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

  • Study type:

    Interventional What is this?

    Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Study phase:

    III What is this?

    During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

Study IDs

  • Site IRB:

    • Rochester, Minnesota: 10-005606
  • NCT ID:

    NCT01190930
  • Sponsor Protocol Number:

    AALL0932

About this study

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. 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • B-ALL patients must be enrolled on AALL08B1 prior to treatment and enrollment on AALL0932
  • 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 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 leukemia
      • No DS
      • Neither favorable nor unfavorable cytogenetics
      • Day 8 PB MRD < 1%
      • Day 29 BM MRD < 0.01%
      • No CNS3 or testicular 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
      • Day 29 BM MRD < 0.01%
      • No CNS3 or testicular 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Vilmarie Rodriguez, M.D.

Open for enrollment

Cancer Center Clinical Trials Referral Office

855-776-0015