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NCT04370301 · ClinicalTrials.gov registry record · Phase 2
Reduced Intensity Haploidentical Transplantation for the Treatment of Primary or Secondary Myelofibrosis
A Phase 2 study of Primary Myelofibrosis and Secondary Myelofibrosis, sponsored by Fred Hutchinson Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT04370301: Recruiting Phase 2 study of Primary Myelofibrosis and Secondary Myelofibrosis, sponsored by Fred Hutchinson Cancer Center.
NCT04370301 is a Phase 2 study of Primary Myelofibrosis and Secondary Myelofibrosis that is actively recruiting participants, run by Fred Hutchinson Cancer Center. The registered enrollment target is 20 participants, below the 120-participant average among 30 other Primary Myelofibrosis trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04370301, a Phase 2 study of Primary Myelofibrosis and Secondary Myelofibrosis, is actively recruiting participants, sponsored by Fred Hutchinson Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This initial cohort of this phase II trial studied the outcomes of using a JAK inhibitor prior to reduced intensity haploidentical (Haplo) transplantation for the treatment of primary or secondary myelofibrosis (MF). The primary risk of using Haplo HCT in patients with MF is graft failure. In the first cohort, all patients engrafted. There were no instances of graft failure. However, a large number of patients did have graft versus host disease as a complication of their transplant. JAK inhibitors have since been approved for the indication of graft versus host disease treatment. And we are also using them for graft versus host disease prevention in a study of MF patients with sibling and unrelated donors. Therefore, we are opening a new cohort of the current study using the JAK inhibitor prior to, during and after Haplo transplant. Our goal is to decrease graft versus host disease in patients receiving a Haplo MF transplant without increasing the risk of graft failure.
Primary Outcome
Primary graft failure is defined as failure to achieve an absolute neutrophil count of \> 500/ul by 42 days after bone marrow or peripheral blood stem cell transplantation. Secondary graft failure is defined as cytopenias after initial engraftment, with (a) donor chimerism of \< 5% or (b) falling donor chimerism with intervention such as second transplant or donor lymphocyte infusion or (c) patient death due to cytopenias, and fall in donor chimerism, even if chimerism is \> 5%. Exclusion criter
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Melphalan
- DRUG JAK Inhibitor
- BIOLOGICAL Recombinant Granulocyte Colony-Stimulating Factor
Study Locations (1)
Washington
- Fred Hutch/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2021-02-09 |
| Est. Completion | 2029-08-31 |
| Phase | Phase 2 |
What NCT04370301 shows while recruiting
NCT04370301 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 120-participant average among 30 other Primary Myelofibrosis trials with a reported enrollment target (83% lower).
The record links to 2 conditions, with Primary Myelofibrosis appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT04370301 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT04370301 about?
NCT04370301 is a clinical study titled "Reduced Intensity Haploidentical Transplantation for the Treatment of Primary or Secondary Myelofibrosis". This initial cohort of this phase II trial studied the outcomes of using a JAK inhibitor prior to reduced intensity haploidentical (Haplo) transplantation for the treatment of primary or secondary myelofibrosis (MF). The primary risk of using Haplo HCT in patients with MF is graft failure. In the fi...
What is the current status of trial NCT04370301?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2021-02-09. Estimated completion is 2029-08-31.
What conditions does trial NCT04370301 study?
This clinical trial studies the following conditions: Primary Myelofibrosis, Secondary Myelofibrosis.
What interventions are being tested in trial NCT04370301?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Melphalan (DRUG), JAK Inhibitor (DRUG), Recombinant Granulocyte Colony-Stimulating Factor (BIOLOGICAL).
Who is sponsoring clinical trial NCT04370301?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04370301 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Primary Myelofibrosis
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 NCT04370301's enrollment target sits among peer trials
20 27th of 30 higher than 3 of 30 other Primary Myelofibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Primary Myelofibrosis 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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