Clinical trial · Interventional
Pentostatin, and Rituximab With and Without Cyclophosphamide for Previously Untreated B-Chronic Lymphocytic Leukemia
Phase II Trial of Pentostatin, and Rituximab With and Without Cyclophosphamide for Previously Untreated B-Chronic Lymphocytic Leukemia (CLL)
NCT00201721CI-TRIAL-00025853completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-Chronic Lymphocytic Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Pentostatin | Drug | Pentostatin | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To assess the rate of complete and overall response using rituximab and pentostatin with and without cyclophosphamide.
- timeFrame
- up to 5 years
- description
- For this evaluation, patients will be classified as complete responders if either of the following types of response are documented * CCR (Clinically based complete remission) denotes NED (No Evidence of Disease) based on baseline clinical parameters. * CR denotes CCR and, in bone marrow, no nodules and \<30% lymphocytes.
Secondary outcomes (1)
- measure
- To monitor and assess toxicity of this regimen.
- timeFrame
- up to 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (3)
- BACKGROUNDKay NE, Geyer SM, Call TG, Shanafelt TD, Zent CS, Jelinek DF, Tschumper R, Bone ND, Dewald GW, Lin TS, Heerema NA, Smith L, Grever MR, Byrd JC. Combination chemoimmunotherapy with pentostatin, cyclophosphamide, and rituximab shows significant clinical activity with low accompanying toxicity in previously untreated B chronic lymphocytic leukemia. Blood. 2007 Jan 15;109(2):405-11. doi: 10.1182/blood-2006-07-033274. Epub 2006 Sep 28. PMID 17008537
- RESULTKay NE, Wu W, Kabat B, LaPlant B, Lin TS, Byrd JC, Jelinek DF, Grever MR, Zent CS, Call TG, Shanafelt TD. Pentostatin and rituximab therapy for previously untreated patients with B-cell chronic lymphocytic leukemia. Cancer. 2010 May 1;116(9):2180-7. doi: 10.1002/cncr.25028. PMID 20187101
- RESULTShanafelt TD, Lin T, Geyer SM, Zent CS, Leung N, Kabat B, Bowen D, Grever MR, Byrd JC, Kay NE. Pentostatin, cyclophosphamide, and rituximab regimen in older patients with chronic lymphocytic leukemia. Cancer. 2007 Jun 1;109(11):2291-8. doi: 10.1002/cncr.22662. PMID 17514743