Phase 2
N=318
Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00558519 ↗Enrolled (actual)
318
Serious AEs
45.4%
Results posted
Jan 2020
Primary outcome: Primary: Complete Response Rate — 89 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- cyclophosphamide (Drug); cytarabine (Drug); daunorubicin hydrochloride (Drug); dexamethasone (Drug); doxorubicin hydrochloride (Drug); mercaptopurine (Drug); methotrexate (Drug); pegaspargase (Drug); thioguanine (Drug); vincristine sulfate (Drug); radiation therapy (Radiation)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- All
- Sponsor
- Alliance for Clinical Trials in Oncology
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Response Rate |
89 | — |
| PRIMARY Event-free Survival |
78.1 | — |
| PRIMARY Disease-free Survival |
81.7 | — |
| PRIMARY Overall Survival |
NA | — |
| PRIMARY Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Event at Least Possibly Related to Treatment (Toxicity) |
286 | — |
Summary
RATIONALE: 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) may kill more cancer cells.
PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating young patients with newly diagnosed acute lymphoblastic leukemia.
Eligibility Criteria
Eligibility Criteria:
- Diagnosis
- Newly diagnosed patients with either B-precursor or T-precursor acute lymphoblastic leukemia (WHO criteria). Burkitt type leukemia as defined per protocol is not eligible. Patients known to have Ph+ ALL at time of diagnosis are not eligible.
- CALGB patients entered on CALGB 10403 who are later found to meet the following criteria for Ph+ ALL should have treatment on this trial discontinued and should be encouraged to enroll on CALGB 10001 or its successor trial:
- BCR-ABL fusion transcript determined by FISH or RT-PCR
- t(9;22)(q34;q11) or variant determined by cytogenetics
Non-CALGB study participants who are later found to be Ph+ should have treatment on this trial discontinued and should be encouraged to enroll on an appropriate clinical trial specifically designed for Ph+ ALL.
- Age: 16 - 39 years
- ECOG Performance Status 0-2
- Patients with Down Syndrome are excluded from this study due to the likelihood of excessive toxicity resulting. These patients should be treated in consultation with a pediatric oncologist.
- Prior Therapy - No prior therapy except for limited treatment with corticosteroids or hydroxyurea and a single dose of intrathecal cytarabine.
- No prior therapy for acute leukemia except emergency therapy (corticosteroids or hydroxyurea) for blast cell crisis, superior vena cava syndrome, or renal failure due to leukemic infiltration of the kidneys. When indicated, leukapheresis or exchange transfusion is recommended to reduce the WBC.
- Single-dose intrathecal cytarabine is allowed prior to registration or prior to initiation of systemic therapy for patient convenience. This is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture. Systemic chemotherapy must begin within 72 hours of this intrathecal therapy.
- Patients receiving prior steroid therapy are eligible for study. The dose and duration of previous steroid therapy should be carefully documented on case report forms.
Data sourced from ClinicalTrials.gov (NCT00558519). 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.