L-asparaginase: Intensification: Given in to the muscle weekly. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| doxorubicin |
| Drug |
Induction Phase: Given intravenously on day 1 and day 2 CNS Therapy: Given intravenously on day 1 Intensification: Given day 1 of each cycle |
|
| vincristine | Drug | Induction: Given intravenously on days 1, 8, 15, and 22. If complete remission not achieved, will be given on days 29, 36 and 43. CNS Therapy: Given intravenously on day 1. Intensification: Given intravenously on day 1 of each cycle. Continuation: Given intravenously on day 1 of each cycle |
|
| methotrexate | Drug | Induction: Given intravenously on day 3. CNS Therapy: Given intrathecally 4 times over two weeks Intensification: Given intrathecally every 18 weeks Continuation: Given intravenously weekly and intrathecally every 18 weeks |
|
| asparaginase | Drug | Induction: Given into the muscle on day 5 |
|
| dexamethasone | Drug | Intensification: Given orally on days 1-5 of each cycle |
|
| cranial radiation | Radiation | Given in 10 daily treatments during CNS therapy phase |
|
| leucovorin | Drug | Induction: Given intravenously or orally 36 hours after methotrexate |
|
| cytarabine | Drug | Induction: Given intrathecally days 1, 15, 29 CNS Therapy: Given intrathecally 4 times over 2 weeks Intensification: Given intrathecally every 18 weeks Continuation: Given intrathecally every 18 weeks |
|
|
| hydrocortisone | Drug | Induction: Given intrathecally on days 15 and 29. Intensification: Given intrathecally every 18 weeks. Continuation: Given intrathecally every 18 weeks. |
|
| 6-mercaptopurine (6-MP) | Drug | CNS Therapy: Taken orally on days 1-14. Intensification: Taken orally on days 1-14. Continuation: Taken orally on days 1-14. |
|
| e. coli L-asparaginase | Drug | Intensification: Given in to the muscle weekly. |
|
| Assessed continuously throughout the treatment period, and annually for 5 years following the completion of protocol treatment, (up to 5 years). Relevant for this measure is 4 years from the date of complete remission. |
| 4-year Overall Survival | Overall Survival (OS) based on the Kaplan-Meier method is defined as the time from study entry to death from any cause, and will be censored the date last known alive. 4-year OS is the percent probability of patients remaining alive 4 years from study entry. | Assessed continuously throughout the treatment period, and annually for 5 years following the completion of protocol treatment (unless the participant dies or is lost to follow-up). Median follow-up for the whole trial is 4.5 years (95% CI:4.1-5.0 years). |
| 4-year Event-Free Survival | Event-Free Survival (EFS) based on the Kaplan-Meier method is defined as the time from study entry to the first event of death during induction therapy, failure to achieve CR at the end of induction, death during remission, or relapse. 4-year EFS is the percent probability of patients remaining alive, relapse-free and without occurrence of second malignant neoplasm 4 years from study entry. Patients not achieving a CR will be considered events at time zero. EFS will be censored at time of last disease assessment. Disease relapse is defined as >25% lymphoblasts identified morphologically in bone marrow aspirate/biopsy, or identification of lymphoblasts in marrow (any percentage) identified to be leukemic by flow cytometry, cytogenetics, FISH, immunohistochemistry, or other tests. Appearance of leukemic cells at any extramedullary site (a single, unequivocal lymphoblast in the CSF may qualify as CNS leukemia) also qualifies if confirmed by the PI. | Assessed continuously throughout the treatment period, and annually for 5 years following the completion of protocol treatment (unless the participant dies or is lost to follow-up). Median follow-up for the whole trial is 4.5 years (95% CI:4.1-5.0 years). |
| Post-Induction Nadir Serum Asparaginase Activity Level | Nadir serum asparaginase activity (NSAA) levels were estimated based on established methods. | Samples for nadir serum asparaginase activity levels were assayed prior to asparaginase dose given during post-induction, at Weeks 2, 4, 7, 10, 13, 16, 19, 22, 25, 28, and 30. |
| Number of Participants With Asparaginase-Related Toxicity | Asparaginase-related toxicity rate is defined as the percentage of patients who experience allergy (all grades), pancreatitis, thrombotic or bleeding complications, bone fracture, or avascular necrosis based on Common Terminology Criteria for Adverse Events (CTCAE) v2. | Assessed on an ongoing basis (at least once every 3 months) while patient is on study, and including the treatment phases of Induction, CNS, Intensification, and Continuation. Treatment duration for this study was a median (range) of 507 days (0-1097). |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| University Of Columbia Medical Center | New York | New York | United States |
| Manitoba Blood & Marrow Transplant Program CancerCare Manitoba | Winnipeg | Manitoba | Canada |
| McMaster University Medical Center | Hamilton | Ontario | Canada |
| Queen's University | Kingston | Ontario | Canada |
| London Health Sciences Centre | London | Ontario | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada |
| Hospital Maisonneuve-Rosemont | Montreal | Quebec | Canada |
| Royal Victoria Hospital | Montreal | Quebec | Canada |
| Saskatoon Cancer Centre | Saskatoon | Saskatchewan | Canada |
| Queen Elizabeth II | Halifax | Canada |
| Started Study Treatment | 2 patients were removed from study prior to receiving any chemotherapy, as they were found to have bilineage leukemia. |
|
| Eligible and Treated |
|
| Achieved Complete Remission |
|
| Initiated Asparaginase Consolidation Therapy |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The analysis dataset is comprised of all enrolled patients.
