Phase 2
N=44
Rituximab, Pentostatin, Cyclophosphamide, and Lenalidomide in Treating Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Leukemia · Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00602836 ↗Enrolled (actual)
44
Serious AEs
20.5%
Results posted
Apr 2012
Primary outcome: Primary: Number of Participants With Complete Response (CR) — 14 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Rituximab (Biological); Cyclophosphamide (Drug); Lenalidomide (Drug); Pentostatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Complete Response (CR) |
14 | — |
| SECONDARY Number of Participants Who Convert From a Nodular Partial Response (nPR), Partial Response (PR), or Stable Disease (SD) After Pentostatin, Cyclophosphamide, and Rituximab (PCR) to a Complete Response (CR) After 6 Courses of Consolidation With Lenalidomide |
5 | — |
| SECONDARY Number of Participants Who Convert From a CR With Minimal Residual Disease (MRD) Positive Status After PCR to a CR With MRD-negative Status After 6 Courses of Consolidation With Lenalidomide |
4 | — |
| SECONDARY Number of Participants With a Response (CR, nPR, PR) |
38 | — |
| SECONDARY Overall Survival (OS) |
NA | — |
| SECONDARY Treatment Free Survival (TFS) |
NA | — |
Summary
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as pentostatin and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Lenalidomide may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving rituximab together with combination chemotherapy and lenalidomide may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving rituximab together with pentostatin, cyclophosphamide, and lenalidomide works in treating patients with previously untreated B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), meeting the following criteria:
- Biopsy-proven SLL according to WHO criteria
- CLL diagnosis* according to NCI working group criteria as evidenced by all of the following:
- Peripheral blood lymphocyte count of > 5,000/mm³
- Small to moderate peripheral blood lymphocyte with 10% within the previous 6 months
- Extreme fatigue attributed to CLL
- Fevers > 100.5º F for 2 weeks without evidence of infection
- Night sweats without evidence of infection
- Evidence of progressive marrow failure as manifested by the development of or worsening anemia (i.e., hemoglobin ≤ 11 g/dL) and/or thrombocytopenia (i.e., platelet count ≤ 100,000/mm³) not due to autoimmune disease
- Symptomatic or progressive lymphadenopathy, splenomegaly, or hepatomegaly
- Progressive lymphocytosis due to CLL with an increase of > 50% over a 2-month period or an anticipated doubling time 3.0 times ULN
- AST and ALT ≤ 3.0 times ULN (unless due to hemolysis or CLL)
- Willing to provide blood samples
- Able to take acetylsalicylic acid (ASA) (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use low molecular weight heparin)
- Not pregnant or nursing
- Negative pregnancy test
- Female patients must use effective double-method contraception beginning 1 month prior to, during, and for 4 weeks after completion of study treatment
- Male patients must use effective contraception during and for 4 weeks after completion of study treatment
- No comorbid conditions, including any of the following:
- New York Heart Association class III or IV heart disease
- Recent myocardial infarction (< 1 month)
- Uncontrolled infection
- Infection with HIV/AIDS
- No other active primary malignancy requiring treatment or that limits survival to ≤ 2 years
- No history of deep venous thrombosis or pulmonary embolism ≤ 12 months prior to study registration
- No active hemolytic anemia requiring immunosuppressive or other pharmacologic therapy
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy or monoclonal antibody-based therapy for treatment of CLL
- Nutraceutical treatments with no established benefit in CLL (e.g., epigallocatechin gallate or other herbal treatments) are not considered prior therapy
- More than 4 weeks since prior radiotherapy
- At least 4 weeks since prior major surgery
- No concurrent corticosteroids
- Concurrent low doses of steroids (e.g., < 10 mg of prednisone or equivalent dose of other steroid) used for treatment of non-hematologic medical conditions allowed
- Prior use of corticosteroids allowed
- No prior thalidomide or lenalidomide
- No concurrent therapeutic doses of coumadin-derivative anticoagulants (e.g., warfarin)
- Doses of ≤ 2 mg daily allowed for thrombosis prophylaxis
- Prophylactic doses of low molecular weight heparin allowed
Data sourced from ClinicalTrials.gov (NCT00602836). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.