Loyola University Medical Center

Gottlieb Memorial Hospital

MacNeal Hospital

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NCT00381680

Low-Dose or High-Dose Vincristine and Combination Chemotherapy in Treating Young Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia

Official Title:

Intensive Treatment for Intermediate-Risk Relapse of Childhood B-precursor Acute Lymphoblastic Leukemia (ALL): A Randomized Trial of Vincristine Strategies

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

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 < 18 months after initial diagnosis
* The following subtypes are not allowed:

* T-lineage ALL
* Mature B-cell (Burkitt's) leukemia (defined as L3 morphology and/or evidence of c-myc translocation)
* Philadelphia-chromosome positive disease
* No Down syndrome (trisomy 21)
* Shortening fraction >= 27% by echocardiogram OR ejection fraction >= 50% by radionuclide angiogram
* Bilirubin < 3.0 mg/dL
* Not pregnant
* Fertile patients must use effective contraception
* No history of peripheral neuropathy >= 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

Disease(s) and\or Condition(s)

B-cell Childhood Acute Lymphoblastic Leukemia

L1 Childhood Acute Lymphoblastic Leukemia

L2 Childhood Acute Lymphoblastic Leukemia

Intermediate Risk Recurrent Childhood Acute Lymphoblastic Leukemia

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: DRUG
    • Name: vincristine sulfate
    • Description: Given IV
    • Arm Group Labels: Arm B: Randomized High Dose Vincristine regimen, Regimen A: Standard vincristine dosing
    • Type: DRUG
    • Name: prednisone
    • Description: Given PO
    • Arm Group Labels: Arm B: Randomized High Dose Vincristine regimen, Regimen A: Standard vincristine dosing
    • Type: DRUG
    • Name: doxorubicin hydrochloride
    • Description: Given IV
    • Arm Group Labels: Arm B: Randomized High Dose Vincristine regimen, Regimen A: Standard vincristine dosing
    • Type: DRUG
    • Name: pegaspargase
    • Description: Given IM
    • Arm Group Labels: Arm B: Randomized High Dose Vincristine regimen, Regimen A: Standard vincristine dosing
    • Type: DRUG
    • Name: cytarabine
    • Description: Given IT or IV
    • Arm Group Labels: Arm B: Randomized High Dose Vincristine regimen, Regimen A: Standard vincristine dosing
    • Type: DRUG
    • Name: methotrexate
    • Description: Given IT or IV
    • Arm Group Labels: Arm B: Randomized High Dose Vincristine regimen, Regimen A: Standard vincristine dosing
    • Type: DRUG
    • Name: dexamethasone
    • Description: Given PO
    • Arm Group Labels: Arm B: Randomized High Dose Vincristine regimen, Regimen A: Standard vincristine dosing
    • Type: DRUG
    • Name: etoposide
    • Description: Given IV
    • Arm Group Labels: Arm B: Randomized High Dose Vincristine regimen, Regimen A: Standard vincristine dosing
    • Type: DRUG
    • Name: cyclophosphamide
    • Description: Given IV
    • Arm Group Labels: Arm B: Randomized High Dose Vincristine regimen, Regimen A: Standard vincristine dosing
    • Type: DRUG
    • Name: leucovorin calcium
    • Description: Given IV or PO
    • Arm Group Labels: Arm B: Randomized High Dose Vincristine regimen, Regimen A: Standard vincristine dosing
    • Type: BIOLOGICAL
    • Name: filgrastim
    • Description: Given IV or SC
    • Arm Group Labels: Arm B: Randomized High Dose Vincristine regimen, Regimen A: Standard vincristine dosing
    • Type: DRUG
    • Name: asparaginase
    • Description: Given IM
    • Arm Group Labels: Arm B: Randomized High Dose Vincristine regimen, Regimen A: Standard vincristine dosing
    • Type: DRUG
    • Name: mercaptopurine
    • Description: Given PO
    • Arm Group Labels: Arm B: Randomized High Dose Vincristine regimen, Regimen A: Standard vincristine dosing
Sponsor
  • Children's Oncology Group