Lenalidomide and Ipilimumab After Stem Cell Transplant in Treating Patients With Hematologic or Lymphoid Malignancies
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 30
Summary
- Conditions
- B-cell Non Hodgkin Lymphoma
- Hematopoietic and Lymphoid Cell Neoplasm
- Leukemia
- Lymphoma
- Plasma Cell Myeloma
- T Cell Non-Hodgkin Lymphoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
Description
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-ver...
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.
Tracking Information
- NCT #
- NCT01919619
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Issa Khouri M.D. Anderson Cancer Center
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