Phase 2 study of cladribine followed by rituximab in patients with hairy cell leukemia.
Farhad Ravandi, Susan O'Brien, Jeffrey Jorgensen...
https://pubmed.ncbi.nlm.nih.gov/21821712/Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID00412594
Study of Cladribine Followed by Rituximab to Treat Hairy Cell Leukemia Evaluating Treatment Response and Safety
Led by M.D. Anderson Cancer Center · Updated on 2026-06-11
150
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the side effects and effectiveness of combining cladribine and rituximab in treating patients with hairy cell leukemia. This phase II trial focuses on how well this combination works to achieve complete response and eradicate minimal residual disease. The study also examines long-term disease-free and overall survival, along with molecular predictors of outcomes. Participants receive cladribine intravenously over 2 hours daily for five days. Starting on day 28, they receive rituximab intravenously once a week for eight weeks, provided there is no disease progression or unacceptable side effects. After completing the treatment, patients are followed for one year with check-ups every three months. During the trial, participants undergo bone marrow and blood tests to assess treatment response and minimal residual disease. Researchers monitor the effectiveness of rituximab in achieving complete response and its impact on survival up to one year. Safety is also tracked, focusing on serious side effects throughout the study period.
CONDITIONS
Brief Title
Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia
Research Team
F
Farhad Ravandi-Kashani
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