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Reduced Intensity Haploidentical Transplantation for the Treatment of Primary or Secondary Myelofibrosis

StatusRecruiting
PhasePhase 2
Started2021-02-09
View on ClinicalTrials.gov ↗

Amendment history

2026-07-17
Study Status v30
Re-verified, no change to tracked fields
2026-01-08
Study Status, Arms and Interventions, Eligibility v29
InterventionsBiospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Bone Marrow Biopsy (Procedure), Computed Tomography (Procedure)…→Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Bone Marrow Biopsy (Procedure), Computed Tomography (Procedure)…
Eligibility criteria+13 characters
Inclusion Criteria: PART 1: JAK INHIBITOR ADMINISTRATION INCLUSION CRITERIA Age >between 18 and 70 years Diagnosis of primary myelofibrosis (PMF) as defined by [...]
2025-12-10
Suspended→Recruiting Study Status, Contacts/Locations v28
Trial statusSuspended→Recruiting
Reason stoppedRecruitment temporarily on hold pending study modification→not stated
Study sitesdetails revised at 1 of 1 site
2025-10-08
Recruiting→Suspended Study Status, Contacts/Locations v27
Trial statusRecruiting→Suspended
Reason stoppednot stated→Recruitment temporarily on hold pending study modification
Primary completion date2026-08-31→2027-04-30
Study sitesdetails revised at 1 of 1 site
2025-04-04
Study Status v26
Re-verified, no change to tracked fields
Show 25 earlier versions
2024-09-04
Study Status v25
Primary completion date2024-08-31→2026-08-31
2024-07-09
Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility v24
Enrollment target10→20
Study arms1→2
Eligibility criteria+61 characters
[...] nderstand and willingness to sign a written informed consent (or legally authorized representative). Patients arriving to our institution for transplant and no [...] r at least 8 weeks immediately prior to conditioning and be ablewilling to continue until day9-12 -4months prepost-transplant as tolerated Karnofsky performance status score >= 70 Calculated creatin [...]
Secondary endpoints7 to 9 entries
Incidence and severity of grade II-IV acute and chronic graft versus host disease (GVHD) Incidence of grade III-IV acute GVHD Incidence of moderate-severe chronic GVHD
Study description+898 characters
OUTLINE: Cohort 1 is now closed and all patients will be enrolled on Cohort 2. COHORT I: JAK INHIBITOR THERAPY: Patients receive a JAK inhibitor at l [...] days 3-4, tacrolimus IV beginning day 5 then orally (PO) for about 6 months, mycophenolate mofetil PO twice daily (BID) or thr [...] beginning day 7 until neutrophil recovery is > 1,500/mm^3. COHORT II: JAK INHIBITOR THERAPY: Patients receive a JAK inhibitor at least 8 weeks prior to the start of HCT conditioning through day -4 before transplantation. Additionally, patients receive a JAK inhibitor following transplantation beginning day +5 through 9-12 [...] [...]
2024-01-03
Study Status, Study Description, Arms and Interventions v23
InterventionsCyclophosphamide (Drug), Fludarabine (Drug), JAK Inhibitor (Drug), Melphalan (Drug), Mycophenolate Mofetil (Drug), Peripheral Blood Stem…→Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Bone Marrow Biopsy (Procedure), Computed Tomography (Procedure)…
Study description+283 characters
[...] -5 to -2, and undergo total-body irradiation (TBI) on day -1 or day -1 and day 0. TRANSPLANT: Patients receive peripheral blood stem cell in [...] beginning day 7 until neutrophil recovery is > 1,500/mm^3. All patients undergo magnetic resonance imaging (MRI), computed tomography (CT), bone marrow biopsy and aspiration and blood sample collection throughout the trial. Patients also undergo echocardiography (ECHO) or multigated acquisition scan (MUGA) on the trial. After completion of study treatment, patients are followed up between day 80-100, at 1 year, and then up to 5 years.
2023-06-06
Study Status v22
Re-verified, no change to tracked fields
2023-03-09
Study Status, Arms and Interventions, Eligibility v21
Eligibility criteria+15 characters
Inclusion Criteria: PART 1: JAK INHIBITOR ADMINISTRATION INCLUSION CRITERIA Age > 18 years Diagnosis of primary myelofibrosis (PMF) as defined by the 2 [...]
2022-12-02
Study Status v20
Primary completion date2021-12-12→2024-08-31
2022-11-30
Study Status v19
Primary completion dateestimated 2024-08-31→confirmed 2021-12-12
2022-11-22
Study Status v18
Re-verified, no change to tracked fields
2022-05-23
Study Status v17
Primary completion date2023-08-31→2024-08-31
Completion date2028-08-31→2029-08-31
2021-11-15
Study Identification, Study Status, Sponsor/Collaborators v16
Collaborators-31 characters
National Cancer Institute (NCI)
2021-05-25
Study Status, Arms and Interventions v15
Re-verified, no change to tracked fields
2021-03-11
Study Status, Eligibility, Contacts/Locations v14
Eligibility criteria+39 characters
[...] the willingness to sign a written informed consent document (or legally authorized representative) Patient must be a potential hematopoietic stem cell transpl [...]
2021-03-03
Study Status v13
Start dateestimated 2021-03-11→confirmed 2021-02-09
2021-02-11
Study Status v12
Start date2021-02-11→2021-03-11
2021-01-11
Study Status v11
Start date2021-01-09→2021-02-11
2020-12-09
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v10
Trial statusNot Yet Recruiting→Recruiting
Start date2020-12-09→2021-01-09
Study sitesdetails revised at 1 of 1 site
2020-11-09
Study Status v9
Start date2020-11-05→2020-12-09
2020-10-05
Study Status v8
Start date2020-10-03→2020-11-05
2020-09-25
Study Identification, Study Status, Arms and Interventions v7
InterventionsCyclophosphamide (Drug), Fludarabine (Drug), Granulocyte Colony-Stimulating Factor (Biological), JAK Inhibitor (Drug), Melphalan (Drug)…→Cyclophosphamide (Drug), Fludarabine (Drug), JAK Inhibitor (Drug), Melphalan (Drug), Mycophenolate Mofetil (Drug), Peripheral Blood Stem…
2020-09-16
Study Status v6
Re-verified, no change to tracked fields
2020-09-03
Study Identification, Study Status v5
Completion date2023-08-31→2028-08-31
Start date2020-09-03→2020-10-03
2020-08-03
Study Status v4
Start date2020-08-01→2020-09-03
2020-07-01
Study Status v3
Start date2020-07-01→2020-08-01
2020-06-01
Study Status v2
Start date2020-06-01→2020-07-01
2020-05-08
Study Status, Study Description, Arms and Interventions, Eligibility v1
InterventionsCyclophosphamide (Drug), Enzyme Inhibitor Therapy (Drug), Fludarabine (Drug), Granulocyte Colony-Stimulating Factor (Biological), Melphalan…→Cyclophosphamide (Drug), Fludarabine (Drug), Granulocyte Colony-Stimulating Factor (Biological), JAK Inhibitor (Drug), Melphalan (Drug)…
Eligibility criteria+2 characters
[...] Part 1 endpoints transcribed from medical records Received ruxolitinibJAK inhibitor for at least 8 weeks immediately prior to conditioning and [...]
2020-04-28
Original filing
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.
Trial Details
NCT Number NCT04370301
Lead Sponsor Fred Hutchinson Cancer Center
Conditions Primary Myelofibrosis, Secondary Myelofibrosis
Enrollment 20 participants
Start Date 2021-02-09
Primary Completion 2027-04-30 (estimated)
Study Completion 2029-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-20