At a glance
ClinicalIndex Comparison Record- ✓Confirmed B-cell CLL with CD5+ B cells, surface immunoglobulin expression, and peripheral blood absolute lymphocyte count >5,000/mm³
- ✓Evidence of disease requiring chemotherapy: symptomatic (weight loss ≥10%, extreme fatigue, fever >100.5°F for 2 weeks, night sweats) OR marrow failure (hemoglobin ≤10 g/dL, platelets ≤100,000/mm³) OR splenomegaly/adenopathy OR progressive lymphocytosis
- ✓Demonstrated progression after at least 1 prior course of alkylating agent or purine nucleoside (e.g., fludarabine) regimen, or failed to achieve meaningful response, or relapsed after prior therapy
- ✓Age ≥18 years
- ✕Bone marrow dysplasia related to prior therapy
- ✕NYHA Class III or IV heart failure
- ✕Prior lenalidomide therapy
- ✕Other malignancy within past 2 years except squamous cell or basal cell skin cancer or carcinoma in situ of cervix
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Trial of Pentostatin, Cyclophosphamide and Rituximab (PCR) Followed by Campath-1H for Previously Treated Relapsed or Refractory Patients With Chronic Lymphocytic Leukemia
In Brief
A Phase 2 clinical trial evaluating rituximab, cyclophosphamide, and 2 other interventions for Leukemia. Completed, enrolled 102 participants across 143 sites.
Detailed Summary
RATIONALE: Drugs used in chemotherapy, such as pentostatin, cyclophosphamide, and CAMPATH-1H work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well pentostatin, cyclophosphamide, rituximab, and CAMPATH-1H work in treating patients with relapsed or refractory B-cell chronic lymphocytic leukemia.