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Evaluate the Safety and Efficacy for Oral Mucositis Prevention of MIT-001 in Auto HSCT

NCT05493800 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-05-29

No results posted yet for this study

Summary

Evaluate the efficacy and safety for the prevention of oral mucositis and PK of MIT-001 for lymphoma or multiple myeloma patients receiving conditioning chemotherapy for autologous hematopoietic stem cell transplantation(auto-HSCT).

Conditions

Interventions

DRUG

MIT-001

Corresponding dose of MIT-001 IV injection during 0.5\~1hr

DRUG

normal saline

normal saline IV injection

Sponsors & Collaborators

  • MitoImmune Therapeutics

    lead INDUSTRY

Principal Investigators

  • Seok-Goo Cho, MD, PhD · Seoul St. Mary's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
19 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2024-06-30
Completion
2024-12-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05493800 on ClinicalTrials.gov