Combination Chemotherapy and Nelarabine for Treating T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT00501826

Provider View

This clinical trial is testing how well a combination of chemotherapy drugs and nelarabine work in treating patients with T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma. The study also looks at the side effects of this treatment.

Patient Parameters

Program Overview

This study is exploring the effects of combining chemotherapy drugs with nelarabine to treat patients with T-cell acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma. Chemotherapy drugs like cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, cytarabine, mercaptopurine, prednisone, pegaspargase, nelarabine, and venetoclax work in different ways to stop cancer cells from growing, dividing, or spreading.

Description

The main goals of this study are to see how well the treatment works in achieving complete remission and how long patients stay free from cancer progression. The study also aims to assess the safety and overall survival of patients receiving this treatment.

The treatment plan includes several courses of chemotherapy drugs given in cycles. In some courses, patients receive a combination of drugs called hyper-CVAD, which includes cyclophosphamide, vincristine, doxorubicin, and dexamethasone. In other courses, patients receive methotrexate and cytarabine. Additionally, patients take venetoclax by mouth during each course.

After certain courses, patients receive nelarabine and pegaspargase. The treatment cycles repeat every 21 days unless the disease progresses or side effects become unacceptable.

For maintenance therapy, patients take mercaptopurine, methotrexate, vincristine, prednisone, and venetoclax. This maintenance phase continues for 30 months if the disease does not progress or side effects remain manageable.

Patients are monitored every 3-6 months after completing the study treatment to track their health and any changes in their condition.

Eligibility Criteria

Inclusion Criteria

  • Have not received previous treatment for T-cell acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma, or have not responded to one induction course of chemotherapy.
  • Have an ECOG performance status of 3 or less, indicating the ability to carry out daily activities with some limitations.
  • Have a serum bilirubin level of 2.0 mg/dL or less, unless the higher level is due to tumor involvement, in which case up to 5.0 mg/dL is acceptable.
  • Have liver enzyme levels (SGOT or SGPT) that are 4 times the upper limit of normal or less.
  • Have a serum creatinine level of 2.0 mg/dL or less, unless the higher level is due to tumor involvement, in which case up to 2.5 mg/dL is acceptable.

Exclusion Criteria

  • Women who are pregnant or breastfeeding.

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