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| ID | Title | Description |
|---|---|---|
| BG000 | Induction, CNS, and Intensification With Pharmacokinetically Individualized Doses of L-asparaginase | prednisone: Induction Phase: Orally days 1-28 doxorubicin: Induction Phase: Intravenously days 1 and 2 CNS Therapy: Intravenously day 1 Intensification: Given day 1 of each cycle vincristine: Induction: Intravenously days 1, 8, 15, and 22. If complete remission not achieved, will be given on days 29, 36 and 43. CNS Therapy: Intravenously day 1. Intensification: Intravenously day 1 of each cycle. Continuation: Intravenously day 1 of each cycle methotrexate: Induction: Intravenously day 3. CNS Therapy: Intrathecally 4x over two weeks Intensification: Intrathecally every 18 weeks Continuation: Intravenously weekly and intrathecally every 18 weeks asparaginase: Induction: Given into the muscle on day 5 dexamethasone: Intensification: Orally days 1-5 of each cycle cranial radiation: 10 daily treatments during CNS phase leucovorin: Induction: Intravenously/orally 36 hours after methotrexate cytarabine: Induction: Intrathecally days 1, 15, 29 CNS Therapy: Intrathecally 4x over 2 weeks Intensification: Intrathecally every 18 weeks Continuation: Intrathecally every 18 weeks hydrocortisone: Induction: Intrathecally days 15 and 29. Intensification: Intrathecally every 18 weeks. Continuation: Intrathecally every 18 weeks. 6-mercaptopurine (6-MP): CNS Therapy: Orally days 1-14. Intensification: Orally on days 1-14. Continuation: Orally on days 1-14. e. coli L-asparaginase: Intensification: Given in to the muscle weekly. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Immunophenotype | Count of Participants | Participants |
| |||||||||||||||||||||||
| White Blood Count (WBC) (x 10^-3) at diagnosis | Count of Participants | Participants |
| |||||||||||||||||||||||
| Central Nervous System (CNS) status at diagnosis | Count of Participants | Participants |
| |||||||||||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Risk classification | ECOG risk is defined as follows: HR includes any patients with an MLL rearrangement or Ph+ and B-cell patients with WBC ≥ 35K or age ≥ 35 years and T-cell patients with WBC ≥ 100K. | Count of Participants | 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 | Asparaginase Completion Rate | Feasibility based on the rate of asparaginase completion defined as the percentage of patients who, after having achieved a complete remission after induction therapy, complete all 30 doses of asparaginase as part of intensification therapy. Complete remission is defined as peripheral blood without lymphoblasts, a bone marrow with <5% lymphoblasts, an antigen-presenting cell (APC) > 1000/mm3, platelets > 100,000/mm3, and no evidence of extramedullary leukemia. | The analysis dataset is comprised of all patients who initiated asparaginase consolidation therapy. | Posted | Number | 80% Confidence Interval | Percentage of patients | Assessed at the end of the 30-week post-induction treatment period or when the participant comes off treatment, whichever occurs first. |
|
|
| |||||||||||||||||||||||||
| Secondary | 4-year Disease-Free Survival | Disease-Free Survival (DFS) based on the Kaplan-Meier method is defined as the time from achieving a complete remission to the first of disease recurrence or death, censored at time of last disease assessment. 4-year DFS is the percent probability of patients remaining alive, relapse-free and without occurrence of second malignant neoplasm 4 years from complete remission. Disease relapse is defined as >25% lymphoblasts identified morphologically in bone marrow aspirate/biopsy, or identification of lymphoblasts in marrow (any percentage) identified to be leukemic by flow cytometry, cytogenetics, fluorescent in situ hybridization (FISH), immunohistochemistry, or other tests. Appearance of leukemic cells at any extramedullary site (a single, unequivocal lymphoblast in the cerebrospinal fluid (CSF) may qualify as CNS leukemia) also qualifies if confirmed by the PI. | The analysis dataset is comprised of all eligible patients who achieved a CR. | Posted | Number | 95% Confidence Interval | Percent probability | Assessed continuously throughout the treatment period, and annually for 5 years following the completion of protocol treatment, (up to 5 years). Relevant for this measure is 4 years from the date of complete remission. |
