Combination chemotherapy and nelarabine for T-cell leukemia and lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial investigates the effectiveness and safety of a combination of chemotherapy drugs and nelarabine in treating patients with T-cell acute lymphoblastic leukemia (ALL) and T-cell lymphoblastic lymphoma. The study aims to determine the complete remission rate, progression-free survival, and overall survival of previously untreated patients. Participants will receive a regimen that includes hyperfractionated cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, cytarabine, nelarabine, and venetoclax, administered in a structured course format. The trial also evaluates the safety and efficacy of adding pegaspargase and venetoclax to the treatment plan.

Why it matters

Who can join: the full rules

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

Where it's running

• M D Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Farhad Ravandi-Kashani — M.D. Anderson Cancer Center
• Study coordinator: Farhad Ravandi-Kashani, MD
• Phone: 713-745-0394

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.