Azacitidine + Lenalidomide Combo in the Elderly With Previously Treated AML & High-Risk MDS

• Status: Terminated
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the trial is to study how the elderly patients who have previously undergone treatment for acute myeloid leukemia and high-rRisk myelodysplastic syndromes, respond to a combined treatment with azacitidine and lenalidomide.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborator: Celgene Corporation
• Treatments: Azacitidine; Lenalidomide; Thalidomide

Criteria

Inclusion Criteria:

• acute myeloid leukemia (AML) (according to the WHO 2008 classification):

• De novo

• Secondary AML previously treated with demethylating agents for AML

• Secondary AML previously treated with demethylating agents for MDS

• Secondary AML previously treated with high dose lenalidomide for AML (≥ 25mg)

• High Risk MDS:

• Del (5q)

• Non-del (5q), previously-treated with lenalidomide.

• Novo or secondary HR-MDS previously treated with demethylating agents

• White blood cell (WBC) ≤ 10,000

• Age ≥ 60

• Not an immediate candidate for allogeneic stem cell transplantation

• Unwilling or unable to receive conventional chemotherapy

• Prior therapy:

• with single agent demethylator (5-Azacitidine or Decitabine)

• with Lenalidomide

• Eastern Cooperative Oncology Group performance status ≤ 2

• Life expectancy > 2 months

• All study participants must be registered into the mandatory RevAssist program

• Willing and able to comply with the requirements of RevAssist

• Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test 10-14 days prior to study enrollment and again within 24 hours of prescribing lenalidomide

• Must commit to either continued abstinence from intercourse or begin two acceptable methods of birth control, at least 28 days before she starts taking lenalidomide.

• 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.

• 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:

• Patients with LR-MDS progressing to HR-MDS after low dose lenalidomide or 5-day azacitidine will not be eligible.

• History of intolerance to thalidomide

-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

• Previous participation on the VIREL study with the concomitant use of azacitidine plus lenalidomide.

• 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

• Breast feeding

• Lactating females must agree not to breast feed while taking lenalidomide

• Other medical or psychiatric illness or organ dysfunction or laboratory abnormality

• Laboratory abnormalities:

• Either creatinine ≥ 1.5 mg / dL or creatinine clearance ≤ 50 mL / min

• Total bilirubin >1.5 x institutional ULN

• AST and ALT > 2.5 x institutional ULN