Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia
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|ClinicalTrials.gov Identifier: NCT00412594|
Recruitment Status : Recruiting
First Posted : December 18, 2006
Last Update Posted : October 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hairy Cell Leukemia Recurrent Hairy Cell Leukemia||Drug: Cladribine Other: Laboratory Biomarker Analysis Biological: Rituximab||Phase 2|
I. To demonstrate the efficacy in achieving complete response of combination of cladribine administered intravenously over 2 hours for 5 days followed by rituximab weekly for 8 weeks in patients with untreated or previously treated hairy cell leukemia.
II. To examine the efficacy of rituximab to eradicate minimal residual disease (MRD) after cladribine therapy (as assessed by immunophenotyping of bone marrow and peripheral blood).
III. To examine the effect of addition of rituximab to cladribine on the long term disease-free (DFS) and overall survival (OS) (as compared with historical controls).
IV. To evaluate potential predictors of outcome including molecular and flow evaluations of MRD, as well as other potential molecular predictors such as v-raf murine sarcoma viral oncogene homolog B1 (BRAF).
Patients receive cladribine intravenously (IV) over 2 hours once daily (QD) on days 1-5 and rituximab IV once weekly for 8 weeks beginning on day 28 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of 2-Chlorodeoxyadenosine (2CDA) Followed by Rituximab in Hairy Cell Leukemia|
|Actual Study Start Date :||June 10, 2004|
|Estimated Primary Completion Date :||June 30, 2023|
|Estimated Study Completion Date :||June 30, 2023|
Experimental: Treatment (cladribine and rituximab)
Patients receive cladribine IV over 2 hours QD on days 1-5 and rituximab IV once weekly for 8 weeks beginning on day 28 in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
- Efficacy of rituximab on achievement of complete response after therapy with cladribine [ Time Frame: At 12 weeks ]Defined as the absence of hairy cells in the bone marrow or the presence of less than 1 percent atypical cells and the disappearance of all evidence of hairy cell leukemia on physical examination. Monitored using the method of Thall, Simon, Estey as extended by Thall and Sung.
- Grade 3-4 therapy related toxicity [ Time Frame: Up to 1 year ]Monitored using the method of Thall, Simon, Estey as extended by Thall and Sung.
- Efficacy of rituximab in eradication of minimal residual disease after cladribine therapy, assessed by immunophenotyping of bone marrow and peripheral blood [ Time Frame: Up to 4 weeks after the last dose of rituximab ]The method of Thall, Simon, Estey as extended by Thall and Sung will be used for efficacy and safety monitoring.
- Efficacy of rituximab on prolongation of event-free survival [ Time Frame: Up to 1 year ]
- Efficacy of rituximab on prolongation of overall survival [ Time Frame: Up to 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00412594
|Contact: Farhad Ravandi-Kashani, MDfirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Farhad Ravandi-Kashani 713-792-7305 email@example.com|
|Principal Investigator: Farhad Ravandi-Kashani|
|Principal Investigator:||Farhad Ravandi-Kashani||M.D. Anderson Cancer Center|