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Lenalidomide

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Subjects are given a single dose of the drug while they are observed and tested for a period of time. If they do not exhibit any adverse side effects the dose is escalated, and a new group of subjects is then given a higher dose.

Lenalidomide will be taken orally once a day for 21 days continuously in 28 day cycles. The dose of the lenalidomide administered to each patient will be based on the group that the patient is enrolled. The dose cycles will be 21 days of a 28 day cycle.

Mehrdad Abedi, MD

The purpose of this study is to determine whether lenalidomide can stop the growth of leukemia stem cells and can be used to prevent the return of leukemia cells after a transplant.

The purpose of this study is determine whether lenalidomide can directly inhibit leukemic stem cells in vivo and can be used to prevent the relapse of leukemia stem cells after transplant. A concern with any post transplant intervention is the possibility of multiple drug interactions, potential for graft versus host disease exacerbation and/or induction of cytopenia. Therefore, the smallest doses of lenalidomide (5 mg) that has been used in this setting will be utilized as dose level 1. Starting six months post-transplant, patients will begin on a daily dose of lenalidomide. Dependent on the cohort, patients will receive 5 to 20 mg of lenalidomide post transplant. The maximum tolerated dose (MTD) will be determined by the incidence of grade III-IV toxicities of all organs and grade II-IV GVHD. Duration of treatment is six months.

Study of Lenalidomide in Patients With Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome

Phase I Trial of Maintenance Lenalidomide in Patients With Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome Post Allogeneic Bone Marrow Transplantation

All patients will be followed closely and evaluated for toxicity. For grade III-IV non hematological toxicity or grade IV hematological toxicity associated with lenalidomide will be held until the toxicity resolves and then will be started at a lower dose; Patients who develop grade II to IV GVHD on study will stop lenalidomide

Percentage of patients with relapse from all the patients who received the transplant.

Percentage of patients who are alive and remain in remission at one year after infusion of stem cells

The percentage of pathologically confirmed cases of acute and/or chronic Graft versus Host disease at one year post transplant

Celgene

University of California, Davis

Professor

Immune System Diseases

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Antirheumatic Agents

Bendamustine Hydrochloride

Rituximab

Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.

Daily maintenance treatment, oral lenalidomide

Maintenance lenalidomide

Terri L Parker, MD

This study will determine whether or not Lenalidomide improves effectiveness of treatment for chronic lymphocytic leukemia following chemotherapy with two drugs commonly used to treat the disease (bendamustine and rituximab).

Maintenance Therapy: Lenalidomide Following Bendamustine and Rituximab Induction Therapy for Chronic Lymphocytic Leukemia

Maintenance Therapy With Lenalidomide Following Bendamustine and Rituximab Induction Therapy for Chronic Lymphocytic Leukemia

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Celgene Corporation

Yale University

Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.

Maintenance lenalidomide: Daily maintenance treatment, oral lenalidomide

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Lenalidomide in Patients With Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome	NCT01433965	Acute Myeloid L... Myelodysplastic...	Lenalidomide	18 Years - 65 Years	University of California, Davis
Study of Lenalidomide in Patients With Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome	NCT01433965	Acute Myeloid L... Myelodysplastic...	Lenalidomide	18 Years - 65 Years	University of California, Davis
Maintenance Therapy: Lenalidomide Following Bendamustine and Rituximab Induction Therapy for Chronic Lymphocytic Leukemia	NCT01465230	Chronic Lymphoc...	Maintenance len...	18 Years - 90 Years	Yale University

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