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RECRUITING Phase 2 ClinicalTrials.gov

Combination Chemotherapy and Nelarabine in Treating Patients With T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Sponsor: M.D. Anderson Cancer Center • ClinicalTrials.gov ID: NCT00501826

Registry updated: 2026-10-08
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Description

This phase II trial studies the side effects and how well combination chemotherapy and nelarabine work in treating patients with T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma. Drugs used in chemotherapy, such as cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, cytarabine, mercaptopurine, prednisone, pegaspargase, nelarabine, and venetoclax work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Interventions

  • Cyclophosphamide (Drug)
    Given IV
  • Cytarabine (Drug)
    Given IV
  • Dexamethasone (Drug)
    Given IV or PO
  • Doxorubicin Hydrochloride (Drug)
    Given IV
  • Mercaptopurine (Drug)
    Given PO
  • Methotrexate (Drug)
    Given IV and PO
  • Nelarabine (Drug)
    Given IV
  • Pegaspargase (Drug)
    Given IV
  • Prednisone (Drug)
    Given PO
  • Venetoclax (Drug)
    Given PO
  • Vincristine Sulfate (Drug)
    Given IV

Eligibility criteria

Inclusion Criteria: * Previously untreated T cell ALL including T cell lymphoblastic lymphoma; failure to one induction course of chemotherapy are eligible; patients in CR after =\< 2 courses are also eligible * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 3 * Serum bilirubin less than or equal to 2.0 mg/dL unless considered due to involvement by tumor when an upper limit of 5.0 mg/dL is acceptable * Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) less than or equal to 4 x upper limit of normal (ULN) * Serum creatinine less than or equal to 2.0 mg/dL unless considered due to involvement by tumor when an upper limit of 2.5 mg/dL is acceptable Exclusion Criteria: * Pregnant or nursing women

Conditions

T Acute Lymphoblastic Leukemia T Lymphoblastic Lymphoma

Locations

  • M D Anderson Cancer Center — Houston, Texas, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record