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ACTIVE NOT RECRUITING Phase 2

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

NCT01522976 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • DRUG Azacitidine
  • OTHER Laboratory Biomarker Analysis
  • DRUG Lenalidomide
  • DRUG Vorinostat

Study Locations (20)

California

  • Kaiser Permanente-Deer Valley Medical Center — Antioch
  • City of Hope Comprehensive Cancer Center — Duarte
  • USC / Norris Comprehensive Cancer Center — Los Angeles
  • Kaiser Permanente-Oakland — Oakland
  • Stanford Cancer Institute Palo Alto — Palo Alto
  • Kaiser Permanente-Richmond — Richmond
  • Kaiser Permanente-South Sacramento — Sacramento
  • Kaiser Permanente Sacramento Medical Center — Sacramento
  • Kaiser Permanente-San Francisco — San Francisco
  • Kaiser Permanente-Santa Teresa-San Jose — San Jose
  • Kaiser Permanente-San Rafael — San Rafael
  • Kaiser Permanente Medical Center - Santa Clara — Santa Clara
  • Kaiser Permanente-Santa Rosa — Santa Rosa
  • Sutter Pacific Medical Foundation — Santa Rosa

Arizona

  • Mayo Clinic in Arizona — Scottsdale
  • Banner University Medical Center - Tucson — Tucson
  • University of Arizona Cancer Center-North Campus — Tucson

Alabama

  • University of Alabama at Birmingham Cancer Center — Birmingham
  • University of South Alabama Mitchell Cancer Institute — Mobile

Arkansas

  • John L McClellan Memorial Veterans Hospital — Little Rock

Trial Details

FieldValue
Enrollment Target 282 participants
Start Date 2012-03-01
Est. Completion 2026-03-19
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01522976

The ClinicalTrials.gov registry entry for NCT01522976 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 282 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 7 conditions, with Myelodysplastic Syndrome appearing as the primary indexed condition, and to 4 interventions — of which Azacitidine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01522976 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Arizona, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01522976 about?

NCT01522976 is a clinical study titled "Azacitidine With or Without Lenalidomide or Vorinostat in Treating Patients With Higher-Risk Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia". 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 gro...

What is the current status of trial NCT01522976?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 282 participants. The study started on 2012-03-01. Estimated completion is 2026-03-19.

What conditions does trial NCT01522976 study?

This clinical trial studies the following conditions: Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome With Excess Blasts, Chronic Myelomonocytic Leukemia-2, Chronic Myelomonocytic Leukemia-1. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01522976?

The interventions under investigation include: Azacitidine (DRUG), Laboratory Biomarker Analysis (OTHER), Lenalidomide (DRUG), Vorinostat (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01522976?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01522976 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial