Phase 2
N=45
Lenalidomide With or Without Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00096044 ↗Enrolled (actual)
45
Serious AEs
64.4%
Results posted
Jul 2017
Primary outcome: Primary: Percentage of Patients Achieving a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) on Single Agent CC-5013 at 6 Months — 68.9 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- rituximab (Biological); lenalidomide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Roswell Park Cancer Institute
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Achieving a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) on Single Agent CC-5013 at 6 Months |
68.9 | — |
| SECONDARY Percentage of Patients Achieving a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) on Combination Therapy of CC-5013+Rituximab |
100 | — |
| SECONDARY Number of Participants With Adverse Events on Single Agent CC-5013 |
0; 3; 7; 33; 2 | — |
| SECONDARY Number of Participants With Adverse Events on Combination Therapy of CC-5013+Rituximab |
1; 0; 3; 3 | — |
| SECONDARY Time to Progression for Single Agent CC-5013 |
23.0 | — |
| SECONDARY Time to Progression for the Combination Therapy of CC-5013+Rituximab |
18.7 | — |
Summary
RATIONALE: Biological therapies such as lenalidomide use different ways to stimulate the immune system and stop cancer cells from growing. 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 lenalidomide with rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying the how well giving lenalidomide with or without rituximab works in treating patients with relapsed or refractory chronic lymphocytic leukemia.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of chronic lymphocytic leukemia (CLL) by flow cytometry
- Relapsed or refractory disease
- Measurable disease, defined by 1 of the following criteria:
- Absolute lymphocyte count ≥ 5,000/mm^3
- Measurable lymphadenopathy or organomegaly
- Received ≥ 1 prior therapy for CLL
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- See Disease Characteristics
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 30,000/mm^3
Hepatic
- Bilirubin ≤ 1.5 mg/dL
- AST and ALT ≤ 2 times upper limit of normal (ULN) (5 times ULN if hepatic metastases are present)
Renal
- Creatinine ≤ 1.5 mg/dL
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective double-method (including barrier) contraception during and for 3 months after study participation
- No known hypersensitivity to thalidomide
- No erythema nodosum characterized by a desquamating rash after prior thalidomide or similar drug administration
- No known anaphylaxis or immunoglobulin E-mediated hypersensitivity to murine proteins
- No serious medical condition or laboratory abnormality that would preclude study participation
- No psychiatric illness that would preclude giving informed consent
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior lenalidomide (CC-5013)
- No concurrent thalidomide
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- No concurrent radiotherapy
Surgery
- Not specified
Other
- At least 4 weeks since prior therapy for CLL
- At least 28 days since prior experimental drug or therapy
- No other concurrent anticancer therapies
- No other concurrent investigational agents
Data sourced from ClinicalTrials.gov (NCT00096044). 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.