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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 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.

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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.

Interventions

  • DRUG Hyperbaric oxygen

Study Locations (1)

New York

  • Wilmot Cancer Institute, University of Rochester - Rochester

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2020-07-01
Est. Completion 2027-03-01
Phase Early Phase 1

Sponsor

Omar Aljitawi

2 total trials

What the Registry Record Tells You About NCT03964506

The ClinicalTrials.gov registry entry for NCT03964506 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (79% lower). The listed sponsor is Omar Aljitawi, which has 2 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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