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Hyperbaric Oxygen Therapy and Allogeneic Peripheral Blood Stem Cell (PBSC) Transplant

Primary Purpose

Acute Myeloid Leukemia, Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Hyperbaric oxygen
Sponsored by
Omar Aljitawi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Allogeneic transplant, Hyperbaric Oxygen

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Voluntary written informed consent
  • Men or women, age ≥ 18 years of age, with upper limit of 75 years old.
  • Subjects with acute myeloid leukemia (AML) or Myelodysplastic Syndrome (MDS) for cohort 1.
  • Subjects with chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), CML, chronic neutrophilic leukemia (CNL), myelofibrosis, and myelodysplastic/myeloproliferative (MDS/MPN) overlap syndrome for cohort 2.
  • Karnofsky performance status (KPS) of ≥ 70%
  • Patients should have New York Heart Association (NYHA) Functional Classification, Class I (ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain) or Class II (ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain).
  • Adequate hepatic, renal, cardiac and pulmonary function to be eligible for transplant. Minimum criteria include: Hepatic: ALT, AST < 4x IULN and serum total bilirubin ≤ 2.0 mg/dL; Renal: serum creatinine: ≤ 2.0 mg/dL; Left ventricular ejection fraction ≥ 45% measured by 2D-ECHO or MUGA scan; EKG with no clinically significant arrhythmia; FEV1, FVC and DLCO ≥ 50% of predicted value (corrected to serum hemoglobin)
  • Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days following completion of therapy. Should a woman or partner become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician and the investigator immediately.
  • A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: Has not undergone a hysterectomy or bilateral oophorectomy; or Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
  • Women of child-bearing potential should have a negative urine or serum pregnancy test within 4 weeks of starting preparative regimen

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Severe chronic obstructive pulmonary disease requiring oxygen supplementation
  • History of spontaneous pneumothorax, prior chest surgery requiring thoracotomy or direct chest irradiation to the lungs
  • Evidence of pneumothorax or significant pulmonary fibrosis on chest imaging within 60 days of transplant.
  • Active malignancy excluding AML, MDS, CMML, aCML CML, CNL, MF and MDS/MPN overlap syndrome.
  • Active ear/sinus infection. Patients with chronic sinusitis or sinus headaches are excluded unless cleared by ear, nose, and throat specialist.
  • Recent sinus surgery (within the last 5 years).
  • Ear surgery excluding myringotomy or ear tubes
  • Subjects must agree to refrain from active tobacco or e-cigarette use 72 hours prior to transplant until complete transplant recovery. Nicotine replacement therapy is allowed.
  • Claustrophobia
  • History of recurrent seizures within 5 years of study enrollment.
  • Uncontrolled asthma
  • Uncontrolled viral or bacterial infection at the time of study enrollment
  • Active or recent (prior 6 months) invasive fungal infection without interdisciplinary (ID) consult and approval
  • Patients who had intrathecal chemotherapy within 2 weeks of starting preparative regimen or cranial irradiation within 4 weeks of starting preparative regimen

Sites / Locations

  • Wilmot Cancer Institute, University of RochesterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort 1- AML or MDS

Cohort 2- CMML, aCML, CML, CNL, MDS/MPN

Arm Description

Patients with will receive HBO therapy one time on day 0 of the transplant. The treatment consists of exposure to hyperbaric oxygen at 2.5 atmospheric absolutes (ATA) for a total of 90 minutes after compression to 2.5 atmosphere absolutes (ATA) in a monoplace hyperbaric chamber (Model 3200/3200R, Sechrist Industries, Inc., USA), breathing 100% oxygen. The subjects will be in the chamber for a total of 120 minutes as approximately 10-15 minutes were spent during the compression and decompression phases and subjects had 10 minute room air breaks every 30 minutes of hyperbaric oxygen treatment.

Patients with will receive HBO therapy one time on day 0 of the transplant. The treatment consists of exposure to hyperbaric oxygen at 2.5 atmospheric absolutes (ATA) for a total of 90 minutes after compression to 2.5 atmosphere absolutes (ATA) in a monoplace hyperbaric chamber (Model 3200/3200R, Sechrist Industries, Inc., USA), breathing 100% oxygen. The subjects will be in the chamber for a total of 120 minutes as approximately 10-15 minutes were spent during the compression and decompression phases and subjects had 10 minute room air breaks every 30 minutes of hyperbaric oxygen treatment.

