Phase 3
N=275
Low-Dose or High-Dose Vincristine and Combination Chemotherapy in Treating Young Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia
B-cell Childhood Acute Lymphoblastic Leukemia · L1 Childhood Acute Lymphoblastic Leukemia · L2 Childhood Acute Lymphoblastic Leukemia · Intermediate Risk Recurrent Childhood Acute Lymphoblastic Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00381680 ↗Enrolled (actual)
275
Serious AEs
18.8%
Results posted
May 2017
Primary outcome: Primary: Event Free Survival. EFS — 66.0 percentage of participants EFS at 3 yrs3
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- vincristine sulfate (Drug); prednisone (Drug); doxorubicin hydrochloride (Drug); pegaspargase (Drug); cytarabine (Drug); methotrexate (Drug); dexamethasone (Drug); etoposide (Drug); cyclophosphamide (Drug); leucovorin calcium (Drug); filgrastim (Biological); asparaginase (Drug); mercaptopurine (Drug)
- Age
- Pediatric, Adult · 1+ yrs
- Sex
- All
- Sponsor
- Children's Oncology Group
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Event Free Survival. EFS |
66.0 | — |
| SECONDARY Frequency and Severity of Adverse Effects |
17.3; 44.4 | — |
| SECONDARY Gene Expression Profile |
— | — |
| SECONDARY Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1 |
50.8; 41.5 | — |
| SECONDARY Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3 |
81.4; 88.9 | — |
| SECONDARY Event Free Survival (EFS) |
88.5; 77.3; 60.0; 46.2; 83.8; 83.3 | — |
| SECONDARY Adjusted Event Free Survival |
82.2; 64.2 | — |
Summary
This randomized phase III trial is studying low-dose vincristine to see how well it works compared with high-dose vincristine when given together with different combination chemotherapy regimens in treating young patients with intermediate-risk relapsed B-cell acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving the drugs in different ways and different doses may kill more cancer cells..
Eligibility Criteria
Inclusion Criteria
- Diagnosis of acute lymphoblastic leukemia (ALL)
- Bone marrow with > 25% L1 or L2 lymphoblasts (M3 marrow)
- Patients with > 25% L3 marrow lymphoblasts and/or evidence of c-myc translocation are not eligible (considered Burkitt's or mature B-cell leukemia)
- Intermediate-risk relapsed disease, meeting 1 of the following criteria:
- Bone marrow relapse ≥ 36 months after initial diagnosis (defined as M3 marrow after previous remission from ALL)
- Combined bone marrow and extramedullary (CNS* and/or testicular**) relapse ≥ 36 months after initial diagnosis
- Isolated extramedullary (CNS* and/or testicular**) relapse = 27% by echocardiogram OR ejection fraction >= 50% by radionuclide angiogram
- Bilirubin = grade 3 within the past month
- No toxicity (i.e. peripheral neuropathy) >= grade 3 attributable to vincristine within the past month
- At least 5 days since prior intrathecal chemotherapy
- No prior hematopoietic stem cell or marrow transplantation
- No prior cranial radiotherapy > 1200 cGy (for patients with CNS relapse)
- No concurrent stem cell transplant
- No concurrent alternative therapy
- No concurrent itraconazole in patients receiving vincristine
- No concurrent intensity-modulated radiotherapy
Data sourced from ClinicalTrials.gov (NCT00381680). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.