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NCT00661999 · ClinicalTrials.gov registry record · Phase 3
Darbepoetin Alfa With or Without Iron in Treating Anemia Caused By Chemotherapy in Patients With Cancer
A Phase 3 study of Lymphoma and Leukemia, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 3
- Development phase
- 502
- Enrollment target
- 2
- Study locations
NCT00661999: Completed Phase 3 study of Lymphoma and Leukemia, sponsored by Mayo Clinic.
NCT00661999 is a Phase 3 study of Lymphoma and Leukemia that has completed, run by Mayo Clinic. The registered enrollment target is 502 participants, roughly in line with the 482-participant average among 299 other Lymphoma trials with a reported enrollment target. The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00661999, a Phase 3 study of Lymphoma and Leukemia, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 502 participants
- Enrollment target
- 2
- Study locations
Study Summary
RATIONALE: Darbepoetin alfa may cause the body to make more red blood cells. Red blood cells contain iron that is needed to carry oxygen to the tissues. It is not yet known whether giving darbepoetin alfa (DA) together with intravenous iron or oral iron is more effective than giving darbepoetin alfa together with a placebo in treating anemia caused by chemotherapy. PURPOSE: This randomized phase III trial is studying giving darbepoetin alfa together with iron to see how well it works compared with giving darbepoetin alfa together with a placebo in treating anemia caused by chemotherapy in patients with cancer.
Primary Outcome
Hematopoietic response was defined as Hemoglobin (Hb) increment of 2.0 g/dL from baseline or achievement of Hb \>= 11 g/dL (whichever occurs first) in the absence of red blood cell transfusions during the preceding 28 days during the treatment period.
Conditions Studied
Interventions
- OTHER placebo
- BIOLOGICAL darbepoetin alfa
- DIETARY_SUPPLEMENT ferrous sulfate
- DRUG sodium ferric gluconate complex in sucrose
Study Locations (2)
Arizona
- Mayo Clinic in Arizona - Scottsdale
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 502 participants |
| Start Date | 2006-01 |
| Est. Completion | 2009-03 |
| Phase | Phase 3 |
What the finished NCT00661999 record still lists
NCT00661999 is an interventional study that assigns participants to a tested intervention. The registered 502 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 482-participant average among 299 other Lymphoma trials with a reported enrollment target.
The record links to 7 conditions, with Lymphoma appearing as the primary indexed condition, and to 4 interventions - of which placebo is the first listed.
NCT00661999 reports a single indexed study location in Arizona, Minnesota.
Frequently Asked Questions
What is clinical trial NCT00661999 about?
NCT00661999 is a clinical study titled "Darbepoetin Alfa With or Without Iron in Treating Anemia Caused By Chemotherapy in Patients With Cancer". RATIONALE: Darbepoetin alfa may cause the body to make more red blood cells. Red blood cells contain iron that is needed to carry oxygen to the tissues. It is not yet known whether giving darbepoetin alfa (DA) together with intravenous iron or oral iron is more effective than giving darbepoetin alfa...
What is the current status of trial NCT00661999?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 502 participants. The study started on 2006-01. Estimated completion is 2009-03.
What conditions does trial NCT00661999 study?
This clinical trial studies the following conditions: Lymphoma, Leukemia, Unspecified Adult Solid Tumor, Protocol Specific, Anemia, Multiple Myeloma and Plasma Cell Neoplasm.
What interventions are being tested in trial NCT00661999?
The interventions under investigation include: placebo (OTHER), darbepoetin alfa (BIOLOGICAL), ferrous sulfate (DIETARY_SUPPLEMENT), sodium ferric gluconate complex in sucrose (DRUG).
Who is sponsoring clinical trial NCT00661999?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00661999 being conducted?
This trial has 2 study locations across Arizona, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT00661999's enrollment target sits among peer trials
502 15th of 299 higher than 285 of 299 other Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma 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.
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