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

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ClinicalTrials.gov Identifier: NCT03490396
Recruitment Status : Recruiting
First Posted : April 6, 2018
Last Update Posted : May 17, 2018
Sponsor:
Collaborator:
PharPoint Research, Inc.
Information provided by (Responsible Party):
Midatech Pharma US Inc.

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.


Condition or disease Intervention/treatment Phase
Oral Mucositis Device: Gelclair Combination Product: First® Mouthwash BLM Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The initial design is a prospective, randomized, single-blind (evaluator), parallel, three arm, controlled clinical study.
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : May 15, 2018
Estimated Primary Completion Date : February 15, 2019
Estimated Study Completion Date : February 15, 2019

Arm Intervention/treatment
Experimental: Arm 1 (Gelclair at time of conditioning)
All subjects in study Arm 1 will receive GEL starting on the first day of conditioning.
Device: Gelclair
Polyvinylpyrrolidone (PVP) and Sodium Hyaluronate-Containing Oral Gel
Other Name: Gelclair Bioadherent Oral Gel

Active Comparator: 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.
Device: Gelclair
Polyvinylpyrrolidone (PVP) and Sodium Hyaluronate-Containing Oral Gel
Other Name: Gelclair Bioadherent Oral Gel

Active Comparator: 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.
Combination Product: First® Mouthwash BLM
Viscous Lidocaine, Diphenhydramine, and Aluminum-magnesium Hydroxide/Simethicone Antacid Suspension Mouthwash
Other Name: Magic Mouth Wash




Primary Outcome Measures :
  1. Incidence/occurrence of any grade Oral Mucositis [ Time Frame: Initial study period (initiation of conditioning through day +14 post-transplant) ]
    Incidence/develop of any grade of OM as assessed via WHO OM grading scale (Grades possible: 1-4)

  2. Area under the curve in mouth and throat soreness (MTS) [ Time Frame: While OM ongoing during study period (initiation of conditioning through day +28 post-transplant) ]

Secondary Outcome Measures :
  1. Time to onset of any grade OM [ Time Frame: Initial study period (initiation of conditioning through day +14 post-transplant) ]
    WHO Grades 1-4

  2. Duration of any grade OM [ Time Frame: Study period (initiation of conditioning through day +28 post-transplant) ]
    WHO Grades 1-4

  3. Severity of OM [ Time Frame: Study period (initiation of conditioning through day +28 post-transplant) ]
    WHO Grades 1-4

  4. Incidence of severe OM [ Time Frame: Study period (initiation of conditioning through day +28 post-transplant) ]
    WHO Grades 3-4

  5. Time to onset of severe OM [ Time Frame: Study period (initiation of conditioning through day +28 post-transplant) ]
    WHO Grades 3-4

  6. Duration of severe OM [ Time Frame: Study period (initiation of conditioning through day +28 post-transplant) ]
    WHO Grades 3-4

  7. Magnitude of OM-related pain control [ Time Frame: While OM ongoing during study period (initiation of conditioning through day +28 post-transplant) ]
    Based on subject grading of mouth and throat soreness (VAS 0 (no pain) to 10 (max pain possible)) prior to each randomized/rescue OM treatment.

  8. Duration of pain control [ Time Frame: While OM ongoing during study period (initiation of conditioning through day +28 post-transplant) ]
    Based on time at a given mouth and throat soreness level and/or need for rescue treatment to control mouth and throat soreness.

  9. Opiate and other background pain medication use [ Time Frame: While OM ongoing during study period (initiation of conditioning through day +28 post-transplant) ]

Other Outcome Measures:
  1. Weight change over study treatment period [ Time Frame: Study period (initiation of conditioning through day +28 post-transplant) ]
  2. Incidence of treatment-emergent infection [ Time Frame: While OM ongoing during study period (initiation of conditioning through day +28 post-transplant) ]
    e.g., bacteremia/febrile neutropenia, including oral infections (e.g., thrush).

  3. Duration of treatment-emergent infections [ Time Frame: While OM ongoing during study period (initiation of conditioning through day +28 post-transplant) ]
    e.g., bacteremia/febrile neutropenia, including oral infections (e.g., thrush).

