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

NCT ID: NCT03490396

Last Updated: 2019-11-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-15
• Study Completion Date: 2019-11-15

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.

Detailed Description

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.

Conditions

Oral Mucositis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Arm 1 (Gelclair at time of conditioning)

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

Group Type: EXPERIMENTAL

Gelclair

Intervention Type: DEVICE

Polyvinylpyrrolidone (PVP) and Sodium Hyaluronate-Containing Oral Gel

Arm 2 (Gelclair when OM diagnosed)

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.

Group Type: ACTIVE_COMPARATOR

Gelclair

Intervention Type: DEVICE

Polyvinylpyrrolidone (PVP) and Sodium Hyaluronate-Containing Oral Gel

Arm 3 (MMW when OM diagnosed)

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.

Group Type: ACTIVE_COMPARATOR

First® Mouthwash BLM

Intervention Type: COMBINATION_PRODUCT

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

Interventions

Gelclair

Polyvinylpyrrolidone (PVP) and Sodium Hyaluronate-Containing Oral Gel

Intervention Type: DEVICE

First® Mouthwash BLM

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

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Gelclair Bioadherent Oral Gel; Magic Mouth Wash

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PharPoint Research, Inc.

INDUSTRY

Sponsor Role: collaborator

Midatech Pharma US Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary Kay Delmedico, PhD

Role: STUDY_DIRECTOR

Midatech Pharma US Inc.

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

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

Boston, Massachusetts, United States

Countries

United States

Related Links

http://www.gelclair.com/

Gelclair Website (Study Agent)

Other Identifiers

GEL-401

Identifier Type: -

Identifier Source: org_study_id