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Risk-Adapted Chemotherapy in Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia

Conditions

B-cell Childhood Acute Lymphoblastic Leukemia | Leukemia | Lymphoid Leukemia | Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia | Untreated Adult Acute Lymphoblastic Leukemia | Untreated Childhood Acute Lymphoblastic Leukemia

Trial Phase

Phase III

Trial Purpose and Description

Trial Purpose

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), giving the drugs in different doses, and giving the drugs in different combinations may kill more cancer cells.

PURPOSE: This partially randomized phase III clinical trial is studying different combinations of risk-adapted chemotherapy regimens and their side effects and comparing how well they work in treating younger patients with newly diagnosed standard-risk acute lymphoblastic leukemia.


Participation Guidelines

Age:
1 Years - 30 Years
Gender:
Both

Eligibility Criteria

Inclusion Criteria:

  • B-ALL patients must be enrolled on AALL08B1 prior to treatment and enrollment on AALL093
  • Patients must have newly diagnosed NCI Standard Risk B-ALL or B-LLy Murphy Stages I or II patients with Down syndrome are also eligible
  • Note: For B-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to B-ALL for tissue processed by other means (i.e. paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of B-LLy defined by the submitting institution will be accepted
  • Meets the criteria for one of the following risk groups after induction therapy
  • Low-risk (LR) disease, defined as meeting the following criteria:
  • Favorable genetics: the presence of simultaneous trisomies of chromosome 4 and 10 (double trisomy DT) or ETV6/RUNX1 fusion
  • Day 8 peripheral blood (PB) minimal residual disease (MRD) < 0.01% - Day 29 bone marrow (BM) MRD < 0.01% - No CNS2*, CNS3*, or testicular&dagger leukemia
  • No steroid pretreatment - No Down syndrome (DS) - Average-risk disease, defined as meeting one of the following sets of criteria:
  • Favorable genetics: the presence of DT or ETV6/RUNX1 fusions
  • Day 8 PB MRD = 0.01% or CNS2* status - Day 29 BM MRD < 0.01% - No CNS3* or testicular&dagger leukemia
  • No DS - Neither favorable nor unfavorable cytogenetics&Dagger
  • Day 8 PB MRD < 1% - Day 29 BM MRD < 0.01%
  • No CNS3* or testicular&dagger leukemia - No DS - Standard-risk with Down syndrome (DS), defined as meeting the following criteria:
  • No mixed-lineage leukemia (MLL)-rearrangement, hypodiploidy**, or Philadelphia chromosome-positive (Ph+) disease&dagger&dagger
  • Day 29 BM MRD < 0.01%&Dagger&Dagger
  • No CNS3* or testicular&dagger leukemia
  • WBC count < 50,000/mm^3
  • No prior cytotoxic chemotherapy for the current diagnosis of ALL or any cancer diagnosed previously - Steroids* and intrathecal cytarabine for the current diagnosis of ALL allowed
  • Inhalational steroids are not considered as pretreatment
  • Patients with testicular leukemia are not eligible for AALL0932
Sponsor:
Children's Oncology Group (The)
 
National Cancer Institute (NCI)
Dates:
08/19/2010
Last Updated:
Study HIC#:
1008007226