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

NCT03490396 | Terminated Phase 4 DMC FDA Device

• 1 other identifier: GEL-401
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Oral Mucositis

Keywords

Oral Mucositis; Stomatitis; Myeloablative

Outcome Measures

Primary Outcomes (2)

• Incidence/occurrence of any grade Oral Mucositis

  Incidence/develop of any grade of OM as assessed via WHO OM grading scale (Grades possible: 1-4)

  Initial study period (initiation of conditioning through day +14 post-transplant)

• Area under the curve in mouth and throat soreness (MTS)

  While OM ongoing during study period (initiation of conditioning through day +28 post-transplant)

Secondary Outcomes (9)

• Time to onset of any grade OM

  Initial study period (initiation of conditioning through day +14 post-transplant)

• Duration of any grade OM

  Study period (initiation of conditioning through day +28 post-transplant)

• Severity of OM

  Study period (initiation of conditioning through day +28 post-transplant)

• Incidence of severe OM

  Study period (initiation of conditioning through day +28 post-transplant)

• Time to onset of severe OM

  Study period (initiation of conditioning through day +28 post-transplant)

Other Outcomes (18)

• Weight change over study treatment period

  Study period (initiation of conditioning through day +28 post-transplant)

• Incidence of treatment-emergent infection

  While OM ongoing during study period (initiation of conditioning through day +28 post-transplant)

• Duration of treatment-emergent infections

  While OM ongoing during study period (initiation of conditioning through day +28 post-transplant)

Study Arms (3)

Arm 1 (Gelclair at time of conditioning)

EXPERIMENTAL

All subjects in study Arm 1 will receive GEL starting on the first day of conditioning.

Device: Gelclair

Arm 2 (Gelclair when OM diagnosed)

ACTIVE COMPARATOR

Subjects in Arm 2 will be observed from initiation of conditioning to Day +14. If subjects develop G1 or G2 OM via WHO OM scale during this period, they will at that time be randomized to immediately receive GEL.

Device: Gelclair

Arm 3 (MMW when OM diagnosed)

ACTIVE COMPARATOR

Subjects in Arm 2 will be observed from initiation of conditioning to Day +14. If subjects develop G1 or G2 OM via WHO OM scale during this period, they will at that time be randomized to immediately receive MMW.

Combination Product: First® Mouthwash BLM

Interventions

Gelclair DEVICE

Polyvinylpyrrolidone (PVP) and Sodium Hyaluronate-Containing Oral Gel

Also known as: Gelclair Bioadherent Oral Gel

Arm 1 (Gelclair at time of conditioning); Arm 2 (Gelclair when OM diagnosed)

First® Mouthwash BLM COMBINATION_PRODUCT

Viscous Lidocaine, Diphenhydramine, and Aluminum-magnesium Hydroxide/Simethicone Antacid Suspension Mouthwash

Also known as: Magic Mouth Wash

Arm 3 (MMW when OM diagnosed)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Midatech Pharma US Inc.: lead
• PharPoint Research, Inc.: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham & Women's Hospital/Dana-Farber Cancer Institute

Boston, Massachusetts, 02120, United States

Location

Related Links

• Gelclair Website (Study Agent)

MeSH Terms

Conditions

Stomatitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Mary Kay Delmedico, PhD

  Midatech Pharma US Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: OM grading via the WHO oral toxicity grading scale will be performed by the trained blinded evaluator at least 3X/week (e.g., M, W and F), with ≤ 48h (±24h) in between each assessment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The initial design is a prospective, randomized, single-blind (evaluator), parallel, three arm, controlled clinical study.

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: April 6, 2018
• Study Start: May 15, 2018
• Primary Completion: November 15, 2019
• Study Completion: November 15, 2019
• Last Updated: November 22, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)