Supersaturated Calcium Phosphate Rinse in Preventing Oral Mucositis in Young Patients Undergoing Autologous or Donor Stem Cell Transplant

Completed · Phase 3 · Has a placebo group

Conditions studied: Childhood Acute Lymphoblastic Leukemia in Remission, Childhood Acute Myeloid Leukemia in Remission, Childhood Chronic Myelogenous Leukemia, Childhood Myelodysplastic Syndromes, Chronic Eosinophilic Leukemia, Chronic Myelomonocytic Leukemia, Chronic Neutrophilic Leukemia, de Novo Myelodysplastic Syndromes, Disseminated Neuroblastoma, Juvenile Myelomonocytic Leukemia, Mucositis, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Previously Treated Childhood Rhabdomyosarcoma, Previously Treated Myelodysplastic Syndromes, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Recurrent Childhood Large Cell Lymphoma, Recurrent Childhood Lymphoblastic Lymphoma, Recurrent Childhood Rhabdomyosarcoma, Recurrent Childhood Small Noncleaved Cell Lymphoma, Recurrent Malignant Testicular Germ Cell Tumor, Recurrent Wilms Tumor and Other Childhood Kidney Tumors, Recurrent/Refractory Childhood Hodgkin Lymphoma, Relapsing Chronic Myelogenous Leukemia, Secondary Acute Myeloid Leukemia, Secondary Myelodysplastic Syndromes, Unspecified Childhood Solid Tumor, Protocol Specific

In brief

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.

Key facts

Study ID

NCT01305200

Run by

Children's Oncology Group

People needed

226

Starts

2011-03-01

Expected to finish

2015-06-30

Last updated by the study team

2019-09-17

Who can join

Age: 4 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients undergoing myeloablative autologous or allogeneic hematopoietic stem cell transplantation (HSCT) for any indication
• One or more of the following donor stem cell sources (autologous or allogeneic):
• Bone marrow
• Placental blood (umbilical cord blood)
• Cytokine-mobilized peripheral blood
• Patients eligible for allogeneic HSCT must have one of the following types of donor stem cells:
• Human leukocyte antigen (HLA)-matched sibling or parent
• Partially matched family donor (mismatched for a single HLA locus [Class I])
• Fully matched unrelated marrow or peripheral blood stem cell donor
• HLA-matched or partially mismatched (at least 4 of 6 match) cord blood (Class I or II)
• Patients expecting to receive any type of myeloablative HSCT conditioning regimen are eligible
• No non-myeloablative or reduced-intensity conditioning regimens
• Eligible patients must not have received palifermin within 30 days prior to enrollment
• Eligible patients must not have received prior treatment with Caphosol

You may not qualify if…

• Females of childbearing potential must have a negative pregnancy test; patients must agree to use an effective birth control method; lactating patients must agree not to nurse a child while on this trial

Where it is running

• Children's Oncology Group — Arcadia, California, United States
• City of Hope — Duarte, California, United States
• Children's Hospital and Research Center at Oakland — Oakland, California, United States
• Rady Children's Hospital - San Diego — San Diego, California, United States
• University of California San Francisco Medical Center-Parnassus — San Francisco, California, United States
• Alfred I duPont Hospital for Children — Wilmington, Delaware, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Miami Children's Hospital — Miami, Florida, United States
• All Children's Hospital — St. Petersburg, Florida, United States
• Children's Healthcare of Atlanta - Egleston — Atlanta, Georgia, United States
• Lurie Children's Hospital-Chicago — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• Kosair Children's Hospital — Louisville, Kentucky, United States
• Children's Hospital-Main Campus — New Orleans, Louisiana, United States
• Floating Hospital for Children at Tufts Medical Center — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• C S Mott Children's Hospital — Ann Arbor, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• The Childrens Mercy Hospital — Kansas City, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Columbia University Medical Center — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Ny Cancer% — Valhalla, New York, United States

Full record on ClinicalTrials.gov

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