Outcomes

Primary Outcome Measures

Immediate safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplantation in Cohort 1
Treatment-limiting toxicities will be assessed 24-hours post-hyperbaric oxygen therapy.
Immediate safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplantation in cohort 2
Treatment-limiting toxicities will be assessed 24-hours post-hyperbaric oxygen therapy.
Long term safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplant in Cohort 1
Possible long-term effects of hyperbaric oxygen therapy treatment prior to allogeneic peripheral blood stem cell transplant will be assessed at day +100 post-transplant
Long term safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplant in Cohort 2
Possible long-term effects of hyperbaric oxygen therapy treatment prior to allogeneic peripheral blood stem cell transplant will be assessed at day +100 post-transplant

Secondary Outcome Measures

Time to neutrophil recovery in Cohort 1
based on the patient having achieved three consecutive days of Absolute Neutrophile Count (ANC) ≥ 500/microliter
Time to neutrophil recovery in Cohort 2
based on the patient having achieved three consecutive days of Absolute Neutrophile Count (ANC) ≥ 500/microliter
Time to complete donor chimerism in Cohort 1
Bone marrow chimerism will be checked on day +30 and day +100 Bone Marrow (BM) samples according to our standard of care
Time to complete donor chimerism in Cohort 2
Bone marrow chimerism will be checked on day +30 and day +100 Bone Marrow (BM) samples according to our standard of care
Incidence of mucositis in Cohort 1
Incidence of graft versus host disease in Cohort 1
Incidence of infection in Cohort 1
Incidence of mucositis in Cohort 2
Incidence of infection in Cohort 2
Incidence of graft versus host disease in Cohort 2

Full Information

First Posted
May 23, 2019
Last Updated
April 3, 2023
Sponsor
Omar Aljitawi
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1. Study Identification

Unique Protocol Identification Number
NCT03964506
Brief Title
Hyperbaric Oxygen Therapy and Allogeneic Peripheral Blood Stem Cell (PBSC) Transplant
Official Title
A Pilot Study to Determine the Safety and Efficacy of Incorporating Hyperbaric Oxygen Therapy Into RIC Fludarabine and Melphalan and Allogeneic Hematopoietic Stem/Progenitor Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Omar Aljitawi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine if hyperbaric oxygen therapy is safe in the setting of stem cell transplantation. This study will also determine if hyperbaric oxygen therapy improves engraftment, graft versus host disease, neutrophil count, and incidence and severity of mucositis (inflammation of the mouth or gut) and infection. This study has two cohorts. The first cohort is subjects with acute myeloid leukemia (AML) or Myelodysplastic Syndrome (MDS). The second cohort is subjects with chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), chronic monocytic leukemia, chronic neutrophilic leukemia (CNL), myelofibrosis, and myelodysplastic/myeloproliferative (MDS/MPN) overlap syndrome. The first cohort has completed the recruitment so only the second cohort will be recruited.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, Atypical Chronic Myeloid Leukemia, Chronic Monocytic Leukemia, Myelofibrosis, Myelodysplastic/Myeloproliferative Neoplasm
Keywords
Allogeneic transplant, Hyperbaric Oxygen

