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NCT03964506 · ClinicalTrials.gov registry record · Early Phase 1
Hyperbaric Oxygen Therapy and Allogeneic Peripheral Blood Stem Cell (PBSC) Transplant
A Early Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Omar Aljitawi.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT03964506: Recruiting Early Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Omar Aljitawi.
NCT03964506 is a Early Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes that is actively recruiting participants, run by Omar Aljitawi. The registered enrollment target is 24 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03964506, a Early Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, is actively recruiting participants, sponsored by Omar Aljitawi.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Treatment-limiting toxicities will be assessed 24-hours post-hyperbaric oxygen therapy.
Conditions Studied
Interventions
- DRUG Hyperbaric oxygen
Study Locations (1)
New York
- Wilmot Cancer Institute, University of Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2020-07-01 |
| Est. Completion | 2027-03-01 |
| Phase | Early Phase 1 |
What NCT03964506 shows while recruiting
NCT03964506 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (79% lower).
The record links to 7 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Hyperbaric oxygen is the first listed.
NCT03964506 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03964506 about?
NCT03964506 is a clinical study titled "Hyperbaric Oxygen Therapy and Allogeneic Peripheral Blood Stem Cell (PBSC) Transplant". 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 (inflamma...
What is the current status of trial NCT03964506?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 24 participants. The study started on 2020-07-01. Estimated completion is 2027-03-01.
What conditions does trial NCT03964506 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, Myelofibrosis, Myelodysplastic/Myeloproliferative Neoplasm.
What interventions are being tested in trial NCT03964506?
The interventions under investigation include: Hyperbaric oxygen (DRUG).
Who is sponsoring clinical trial NCT03964506?
This trial is sponsored by Omar Aljitawi, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03964506 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03964506's enrollment target sits among peer trials
24 225th of 306 higher than 75 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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