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NCT00843882 · ClinicalTrials.gov registry record · Phase 3

Lenalidomide With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome and Anemia

A Phase 3 study of Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 3
Development phase
247
Enrollment target
20
Study locations

NCT00843882: Active Phase 3 study of Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia, sponsored by National Cancer Institute (NCI).

NCT00843882 is a Phase 3 study of Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 247 participants, above the 205-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (20% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00843882, a Phase 3 study of Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
247 participants
Enrollment target
20
Study locations

Study Summary

This randomized phase III trial studies lenalidomide to see how well it works with or without epoetin alfa in treating patients with myelodysplastic syndrome and anemia. Lenalidomide may stop the growth of myelodysplastic syndrome by blocking blood flow to the cells. Colony stimulating factors, such as epoetin alfa, may increase the number of immune cells found in bone marrow or peripheral blood. It is not yet known whether lenalidomide is more effective with or without epoetin alfa in treating patients with myelodysplastic syndrome and anemia.

Primary Outcome

Major erythroid response is defined as transfusion-independence for ≥ 8 consecutive weeks for patients who were red blood cell transfusion-dependent at baseline AND a ≥ 1 g/dL hemoglobin rise compared to mean pre-transfusion baseline value; or a \> 2 g/dL rise in hemoglobin without transfusion for non-transfusion dependent patients.

Interventions

  • PROCEDURE Bone Marrow Biopsy
  • OTHER Laboratory Biomarker Analysis
  • DRUG Lenalidomide
  • BIOLOGICAL Epoetin Alfa

Study Locations (20)

California

  • Kaiser Permanente-Anaheim - Anaheim
  • Kaiser Permanente-Baldwin Park - Baldwin Park
  • Kaiser Permanente-Bellflower - Bellflower
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
  • Kaiser Permanente-Fontana - Fontana
  • Marin Cancer Care Inc - Greenbrae
  • Kaiser Permanente South Bay - Harbor City
  • Kaiser Permanente-Irvine - Irvine
  • Kaiser Permanente Los Angeles Medical Center - Los Angeles
  • Kaiser Permanente West Los Angeles - Los Angeles

Alaska

  • Alaska Breast Care and Surgery LLC - Anchorage
  • Alaska Women's Cancer Care - Anchorage
  • Anchorage Oncology Centre - Anchorage
  • Katmai Oncology Group - Anchorage
  • Providence Alaska Medical Center - Anchorage
  • Fairbanks Memorial Hospital - Fairbanks

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

Trial Details

FieldValue
Enrollment Target 247 participants
Start Date 2009-01-29
Est. Completion 2026-10-02
Phase Phase 3
National Cancer Institute (NCI)

3,257 total trials

What the registry record for NCT00843882 still lists

NCT00843882 is an interventional study that assigns participants to a tested intervention. The registered 247 participants enrollment target is mid-sized for trials with a published cap, above the 205-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (20% higher).

The record links to 4 conditions, with Myelodysplastic Syndrome appearing as the primary indexed condition, and to 4 interventions - of which Bone Marrow Biopsy is the first listed.

NCT00843882 names 20 study sites across 4 states, led by California, Alaska, Arizona.

Frequently Asked Questions

What is clinical trial NCT00843882 about?

NCT00843882 is a clinical study titled "Lenalidomide With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome and Anemia". This randomized phase III trial studies lenalidomide to see how well it works with or without epoetin alfa in treating patients with myelodysplastic syndrome and anemia. Lenalidomide may stop the growth of myelodysplastic syndrome by blocking blood flow to the cells. Colony stimulating factors, such...

What is the current status of trial NCT00843882?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 247 participants. The study started on 2009-01-29. Estimated completion is 2026-10-02.

What conditions does trial NCT00843882 study?

This clinical trial studies the following conditions: Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, Anemia, de Novo Myelodysplastic Syndrome.

What interventions are being tested in trial NCT00843882?

The interventions under investigation include: Bone Marrow Biopsy (PROCEDURE), Laboratory Biomarker Analysis (OTHER), Lenalidomide (DRUG), Epoetin Alfa (BIOLOGICAL).

Who is sponsoring clinical trial NCT00843882?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00843882 being conducted?

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

Similar trials for Myelodysplastic Syndrome

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00843882's enrollment target sits among peer trials

247 15th of 134 higher than 120 of 134 other Myelodysplastic Syndrome trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Myelodysplastic Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00843882, the US trial registry maintained by the National Library of Medicine. NCT00843882 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.