Gelclair at Conditioning or After Oral Mucositis Diagnosed vs. Magic Mouth Wash in Stem Cell Transplant Recipients

Description

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.

Study Start Date

April, 09 2018

Estimated Completion Date

February 2019

Interventions

  • Device: Gelclair
  • Combination Product: First® Mouthwash BLM

Study ID

Midatech Pharma US Inc. -- GEL-401

Status

Recruiting

Trial ID

NCT03490396

Study Type

Interventional

Trial Phase

Phase 4

Enrollment Quota

60

Sponsor

Midatech Pharma US Inc.

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).

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (2)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Areej ElJawahri MD 617-643-4003 Ael-jawahri@mgh.harvard.edu
Brigham Womens HospitalDanaFarber Cancer Institute - Boston, Massachusetts 3.1 miles Nathaniel S Treister DMD DMSc 617-732-6570 ntreister@partners.org

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