A Phase 2 interventional study of Lenalidomide in Chronic Lymphocytic Leukemia, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-10.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
The goal of this clinical research study is to learn if Revlimid (lenalidomide) can help to reduce the level of leukemia in your body. The safety of this drug will also be studied.
The Study Drug:
Lenalidomide is designed to change the body's immune system and may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may decrease or prevent the growth of cancer cells.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take lenalidomide by mouth every night each day for up to 12 months. You should swallow lenalidomide capsules whole, with water, at the same time each day. Do not break, chew, or open the capsules. If you miss a dose of lenalidomide, take it as soon as you remember on the same day. If you miss a dose, it should not be made up on another day.
The dose and schedule of lenalidomide may be changed, depending on the side effects you may experience.
Study Visits:
Once a week during the first 4 weeks, blood (about 1 tablespoon) will be drawn for routine tests. Blood may be drawn more often if the dose of lenalidomide needs to be changed or if you experience side effects.
After the first 4 weeks, blood (about 1 tablespoon) will be drawn for routine tests every 2 weeks until the doctor thinks your dose of lenalidomide will not change. After this, blood (about 1 tablespoon) will then be drawn every 4 weeks for routine tests.
On Month 4 and 12 (+14 days), you will have a physical exam and blood (about 2-3 teaspoons) will be drawn to check the status of the disease.
On Month 4 and 12 (+14 days), and then every 3 months after that (unless your study doctor does not think it is necessary), you will have a bone marrow biopsy and aspirate to check the status of the disease.
Length of Study:
You will continue receiving the study drug for up to 12 months. You will continue having study visits for as long as the disease remains stable. You will be taken off study early if the disease gets worse or intolerable side effects occur.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 33 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Lenalidomide 10 mg daily given for 12 months.
Drug: Lenalidomide
10 mg daily given for 12 months
Also known as: Revlimid
Improvement in Quality of Remission: Number of Participants With Response Versus No Response by NCI Working Group Criteria Disease Status Change at Start/End of Lenalidomide Consolidation
To evaluate ability of lenalidomide to improve quality of remission (e.g. from partial remission (PR) to complete remission (CR)), disease status assessed at start \& end of Lenalidomide consolidation. NCI Working Group Response Criteria: Participants who began therapy in PR, improvement of status to nodular partial remission (nPR) or CR; Participants in nPR (otherwise CR, bone marrow nodules identified histologically), improvement of status to CR. Participants in CR, resolution of measurable disease in blood \&/or bone marrow per immuno flow cytometry or PCR testing. Progressive Disease (PD): One or more of following: \>50% increase in sum of products of =/\>2 lymph nodes on 2 consecutive examinations; One+ node must be \>2 cm or appearance of new enlarged lymph nodes; \>50% increase in liver \&/or spleen as determined by physical examination/appearance of splenomegaly not previously present; \>50% increase in circulating lymphocytes with absolute count \>10,000.
Time frame: Baseline to 12 Months, Disease status assessed at Start/End of Lenalidomide Consolidation
Response Assessments: Disease Status at the End of Lenalidomide Consolidation Per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Response Criteria
Complete remission (CR), requiring absence of peripheral blood clonal lymphocytes by immunophenotyping, absence of lymphadenopathy, absence of hepatomegaly or splenomegaly, absence of constitutional symptoms and satisfactory blood counts; positive or negative minimal residual disease (MRD); Partial remission (PR), defined as ≥ 50% fall in lymphocyte count, ≥ 50% reduction in lymphadenopathy or ≥ 50% reduction in liver or spleen, together with improvement in peripheral blood counts; Nodular Partial Remission (nPR) is CR with bone marrow nodules identified histologically. Progressive disease (PD), defined as ≥ 50% rise in lymphocyte count to \> 5 x109/L, ≥ 50% increase in lymphadenopathy, ≥ 50% increase in liver or spleen size, Richter's transformation, or new cytopenias due to CLL; Stable disease, defined as not meeting criteria for CR, PR or PD.
Time frame: 12 Months, Disease status assessed at the End of Lenalidomide Consolidation
Time to Progression
Time from the start of study drug therapy to the first documentation of disease progression. Progressive disease characterized by at least one of the following: \>50% increase in the sum of products of at least 2 lymph nodes on 2 consecutive examinations. At least one node larger than 2 cm. Or, appearance of new enlarged lymph nodes. \>50% increase in size of liver and/or spleen as determined by physical examination or appearance of splenomegaly which was not previously present. \>50% increase in number of circulating lymphocytes with absolute count of at least 10,000.
