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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01305200
The ClinicalTrials.gov registry entry for NCT01305200 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 226 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 86-participant average among 73 other Chronic Myelomonocytic Leukemia trials with a reported enrollment target (163% higher). The listed sponsor is Children's Oncology Group, which has 342 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.
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