HBOT in the Treatment and Prevention of aGVHD

Acute-graft-versus-host Disease Clinical Trial

Official title:

Hyperbaric Oxygen Therapy Improve Acute Graft-Versus-Host Disease in Patients Underwent Allogeneic Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05078073
• Other study ID #: HBOT in aGVHD
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2021
• Est. completion date: August 10, 2025

Study information

• Verified date: September 2021
• Source: Shandong Provincial Hospital
• Contact: Yujie Jiang, Dr.
• Phone: 86-13370506886
• Email: yujiejiang05[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a potentially curative therapeutic strategy for patients with hematopoietic malignancies. However, the therapeutic benefits and wider application of allo-HSCT are limited by acute graft-versus-host disease (aGVHD), the latter remains a major obstacle against long-term survival for this population. New aGVHD prophylactic and therapeutic strategies that are superior in efficacy, safety, cost-effectiveness, and less technically demanding are still in desperate need. Hyperbaric oxygen therapy (HBOT) has been confirmed as an effective and economical therapeutic modality for hemorrhagic cystitis (HC) whether induced by infection or acute graft-versus-host disease (aGVHD) for transplant recipients. However, little is known about its involvement in aGVHD. In this study, the investigators designed a randomized, controlled, and open clinical trial to confirm the safety and efficacy of HBOT on aGVHD in patient underwent allo-HSCT.

Description:

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a potentially curative therapeutic strategy for patients with hematopoietic malignancies. However, the therapeutic benefits and wider application of allo-HSCT are limited by acute graft-versus-host disease (aGVHD), the latter remains a major obstacle against long-term survival for this population. New aGVHD prophylactic and therapeutic strategies that are superior in efficacy, safety, cost-effectiveness, and less technically demanding are still in desperate need.

Although a variety of immune and non-immune cells are involved in the development of aGVHD, reactive oxygen species (ROS) has been proved as the primary triggers of the inflammatory response and play a key role in the pathogenesis of aGVHD. Therefore, strategies targeting ROS production are crucial for effectively managing aGVHD. Hyperbaric oxygen therapy (HBOT) is a well-established treatment method, which is used to improve non-healing ulcers secondary to aGVHD and hemorrhagic cystitis (HC) after allo-HSCT whether induced by infection or aGVHD. Even the exact mechanism is not fully understood, HBOT was demonstrated to reduce a series of pro-inflammatory cytokines release and can improve the action of antibiotics.

In this study, the investigators plan to initiate a randomized, controlled, and open clinical cohort study confirm the safety and efficacy of HBOT on aGVHD in patient underwent allo-HSCT.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 10, 2025
• Est. primary completion date: August 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients undergoing allogeneic stem cell transplantation

• Patients develop aGVHD

• The count of neutrophilia cells over 0.5 * 109/L, hemoglobin over 60 g/L, platelet over 30 *109/L

• Signed informed consent

Exclusion Criteria:

• Unsuitable to the study due to severe complication such as uncontrolled severe infection

• Claustrophobia

• Ear diseases such as otitis media

• Eye diseases such as glaucoma

• Epilepsy history

• Important organ dysfunction

• Coagulopathy

Related Conditions & MeSH terms

• Acute-graft-versus-host Disease
• Graft vs Host Disease
• Hyperbaric Oxygen Therapy

Intervention

Device:
• Hyperbaric oxygen therapy
Patients with aGVHD treated with HBOT every two days

Locations

Country	Name	City	State
China	Shandong Provincial Hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Provincial Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate of HBOT as complete response or partial response for the treatment of aGVHD	Complete or partial response rate of HBOT for the treatment of aGVHD will be measured using Bayesian method.	Four years
Primary	Incidence of aGVHD when HBOT was administrated as prophylaxis measurement at one month after transplant	At one month after transplant, HBOT will be administrated every three days (up to 6 times) to recipients without aGVHD evidence, the incidence of aGVHD will be counted.	100 days post transplant
Secondary	Overall survival rate	Will be summarized by frequency and 95% confidence interval. The distribution of time-to-event endpoints will be estimated by Kaplan-Meier estimate. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test. Cox proportional hazards regression will be employed for multivariate analysis on time-to-event outcomes.	Four years
Secondary	Leukemia-free survival rate	Will be summarized by frequency and 95% confidence interval. The distribution of time-to-event endpoints will be estimated by Kaplan-Meier estimate. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test. Cox proportional hazards regression will be employed for multivariate analysis on time-to-event outcomes.	Four years
Secondary	Relapse rate	Relapse rate of recipients will be measured using Bayesian method. Will be summarized by frequency and 95% confidence interval.	Four years
Secondary	Incidence of adverse events of HBOT	Toxicities will be summarized by grade and by their relationship to treatment.	Four years