NCT01919619

Lenalidomide and Ipilimumab After Stem Cell Transplant in Treating Patients With Hematologic or Lymphoid Malignancies

A Pilot Study of Lenalidomide Alternating With Ipilimumab Post Allogeneic and Autologous Stem Cell Transplantation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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-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.

Conditions

• B-Cell Non-Hodgkin Lymphoma
• Hematopoietic and Lymphoid Cell Neoplasm
• Leukemia
• Lymphoma
• Plasma Cell Myeloma
• T-Cell Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	Ipilimumab	Given IV
DRUG	Lenalidomide	Given PO

Timeline

• Start date: 2013-11-04
• Primary completion: 2024-05-03
• Completion: 2024-05-03
• First posted: 2013-08-09
• Last updated: 2024-12-03
• Results posted: 2024-12-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study