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NCT05327023 · ClinicalTrials.gov registry record · Phase 1
Donor Lymphocyte Infusion After Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
A Phase 1 study of Hematologic Neoplasms, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 430
- Enrollment target
- 1
- Study location
NCT05327023: Recruiting Phase 1 study of Hematologic Neoplasms, sponsored by National Cancer Institute (NCI).
NCT05327023 is a Phase 1 study of Hematologic Neoplasms that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 430 participants, below the 1,005-participant average among 20 other Hematologic Neoplasms trials with a reported enrollment target (57% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05327023, a Phase 1 study of Hematologic Neoplasms, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 430 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: People with blood cancers often receive blood or bone marrow transplants. But even with these treatments, the risk of relapse is high. Researchers want to see if giving the transplant recipient an infusion of lymphocytes (a type of white blood cell) from their transplant donor early after the transplant can reduce that risk. Objective: To learn if giving donor lymphocytes early after a transplant will help reduce the risk of relapse for people with certain blood cancers. Eligibility: Adults aged 18-65 with high-risk leukemia, lymphoma, myelodysplastic syndrome, or multiple myeloma that does not respond well to standard treatments and/or has a high risk of relapse. Healthy potential bone marrow and lymphocyte donor relatives aged 12 and older are also needed. Design: Participants will be screened with: Physical exam Blood and urine tests Spinal tap Eye exam Dental exam Heart and lung tests Imaging scans. A radioactive substance may be injected in their arm if a PET scan is needed. Bone marrow aspiration and biopsy Some screening tests will be repeated during the study. Participants will stay at the NIH hospital for about 4 weeks. They will receive a central venous catheter. They will get chemotherapy and other drugs starting 6 days before transplant. Then they will have their transplant. They will receive donor white blood cells 7 days later. They will give blood, bone marrow, urine, and stool samples for research. They must stay near NIH for at least 100 days after transplant. Participants will have periodic follow-up visits for 5 years. Healthy donors will have 2-3 visits. They will give blood, bone marrow, white blood cells, and stool samples for research. Participation will last for 5 years....
Primary Outcome
fraction of evaluable patients who experience steroid-refractory grade III-IV aGVHD at day +60 will be determined and reported along with 80% and 95% two-sided confidence intervals.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Busulfan
- DRUG Mycophenolate mofetil
- PROCEDURE donor lymphocyte infusion
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 430 participants |
| Start Date | 2022-05-23 |
| Est. Completion | 2029-07-02 |
| Phase | Phase 1 |
What NCT05327023 shows while recruiting
NCT05327023 is an interventional study that assigns participants to a tested intervention. The registered 430 participants enrollment target is mid-sized for trials with a published cap, below the 1,005-participant average among 20 other Hematologic Neoplasms trials with a reported enrollment target (57% lower).
The record links to 1 condition, with Hematologic Neoplasms appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT05327023 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05327023 about?
NCT05327023 is a clinical study titled "Donor Lymphocyte Infusion After Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies". Background: People with blood cancers often receive blood or bone marrow transplants. But even with these treatments, the risk of relapse is high. Researchers want to see if giving the transplant recipient an infusion of lymphocytes (a type of white blood cell) from their transplant donor early aft...
What is the current status of trial NCT05327023?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 430 participants. The study started on 2022-05-23. Estimated completion is 2029-07-02.
What conditions does trial NCT05327023 study?
This clinical trial studies the following conditions: Hematologic Neoplasms.
What interventions are being tested in trial NCT05327023?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Busulfan (DRUG), Mycophenolate mofetil (DRUG), donor lymphocyte infusion (PROCEDURE).
Who is sponsoring clinical trial NCT05327023?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05327023 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT05327023's enrollment target sits among peer trials
430 5th of 20 higher than 16 of 20 other Hematologic Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hematologic Neoplasms 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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