NCT01615042

Phase I Study of Lenalidomide in Patients With Acute Leukemia

Phase I Trial of High Dose Lenalidomide in Patients With Refractory/Relapsed Acute Leukemia as a Bridge to Bone Marrow Transplant

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Mehrdad Abedi, MD · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Lenalidomide is a drug that alters the immune system and it may also be directly toxic to tumor. Therefore, in theory, it may reduce or prevent the growth of cancer cells or directly kill them. We will be studying how lenalidomide can be used to decrease bone marrow blast cells in preparation for a bone transplant.

Detailed description

We hypothesize that lenalidomide in high doses can be used to decrease bone marrow blast count in patients with relapsed or refractory acute myeloid leukemia in preparation for an allogeneic stem cell transplant with acceptable toxicities that are no worse than current cytotoxic chemotherapeutic agents. The known dose-limiting toxicity at 75 mg was excessive fatigue in a previous phase I trial which in this study may be irrelevant as all study participants will have an in-patient status.

Conditions

• Acute Leukemia

Interventions

Type	Name	Description
DRUG	Lenalidomide	Oral capsule, daily, 50mg-100mg, one cycle (21 days)

Timeline

• Start date: 2012-08-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2012-06-08
• Last updated: 2020-05-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study