Status:
COMPLETED
Pentostatin, Cyclophosphamide, and Rituximab Followed By Campath-1H in Patients With Relapsed or Refractory B-Cell CLL
Lead Sponsor:
Eastern Cooperative Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 antibodie...
Detailed Description
OBJECTIVES: Primary * Determine the objective response rate (complete remission, partial remission \[PR\], or nodular PR) in patients with relapsed or refractory B-cell chronic lymphocytic leukemia ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Diagnosis of B-cell chronic lymphocytic leukemia (CLL) meeting the following criteria:
- Peripheral blood absolute lymphocyte count greater than 5,000/mm\^3
- Lymphocytosis must comprise small to moderate size lymphocytes with no greater than 55% prolymphocytes, atypical lymphocytes, or lymphoblasts morphologically
- Phenotypically characterized CLL defined by the following:
- Predominant population of cells share B-cell antigens with CD5 in the absence of other pan-T-cell markers (CD3 or CD2)
- B cell expresses either kappa or lambda light chains
- Surface immunoglobulin with low cell surface density expression
- Requires chemotherapy, as indicated by any of the following:
- Disease-related symptoms
- Weight loss of 10% or more within the past 6 months
- Extreme fatigue
- Fevers greater than 100.5°F for 2 weeks without evidence of infection
- Night sweats without evidence of infection
- Evidence of progressive marrow failure manifested by the development of or worsening anemia (hemoglobin no greater than 10 g/dL) and/or thrombocytopenia (platelet count no greater than 100,000/mm\^3)
- Massive (i.e., greater than 6 cm below left costal margin) or progressive splenomegaly
- Massive nodes or clusters (i.e., greater than 10 cm in longest diameter) or progressive adenopathy
- Progressive lymphocytosis with an increase of greater than 50% over a 2-month period OR an anticipated doubling time of less than 6 months
- Demonstrated progression after at least 1 course of either an alkylating agent-based or purine nucleoside-based (e.g., fludarabine) regimen OR failed to achieve a meaningful response OR relapsed after prior therapy
- Patients who have relapsed after a pentostatin-based regimen are eligible provided the response was greater than 12 months prior to study entry
- 18 and over
- ECOG Performance Status 0-2
- Bilirubin no greater than 2 mg/dL (unless secondary to tumor, hemolysis, or Gilbert syndrome)
- Creatinine no greater than 2.0 mg/dL
- Creatinine clearance ≥ 30 mL/min
- Negative pregnancy test
- Fertile patients must use 2 methods of effective contraception (including 1 barrier method) for at least 28 days before starting lenalidomide, while participating in the study, and for at least 28 days after discontinuation/stopping lenalidomide
- At least 8 weeks since prior rituximab
- At least 6 weeks since prior chemotherapy
- At least 1 year since prior pentostatin, cyclophosphamide, and rituximab (PCR) therapy
- PCR therapy at least 1 year prior to study entry allowed
- Exclusion criteria:
- Bone marrow dysplasia related to prior therapy
- New York Heart Association class III or IV heart failure
- Prior lenalidomide
- Other malignancy within the past 2 years except squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
- Pregnant or nursing
- Concurrent oral or IV antibiotics for active infection
Exclusion
Key Trial Info
Start Date :
April 14 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 6 2018
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00074282
Start Date
April 14 2005
End Date
May 6 2018
Last Update
June 29 2023
Active Locations (143)
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1
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
2
Aurora Presbyterian Hospital
Aurora, Colorado, United States, 80012
3
Boulder Community Hospital
Boulder, Colorado, United States, 80301-9019
4
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States, 80933