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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-01493 | Registry Identifier | NCI Clinical Trial Registration Program |
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| Name | Class |
|---|---|
| Gateway for Cancer Research | OTHER |
| Baylor College of Medicine | OTHER |
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The purpose of this study is to test the good and bad effects of the study drugs bortezomib and vorinostat when they are given in combination with chemotherapy commonly used to treat acute lymphoblastic leukemia (ALL) in infants. For example, adding these drugs could decrease the number of leukemia cells, but it could also cause additional side effects. Bortezomib and vorinostat have been approved by the US Food and Drug Administration (FDA) to treat other cancers in adults, but they have not been approved for treating children with leukemia. With this research, we plan to meet the following goals:
PRIMARY OBJECTIVE:
SECONDARY OBJECTIVES:
Treatment will consist of 4 main phases: Remission Induction, Consolidation, Reinduction, and Maintenance. High risk patients will receive a reintensification phase prior to transplant in first remission.
REMISSION INDUCTION: Chemotherapy will be given in an attempt to induce the participant's leukemia into remission. Drugs given are intrathecal triple drug treatment with methotrexate, hydrocortisone and Ara-C (ITMHA); dexamethasone; vorinostat; bortezomib; PEG-asparaginase; mitoxantrone; cyclophosphamide; cytarabine; and 6-mercaptopurine.
CONSOLIDATION PHASE: After the participant's blood counts have recovered from Remission Induction, he/she will move to the consolidation phase. This therapy is given to kill any remaining leukemia cells. Drugs given are ITMHA, high-dose methotrexate, and 6-mercaptopurine.
RE-INDUCTION: This phase aims to improve the participant's overall response to therapy by again seeking to bring his/her leukemia into remission. Drugs given are ITMHA, mitoxantrone, peg-asparaginase, dexamethasone, bortezomib, and vorinostat.Participants that achieve MRD negative status following Re-Induction may proceed directly to stem cell transplant (SCT) (SCT not part of this study).
RE-INTENSIFICATION: Participants that remain MRD positive following Consolidation or Reinduction may receive Chimeric Antigen Receptor T-Cell therapy (CART), if available (CART is not part of this study), or proceed to a Reintensification phase then go on to stem cell transplant (SCT).
MAINTENANCE PHASE: Participants with negative MRD after consolidation will skip the re-intensification phase and proceed to receive maintenance therapy to keep the leukemia from returning. Drugs given are ITMHA, dexamethasone, vincristine, 6-mercaptopurine and methotrexate. Each cycle of these drugs lasts 28 days and will be repeated up to 20 times as long as there are no serious side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Participants who meet eligibility requirements will receive remission induction, consolidation treatment, reinduction, reintensification and maintenance therapy. Interventions: ITMHA, dexamethasone, mitoxantrone, pegaspargase or asparaginase Erwinia chrysanthemi, bortezomib, vorinostat, cyclophosphamide, mercaptopurine, methotrexate, leucovorin calcium, cytarabine, etoposide, and vincristine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ITMHA | Drug | Given intrathecally (IT). |
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|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Treatment-related Mortality (TRM) | Number of treatment related deaths divided by total number of patients during induction or reinduction therapy. Presented as percentage | At the end of reinduction (up to 5 months after start of therapy) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With 3-year Event Free Survival (EFS) | Event-free survival (EFS) will be estimated by the Kaplan-Meier estimator. For EFS, relapse and second malignancies will be considered as failures in addition to death in complete remission. The time to EFS will be set to 0 for patients who fail to achieve complete remission. EFS probability will be estimated with 95% confidence intervals. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tanja Gruber, MD, PhD | Lucile Packard Children's Hospital Stanford University | Study Chair |
| Sima Jeha, MD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States | ||
| Children's Hospital of Orange County |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41692013 | Derived | Gruber TA, Jeha S, Deyell RJ, Lewis V, Chang BH, Lowe EJ, Frediani J, Vezina C, Michon B, Richards M, Breese EH, Tran TH, Lacayo N, Bolen C, Desai S, Pauley JL, Huang M, Ashcraft E, Cheng C, Schultz KR, Stork L, Schlis K, Huynh VT, Gossai N, Messinger YH, Bittencourt H, Horton TM, Athale U, Stearns D, Schiff D, Gaynon PS. Bortezomib and vorinostat in combination with mitoxantrone, dexamethasone, and pegasparaginase during induction and reinduction for infants with acute lymphoblastic leukaemia: a multicentre single-arm phase 1/2 study. Lancet Haematol. 2026 Mar;13(3):e144-e156. doi: 10.1016/S2352-3026(25)00357-6. Epub 2026 Feb 12. |
| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
