Combination chemotherapy and nelarabine for T-cell leukemia and lymphoma
Phase II Study of Hyper-CVAD Plus Nelarabine in Previously Untreated T-ALL and Lymphoblastic Lymphoma
This study is testing a new combination of chemotherapy drugs and nelarabine to see if it helps people with T-cell leukemia and lymphoma feel better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, methotrexate, cyclophosphamide, doxorubicin, prednisone |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT00501826 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are previously untreated patients diagnosed with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma.
Not a fit: Patients who are pregnant or nursing will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve remission rates and overall survival for patients with T-cell acute lymphoblastic leukemia and lymphoblastic lymphoma.
How similar studies have performed: Other studies have shown promise with similar chemotherapy combinations, but this specific approach with nelarabine is being evaluated for its unique efficacy.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.