Status:
TERMINATED
Azacitidine + Lenalidomide Combo in the Elderly With Previously Treated AML & High-Risk MDS
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Celgene Corporation
Conditions:
Leukemia
Acute Myeloid Leukemia (AML)
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief 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 treatme...
Detailed Description
This is an open label, single-center, and phase 2 study of the combination of azacitidine with lenalidomide in previously treated elderly patients with acute myeloid leukemia (AML) and/or high-risk my...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01442714
Start Date
August 1 2011
End Date
May 1 2014
Last Update
January 3 2018
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305