Azacitidine Plus Lenalidomide Combination in Elderly Patients With Previously Treated AML and High-Risk MDS (VIREL2 Trial)

Primary Objective: - Determine the lack of disease progression (CR/CRi/PR/HI rate) after 6 cycles of treatment with the combination of azacitidine plus lenalidomide in previously treated patients with Acute Myeloid Leukemia (AML) and high-risk Myelodysplastic Syndromes (HR-MDS). Secondary Objective: - Determine the 42-day survival after treatment with this combination in elderly patients with previously treated AML/HR-MDS patients

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : Lenalidomide
  • drug : Azacitidine

Phase: Phase 2

Eligibility

Ages Eligible For Study:

60 Years - N/A

Inclusion Criteria

To be eligible to participate in this study, a patient must meet the following criteria (at the principal investigators' discretion): - AML (according to the WHO 2008 classification), including: - de novo or secondary AML previously treated with demethylating agents for AML - secondary AML previously treated with demethylating agents for MDS - de novo or secondary AML previously treated with high dose lenalidomide for AML (>=25mg) - High Risk MDS, including - Del (5q) and non-del (5q), previously treated with lenalidomide. - novo or secondary HR-MDS previously treated with demethylating agents - White blood cell count (WBC) at initiation of treatment <= 10,000 o 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 and not an immediate candidate for allogeneic stem cell transplantation - Unwilling or unable to receive conventional chemotherapy - Prior therapy, with either single agent demethylator (5-Azacitidine or Decitabine) and/or Lenalidomide - 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

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Contact information

Primary Contact:

Jack Taw 650-723-2781

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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