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NCT07524530 · ClinicalTrials.gov registry record · Phase 2
Stem Cell Transplantation for Participants With Germline RUNX1 Associated Blood Cancers
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Not yet
- Registry status
- Phase 2
- Development phase
- 98
- Enrollment target
NCT07524530: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT07524530 is a Phase 2 study that has not yet begun recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 98 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07524530, a Phase 2 study, has not yet begun recruiting, sponsored by National Cancer Institute (NCI).
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 98 participants
- Enrollment target
Study Summary
Background: Some blood cancers can be caused by germline variants (changes) in a person s RUNX1 gene. Germline variants are genetic inherited changes a person is born with. Stem cell transplants are used to treat many diseases including blood cancers. Stem cell transplantation for patients with germline RUNX1 mutation driven blood cancers is standard of care and available in most major medical centers. The difference with this transplantation protocol is that it is prospective, only available to participants with germline RUNX1 variants and designed to determine the extent to which tailoring chemotherapy and supportive care medication doses for each individual patient may improve outcomes compared to data derived from retrospective transplantation protocols for patients with RUNX1 varinats which is less accurate. Objective: The primary objective of this protocol is to determine how tailored doses of chemotherapy and supportive care medications may improve disease free survival as compared to historical/expected disease free survival. Eligibility: People aged 4 to 70 years with blood cancer caused by a RUNX1 gene mutation. Other participants are also needed: (1) stem cell donors; (2) relatives who do not have a mutation in the RUNX1 gene; and (3) healthy volunteers. Design: Participants with blood cancer will be screened during approximately 1-3 months before transplatation. They will have blood tests and tests of their heart and lung function. A sample of bone marrow may be taken. A flexible tube (central line) will be inserted into a vein in participants chest or lower neck. This line will remain in place during the hospitalization and be used to draw blood and administer drugs. These lines are almost always transitioned to a peripherally inserted central catheter (PICC) line at the time of hospital discharge. Participants will be inpatient for 4 to 5 weeks. They will receive drugs to prepare their body for the stem cell transplant. Some may also receive r
Primary Outcome
The proportion of participants with disease-free survival (DFS) at one year post transplantation will be reported separately by treatment arm along with 80% and 95% two-sided confidence intervals.
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Busulfan
- RADIATION Total Body Irradiation
- BIOLOGICAL Hematopoietic stem cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2026-07-15 |
| Est. Completion | 2036-06-01 |
| Phase | Phase 2 |
What is known before NCT07524530 opens enrollment
NCT07524530 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT07524530 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07524530 about?
NCT07524530 is a clinical study titled "Stem Cell Transplantation for Participants With Germline RUNX1 Associated Blood Cancers". Background: Some blood cancers can be caused by germline variants (changes) in a person s RUNX1 gene. Germline variants are genetic inherited changes a person is born with. Stem cell transplants are used to treat many diseases including blood cancers. Stem cell transplantation for patients with ger...
What is the current status of trial NCT07524530?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 98 participants. The study started on 2026-07-15. Estimated completion is 2036-06-01.
What interventions are being tested in trial NCT07524530?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Busulfan (DRUG), Total Body Irradiation (RADIATION), Hematopoietic stem cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT07524530?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07524530's enrollment target sits among peer trials
98 743rd of 2000 higher than 1,255 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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