Randomized Phase II Trial of Rituximab With Either Pentostatin or Bendamustine for Multiply Relapsed or Refractory Hairy Cell Leukemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01059786|
Recruitment Status : Recruiting
First Posted : February 1, 2010
Last Update Posted : December 20, 2017
- Researchers are attempting to develop new treatments for hairy cell leukemia (HCL) that has not responded well to or has recurred after standard HCL therapies. One nonstandard treatment for HCL is rituximab, an antibody that binds to the cancer cells and helps the immune system destroy them. By combining rituximab with other anti-cancer drugs, researchers hope to determine whether the combined drugs are successful in treating HCL.
- Pentostatin and bendamustine are two anti-cancer drugs that have been used to treat different kinds of blood and immune system cancers. Bendamustine is approved to treat other kinds of leukemia and lymphoma, but it has not been used to treat HCL. Pentostatin has been used for more than 20 years to treat HCL, but it has not been combined with rituximab in official clinical trials.
- To determine whether rituximab with either pentostatin or bendamustine is a more effective treatment for HCL than rituximab alone.
- To determine whether pentostatin or bendamustine is a more effective treatment for HCL when combined with rituximab.
- Individuals at least 18 years of age who have been diagnosed with hairy cell leukemia that has not responded well to or has relapsed after standard HCL therapies.
- The study will last for four treatment cycles of 28 days each.
- Prior to the study, participants will be screened with a full medical history and physical exam, bone marrow biopsy (if one has not been performed in the last 6 months), computed tomography (CT) or ultrasound scan, tumor measurements, and other tests as required by the researchers. Participants will provide blood and urine samples at this time as well.
- Rituximab with bendamustine: Participants will receive rituximab on Days 1 and 15 of each cycle and bendamustine on Days 1 and 2 of each cycle, for a total of four cycles.
- Rituximab with pentostatin: Participants will receive rituximab on Days 1 and 15 of each cycle and pentostatin on rituximab on Days 1 and 15 of each cycle, for a total of four cycles.
- Participants will have regular tests during the treatment cycles, including bone marrow biopsies and CT or ultrasound scans. Participants will also provide regular blood and urine samples to assess the results of treatment.
|Condition or disease||Intervention/treatment||Phase|
|Hairy Cell Leukemia||Drug: Pentostatin Drug: Rituximab Drug: Bendamustine||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||74 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Phase II Trial of Rituximab With Either Pentostatin or Bendamustine for Multiply Relapsed or Refractory Hairy Cell Leukemia|
|Study Start Date :||December 18, 2009|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||December 31, 2018|
Experimental: Arm 1
Rituximab + Bendamustine
Rituximab 375 mg/m2 on day 1, 15 for 6 x 28-day cycles (all 68 patients)Drug: Bendamustine
28 patients to bendamustine 90 mg/m2/day, days 1 and 2 each cycle
Experimental: Arm 2
Rituximab + Pentostatin
28 patients to pentostatin 4 mg/m2 days 1 and 15 of each cycle.Drug: Rituximab
Rituximab 375 mg/m2 on day 1, 15 for 6 x 28-day cycles (all 68 patients)
- To determine if pentostatin + rituximab and bendamustine + rituximab are each associated with adequate response rates (ORR=PR+CR) in patients with relapsed HCL, and, if so, to select which combination is likely to be superior. [ Time Frame: 4 years ]
- Compare rituximab plus either pentostatin or bendamustine in termsof MRD-free survival, disease-free survival, overall survival and toxicity, including to CD4+ T-cells. [ Time Frame: 4 years ]
- Compare the 2 regimens in crossover when used after failure of the1st regimen. [ Time Frame: 4 years ]
- Determine if MRD levels and tumor markers (soluble CD25 and CD22,and RQ-PCR) correlate with response and clinical endpoints, and if bone marrow MRI signal correlates with BMBx results, and whetherthese tests could in some cases possibly re... [ Time Frame: 4 years ]
- Study the mechanism of thrombocytopenia after purine analog plusrituximab. [ Time Frame: 4 years ]
- Study HCL biology by cloning, sequencing and characterizing monoclonal immunoglobulin rearrangements, and other genes. [ Time Frame: 4 years ]
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): NCT01059786
|Contact: Theresa Yu, R.N.||(_30) email@example.com|
|Contact: Robert J Kreitman, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office (888) NCI-1937|
|Principal Investigator:||Robert J Kreitman, M.D.||National Cancer Institute (NCI)|