Lenalidomide in Acute Leukemias and Chronic Lymphocytic Leukemia.
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Purpose
Rationale:
Lenalidomide has properties of thalidomide and appears to have some activity against cancer in laboratory tests. Researchers are still learning how lenalidomide works against cancer in patients. Some ways that this drug seems to produce anti-cancer effects include through stimulating the immune system and blocking blood vessels contributing to cancer growth. The current study will explore different dose levels in patients to gather more information about lenalidomide.
Purpose:
This study will assess the maximum tolerated dose of lenalidomide in patients with relapsed or refractory acute leukemias and chronic lymphocytic leukemias. Toxicity or side effects within patients will also be evaluated. Other purposes of this study include analyzing preliminary clinical activity, pharmacokinetics, and pharmacodynamics. Pharmacokinetics refers to the activity of drugs in the body over a period of time, including how drugs are absorbed, distributed, localized in tissues, and excreted. Pharmacodynamics refers to the bodily processes that lead the drug to effect cancer and other cellular components in the body.
Treatment:
Study participants will be given lenalidomide through intravenous infusions once every 28 days. A 28-day period constitutes a cycle. Since this study will assess the maximum tolerated dose of lenalidomide, some study participants will receive different amounts of this drug compared to others depending upon when each individual enrolls in the study. Each group of 3 to 6 study participants will receive a higher dose of lenalidomide until the maximum tolerated dose is established. Several tests will be performed throughout the study, including bone marrow biopsies. Imaging exams will be conducted as well. Treatments will be discontinued due to disease growth or intolerable adverse effects. Lenalidomide administration will be repeated for 12 or more cycles in patients that experience clinical benefit.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Chronic Lymphocytic Leukemia |
Drug: lenalidomide |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Study of Lenalidomide in Acute Leukemias and Chronic Lymphocytic Leukemia. |
- Maximum tolerable dose [ Time Frame: Every 2 weeks during cycle 1; Monthly during subsequent cycles ] [ Designated as safety issue: Yes ]
- Toxicities of lenalidomide [ Time Frame: Every 2 weeks during cycle 1; Monthly for subsequent cycles ] [ Designated as safety issue: Yes ]
- preliminary clinical activity [ Time Frame: Twice weekly during cycle 1; Weekly during cycles 2-6; Monthly thereafter ] [ Designated as safety issue: No ]
- plasma and cellular pharmacokinetics [ Time Frame: Days 1, 8, 15 and 21 of first cycle. ] [ Designated as safety issue: No ]
- pharmacodynamics [ Time Frame: Days 1, 8 and 26. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 84 |
| Study Start Date: | April 2007 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Lenalidomide in patients with AML or ALL
|
Drug: lenalidomide
Dose level -1: 2.5 mg daily for days 1-7, 2.5 mg daily for days 8-21. Dose level 1: 2.5 mg daily for days 1-7, 5 mg daily for days 8-21. Dose level 2: 2.5 mg daily for days 1-7, 7.5 mg daily for days 8-21. Dose level 3: 2.5 mg daily for days 1-7, 10 mg daily for days 8-21. Dose level 4: 2.5 mg daily for days 1-7, 15 mg daily for days 8-21
Other Name: Revlimid
|
|
Experimental: 2
Lenalidomide in patients with CLL
|
Drug: lenalidomide
Dose level -1: 2.5 mg daily for days 1-7, 2.5 mg daily for days 8-21. Dose level 1: 2.5 mg daily for days 1-7, 5 mg daily for days 8-21. Dose level 2: 2.5 mg daily for days 1-7, 7.5 mg daily for days 8-21. Dose level 3: 2.5 mg daily for days 1-7, 10 mg daily for days 8-21. Dose level 4: 2.5 mg daily for days 1-7, 15 mg daily for days 8-21
Other Name: Revlimid
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Blood blast count must be < 40,000/uL prior to initiation of therapy. Hydroxyurea (up to 6g/day) may be administered prior to initiation of therapy and during the first week to maintain blood blast count < 40,000/uL
- ECOG performance status 0-2.
- Patients with CNS involvement will be considered eligible for this study if no residual leukemic cells are detected in the CSF following intrathecal chemotherapy or radiation.
Exclusion Criteria:
- Patients with acute promyelocytic leukemia are excluded unless patient has failed salvage therapy with arsenic.
- Patients with HIV are excluded due to increased risk of infectious complications, marrow suppression, and potential interactions with antiviral therapy.
- CLL patients who have had chemotherapy (with the exception of hydroxyurea) or radiotherapy within 4 weeks prior to entering the study are excluded. CLL patients receiving corticosteroids (within 2 weeks) for treatment of disease (other than autoimmune manifestations of CLL) are not eligible.
- Patients who have received mitomycin C or nitrosourea require a six weeks recovery period before they can be enrolled on the current study.
- Patients with the following abnormal clinical values are excluded (unless abnormalities in these parameters are directly attributable to malignancy): Serum creatinine >2.0 mg/dl Total bilirubin > 2 x upper limit of normal (unless due to Gilbert's syndrome) ALT and AST > 5 x upper limit of normal
Contacts and Locations| United States, Ohio | |
| Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| Principal Investigator: | William Blum, MD | Ohio State University |
More Information
Additional Information:
No publications provided by Ohio State University Comprehensive Cancer Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Ohio State University Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00466895 History of Changes |
| Other Study ID Numbers: | OSU-06003, NCI-2011-03218 |
| Study First Received: | April 26, 2007 |
| Last Updated: | October 20, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Myeloid, Acute Leukemia, Myeloid Leukemia, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lenalidomide |
Thalidomide Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013