Condition or disease | Intervention/treatment | Phase |
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Acute Myeloid Leukemia Myelodysplastic Syndromes | Drug: Hyperbaric oxygen | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 12 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | July 1, 2020 |
Estimated Primary Completion Date : | March 2022 |
Estimated Study Completion Date : | March 2022 |
Arm | Intervention/treatment |
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Experimental: Hyperbaric Oxygen Therapy
Patients 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.
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Drug: Hyperbaric oxygen
Reduced intensity conditioning Fludarabine and Melphalan with Hyperbaric Oxygen and Allogeneic Hematopoietic Stem Cell Transplant
Other Name: HBO
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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Regulatory Coordinator | (585) 276-7078 | Lisa_Metzger@URMC.Rochester.edu |
United States, New York | |
Wilmot Cancer Institute, University of Rochester | Recruiting |
Rochester, New York, United States, 14642 | |
Contact: Omar Aljitawi | |
Contact: Lisa Metzger |
Principal Investigator: | Omar S Aljitawi, MBBS | University of Rochester |
Tracking Information | |||||||||||||||||||
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First Submitted Date ICMJE | May 23, 2019 | ||||||||||||||||||
First Posted Date ICMJE | May 28, 2019 | ||||||||||||||||||
Last Update Posted Date | December 16, 2020 | ||||||||||||||||||
Actual Study Start Date ICMJE | July 1, 2020 | ||||||||||||||||||
Estimated Primary Completion Date | March 2022 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||
Change History | |||||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||
Descriptive Information | |||||||||||||||||||
Brief Title ICMJE | Hyperbaric Oxygen Therapy and Allogeneic Peripheral Blood Stem Cell (PBSC) Transplant | ||||||||||||||||||
Official Title ICMJE | 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 | ||||||||||||||||||
Brief Summary | Subjects with Acute Myeloblastic Leukemia (AML) and myelodysplastic syndrome (MDS) who are considered eligible for reduced intensity conditioning allogeneic stem cell transplant by the transplant team at WCI (Wilmot Cancer Institute)will be enrolled in the study. Patients will receive Fludarabine starting day -6 and Melphalan on day -2 and HBO (Hyperbaric Oxygen) therapy on day 0 of the transplant. Subjects will be followed for any toxicity related to therapy. After neutrophil recovery is documented, the patients will be seen in clinic at least weekly through day +100. | ||||||||||||||||||
Detailed Description | Subjects with Acute Myeloblastic Leukemia (AML) and myelodysplastic syndrome (MDS), who are considered eligible for reduced intensity conditioning allogeneic stem cell transplant by the transplant team at WCI(Wilmot Cancer Institute) will be enrolled in the study. Fludarabine 30mg/M2 will be given IV over 30-60 minutes on days -6 to -2 and Melphalan 140mg/M2 will be given IV over 4-hours once on day -2 of the preparative regimen. Patients will receive HBO therapy 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 will be seen daily until neutrophil count engraftment is documented. After neutrophil recovery is documented, the patients will be seen in clinic at least weekly through day +100. A final visit will be scheduled day +100. As part of routine care, subjects will be followed daily or as directed by the treating physician until neutrophil recovery, defined as three consecutive days of achieving a neutrophil count of >500/mm3. Laboratory testing will occur per institutional guidelines. Follow-up will continue until Day +100. Donor chimerism and disease status will be determined by bone marrow biopsy on Day +30 and day +100 post-transplant. | ||||||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||||||
Study Phase ICMJE | Early Phase 1 | ||||||||||||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: Hyperbaric oxygen
Reduced intensity conditioning Fludarabine and Melphalan with Hyperbaric Oxygen and Allogeneic Hematopoietic Stem Cell Transplant
Other Name: HBO
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Study Arms ICMJE | Experimental: Hyperbaric Oxygen Therapy
Patients 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: Drug: Hyperbaric oxygen
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Publications * | Not Provided | ||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||||
Recruitment Status ICMJE | Recruiting | ||||||||||||||||||
Estimated Enrollment ICMJE |
12 | ||||||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||||||
Estimated Study Completion Date ICMJE | March 2022 | ||||||||||||||||||
Estimated Primary Completion Date | March 2022 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||||||||||||
Removed Location Countries | |||||||||||||||||||
Administrative Information | |||||||||||||||||||
NCT Number ICMJE | NCT03964506 | ||||||||||||||||||
Other Study ID Numbers ICMJE | UBMT-19163 | ||||||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Omar Aljitawi, University of Rochester | ||||||||||||||||||
Study Sponsor ICMJE | Omar Aljitawi | ||||||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||||||
Investigators ICMJE |
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PRS Account | University of Rochester | ||||||||||||||||||
Verification Date | December 2020 | ||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |