Combining cladribine and rituximab to treat hairy cell leukemia
Phase II Study of 2-Chlorodeoxyadenosine (2CDA) Followed by Rituximab in Hairy Cell Leukemia
This study is testing if combining two drugs, cladribine and rituximab, can effectively treat hairy cell leukemia, especially in patients whose cancer has come back.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, rituximab, Immunotherapy |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT00412594 on ClinicalTrials.gov |
What this trial studies
This phase II trial investigates the effectiveness and side effects of cladribine and rituximab in treating patients with hairy cell leukemia, including those with recurrent disease. The study involves administering cladribine intravenously for five days, followed by rituximab weekly for eight weeks. The primary objectives include assessing the complete response rate, the eradication of minimal residual disease, and the long-term disease-free and overall survival rates. Additionally, the trial aims to identify potential predictors of treatment outcomes through molecular evaluations.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with hairy cell leukemia, including those with relapsed disease who have had no more than one prior therapy.
Not a fit: Patients with active infections, central nervous system metastases, or significant heart disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment combination could lead to improved response rates and survival outcomes for patients with hairy cell leukemia.
How similar studies have performed: Other studies have shown promising results with similar combinations of chemotherapy and immunotherapy in treating various cancers, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years and older * Diagnosis of hairy cell leukemia (HCL) established by bone marrow examination * Patients with relapsed disease are eligible if they have had no more than one prior therapy * Women of child-bearing potential must use birth control (oral contraceptive, barrier, abstinence or any other acceptable method) for the duration of the study * Performance status =\< 3 * Creatinine less than or equal to 2.0 unless related to the disease * Bilirubin less than or equal to 3.0 * Transaminases less than or equal 3 x upper limit of normal unless related to the disease * No prior investigational agent in the 4 weeks prior to initiation of therapy Exclusion Criteria: * Unable or unwilling to sign the consent form * Known infection with human immunodeficiency virus (HIV), hepatitis B or C * Presence of active infection * Presence of central nervous system (CNS) metastases * New York Heart Association classification III or IV heart disease * Prior chemotherapy (last 4 weeks)
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
- Email: fravandi@mdanderson.org
- Phone: 713-792-7305
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.