Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00072969 · ClinicalTrials.gov registry record · Phase 2
A Randomized Trial of Recombinant Humanized Anti-IL-2 Receptor Antibody (Daclizumab) Versus Antithymocyte Globulin (ATG) to Treat the Cytopenia of Myelodysplastic Syndrome (MDS)
A Phase 2 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 2
- Development phase
- 132
- Enrollment target
NCT00072969: Completed Phase 2 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT00072969 is a Phase 2 study that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 132 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00072969, a Phase 2 study, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 132 participants
- Enrollment target
Study Summary
This study will evaluate a new immunosupressive therapy, Daclizumab, and compare it with antithymocyte globulin (ATG) to treat cytopenia, that is, the deficiency of cellular elements of the blood, in myelodysplastic syndrome (MDS). Daclizumab is an anti-interleukin-2 receptor (IL-2) antibody. MDS, also known as myelodysplasia, is a disorder that can cause anemia, spontaneous bleeding, and greater risk of infections. Although the bone marrow can still produce some blood cells, very few reach the bloodstream. The cause of MDS is not known, although its behavior is. Many patients need transfusions of red blood cells. They may also develop leukemia, which is often quite resistant to treatment with chemotherapy. However, the progression of the disorder to leukemia is usually slow, taking many years. Patients 18 years of age and older who have MDS may be eligible for this study. Participants will undergo the following tests and procedures: * Medical history and physical examination. * Collection of blood for tests including blood counts, liver and kidney function, and antibodies against common viruses. * Chest x-ray. * Electrocardiogram. * Bone marrow sample to confirm the diagnosis. Participants will randomly receive either ATG or Daclizumab. If they are in the group to receive ATG, they will be admitted as inpatients to undergo the first 10 to 14 days of treatment. If they do not already have a catheter in one of the large veins of the neck, chest, or arm, one will be placed. ATG will be given through the catheter. Blood counts and other blood analysis will be monitored daily while the patients are treated. After about 10 days, they will be released, to be under the care of their referring physicians. Those participants who are in the group to receive Daclizumab will receive a total of five doses, one every 2 weeks, over 8 weeks, given through a vein as a 15-minute infusion. The first, third, and fifth dose will be given at the outpatient clinic. The second and fourt
Interventions
- DRUG Daclizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2003-11 |
| Est. Completion | 2005-08 |
| Phase | Phase 2 |
What the finished NCT00072969 record still lists
NCT00072969 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Daclizumab is the first listed.
NCT00072969 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00072969 about?
NCT00072969 is a clinical study titled "A Randomized Trial of Recombinant Humanized Anti-IL-2 Receptor Antibody (Daclizumab) Versus Antithymocyte Globulin (ATG) to Treat the Cytopenia of Myelodysplastic Syndrome (MDS)". This study will evaluate a new immunosupressive therapy, Daclizumab, and compare it with antithymocyte globulin (ATG) to treat cytopenia, that is, the deficiency of cellular elements of the blood, in myelodysplastic syndrome (MDS). Daclizumab is an anti-interleukin-2 receptor (IL-2) antibody. MDS, a...
What is the current status of trial NCT00072969?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 132 participants. The study started on 2003-11. Estimated completion is 2005-08.
What interventions are being tested in trial NCT00072969?
The interventions under investigation include: Daclizumab (DRUG).
Who is sponsoring clinical trial NCT00072969?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00072969's enrollment target sits among peer trials
132 539th of 2000 higher than 1,460 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01766297 · 132 participants · Phase 2
Phase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer
- NCT04002947 · 132 participants · Phase 2
Acalabrutinib With DA-EPOCH-R or R-CHOP for People With Untreated Diffuse Large B-cell Lymphoma
- NCT04128189 · 132 participants · Phase 3
Shingrix in Renal Transplant Recipients
- NCT04199780 · 132 participants · NA
Effects of tDCS Combined With CBI on Postsurgical Pain
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia