Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
A Phase 1 Study of Lenalidomide Maintenance Following Allogeneic Hematopoietic Cell Transplantation in Patients With Select High Risk Hematological Malignancies
Verified date | September 2017 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This phase I clinical trial is studying the side effects and the best dose of lenalidomide after donor bone marrow transplant in treating patients with high-risk hematologic cancer. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing.
Status | Completed |
Enrollment | 17 |
Est. completion date | November 9, 2012 |
Est. primary completion date | November 9, 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologically confirmed hematologic malignancy meeting 1 of the following criteria: - High-risk acute myeloid leukemia meeting 1 the following criteria: - First complete response (CR) and = 60 years of age OR < 60 years of age with high-risk cytogenetics as defined by CALGB OR high-molecular risk and not eligible or willing to undergo myeloablative conditioning - Second or later complete remission - Not in remission but with < 5% blasts within 3 weeks of start of conditioning chemotherapy for allogeneic transplantation - Patients with a history of CNS involvement allowed provided disease is in remission at the time of transplantation - Patients with non-Hodgkin lymphoma who are candidates for allogeneic stem cell transplantation will be eligible; patients who have relapsed status post autologous transplantation are eligible as long as they demonstrate chemotherapy sensitive disease; patients with a history of CNS involvement are eligible if this aspect of the disease is in remission at the time of transplantation - High-risk chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or primary and secondary B-prolymphocytic leukemia (PLL) meeting 1 of the following criteria: - del(17p13.1) disease that has been treated (may have been given as consolidation therapy) - Less than PR to chemoimmunotherapy or relapsed within 2 years of treatment - Nucleoside analog refractory disease or disease that relapsed after two prior regimens - Patients with Richter (large cell) transformation allowed provided the large cell component of the disease is in remission (< 10% large cells in the bone marrow allowed) - Patient has undergone an allogeneic stem cell transplantation using a reduced-intensity or non-myeloablative conditioning regimen within the past 60 days - At least 40% T-cell donor chimerism at day 30 - ECOG performance status 0-2 (Karnofsky 60-100%) - Life expectancy > 3 months - Myeloid engraftment with absolute neutrophil count > 1,000/µL and platelet count > 50,000/µL (after allogeneic hematopoietic stem cell transplantation [AHSCT]) - Total bilirubin normal - AST and ALT = 2.5 times upper limit of normal (ULN) - AST < 3 times ULN after AHSCT - Creatinine clearance = 50 mL/min in stratum 1 or = 30 mL/min in stratum 2 - DLCO > 40% with no symptomatic pulmonary disease - LVEF = 30% by echocardiogram or MUGA - Not pregnant or nursing - Negative pregnancy test - Fertile patients must agree to use two acceptable methods of contraception (one highly effective method and one additional effective method) or practice abstinence for = 28 days before, during, and = 28 days after completing lenalidomide - HIV negative - No uncontrolled infection requiring intravenous therapy or poorly controlled diabetes mellitus - No history of allergic reactions attributed to compounds of similar chemical or biologic composition to lenalidomide - No uncontrolled intercurrent illness including, but not limited to, any of the following: - Ongoing or active infection - Symptomatic congestive heart failure - Unstable angina pectoris - Cardiac arrhythmia - Psychiatric illness and/or social situations that would limit compliance with study requirements - No history of grade 3 or 4 graft-vs-host disease (GVHD) - If patient has acute GVHD grade 1 or 2, GVHD must be controlled and dose of oral prednisone or equivalent = 20 mg per day (after AHSCT) - More than 4 weeks since prior chemotherapy (excluding steroids), radiotherapy, or radioimmunoconjugate therapy (6 weeks for nitrosoureas or mitomycin C) and recovered - No other concurrent investigational agents |
Country | Name | City | State |
---|---|---|---|
United States | Ohio State University Comprehensive Cancer Center | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MTD of lenalidomide after allogeneic hematopoietic stem cell transplantation graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 | Up to day 28 | ||
Secondary | Overall response in patients treated with lenalidomide according to the International Working Group (IWG) criteria | Estimated using exact binomial methods along with its confidence interval. The non-parametric Wilcoxon signed-rank procedure will be used to compare to baseline values for correlative studies. | Up to day 365 |
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