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Fifty patients were enrolled between January 2016 to November 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Stratum 1 | Patient is < 365 days of age at the time of diagnosis. Patient has newly diagnosed acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia with ≥25% blasts in the bone marrow (M3), with or without extramedullary disease. Patients with T-cell ALL are eligible. Patients with bilineage or biphenotypic acute leukemia are eligible, provided the morphology and immunophenotype are predominantly lymphoid. Limited prior therapy, including hydroxyurea for 72 hours or less, systemic glucocorticoids for one week or less, one dose of vincristine, and one dose of intrathecal chemotherapy. Written informed consent following Institutional Review Board, NCI, FDA, and OHRP Guidelines. |
| 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 | Nov 11, 2021 |
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| Dexamethasone | Drug | Given orally (PO) or naso-gastrically (NG) or intravenously (IV). |
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| Mitoxantrone | Drug | Given IV. |
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| Pegaspargase | Drug | Given IV. If participant is allergic to pegaspargase, Asparaginase Erwinia Chrysanthemi will be used. |
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| Asparaginase Erwinia Chrysanthemi | Drug | Asparaginase Erwinia Chrysanthemi will be used in case of allergy or intolerance of participant to PEG-asparaginase. Given IV (preferred) or intramuscularly (IM). |
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| Bortezomib | Drug | Given IV. |
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| Vorinostat | Drug | Taken PO or NG. |
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| Cyclophosphamide | Drug | Given IV. |
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| Mercaptopurine | Drug | Given PO or NG. |
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| Methotrexate | Drug | Given IV, IM or PO. |
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| Leucovorin Calcium | Drug | Leucovorin rescue PO or IV. |
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| Cytarabine | Drug | Given IV. |
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| Etoposide | Drug | Given IV. In case of participant allergy, etoposide phosphate (Etopophos®) will be given. |
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| Vincristine | Drug | Given IV. |
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| 3 years after completion of therapy (up to 5 years after start of therapy) |
| Percentage of Participants With 5-year Overall Survival (OS) | Overall survival (OS) will be estimated by the Kaplan-Meier estimator with 95% confidence intervals. | 5 years after completion of therapy (up to 7 years after start of therapy) |
| Minimal Residual Disease (MRD) Positivity Using Flow Cytometry or PCR at Induction Day 22, End of Induction, End of Consolidation, and End of Maintenance. | Proportion of participants with positive MRD at the end of each therapy block. The proportion of MRD positive patients is determined by the number of patients that are MRD positive at the end of each therapy block divided by the number of patients that completed each therapy block. | At the end of induction day 22 (approximately 3 weeks), end of induction (approximately 6 weeks), end of consolidation (approximately 14 weeks), and end of maintenance therapy (approximately 2 years) |
| Orange |
| California |
| 92868 |
| United States |
| Lucile Packard Children's Hospital Stanford University | Palo Alto | California | 94304 | United States |
| Children's Hospital and Clinics of Minnesota | Minneapolis | Minnesota | 55404 | United States |
| St. Jude Affiliate-Charlotte | Charlotte | North Carolina | 28204 | United States |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| Children's Hospital of the King's Daughters (CHKD) | Norfolk | Virginia | 23507 | United States |
| Alberta Children's Hospital | Calgary | Alberta | T3A 6A8 | Canada |
| Stollery Children's Hospital | Edmonton | Alberta | T6G 2B7 | Canada |
| Children's & Women's Health Centre of British Columbia | Vancouver | British Columbia | V6H 3V4 | Canada |
| Centre Hospitalier Universitaire Sainte-Justine | Montreal | Quebec | H3T 1C5 CAN | Canada |
| The Montreal Children's Hospital (MUHC-McGill) | Montreal | Quebec | H4A 3J1 | Canada |
| Centre Hospitalier Universitaire de Quebec | Québec | Quebec | G1V 4G2 | Canada |
| Clinical Trials Open at St. Jude | View source |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stratum 1 | Patient is < 365 days of age at the time of diagnosis. Patient has newly diagnosed acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia with ≥25% blasts in the bone marrow (M3), with or without extramedullary disease. Patients with T-cell ALL are eligible. Patients with bilineage or biphenotypic acute leukemia are eligible, provided the morphology and immunophenotype are predominantly lymphoid. Limited prior therapy, including hydroxyurea for 72 hours or less, systemic glucocorticoids for one week or less, one dose of vincristine, and one dose of intrathecal chemotherapy. Written informed consent following Institutional Review Board, NCI, FDA, and OHRP Guidelines. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | months |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | 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 | Percentage of Treatment-related Mortality (TRM) | Number of treatment related deaths divided by total number of patients during induction or reinduction therapy. Presented as percentage | Posted | Count of Participants | Participants | At the end of reinduction (up to 5 months after start of therapy) |
