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Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders

StatusRecruiting
PhasePhase 2
Started2018-03-30
View on ClinicalTrials.gov ↗

Amendment history

2026-06-23
Study Status v17
Primary completion date2026-06-10→2027-06-10
Completion date2027-06-10→2028-06-10
2025-06-23
Study Status v16
Primary completion date2025-06-10→2026-06-10
Completion date2026-06-10→2027-06-10
2025-02-03
Study Status v15
Primary completion date2025-01-10→2025-06-10
Completion date2025-11-10→2026-06-10
2024-04-15
2 amendments v13-v14
2 re-verifications since 2023-04-14, no change to tracked fields
2022-04-12
Study Status, Study Design, Eligibility v12
Enrollment target40→300
Eligibility criteriarevised
-Inclusion Criteria: Age: ≤ 60 years of age Performance Status: Karnofsky ≥ 8070%, Lansky play score ≥ 70 Consent: Voluntary written consent [...]
Show 11 earlier versions
2021-05-21
Study Status, Eligibility, Contacts/Locations v11
Eligibility criteria+411 characters
-Inclusion Criteria: Age, Performance Status, Consent: Age: ≤ 5560 years of age Performance Status: Karnofsky ≥ 80%, Lansky pl [...] rental/guardian) Adequate Organ Function: Renal: Creatinine ≤<2x 2.0upper mg/dl (adults) and creatinine clearance ≥ 40 mL/min (pediatrics). Adults with a creatinine > 1.2 mg/dl or a historylimit of renalnormal. Patients dysfunctionabove this limit must have estimated creatinine clearance ≥ 40 ml/min/1.73m2 as determined by an age-appropriate method, such as cystatin C GFR. Hepatic: Bilirubin, AST, alkaline phosphatase <4 times the u [...] city of oxygen, corrected for hemoglob [...]
Study sitescontacts updated at 1 of 1 site
2020-12-28
Study Status v10
Re-verified, no change to tracked fields
2019-12-26
Study Status v9
Primary completion date2023-11-10→2025-01-10
Completion date2024-11-10→2025-11-10
Start dateestimated 2019-12-10→confirmed 2018-03-30
2019-03-20
Study Status, Eligibility v8
Eligibility criteria-125 characters
[...] resentative; or parental/guardian) Adequate Organ Function: HCT-CI score (East bank adults only): ≤ 4 link to HCT-CI calculator (http://www.qxmd.com/calculate-online/hematology/hct-ci) Renal: Creatinine ≤ 2.0 mg/dl (adults) and creatinine cleara [...]
2019-01-31
Study Status, Eligibility v7
Eligibility criteria+84 characters
[...] dequate Organ Function: HCT-CI score (East bank adults only): ≤ 4 link to HCT-CI calculator (http://www.qxmd.com/calculate-online/hematology/hct-ci) Renal: Creatinine ≤ 2.0 mg/dl (adults) and creatinine clear [...]
2019-01-02
Study Status v6
Primary completion date2022-11-10→2023-11-10
Completion date2023-11-10→2024-11-10
Start date2018-12-10→2019-12-10
2018-10-01
Study Status, Arms and Interventions, Eligibility v5
Eligibility criteria+41 characters
[...] resentative; or parental/guardian) Adequate Organ Function: HCT-CI score (East bank adults only) ≤ 4 Renal: Creatinine ≤ 2.0 mg/dl (adults) and creatinine cleara [...]
2018-09-25
Study Status v4
Re-verified, no change to tracked fields
2018-05-18
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Study sites0→1
2017-12-15
Study Status v2
Primary completion date2021-11-10→2022-11-10
Completion date2022-11-10→2023-11-10
Start date2017-12-10→2018-12-10
2017-12-03
Study Status v1
Start date2017-11-10→2017-12-10
2017-10-16
Original filing
Masonic Cancer Center, University of Minnesota
58 trials monitored
See 2 trials at risk
Leukemia
2,553 trials monitored
See 134 trials at risk
Non-Hodgkin Lymphoma
1,512 trials monitored
See 79 trials at risk
Multiple Myeloma
1,228 trials monitored
See 75 trials at risk
and 9 more diseases
This is a Phase II study of allogeneic hematopoietic stem cell transplant (HCT) using a myeloablative preparative regimen (of either total body irradiation (TBI); or, fludarabine/busulfan for patients unable to receive further radiation). followed by a post-transplant graft-versus-host disease (GVHD) prophylaxis regimen of post-transplant cyclophosphamide (PTCy), tacrolimus (Tac), and mycophenolate mofetil (MMF).
Trial Details
NCT Number NCT03314974
Lead Sponsor Masonic Cancer Center, University of Minnesota
Conditions Acute Leukemia, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Lymphoma, Chronic Myelogenous Leukemia, Plasma Cell Leukemia, Myeloproliferative Neoplasms, Myelofibrosis +20 more
Enrollment 300 participants
Start Date 2018-03-30
Primary Completion 2027-06-10 (estimated)
Study Completion 2028-06-10 (estimated)
Updated on ClinicalTrials.gov 2026-06-25