Azacitidine + Lenalidomide Combo in the Elderly With Previously Treated AML & High-Risk MDS
Stopped early · Phase 2
Conditions studied: Leukemia, Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS)
In brief
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.
Key facts
- Study ID
- NCT01442714
- Run by
- Stanford University
- People needed
- 33
- Starts
- 2011-08-01
- Expected to finish
- 2014-05-01
- Last updated by the study team
- 2018-01-03
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Stanford University School of Medicine — Stanford, California, United States
Full record on ClinicalTrials.gov
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