test

Newly Diagnosed High Risk B-Precursor ALL - Clofarabine

Conditions

Leukemia, not otherwise specified

Trial Phase

Phase III

Trial Purpose and Description

Trial Purpose

1.) To determine if the administration of post-Induction age adjusted ITT on an MBFM-IMHDM backbone will improve 5-year DFS of children with HR-ALL compared to age adjusted IT MTX.
2.) To determine, in a randomized fashion, if the cyclophosphamide + etoposide containing regimen (Experimental Arm 1) or the clofarabine + cyclophosphamide + etoposide combination regimen (Experimental Arm 2) will improve the 4-year DFS of children, adolescents, and young adults with VHR-ALL compared to a modified MBFM-IMHDM regimen that contains a second IM (Control Arm).
3.) To determine, in a randomized fashion, if the cyclophosphamide + etoposide + clofarabine containing combination regimen (Experimental Arm 2) will improve the 4-year DFS of children, adolescents, and young adults with VHR-ALL compared to the cyclophosphamide + etoposide combination regimen (Experimental Arm 1).


Participation Guidelines

Age:
365 Days - 31 Years
Gender:
Both

Eligibility Criteria

Inclusion Criteria:

  • Patients must be > 365 days and <31 years of age
  • White Blood Cell Count (WBC) Criteria Age 1-9.99 years: WBC &ge 50 000/&muL Age 10-30.99 years: Any WBC Age 1-30.99 years: Any WBC with: a) Testicular leukemia b) CNS leukemia (CNS3) c) Steroid pretreatment.
  • Patients must have newly diagnosed B-precursor ALL. Patients with Down syndrome are also eligible.
  • Patients must be enrolled on AALL08B1 prior to enrollment on AALL1131.

Exclusion Criteria:

  • Patients must not have received any prior cytotoxic chemotherapy for the current diagnosis of ALL or any cancer diagnosed previously, with the exception of steroids and intrathecal cytarabine for the current diagnosis of ALL. Patients cannot have secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy.
  • Patients receiving prior steroid therapy may be eligible for AALL1131 Post Induction.
  • Patients with BCR-ABL1 fusion (not eligible for post-Induction therapy on this study non-DS patients may be eligible to enroll in AALL0622 or successor COG Ph+ ALL trial by Day 15 Induction)
  • DS HR-ALL patients with Induction failure or BCR-ABL1.
  • VHR-ALL patients with significant hepatic dysfunction at the time of post-Induction randomization defined as: Direct bilirubin > 1.5 x upper limit of normal (ULN) for age SGPT (ALT) > 3 x upper limit of normal (ULN) for age Lipase > 2.0 x upper limit of normal (ULN) for age.
  • VHR-ALL patients with known Hepatitis B or C infection or history of cirrhosis at the time of post-Induction randomization
  • Females of childbearing potential must have a negative pregnancy test. Patients of childbearing potential must agree to use an effective birth control method.
  • Female patients who are lactating must agree to stop breast-feeding.
Sponsor:
Children's Oncology Group (The)
Dates:
04/11/2012
Last Updated:
Study HIC#:
1203009873