Pentostatin, Cyclophosphamide, and Rituximab Followed By Campath-1H in Patients With Relapsed or Refractory B-Cell CLL

• Status: Completed
• Trial end date: 2018-05-06
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eastern Cooperative Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Alemtuzumab; Cyclophosphamide; Lenalidomide; Pentostatin; Rituximab; Thalidomide

Criteria

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