  4. Use of anti-infectives for treatment-emergent infections [ Time Frame: While OM ongoing during study period (initiation of conditioning through day +28 post-transplant) ]
    Exploratory Endpoint

  5. Duration of anti-infective use for treatment-emergent infections [ Time Frame: While OM ongoing during study period (initiation of conditioning through day +28 post-transplant) ]
  6. Dose level of anti-infectives for treatment-emergent infections [ Time Frame: While OM ongoing during study period (initiation of conditioning through day +28 post-transplant) ]
  7. Days of hospitalization post-SCT [ Time Frame: Study period (initiation of conditioning through day +28 post-transplant) ]
  8. Incidence of need for a modified diet [ Time Frame: While OM ongoing during study period (initiation of conditioning through day +28 post-transplant) ]
    For example, soft, liquid, TPN

  9. Duration of need for a modified diet [ Time Frame: While OM ongoing during study period (initiation of conditioning through day +28 post-transplant) ]
    For example, soft, liquid, TPN

  10. Treatment Compliance with randomized OM treatment [ Time Frame: Study period (initiation of conditioning through day +28 post-transplant) ]
    Assessed by determining the number of randomized treatments actually taken relative to the number of treatments required (i.e., treatment compliance)

  11. Use of rescue treatments other than randomized agent for managing OM [ Time Frame: While OM ongoing during study period (initiation of conditioning through day +28 post-transplant) ]
  12. Incidence of treatment-emergent xerostomia ≥ G2 [ Time Frame: Study period (initiation of conditioning through day +28 post-transplant) ]
  13. Duration of treatment-emergent xerostomia ≥ G2 [ Time Frame: Study period (initiation of conditioning through day +28 post-transplant) ]
  14. Use of treatments/medications to manage xerostomia [ Time Frame: Study period (initiation of conditioning through day +28 post-transplant) ]
  15. Duration of use for treatments/medications to manage xerostomia [ Time Frame: Study period (initiation of conditioning through day +28 post-transplant) ]
  16. Impact of OM on activities of daily living [ Time Frame: Study period (initiation of conditioning through day +28 post-transplant) ]
    Via validated oral mucositis daily questionnaire (OMDQ)

  17. Diarrhea associated with OM [ Time Frame: Study period (initiation of conditioning through day +28 post-transplant) ]
    Via validated oral mucositis daily questionnaire (OMDQ)

  18. Exploratory Safety/Tolerability of GEL and MMW [ Time Frame: Study period (initiation of conditioning through day +28 post-transplant) ]
    Assessed by treatment-emergent and related adverse events/serious adverse events/unanticipated adverse device effects and subject reported tolerability.



Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490396


Contacts
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Contact: Nathaniel S Treister, DMD, DMSc 617-732-6570 ntreister@partners.org
Contact: Lisa B Johnson, RDH, MS, MPH 617-732-6885 lbennettjohnson@partners.org

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Areej El-Jawahri, MD    617-643-4003    Ael-jawahri@mgh.harvard.edu   
Contact: Jami Brown    617-724-9190    JBROWN56@mgh.harvard.edu   
Principal Investigator: Areej El-Jawahri, MD         
Brigham & Women's Hospital/Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02120
Contact: Nathaniel S Treister, DMD, DMSc    617-732-6570    ntreister@partners.org   
Contact: Lisa B Johnson, RDH, MS, MPH    617-732-6885    lbennettjohnson@partners.org   
Principal Investigator: Nathaniel S Treister, DMD, DMSc         
Sub-Investigator: Corey Culter, MD, MPH         
Sponsors and Collaborators
Midatech Pharma US Inc.
PharPoint Research, Inc.
Investigators
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Study Director: Mary Kay Delmedico, PhD Midatech Pharma US Inc.

Additional Information:
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Responsible Party: Midatech Pharma US Inc.
ClinicalTrials.gov Identifier: NCT03490396     History of Changes
Other Study ID Numbers: GEL-401
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Midatech Pharma US Inc.:
Oral Mucositis
Stomatitis
Myeloablative

Additional relevant MeSH terms:
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Mucositis
Stomatitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Diphenhydramine
Lidocaine
Promethazine
Magnesium Hydroxide
Aluminum hydroxide, magnesium hydroxide, drug combination
Simethicone
Hyaluronic Acid
Antacids
Povidone
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents