Acute Myeloid Leukemia Clinical Trial
Traumeel® S in Preventing and Treating Mucositis in Young Patients Undergoing Stem Cell Transplantation
Summary
RATIONALE: Traumeel® S (a mouth rinse) may be effective in preventing or decreasing the severity of oral mucositis caused by chemotherapy in young patients who are undergoing stem cell transplantation.
PURPOSE: This randomized clinical trial is studying how well Traumeel® S works in preventing or treating mucositis in young patients who are receiving chemotherapy with or without total-body irradiation before undergoing stem cell transplantation.
Full Description
OBJECTIVES:
Compare the efficacy of Traumeel® S vs placebo in reducing the severity and duration of chemotherapy-induced (with or without total body irradiation) mucositis in pediatric patients undergoing hematopoietic stem cell transplantation.
Determine the safety of this drug in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to treatment with total body irradiation during conditioning chemotherapy (yes vs no), type of transplantation (autologous vs allogeneic), and participating institution (COG vs foreign). Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive oral Traumeel® S mouth rinse 5 times daily beginning on day -1 before transplantation.
Arm II: Patients receive oral placebo mouth rinse 5 times daily beginning on day -1 before transplantation.
In both arms, treatment continues until day 20 post-transplantation OR until mucositis resolves to Walsh score ≤ 1 for 2 consecutive days.
Patients are followed until day 100 post-transplantation.
PROJECTED ACCRUAL: A total of 180 patients (90 per treatment arm) will be accrued for this study within 2 years.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Planned treatment with allogeneic or autologous hematopoietic stem cell transplantation
Conditioning chemotherapy regimen for transplantation must be myeloablative
Source of stem cells from any of the following:
Bone marrow
Placental cord
Cytokine-mobilized peripheral blood
Availability of 1 of the following donor types:
HLA-matched sibling or parent
Related donor mismatched for a single HLA locus (class I or II)
Unrelated marrow or peripheral blood stem cell donor
Unrelated umbilical cord blood HLA-matched or mismatched (class I) donor
PATIENT CHARACTERISTICS:
Age
3 to 25
Performance status
Not specified
Life expectancy
Not specified
Hematopoietic
Not specified
Hepatic
Not specified
Renal
Not specified
Other
No known allergy to Echinacea
Not pregnant or nursing
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
See Disease Characteristics
Chemotherapy
See Disease Characteristics
Endocrine therapy
Not specified
Radiotherapy
Not specified
Surgery
Not specified
Other
No concurrent oral vancomycin paste
No concurrent oral glutamine supplementation
No other mouth care or oral medications within 30 minutes after administration of study drugs
No other concurrent treatment to prevent mouth sores
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There are 44 Locations for this study
Birmingham Alabama, 35294, United States
Los Angeles California, 90095, United States
Orange California, 92868, United States
Stanford California, 94305, United States
Washington District of Columbia, 20010, United States
Gainesville Florida, 32610, United States
Jacksonville Florida, 32207, United States
Miami Florida, 33136, United States
St. Petersburg Florida, 33701, United States
Tampa Florida, 33607, United States
Atlanta Georgia, 30322, United States
Honolulu Hawaii, 95813, United States
Indianapolis Indiana, 46202, United States
Iowa City Iowa, 52242, United States
Kansas City Kansas, 66160, United States
New Orleans Louisiana, 70118, United States
Baltimore Maryland, 21231, United States
Boston Massachusetts, 02111, United States
Ann Arbor Michigan, 48109, United States
Grand Rapids Michigan, 49503, United States
Minneapolis Minnesota, 55404, United States
Minneapolis Minnesota, 55455, United States
Jackson Mississippi, 39216, United States
St. Louis Missouri, 63110, United States
Bronx New York, 10461, United States
New Hyde Park New York, 11040, United States
New York New York, 10032, United States
Syracuse New York, 13210, United States
Valhalla New York, 10595, United States
Cleveland Ohio, 44106, United States
Oklahoma City Oklahoma, 73104, United States
Pittsburgh Pennsylvania, 15213, United States
Charleston South Carolina, 29425, United States
Dallas Texas, 75390, United States
Fort Worth Texas, 76104, United States
San Antonio Texas, 78229, United States
Norfolk Virginia, 23507, United States
Randwick New South Wales, 2031, Australia
Westmead New South Wales, 2145, Australia
Perth Western Australia, 6001, Australia
Kingston Ontario, K7L 3, Canada
Montreal Quebec, H3H 1, Canada
Montreal Quebec, H3T 1, Canada
Tel Hashomer , 52621, Israel
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