Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma
Conditions
Keywords
Monoclonal Antibody Therapy, Biologic Response Modifier Therapy, CLL, SLL, chemo-care (CC) 5013- Revlimid, Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia
Brief summary
This study will evaluate the safety and effectiveness of a new drug called lenalidomide (Revlimid) for treating patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) who relapsed after their initial treatment. Patients 21 years of age and older with CLL or SLL who have previously received standard treatment may be eligible for this study. Participants take lenalidomide capsules once a day for 21 days, followed by 21 days off the drug. This constitutes one treatment cycle. Treatment continues for four cycles as long as the medicine is tolerated. After four cycles, patients who respond completely continue treatment for another two cycles; patients who respond partially continue treatment for another four cycles; and patients who do not respond stop treatment but continue to be followed for safety. ...
Detailed description
There is evidence that lenalidomide has single agent activity in chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL). Optimal dosing of lenalidomide in CLL has not been established yet. A pilot clinical trial in CLL studied single agent lenalidomide cycled every 4 weeks with 25 mg for three weeks on and one week off drug. In this trial dose reductions have been necessary secondary to prolonged neutropenia or thrombocytopenia in a majority of patients. However, there was also remarkable efficacy and evidence for an immune stimulatory effect of lenalidomide. Therefore, we propose this phase II trial using 20 mg lenalidomide (Revlimid(Registered Trademark)) 3 weeks on and 3 weeks off for 4 cycles in subjects who have been previously treated for chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL). Subjects with at least partial response (PR) may go on to receive 4 additional cycles. The primary objective of the trial is to test the efficacy of a more tolerable dosing scheme of lenalidomide.
Interventions
DRUGLenalidomide
Lenalidomide (Revlimid) regimen testing to determine efficacy for SLL/ CLL subjects
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Georg Aue, M.D.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* INCLUSION CRITERIA: 1. Diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL). 2. Failed prior standard of care therapy for CLL. 3. Neutrophil count (ANC) greater than or equal to 500/microliter (mcL). 4. Platelet count greater than or equal to 20,000/mcL. 5. Age 21-99.
Exclusion criteria
1. Chronic or current clinically significant infection, including HIV positivity or uncontrolled infection. 2. Eastern Cooperative Oncology Group (ECOG) performance greater than 2. 3. Other concurrent anticancer therapies. 4. Less than 4 weeks from last systemic therapy for CLL. Steroids up to 2 weeks before the start of treatment are permissible. 5. Moribund status or concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious, or metabolic disease of such severity that it would preclude the patient's ability to tolerate protocol therapy. 6. Creatinine greater than 1.5 times the upper limit of normal. 7. Women who are pregnant or nursing, as well as women of childbearing potential who are unwilling to use a dual method of contraception. 8. Men who are unwilling to use a barrier protection. 9. Inability to understand the investigational nature of the study; inability to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Establish the Overall Response Rate Measured at 24 Weeks After First Dose of Lenalidomide Using This Dosing Regimen | 24 weeks of lenalidomide therapy | To establish the overall response rate based on peripheral blood measures (absolute neutrophil count, platelets, and/or hemoglobin), lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; and bone marrow biopsy measured at 24 weeks after first dose of lenalidomide using this dosing regimen |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CLL Subjects Response to Lenalidomide (Revlimid) To establish a response rate to lenalidomide (Revlimid) in subjects with chronic lymphocytic leukemia (CLL)/ small lymphocytic leukemia (SLL) using a 3 week on, 3 week off dosing regimen. The responses will be categorized using the revised 1996 National Cancer Institute - sponsored working guidelines. The response rate will be based on changes in peripheral blood measures (ANC, platelets and/or hemoglobin), lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; and bone marrow biopsy measured at 24 weeks after the first dose of lenalidomide using the protocol dosing regimen. Complete responders will respond to treatment after 2 cycles. Partial responders will respond to treatment after 4 cycles. | 33 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 28 |
Baseline characteristics
| Characteristic | CLL Subjects Response to Lenalidomide (Revlimid) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 14 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 26 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 32 / 33 |
| serious Total, serious adverse events | 8 / 33 |
Outcome results
Primary
To Establish the Overall Response Rate Measured at 24 Weeks After First Dose of Lenalidomide Using This Dosing Regimen
To establish the overall response rate based on peripheral blood measures (absolute neutrophil count, platelets, and/or hemoglobin), lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; and bone marrow biopsy measured at 24 weeks after first dose of lenalidomide using this dosing regimen
Time frame: 24 weeks of lenalidomide therapy
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CLL Subject Response Rate After Lenalidomide Therapy | To Establish the Overall Response Rate Measured at 24 Weeks After First Dose of Lenalidomide Using This Dosing Regimen | Complete response | 0 participants |
| CLL Subject Response Rate After Lenalidomide Therapy | To Establish the Overall Response Rate Measured at 24 Weeks After First Dose of Lenalidomide Using This Dosing Regimen | Partial response | 5 participants |
| CLL Subject Response Rate After Lenalidomide Therapy | To Establish the Overall Response Rate Measured at 24 Weeks After First Dose of Lenalidomide Using This Dosing Regimen | No response | 28 participants |