5-Azacytidine With Lenalidomide in Patients With High Risk Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)

This study is ongoing, but not recruiting participants.
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
First received: December 23, 2009
Last updated: April 9, 2014
Last verified: April 2014

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
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:
  • 5-AZA
  • Azacitidine
  • Vidaza
  • 5-AZC
  • AZA-CR
  • Ladakamycin
Drug: Lenalidomide
Starting dose 10 mg orally daily x 5 days on days 6 to 10.
Other Names:
  • CC-5013
  • Revlimid

  Show Detailed Description


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients with higher risk MDS (bone marrow blasts >/= 10% to 30% inclusive) of any age who refuse or are not eligible for frontline chemotherapy.
  2. No prior therapy for higher risk MDS as defined above.
  3. Performance status of </= 2 by the ECOG scale.
  4. Signed informed consent indicating that patients are aware of the investigational nature of this study in keeping with the policies of UTMDACC.
  5. 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.
  6. Adequate liver function (bilirubin of </= 2mg/dL, SGPT </= 2.5 x ULN or 5 x ULN if related to leukemia tissue infiltration)
  7. Renal function - creatinine </= 2mg/dL, patients with CrCl < 30ml/min are excluded.
  8. All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
  9. 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.
  10. 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:

  1. Nursing and pregnant females.
  2. Known or suspected hypersensitivity to azacitidine or mannitol.
  3. Patients with advanced malignant hepatic tumors.
  4. Unwilling or unable to remain in compliance with the RevAssist® program.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01038635

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Celgene Corporation
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, NCI-2011-01941
Study First Received: December 23, 2009
Last Updated: April 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Myelodysplastic Syndrome
Acute Myelogenous Leukemia

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Bone Marrow Diseases
Hematologic Diseases
Neoplasms by Histologic Type
Precancerous Conditions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Growth Inhibitors
Growth Substances
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on March 25, 2015