Gelclair at Conditioning or After Oral Mucositis Diagnosed vs. Magic Mouth Wash in Stem Cell Transplant Recipients
| Status: | Recruiting |
|---|---|
| Conditions: | Dental |
| Therapuetic Areas: | Dental / Maxillofacial Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/19/2018 |
| Start Date: | May 15, 2018 |
| End Date: | February 15, 2019 |
| Contact: | Nathaniel S Treister, DMD, DMSc |
| Email: | ntreister@partners.org |
| Phone: | 617-732-6570 |
An Adaptive Design, Single-Blind, Randomized, Controlled Study Investigating Polyvinylpyrrolidone (PVP) and Sodium Hyaluronate-Containing Oral Gel (Gelclair®) in Comparison to Viscous Lidocaine, Diphenhydramine, and Aluminum-magnesium Hydroxide/Simethicone Antacid Suspension Mouthwash ("Magic Mouthwash") for the Management of Oral Mucositis Associated With High Dose Chemotherapy and Methotrexate in Allogeneic Stem Cell Transplant Recipients
Patients receiving high-dose chemotherapy/conditioning prior to stem cell transplantation
(SCT) are at high risk for developing painful lesions in the oral cavity, known as oral
mucositis (OM).
In this high risk adult population, the study objectives are to investigate the efficacy and
tolerability of Gelclair® (GEL; an FDA cleared medical device indicated for the management of
painful oral lesions) and ideal timing of initiation of therapy (at the time of conditioning
or after mild OM is diagnosed) for the management of oral mucositis (OM), relative to a
commercially available compounded mouth wash (First® Mouthwash BLM "Magic Mouth Wash"; MMW)
initiated after mild OM is diagnosed. The study may be adapted based on an interim analysis
and recommendations of the interim data review committee.
(SCT) are at high risk for developing painful lesions in the oral cavity, known as oral
mucositis (OM).
In this high risk adult population, the study objectives are to investigate the efficacy and
tolerability of Gelclair® (GEL; an FDA cleared medical device indicated for the management of
painful oral lesions) and ideal timing of initiation of therapy (at the time of conditioning
or after mild OM is diagnosed) for the management of oral mucositis (OM), relative to a
commercially available compounded mouth wash (First® Mouthwash BLM "Magic Mouth Wash"; MMW)
initiated after mild OM is diagnosed. The study may be adapted based on an interim analysis
and recommendations of the interim data review committee.
Adult patients at high risk for developing OM receiving one of the following myeloablative
(MA) pre-transplant conditioning regimens prior to allogeneic transplant along with
methotrexate (MTX) as part of graft vs. host disease (GVHD) prophylaxis meeting all other
eligibility criteria will be enrolled:
- FluBu based regimens: either fludarabine: 30 mg/m^2 x 4 days and busulfan 0.8 mg/kg IV
q6h x 4 days; both given daily starting at day -4 OR fludarabine: 40 mg/m^2 and
busulfan: 3.2 mg/kg both given daily on days -6 through -3.
- Bu/Cy: busulfan, 0.8 mg/kg IV q6h x 4 days (-7 through -4); cyclophosphamide: 60 mg/kg
IV once on days -3 and -2
- Cy/TBI: Cyclophosphamide, 60 mg/kg IV given twice between days -3 and -1 and TBI
fractionated (generally over 3 days) for a total of 12Gy
GVHD Prophylaxis:
• Regimens including methotrexate (MTX; 15 mg/m^2 planned to be given on days 1, 3, 6 and
11); addition of other agents given along with MTX (e.g., tacrolimus, sirolimus) is
acceptable.
Duration of treatment:
- Arm 1: GEL treatment a minimum of 4x/day initiated from 1st day of conditioning through
OM resolution (G0), up to a maximum of 20d.
- Arms 2 (GEL) and 3 (MMW): Treatment a minimum of 4x/day initiated when G1 or G2 OM
diagnosed during observation period (through Day +14 relative to stem cell infusion)
through OM resolution (G0), up to a maximum of 20d.
(MA) pre-transplant conditioning regimens prior to allogeneic transplant along with
methotrexate (MTX) as part of graft vs. host disease (GVHD) prophylaxis meeting all other
eligibility criteria will be enrolled:
- FluBu based regimens: either fludarabine: 30 mg/m^2 x 4 days and busulfan 0.8 mg/kg IV
q6h x 4 days; both given daily starting at day -4 OR fludarabine: 40 mg/m^2 and
busulfan: 3.2 mg/kg both given daily on days -6 through -3.
- Bu/Cy: busulfan, 0.8 mg/kg IV q6h x 4 days (-7 through -4); cyclophosphamide: 60 mg/kg
IV once on days -3 and -2
- Cy/TBI: Cyclophosphamide, 60 mg/kg IV given twice between days -3 and -1 and TBI
fractionated (generally over 3 days) for a total of 12Gy
GVHD Prophylaxis:
• Regimens including methotrexate (MTX; 15 mg/m^2 planned to be given on days 1, 3, 6 and
11); addition of other agents given along with MTX (e.g., tacrolimus, sirolimus) is
acceptable.
Duration of treatment:
- Arm 1: GEL treatment a minimum of 4x/day initiated from 1st day of conditioning through
OM resolution (G0), up to a maximum of 20d.
- Arms 2 (GEL) and 3 (MMW): Treatment a minimum of 4x/day initiated when G1 or G2 OM
diagnosed during observation period (through Day +14 relative to stem cell infusion)
through OM resolution (G0), up to a maximum of 20d.
Inclusion Criteria:
- Be age ≥ 18 years old.
- Have Karnofsky performance status score ≥ 70.
- Be scheduled to receive one of 3 myeloablative conditioning regimens (defined in
population) followed by allogeneic SCT for hematological malignancy.
- Have anticipated in-patient status for 14 to 20 days from the time of transplant.
- Be willing and capable of swishing/gargling oral gel/solution as required per
protocol.
- Be willing and capable of completing the assessments and adhering to protocol
requirements.
- Be willing and able to provide written informed consent.
To be randomized to begin treatment, subjects randomized to Arms 2 or 3 must also meet the
following criterion:
-Be diagnosed with G1 or G2 OM via WHO OM scale during observation period from conditioning
to Day +14.
Exclusion Criteria:
- Subjects receiving pre-transplant conditioning/GVHD prophylaxis regimens other than
those defined, herein.
- Use of topical or systemic agents/treatments for OM within 2 weeks of treatment day 1.
- Evidence of uncontrolled infection (oral/oropharyngeal or systemic), including oral
herpes or unexplained febrile illness (≥ 99.5F /37.5C) requiring systemic
anti-infectives, within 7d of treatment Day 1.
- Subjects with active oral lesions or other mouth/throat soreness within 7d of study
randomization.
- Any other criteria, in the opinion of the investigator that would make the subject
unsuitable for study participation.
For subjects randomized to Treatment Arms 2 or 3 during observation period:
-OM ≥ G3 diagnosed prior to initiating randomized treatment during observation period
(conditioning through Day +14; i.e., missed treatment window).
We found this trial at
2
sites
Boston, Massachusetts 02115
Principal Investigator: Nathaniel S Treister, DMD, DMSc
Phone: 617-732-6570
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185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Areej El-Jawahri, MD
Phone: 617-643-4003
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