| |||||||||||||||||||||||||||
| Secondary | 4-year Overall Survival | Overall Survival (OS) based on the Kaplan-Meier method is defined as the time from study entry to death from any cause, and will be censored the date last known alive. 4-year OS is the percent probability of patients remaining alive 4 years from study entry. | The analysis dataset is comprised of all eligible patients. | Posted | Number | 95% Confidence Interval | Percent probability | Assessed continuously throughout the treatment period, and annually for 5 years following the completion of protocol treatment (unless the participant dies or is lost to follow-up). Median follow-up for the whole trial is 4.5 years (95% CI:4.1-5.0 years). |
| |||||||||||||||||||||||||||
| Secondary | 4-year Event-Free Survival | Event-Free Survival (EFS) based on the Kaplan-Meier method is defined as the time from study entry to the first event of death during induction therapy, failure to achieve CR at the end of induction, death during remission, or relapse. 4-year EFS is the percent probability of patients remaining alive, relapse-free and without occurrence of second malignant neoplasm 4 years from study entry. Patients not achieving a CR will be considered events at time zero. EFS will be censored at time of last disease assessment. Disease relapse is defined as >25% lymphoblasts identified morphologically in bone marrow aspirate/biopsy, or identification of lymphoblasts in marrow (any percentage) identified to be leukemic by flow cytometry, cytogenetics, FISH, immunohistochemistry, or other tests. Appearance of leukemic cells at any extramedullary site (a single, unequivocal lymphoblast in the CSF may qualify as CNS leukemia) also qualifies if confirmed by the PI. | The analysis dataset is comprised of all eligible patients. | Posted | Number | 95% Confidence Interval | Percent probability | Assessed continuously throughout the treatment period, and annually for 5 years following the completion of protocol treatment (unless the participant dies or is lost to follow-up). Median follow-up for the whole trial is 4.5 years (95% CI:4.1-5.0 years). |
| |||||||||||||||||||||||||||
| Secondary | Post-Induction Nadir Serum Asparaginase Activity Level | Nadir serum asparaginase activity (NSAA) levels were estimated based on established methods. | The analysis dataset is comprised of all eligible patients for whom serum asparaginase activity levels were assayed. | Posted | Median | Full Range | IU/ml | Samples for nadir serum asparaginase activity levels were assayed prior to asparaginase dose given during post-induction, at Weeks 2, 4, 7, 10, 13, 16, 19, 22, 25, 28, and 30. |
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Asparaginase-Related Toxicity | Asparaginase-related toxicity rate is defined as the percentage of patients who experience allergy (all grades), pancreatitis, thrombotic or bleeding complications, bone fracture, or avascular necrosis based on Common Terminology Criteria for Adverse Events (CTCAE) v2. | The analysis dataset is comprised of all eligible patients. | Posted | Number | participants | Assessed on an ongoing basis (at least once every 3 months) while patient is on study, and including the treatment phases of Induction, CNS, Intensification, and Continuation. Treatment duration for this study was a median (range) of 507 days (0-1097). |
|
Adverse events (AE) were continuously monitored and reported every 3 months during treatment. Adverse events were monitored for the treatment duration of this study, which was a median (range) of 507 days (0-1097). All-Cause Mortality was monitored for the duration of follow-up for this study, which was a median (range) of 3.2 (0-7.9) years. Data is reported for the entire study cohort.
Reporting included all observed adverse events, with grade and attribution to study treatment. Maximum grade by type was calculated with serious adverse events defined as either 1) G5, 2) G4 unless myelosuppression or unequivocally due to disease or considered expected for chemotherapy drugs used, 3) G2 or G3 events that are unexpected and Possibly, Probably, or Definitely related to study treatment. Since SAE data was not collected separately, all AEs have been reported in the SAE table.