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1- AML or MDS
Arm Type
Experimental
Arm Description
Patients with will receive HBO therapy one time on day 0 of the transplant. The treatment consists of exposure to hyperbaric oxygen at 2.5 atmospheric absolutes (ATA) for a total of 90 minutes after compression to 2.5 atmosphere absolutes (ATA) in a monoplace hyperbaric chamber (Model 3200/3200R, Sechrist Industries, Inc., USA), breathing 100% oxygen. The subjects will be in the chamber for a total of 120 minutes as approximately 10-15 minutes were spent during the compression and decompression phases and subjects had 10 minute room air breaks every 30 minutes of hyperbaric oxygen treatment.
Arm Title
Cohort 2- CMML, aCML, CML, CNL, MDS/MPN
Arm Type
Experimental
Arm Description
Patients with will receive HBO therapy one time on day 0 of the transplant. The treatment consists of exposure to hyperbaric oxygen at 2.5 atmospheric absolutes (ATA) for a total of 90 minutes after compression to 2.5 atmosphere absolutes (ATA) in a monoplace hyperbaric chamber (Model 3200/3200R, Sechrist Industries, Inc., USA), breathing 100% oxygen. The subjects will be in the chamber for a total of 120 minutes as approximately 10-15 minutes were spent during the compression and decompression phases and subjects had 10 minute room air breaks every 30 minutes of hyperbaric oxygen treatment.
Intervention Type
Drug
Intervention Name(s)
Hyperbaric oxygen
Other Intervention Name(s)
HBO
Intervention Description
Reduced intensity conditioning Fludarabine and Melphalan with Hyperbaric Oxygen and Allogeneic Hematopoietic Stem Cell Transplant
Primary Outcome Measure Information:
Title
Immediate safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplantation in Cohort 1
Description
Treatment-limiting toxicities will be assessed 24-hours post-hyperbaric oxygen therapy.
Time Frame
24 hours
Title
Immediate safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplantation in cohort 2
Description
Treatment-limiting toxicities will be assessed 24-hours post-hyperbaric oxygen therapy.
Time Frame
24 hours
Title
Long term safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplant in Cohort 1
Description
Possible long-term effects of hyperbaric oxygen therapy treatment prior to allogeneic peripheral blood stem cell transplant will be assessed at day +100 post-transplant
Time Frame
100 days
Title
Long term safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplant in Cohort 2
Description
Possible long-term effects of hyperbaric oxygen therapy treatment prior to allogeneic peripheral blood stem cell transplant will be assessed at day +100 post-transplant
Time Frame
100 days
Secondary Outcome Measure Information:
Title
Time to neutrophil recovery in Cohort 1
Description
based on the patient having achieved three consecutive days of Absolute Neutrophile Count (ANC) ≥ 500/microliter
Time Frame
100 days
Title
Time to neutrophil recovery in Cohort 2
Description
based on the patient having achieved three consecutive days of Absolute Neutrophile Count (ANC) ≥ 500/microliter
Time Frame
100 days
Title
Time to complete donor chimerism in Cohort 1
Description
Bone marrow chimerism will be checked on day +30 and day +100 Bone Marrow (BM) samples according to our standard of care
Time Frame
100 days
Title
Time to complete donor chimerism in Cohort 2
Description
Bone marrow chimerism will be checked on day +30 and day +100 Bone Marrow (BM) samples according to our standard of care
Time Frame
100 days
Title
Incidence of mucositis in Cohort 1
Time Frame
100 days
Title
Incidence of graft versus host disease in Cohort 1
Time Frame
100 days
Title
Incidence of infection in Cohort 1
Time Frame
100 days
Title
Incidence of mucositis in Cohort 2
Time Frame
100 days
Title
Incidence of infection in Cohort 2
Time Frame
100 days
Title
Incidence of graft versus host disease in Cohort 2
Time Frame
100 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Voluntary written informed consent Men or women, age ≥ 18 years of age, with upper limit of 75 years old. Subjects with acute myeloid leukemia (AML) or Myelodysplastic Syndrome (MDS) for cohort 1. Subjects with chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), CML, chronic neutrophilic leukemia (CNL), myelofibrosis, and myelodysplastic/myeloproliferative (MDS/MPN) overlap syndrome for cohort 2. Karnofsky performance status (KPS) of ≥ 70% Patients should have New York Heart Association (NYHA) Functional Classification, Class I (ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain) or Class II (ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain). Adequate hepatic, renal, cardiac and pulmonary function to be eligible for transplant. Minimum criteria include: Hepatic: ALT, AST < 4x IULN and serum total bilirubin ≤ 2.0 mg/dL; Renal: serum creatinine: ≤ 2.0 mg/dL; Left ventricular ejection fraction ≥ 45% measured by 2D-ECHO or MUGA scan; EKG with no clinically significant arrhythmia; FEV1, FVC and DLCO ≥ 50% of predicted value (corrected to serum hemoglobin) Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days following completion of therapy. Should a woman or partner become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician and the investigator immediately. A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: Has not undergone a hysterectomy or bilateral oophorectomy; or Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months) Women of child-bearing potential should have a negative urine or serum pregnancy test within 4 weeks of starting preparative regimen Exclusion Criteria: Pregnant or breastfeeding Severe chronic obstructive pulmonary disease requiring oxygen supplementation History of spontaneous pneumothorax, prior chest surgery requiring thoracotomy or direct chest irradiation to the lungs Evidence of pneumothorax or significant pulmonary fibrosis on chest imaging within 60 days of transplant. Active malignancy excluding AML, MDS, CMML, aCML CML, CNL, MF and MDS/MPN overlap syndrome. Active ear/sinus infection. Patients with chronic sinusitis or sinus headaches are excluded unless cleared by ear, nose, and throat specialist. Recent sinus surgery (within the last 5 years). Ear surgery excluding myringotomy or ear tubes Subjects must agree to refrain from active tobacco or e-cigarette use 72 hours prior to transplant until complete transplant recovery. Nicotine replacement therapy is allowed. Claustrophobia History of recurrent seizures within 5 years of study enrollment. Uncontrolled asthma Uncontrolled viral or bacterial infection at the time of study enrollment Active or recent (prior 6 months) invasive fungal infection without interdisciplinary (ID) consult and approval Patients who had intrathecal chemotherapy within 2 weeks of starting preparative regimen or cranial irradiation within 4 weeks of starting preparative regimen
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Regulatory Coordinator
Phone
(585) 276-7078
Email
Lisa_Metzger@URMC.Rochester.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omar S Aljitawi, MBBS
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wilmot Cancer Institute, University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Omar Aljitawi
First Name & Middle Initial & Last Name & Degree
Lisa Metzger

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All individual participant data collected during the trial will be shared after deidentification, including dictionaries.
IPD Sharing Time Frame
Data will be available immediately following publication. No end date.
IPD Sharing Access Criteria
Anyone who wishes to access the data for any type of analyses.

Learn more about this trial

Hyperbaric Oxygen Therapy and Allogeneic Peripheral Blood Stem Cell (PBSC) Transplant

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