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

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
• - 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).