Lenalidomide After Donor Bone Marrow Transplant in Treating Patients With High-Risk Hematologic Cancers

Completed · Phase 1

Conditions studied: Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1, Adult Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A, Adult Acute Promyelocytic Leukemia With PML-RARA, Adult Grade III Lymphomatoid Granulomatosis, Adult Nasal Type Extranodal NK/T-Cell Lymphoma, Alkylating Agent-Related Acute Myeloid Leukemia, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-Cell Lymphoma, Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue, Hepatosplenic T-Cell Lymphoma, Intraocular Lymphoma, Lymphomatous Involvement of Non-Cutaneous Extranodal Site, Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Nodal Marginal Zone Lymphoma, Post-Transplant Lymphoproliferative Disorder, Primary Cutaneous B-Cell Non-Hodgkin Lymphoma, Prolymphocytic Leukemia, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Grade III Lymphomatoid Granulomatosis, Recurrent Adult Immunoblastic Lymphoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Adult T-Cell Leukemia/Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Mycosis Fungoides and Sezary Syndrome, Recurrent Non-Hodgkin Lymphoma, Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Refractory Hairy Cell Leukemia, Richter Syndrome, Small Intestinal Lymphoma, Splenic Marginal Zone Lymphoma, T-Cell Large Granular Lymphocyte Leukemia, Testicular Lymphoma, Waldenstrom Macroglobulinemia

In brief

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.

Key facts

Study ID

NCT01254578

Run by

National Cancer Institute (NCI)

People needed

17

Starts

2010-11-24

Expected to finish

2012-11-09

Last updated by the study team

2017-09-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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