Time frame: From baseline to 12 months
Recruitment Period: February 28, 2008 to January 7, 2015. All recruitment done at The University of Texas MD Anderson Cancer Center.
| Milestone | Lenalidomide |
|---|---|
| Started | 33 |
| Completed | 31 |
| Not completed | 2 |
| Withdrew: Withdrawal by subject | 2 |
To evaluate ability of lenalidomide to improve quality of remission (e.g. from partial remission (PR) to complete remission (CR)), disease status assessed at start \& end of Lenalidomide consolidation. NCI Working Group Response Criteria: Participants who began therapy in PR, improvement of status to nodular partial remission (nPR) or CR; Participants in nPR (otherwise CR, bone marrow nodules identified histologically), improvement of status to CR. Participants in CR, resolution of measurable disease in blood \&/or bone marrow per immuno flow cytometry or PCR testing. Progressive Disease (PD): One or more of following: \>50% increase in sum of products of =/\>2 lymph nodes on 2 consecutive examinations; One+ node must be \>2 cm or appearance of new enlarged lymph nodes; \>50% increase in liver \&/or spleen as determined by physical examination/appearance of splenomegaly not previously present; \>50% increase in circulating lymphocytes with absolute count \>10,000.
| participants | Lenalidomide |
|---|---|
| Response | 10 |
| No Response | 21 |
Complete remission (CR), requiring absence of peripheral blood clonal lymphocytes by immunophenotyping, absence of lymphadenopathy, absence of hepatomegaly or splenomegaly, absence of constitutional symptoms and satisfactory blood counts; positive or negative minimal residual disease (MRD); Partial remission (PR), defined as ≥ 50% fall in lymphocyte count, ≥ 50% reduction in lymphadenopathy or ≥ 50% reduction in liver or spleen, together with improvement in peripheral blood counts; Nodular Partial Remission (nPR) is CR with bone marrow nodules identified histologically. Progressive disease (PD), defined as ≥ 50% rise in lymphocyte count to \> 5 x109/L, ≥ 50% increase in lymphadenopathy, ≥ 50% increase in liver or spleen size, Richter's transformation, or new cytopenias due to CLL; Stable disease, defined as not meeting criteria for CR, PR or PD.
| participants | Assessment at End of Consolidation |
|---|---|
| CR, MRD Positive or Negative | 13 |
| PR | 8 |
| nPR | 7 |
| PD | 1 |
Time from the start of study drug therapy to the first documentation of disease progression. Progressive disease characterized by at least one of the following: \>50% increase in the sum of products of at least 2 lymph nodes on 2 consecutive examinations. At least one node larger than 2 cm. Or, appearance of new enlarged lymph nodes. \>50% increase in size of liver and/or spleen as determined by physical examination or appearance of splenomegaly which was not previously present. \>50% increase in number of circulating lymphocytes with absolute count of at least 10,000.
| Months | Lenalidomide |
|---|---|
| Time to Progression | 8 (6.6 to 9.4) |
Collected over Adverse event collection for 12 months of treatment.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lenalidomide | — | 8/33 (24.2%) | 27/33 (81.8%) |
| Event | Lenalidomide |
|---|---|
| NeutropeniaBlood and lymphatic system disorders | 8/33 |
| THROMBOSIS/THROMBUS/EMBOLISMVascular disorders | 2/33 |
| ThrombocytopeniaBlood and lymphatic system disorders | 1/33 |
| Pulmonary EmbolusRespiratory, thoracic and mediastinal disorders | 1/33 |
| Infections, Respiratory syncytial virus (RSV)Infections and infestations | 1/33 |
| PNEUMONITISRespiratory, thoracic and mediastinal disorders | 1/33 |
| Event | Lenalidomide |
|---|---|
| HEMOGLOBIN INCREASEDInvestigations | 18/33 |
| Neutrophils, AGC (absolute granulocyte counts) IncreasedBlood and lymphatic system disorders | 17/33 |
| FATIGUEGeneral disorders | 16/33 |
| LeukocytosisBlood and lymphatic system disorders | 13/33 |
| Platelet count decreasedInvestigations | 12/33 |
| METABOLIC/LABORATORY (OTHER)Metabolism and nutrition disorders | 10/33 |
| DIARRHEAGastrointestinal disorders | 9/33 |
| COUGHRespiratory, thoracic and mediastinal disorders | 8/33 |
| RASH/DESQUAMATIONSkin and subcutaneous tissue disorders | 8/33 |
| PAINGeneral disorders | 8/33 |
| Age, Continuous(years) | Lenalidomide |
|---|---|
| Median | 59 (39 to 80) |
| Sex: Female, Male(Participants) | Lenalidomide |
|---|---|
| Female | 11 |
| Male | 22 |
| Race (NIH/OMB)(Participants) | Lenalidomide |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 32 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Lenalidomide |
|---|---|
| United States | 33 |
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center