|
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With 3-year Event Free Survival (EFS) | Event-free survival (EFS) will be estimated by the Kaplan-Meier estimator. For EFS, relapse and second malignancies will be considered as failures in addition to death in complete remission. The time to EFS will be set to 0 for patients who fail to achieve complete remission. EFS probability will be estimated with 95% confidence intervals. | Posted | Number | 95% Confidence Interval | percentage of participants | 3 years after completion of therapy (up to 5 years after start of therapy) |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With 5-year Overall Survival (OS) | Overall survival (OS) will be estimated by the Kaplan-Meier estimator with 95% confidence intervals. | Posted | Number | 95% Confidence Interval | percentage of participants | 5 years after completion of therapy (up to 7 years after start of therapy) |
|
| |||||||||||||||||||||||||||
| Secondary | Minimal Residual Disease (MRD) Positivity Using Flow Cytometry or PCR at Induction Day 22, End of Induction, End of Consolidation, and End of Maintenance. | Proportion of participants with positive MRD at the end of each therapy block. The proportion of MRD positive patients is determined by the number of patients that are MRD positive at the end of each therapy block divided by the number of patients that completed each therapy block. | The number analyzed is different from the overall number analyzed because the patient(s) MRD at that time period was not evaluated due to induction failure, death, or relapse. | Posted | Count of Participants | Participants | At the end of induction day 22 (approximately 3 weeks), end of induction (approximately 6 weeks), end of consolidation (approximately 14 weeks), and end of maintenance therapy (approximately 2 years) |
|
Adverse event data are collected from Induction day 1 until 30 days after the end of maintenance, approximately 2 years. Some patients are still receiving treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stratum 1 | Patient is < 365 days of age at the time of diagnosis. Patient has newly diagnosed acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia with ≥25% blasts in the bone marrow (M3), with or without extramedullary disease. Patients with T-cell ALL are eligible. Patients with bilineage or biphenotypic acute leukemia are eligible, provided the morphology and immunophenotype are predominantly lymphoid. Limited prior therapy, including hydroxyurea for 72 hours or less, systemic glucocorticoids for one week or less, one dose of vincristine, and one dose of intrathecal chemotherapy. Written informed consent following Institutional Review Board, NCI, FDA, and OHRP Guidelines. | 17 | 50 | 27 | 50 | 50 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Heart failure | Cardiac disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Left ventricular systolic dysfunction | Cardiac disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Ileal perforation | Gastrointestinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Typhlitis | Gastrointestinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Catheter related infection | Infections and infestations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Infections and infestations - Other, specify | Infections and infestations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Meningitis | Infections and infestations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Peritoneal infection | Infections and infestations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Rhinitis infective | Infections and infestations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Small intestine infection | Infections and infestations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Weight loss | Investigations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Metabolism and nutrition disorders - Other, specify | Metabolism and nutrition disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Tumor lysis syndrome | Metabolism and nutrition disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Bronchopulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Laryngeal obstruction | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Pharyngeal mucositis | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Fever | General disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Localized edema | General disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Endocrine disorders - Other, specify | Endocrine disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Eye disorders - Other, specify | Eye disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Gastric hemorrhage | Gastrointestinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Typhlitis | Gastrointestinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Fatigue | General disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Fever | General disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| General disorders and administration site conditions - Other, specify | General disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Irritability | General disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Localized edema | General disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Pain | General disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Hepatobiliary disorders - Other, specify | Hepatobiliary disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Catheter related infection | Infections and infestations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Infections and infestations - Other, specify | Infections and infestations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Mucosal infection | Infections and infestations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Penile infection | Infections and infestations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Rhinitis infective | Infections and infestations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Postoperative hemorrhage | Injury, poisoning and procedural complications | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Cholesterol high | Investigations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Creatinine increased | Investigations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Fibrinogen decreased | Investigations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| GGT increased | Investigations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Investigations - Other, specify | Investigations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Lymphocyte count increased | Investigations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Weight gain | Investigations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Weight loss | Investigations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| White blood cell decreased | Investigations | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Alkalosis | Metabolism and nutrition disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Hypermagnesemia | Metabolism and nutrition disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Hypertriglyceridemia | Metabolism and nutrition disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Hyperuricemia | Metabolism and nutrition disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Tumor lysis syndrome | Metabolism and nutrition disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Movements involuntary | Nervous system disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Nervous system disorders - Other, specify | Nervous system disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Hoarseness | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Laryngospasm | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Pharyngeal mucositis | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Stridor | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Periorbital edema | Skin and subcutaneous tissue disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Skin ulceration | Skin and subcutaneous tissue disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Hematoma | Vascular disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | NCI CTCAE v4.0 | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
MSA states Site is unable to publish until all completed case report forms have been delivered to Sponsor, (Study Completion). Site shall have the right to publish after publication of a multi-center publication coordinated by the Sponsor or (12) mths. after Study Completion; provided, that prior to any such publication or public release of such data, Site shall furnish Sponsor with a copy of any proposed publication at least (45)days in advance of the proposed publication or presentation date.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tanja A. Gruber, MD, PhD | Lucile Packard Children's Hospital | (650) 723-5535 | tagruber@stanford.edu |
| Apr 21, 2023 |
| Prot_SAP_000.pdf |
| 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 |
|---|---|
| D008727 | Methotrexate |
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| D008942 | Mitoxantrone |
| C042705 | pegaspargase |
| C000718243 | asparaginase erwinia chrysanthemi recombinant |
| D001215 | Asparaginase |
| D000069286 | Bortezomib |
| D000077337 | Vorinostat |
| D003520 | Cyclophosphamide |
| D015122 | Mercaptopurine |
| D002955 | Leucovorin |
| D003561 | Cytarabine |
| D005047 | Etoposide |
| D014750 | Vincristine |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011809 | Quinones |
| D000581 | Amidohydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D006877 | Hydroxamic Acids |
| D006898 | Hydroxylamines |
| D006880 | Hydroxy Acids |
| D002264 | Carboxylic Acids |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D013438 | Sulfhydryl Compounds |
| D011687 | Purines |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D003067 | Coenzymes |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D054836 | Indolizidines |
| D007212 | Indolizines |
Not provided
Not provided
| Other |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|