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 | Induction, CNS, and Intensification With Pharmacokinetically Individualized Doses of L-asparaginase | prednisone: Induction Phase: Orally days 1-28 doxorubicin: Induction Phase: Intravenously days 1 and 2 CNS Therapy: Intravenously day 1 Intensification: Given day 1 of each cycle vincristine: Induction: Intravenously days 1, 8, 15, and 22. If complete remission not achieved, will be given on days 29, 36 and 43. CNS Therapy: Intravenously day 1. Intensification: Intravenously day 1 of each cycle. Continuation: Intravenously day 1 of each cycle methotrexate: Induction: Intravenously day 3. CNS Therapy: Intrathecally 4x over two weeks Intensification: Intrathecally every 18 weeks Continuation: Intravenously weekly and intrathecally every 18 weeks asparaginase: Induction: Given into the muscle on day 5 dexamethasone: Intensification: Orally days 1-5 of each cycle cranial radiation: 10 daily treatments during CNS phase leucovorin: Induction: Intravenously/orally 36 hours after methotrexate cytarabine: Induction: Intrathecally days 1, 15, 29 CNS Therapy: Intrathecally 4x over 2 weeks Intensification: Intrathecally every 18 weeks Continuation: Intrathecally every 18 weeks hydrocortisone: Induction: Intrathecally days 15 and 29. Intensification: Intrathecally every 18 weeks. Continuation: Intrathecally every 18 weeks. 6-mercaptopurine (6-MP): CNS Therapy: Orally days 1-14. Intensification: Orally on days 1-14. Continuation: Orally on days 1-14. e. coli L-asparaginase: Intensification: Given in to the muscle weekly. | 40 | 98 | 98 | 98 | 0 | 98 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Cardiac disorders - Other, specify | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Ear and labyrinth disorders - Other, specify | Ear and labyrinth disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hearing impaired | Ear and labyrinth disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Middle ear inflammation | Ear and labyrinth disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Cushingoid | Endocrine disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Endocrine disorders - Other, specify | Endocrine disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Cataract | Eye disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dry eye | Eye disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Extraocular muscle paresis | Eye disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Eye disorders - Other, specify | Eye disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Glaucoma | Eye disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Night blindness | Eye disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Photophobia | Eye disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Watering eyes | Eye disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dysphasia | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Gastric hemorrhage | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Rectal pain | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Chills | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| General disorders and administration site conditions - Other, specify | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Injection site reaction | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Pain | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hepatobiliary disorders - Other, specify | Hepatobiliary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Anaphylaxis | Immune system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Immune system disorders - Other, specify | Immune system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Catheter related infection | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Infections and infestations - Other, specify | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | CTCAE (2.0) | Systematic Assessment |
| |
| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE (2.0) | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | CTCAE (2.0) | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| CPK increased | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Cardiac troponin I increased | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Cardiac troponin T increased | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Cholesterol high | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Fibrinogen decreased | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| GGT increased | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| INR increased | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Investigations - Other, specify | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Lipase increased | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Serum amylase increased | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Weight gain | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Alkalosis | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypertriglyceridemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hyperuricemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Tumor lysis syndrome | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Avascular necrosis | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Arachnoiditis | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Cognitive disturbance | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Extrapyramidal disorder | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Intracranial hemorrhage | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Leukoencephalopathy | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Nervous system disorders - Other, specify | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Vasovagal reaction | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Euphoria | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Personality change | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Psychosis | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Renal and urinary disorders - Other, specify | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Urine discoloration | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Irregular menstruation | Reproductive system and breast disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Reproductive system and breast disorders - Other, specify | Reproductive system and breast disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Vaginal dryness | Reproductive system and breast disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Vaginal hemorrhage | Reproductive system and breast disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Vaginal inflammation | Reproductive system and breast disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Apnea | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Bronchopulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Voice alteration | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Nail loss | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Photosensitivity | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Skin hypopigmentation | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Flushing | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hot flashes | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Vascular disorders - Other, specify | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dan DeAngelo | Dana Farber Cancer Institute | 617-582-8410 | Daniel_Deangelo@dfci.harvard.edu |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| 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 |
|---|---|
| D011241 | Prednisone |
| D004317 | Doxorubicin |
| D014750 | Vincristine |
| D008727 | Methotrexate |
| D001215 | Asparaginase |
| D003907 | Dexamethasone |
| D002955 | Leucovorin |
| D003561 | Cytarabine |
| D006854 | Hydrocortisone |
| D015122 | Mercaptopurine |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D000581 | Amidohydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D011246 | Pregnadienetriols |
| D013259 | Steroids, Fluorinated |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D003067 | Coenzymes |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| 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 |
| D013438 | Sulfhydryl Compounds |
| D013457 | Sulfur Compounds |
| D011687 | Purines |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Unknown |
|
| CNS 3 (+) CSF WBC >=5 with blasts |
|
| Unknown |
|
|
|
|
|
|
|
|
|
|
|