Phase I/II of Azacitidine + Lenalidomide for Previously Untreated Elderly Patients With Acute Myeloid Leukemia

This study has been completed.
Celgene Corporation
Information provided by (Responsible Party):
Bruno C. Medeiros, Stanford University Identifier:
First received: April 28, 2009
Last updated: August 9, 2012
Last verified: August 2012

The purpose of this study is to first determine the highest dose of the drugs that can be safely taken. The study will look at the side effects of the combination and whether the treatment schedule is tolerated. After the right dose is determined, the study will look at whether the combination is effective in patients with AML who are older than 60 and have never been treated before.

Condition Intervention Phase
Adult Acute Myeloblastic Leukemia
Drug: Lenalidomide
Drug: Azacitidine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Azacitidine in Combination With Lenalidomide for Previously Untreated Elderly Patients With Acute Myeloid Leukemia

Resource links provided by NLM:

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • CR rate and remission duration, to be measured after Phase II [ Time Frame: AT MEDIAN FOLLOW UP OF 12 MONTHS ] [ Designated as safety issue: No ]
  • Determination of maximum tolerated dose and adverse event profile, to be measured during Phase I [ Time Frame: AFTER COMPLETION OF EACH TREATMENT CYCL ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 30-day survival rate [ Time Frame: AT MEDIAN FOLLOW UP OF 12 MONTHS ] [ Designated as safety issue: No ]
  • Determination of in vivo biological interaction between azacitidine and lenalidomide using laboratory-based techniques, and correlation of these results with clinical outcomes [ Time Frame: AT COMPLETION OF PHASE I PORTION ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: April 2009
Study Completion Date: June 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Azacitidine and Lenalidomide
dose escalation
Drug: Lenalidomide
5-10mg, 25mg, PO
Other Names:
  • CC-5013
  • Revlimid
Drug: Azacitidine
Other Names:
  • 5-azacytidine
  • Vidaza


Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • WHO-confirmed AML, other than APL
  • White blood cell count (WBC) at initiation of treatment <= 10,000

    • If WBC is > 10,000 patients may be started on an appropriate dose of hydroxyurea (to be determined by the investigators), until WBC < 10,000, at which time the hydroxyurea will be discontinued for 24 hours prior to enrollment
  • Age >= 60 years and not a candidate for allogeneic stem cell transplantation
  • Unwilling or unable to receive conventional chemotherapy
  • No prior therapy, with the exception of supportive care measures such as growth factor support, blood product transfusions, apheresis or hydroxyurea
  • ECOG performance status <= 2 (See Appendix C for definitions)
  • Life expectancy > 2 months
  • 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 10 - 14 days prior to study enrollment 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. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. (See Appendix A: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods).
  • Willing and able to understand and voluntarily sign a written informed consent
  • Able to adhere to the study visit schedule and other protocol requirements

Exclusion Criteria:

  • Prior therapy with lenalidomide
  • Relapsed or refractory disease
  • History of intolerance to thalidomide or development of erythema nodosum while taking thalidomide or similar drugs
  • Known or suspected hypersensitivity to azacitidine or mannitol
  • Patients with advanced malignant hepatic tumors.
  • Concomitant treatment with other anti-neoplastic agents, with the exception of hydroxyurea
  • Anti-neoplastic treatment less than four weeks prior to enrollment, with the exception of hydroxyurea
  • Use of any other experimental drug or therapy within 28 days of baseline
  • Inability to swallow or absorb drug
  • Active opportunistic infection or treatment for opportunistic infection within four weeks of first day of study drug dosing
  • New York Heart Association Class III or IV heart failure
  • Unstable angina pectoris
  • Uncontrolled cardiac arrhythmia
  • Uncontrolled psychiatric illness that would limit compliance with requirements
  • Known HIV infection
  • Pregnant or breast feeding females; lactating females must agree not to breast feed while taking lenalidomide
  • Other medical or psychiatric illness or organ dysfunction or laboratory abnormality which in the opinion of the investigator would compromise the patient's safety or interfere with data interpretation
  • Laboratory abnormalities:

    • Either creatinine >=1.5 mg/dL or creatinine clearance <=50 mL/min
    • Total bilirubin > 1.5 x institutional ULN (unless documented Gilbert's syndrome)
    • AST and ALT > 2.5 x institutional ULN
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00890929

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Celgene Corporation
Principal Investigator: Bruno Carneiro de Medeiros Stanford University
Principal Investigator: Daniel Aaron Pollyea Stanford University
  More Information

No publications provided by Stanford University

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bruno C. Medeiros, Assistant Professor, Stanford University Identifier: NCT00890929     History of Changes
Other Study ID Numbers: HEMAML0011, SU-04242009-2385, RV-AML-0410
Study First Received: April 28, 2009
Last Updated: August 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors processed this record on October 16, 2014