This pilot clinical trial studies the side effects of lenalidomide and ipilimumab after stem cell transplant in treating patients with hematologic or lymphoid malignancies. Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Immunotherapy with monoclonal antibodies, such as ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide with ipilimumab may be a better treatment for hematologic or lymphoid malignancies.
PRIMARY OBJECTIVES: I. To assess the safety of lenalidomide in combination with ipilimumab in autologous and allogeneic stem cell transplantation. SECONDARY OBJECTIVES: I. Overall response rate. II. Overall survival, progression-free survival. III. Cumulative incidence of acute and chronic graft-versus-host disease (GVHD) with the competing risk of relapse in allogeneic transplant patients. OUTLINE: Patients receive lenalidomide orally (PO) once daily (QD) on days 1-21 of courses 1, 3, 5 and 7. Beginning 1-3 days after the last dose of lenalidomide patients receive one dose of ipilimumab intravenously (IV) over 90 minutes of courses 2, 4, 6 and 8. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 1, 3, 6, 12, 24, and 36 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Given IV
Given PO
M D Anderson Cancer Center
Houston, Texas, United States
Number of Participants Experienced Severe Toxicity From Lenalidomide and Ipilimumab Post Transplant
Any grade 4 hematological toxicity or grade 3-5 organ toxicity 30 days following the last dose of study drug.
Time frame: Up to 30 days following the last dose of study drugs
Number of Participants Achieved Complete Remission
CR is defined as a complete resolution of all target lesions by CT scans with complete normalization of FDG-PET uptake in all areas, and bone marrow biopsy negativity.
Time frame: Up to 30 days following the last dose of study drug
Progression-free Survival
Number of participants that are alive and disease free 36 months long post transplant
Time frame: Up to 36 months
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