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NCT01305200 · ClinicalTrials.gov registry record · Phase 3
Supersaturated Calcium Phosphate Rinse in Preventing Oral Mucositis in Young Patients Undergoing Autologous or Donor Stem Cell Transplant
A Phase 3 study of Chronic Myelomonocytic Leukemia and Juvenile Myelomonocytic Leukemia, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 226
- Enrollment target
- 20
- Study locations
NCT01305200: Completed Phase 3 study of Chronic Myelomonocytic Leukemia and Juvenile Myelomonocytic Leukemia, sponsored by Children's Oncology Group.
NCT01305200 is a Phase 3 study of Chronic Myelomonocytic Leukemia and Juvenile Myelomonocytic Leukemia that has completed, run by Children's Oncology Group. The registered enrollment target is 226 participants, above the 86-participant average among 73 other Chronic Myelomonocytic Leukemia trials with a reported enrollment target (163% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01305200, a Phase 3 study of Chronic Myelomonocytic Leukemia and Juvenile Myelomonocytic Leukemia, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 226 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase III trial is studying how well Caphosol rinse works in preventing mucositis in young patients undergoing autologous or donor stem cell transplant. Supersaturated calcium phosphate (Caphosol) rinse may be able to prevent mucositis, or mouth sores, in patients undergoing stem cell transplant.
Primary Outcome
Mean days of severe (WHO Grade 3 or 4) Mucositis.
Conditions Studied
Interventions
- OTHER placebo
- OTHER questionnaire administration
- PROCEDURE quality-of-life assessment
- DRUG supersaturated calcium phosphate rinse
Study Locations (20)
California
- Children's Oncology Group - Arcadia
- City of Hope - Duarte
- Children's Hospital and Research Center at Oakland - Oakland
- Rady Children's Hospital - San Diego - San Diego
- University of California San Francisco Medical Center-Parnassus - San Francisco
Florida
- Miami Children's Hospital - Miami
- All Children's Hospital - St. Petersburg
Illinois
- Lurie Children's Hospital-Chicago - Chicago
- University of Chicago - Chicago
Massachusetts
- Floating Hospital for Children at Tufts Medical Center - Boston
- Dana-Farber Cancer Institute - Boston
Delaware
- Alfred I duPont Hospital for Children - Wilmington
District of Columbia
- Children's National Medical Center - Washington D.C.
Georgia
- Children's Healthcare of Atlanta - Egleston - Atlanta
Indiana
- Riley Hospital for Children - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 226 participants |
| Start Date | 2011-03 |
| Est. Completion | 2015-06-30 |
| Phase | Phase 3 |
What the finished NCT01305200 record still lists
NCT01305200 is an interventional study that assigns participants to a tested intervention. The registered 226 participants enrollment target is mid-sized for trials with a published cap, above the 86-participant average among 73 other Chronic Myelomonocytic Leukemia trials with a reported enrollment target (163% higher).
The record links to 10 conditions, with Chronic Myelomonocytic Leukemia appearing as the primary indexed condition, and to 4 interventions - of which placebo is the first listed.
NCT01305200 names 20 study sites across 13 states, led by California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT01305200 about?
NCT01305200 is a clinical study titled "Supersaturated Calcium Phosphate Rinse in Preventing Oral Mucositis in Young Patients Undergoing Autologous or Donor Stem Cell Transplant". This randomized phase III trial is studying how well Caphosol rinse works in preventing mucositis in young patients undergoing autologous or donor stem cell transplant. Supersaturated calcium phosphate (Caphosol) rinse may be able to prevent mucositis, or mouth sores, in patients undergoing stem cel...
What is the current status of trial NCT01305200?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 226 participants. The study started on 2011-03. Estimated completion is 2015-06-30.
What conditions does trial NCT01305200 study?
This clinical trial studies the following conditions: Chronic Myelomonocytic Leukemia, Juvenile Myelomonocytic Leukemia, de Novo Myelodysplastic Syndromes, Childhood Acute Lymphoblastic Leukemia in Remission, Childhood Myelodysplastic Syndromes.
What interventions are being tested in trial NCT01305200?
The interventions under investigation include: placebo (OTHER), questionnaire administration (OTHER), quality-of-life assessment (PROCEDURE), supersaturated calcium phosphate rinse (DRUG).
Who is sponsoring clinical trial NCT01305200?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01305200 being conducted?
This trial has 20 study locations across California, Delaware, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01305200's enrollment target sits among peer trials
226 8th of 73 higher than 66 of 73 other Chronic Myelomonocytic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Myelomonocytic Leukemia 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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