Azacitidine With or Without Lenalidomide or Vorinostat in Treating Patients With Higher-Risk Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia

Conditions

• Chronic Myelomonocytic Leukemia
• Chronic Myelomonocytic Leukemia-1
• Chronic Myelomonocytic Leukemia-2
• Myelodysplastic Syndrome
• Myelodysplastic Syndrome With Excess Blasts
• Myelodysplastic Syndrome With Excess Blasts-1
• Myelodysplastic Syndrome/Acute Myeloid Leukemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Azacitidine — DRUG
  Given SC or IV
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Lenalidomide — DRUG
  Given PO
• Vorinostat — DRUG
  Given PO

Study Details

This randomized phase II/III trial studies how well azacitidine works with or without lenalidomide or vorinostat in treating patients with higher-risk myelodysplastic syndromes or chronic myelomonocytic leukemia. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, stopping them from dividing, or by stopping them from spreading. Lenalidomide may stop the growth of cancer cells by stopping blood flow to the cancer. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether azacitidine is more effective with or without lenalidomide or vorinostat in treating myelodysplastic syndromes or chronic myelomonocytic leukemia.

Key Dates

Start date

Mar 1, 2012

Status verified

Mar 2026

Primary completion

Jun 1, 2015

Completion

Mar 31, 2027

Study Design

Enrollment

282 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (azacitidine and lenalidomide)
  Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm II (azacitidine)
  Patients receive azacitidine as in Arm I. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm III (azacitidine and vorinostat)
  Patients receive azacitidine as in Arm I and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Response Rate (Phase II) [ Time Frame: Up to 5 years ]

Locations (280)

Find similar trials in Birmingham, AL

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