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NCT03922035 · ClinicalTrials.gov registry record · Phase 1
CBM588 in Improving Clinical Outcomes in Patients Who Have Undergone Donor Hematopoietic Stem Cell Transplant
A Phase 1 study of Hematopoietic and Lymphoid Cell Neoplasm, sponsored by City of Hope Medical Center.
- Active
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT03922035: Active Phase 1 study of Hematopoietic and Lymphoid Cell Neoplasm, sponsored by City of Hope Medical Center.
NCT03922035 is a Phase 1 study of Hematopoietic and Lymphoid Cell Neoplasm that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 36 participants, below the 953-participant average among 104 other Hematopoietic and Lymphoid Cell Neoplasm trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03922035, a Phase 1 study of Hematopoietic and Lymphoid Cell Neoplasm, is active but no longer recruiting, sponsored by City of Hope Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
This pilot trial studies the side effects and how well CBM588 works in improving clinical outcomes in patients who have undergone donor hematopoietic stem cell transplant. Gut microbiota (formerly called gut flora) is the name given to the microbe (bacteria) population living in the intestine. Gut bacteria help the body to digest certain foods that the stomach and small intestine have not been able to digest. CBM588, may increase gut bacteria biodiversity, prevent recurrent symptoms of gastrointestinal toxicity (ranging from diarrhea to life-threatening inflammation of the colon).
Primary Outcome
Will be scored according to the modified Bearman Scale and National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 scale. Observed toxicities will be summarized in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment and reversibility or outcome.
Conditions Studied
Interventions
- OTHER Best Practice
- DRUG Clostridium butyricum CBM 588 Probiotic Strain
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2019-04-18 |
| Est. Completion | 2026-03-04 |
| Phase | Phase 1 |
What the registry record for NCT03922035 still lists
NCT03922035 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 953-participant average among 104 other Hematopoietic and Lymphoid Cell Neoplasm trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Hematopoietic and Lymphoid Cell Neoplasm appearing as the primary indexed condition, and to 2 interventions - of which Best Practice is the first listed.
NCT03922035 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03922035 about?
NCT03922035 is a clinical study titled "CBM588 in Improving Clinical Outcomes in Patients Who Have Undergone Donor Hematopoietic Stem Cell Transplant". This pilot trial studies the side effects and how well CBM588 works in improving clinical outcomes in patients who have undergone donor hematopoietic stem cell transplant. Gut microbiota (formerly called gut flora) is the name given to the microbe (bacteria) population living in the intestine. Gut b...
What is the current status of trial NCT03922035?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2019-04-18. Estimated completion is 2026-03-04.
What conditions does trial NCT03922035 study?
This clinical trial studies the following conditions: Hematopoietic and Lymphoid Cell Neoplasm.
What interventions are being tested in trial NCT03922035?
The interventions under investigation include: Best Practice (OTHER), Clostridium butyricum CBM 588 Probiotic Strain (DRUG).
Who is sponsoring clinical trial NCT03922035?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03922035 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hematopoietic and Lymphoid Cell Neoplasm
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03922035's enrollment target sits among peer trials
36 75th of 104 higher than 29 of 104 other Hematopoietic and Lymphoid Cell Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hematopoietic and Lymphoid Cell Neoplasm 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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