This trial is active, not recruiting.

Condition b-chronic lymphocytic leukemia
Treatments pentostatin, rituximab, cyclophosphamide
Phase phase 2
Target CD20
Sponsor John Byrd
Collaborator Astex Pharmaceuticals
Start date July 2002
End date November 2013
Trial size 28 participants
Trial identifier NCT00201721, NCT00423423, OSU-0143


This study aims to assess the rate of complete and overall response using rituximab and pentostatin with and without cyclophosphamide, to monitor and assess toxicity of this regimen, and to determine the overall and progression-free survival in CLL patients

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

To assess the rate of complete and overall response using rituximab and pentostatin with and without cyclophosphamide.
time frame: up to 5 years

Secondary Outcomes

To monitor and assess toxicity of this regimen.
time frame: up to 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Diagnosis of B-CLL (no mantle cell) - Must have active disease - Age >=18 yo - ECOG 0-3 - No radiation or surgery <4 weeks Exclusion Criteria: - Any of the following comorbid conditions: - New York Heart Association Class III or IV heart disease - Recent myocardial infarction (<1 month) - Uncontrolled infection - Active infection with the human immunodeficiency virus (HIV/AIDS) as further severe immunosuppression with this regimen may occur. - Pregnant or nursing women - Men or women of child bearing potential must use adequate contraception. - Active primary malignancy requiring treatment or limits survival to ≤2 years. - Any radiation therapy ≤4 weeks prior to study entry. - Any major surgery ≤4 weeks prior to study entry.

Additional Information

Official title Phase II Trial of Pentostatin, and Rituximab With and Without Cyclophosphamide for Previously Untreated B-Chronic Lymphocytic Leukemia (CLL)
Principal investigator John Byrd
Description Rationale: Research indicates that both cyclophosphamide and pentostatin work synergistically against cancer cells and have a high response rate against chronic lymphocytic leukemia (CLL) without creating severe side effects in patients. In addition, studies have shown that rituximab, a therapy that targets the immune system, has the highest efficacy against CLL and the lowest toxicity rate when compared with other immunotherapy drugs. Studies also show that rituximab enhances the efficacy of the chemotherapy agents cyclophosphamide and pentostatin. This study offers the combination of immunotherapy with two promising chemotherapy agents against CLL. Purpose: This study is evaluating the efficacy and safety of combination treatment with cyclophosphamide, pentostatin, and rituximab in patients with CLL. Several tests evaluating the genetic and molecular components of CLL will also be performed. Some of these tests will be conducted before, during, and after treatments to assess changes resulting from the study drugs. Each patient's outcome will be assessed in relation to various aspects of their genes.
Trial information was received from ClinicalTrials.gov and was last updated in June 2012.
Information provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center.