5-Azacytidine With Lenalidomide in Patients With High Risk Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)
This study is currently recruiting participants.
Verified June 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01038635
First received: December 23, 2009
Last updated: June 10, 2013
Last verified: June 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of lenalidomide that can be given in combination with azacitidine to patients with MDS or AML.
The goal of Phase 2 of this study is to learn if the combination dose of azacitidine and lenalidomide found in Phase 1 can help to control MDS and/or AML.
The safety of this drug combination will be studied in both Phases.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Drug: 5-Azacytidine Drug: Lenalidomide |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I/II Study of the Combination of 5-azacitidine With Lenalidomide in Patients With High Risk Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML) |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Maximum Dose Tolerated (MTD) [ Time Frame: 3-8 week cycles ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 88 |
| Study Start Date: | December 2009 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 5-Azacytidine + Lenalidomide
5-Azacytidine 75 mg/m^2 by vein daily x 5 days on days 1 to 5. Lenalidomide starting dose 10 mg orally daily x 5 days on days 6 to 10.
|
Drug: 5-Azacytidine
75 mg/m^2 IV daily x 5 days on days 1 to 5.
Other Names:
Drug: Lenalidomide
Starting dose 10 mg orally daily x 5 days on days 6 to 10.
Other Names:
|
Show Detailed Description Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with higher risk MDS (bone marrow blasts >/= 10% to 30% inclusive) of any age who refuse or are not eligible for frontline chemotherapy.
- No prior therapy for higher risk MDS as defined above.
- Performance status of </= 2 by the ECOG scale.
- Signed informed consent indicating that patients are aware of the investigational nature of this study in keeping with the policies of UTMDACC.
- Hydroxyurea for patients with rapidly proliferative disease can be used up to 24 hours prior to therapy but not concomitantly with 5-azacitidine or lenalidomide. Hydroxyurea can be used once the patient has completed the planned 5 azacitidine and lenalidomide treatment.
- Adequate liver function (bilirubin of </= 2mg/dL, SGPT </= 2.5 x ULN or 5 x ULN if related to leukemia tissue infiltration)
- Renal function - creatinine </= 2mg/dL, patients with CrCl < 30ml/min are excluded.
- All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing.
- Continued from #9: Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy.
Exclusion Criteria:
- Nursing and pregnant females.
- Known or suspected hypersensitivity to azacitidine or mannitol.
- Patients with advanced malignant hepatic tumors.
- Unwilling or unable to remain in compliance with the RevAssist® program.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01038635
Contacts
| Contact: Guillermo Garcia-Manero, MD | 713-745-3428 |
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Guillermo Garcia-Manero, MD | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Celgene Corporation
Investigators
| Study Chair: | Guillermo Garcia-Manero, MD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01038635 History of Changes |
| Other Study ID Numbers: | 2009-0467 |
| Study First Received: | December 23, 2009 |
| Last Updated: | June 10, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
5-Azacytidine 5-Aza Lenalidomide Revlimid CC-5103 |
Myelodysplastic Syndrome MDS Acute Myelogenous Leukemia AML |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Myelodysplastic Syndromes Preleukemia Neoplasms by Histologic Type Neoplasms Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Azacitidine Lenalidomide Thalidomide Antimetabolites, Antineoplastic Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors 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 June 17, 2013