Treatment of Graft Failure After Hematopoietic Stem Cell Transplantation
NCT ID: NCT02161783
Last Updated: 2024-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2014-10-06
2032-01-30
Brief Summary
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The graft will consist of bone marrow or G-CSF mobilized peripheral blood from a haploidentical related donor. The source of stem cells will be determined by the transplant team based on factors such as patient's age, medical history, donor availability and will be according to the current University of Minnesota Blood and Marrow Transplantation Program selection guidelines.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Treatment
This regimen consists of cyclophosphamide and fludarabine with low dose total body irradiation (TBI), followed by hematopoietic stem cell infusion.
Fludarabine
Fludarabine 30 mg/m2 IV over 1 hour given on days -6 through -2 of transplant.
Cyclophosphamide
Cyclophosphamide 14.5 mg/kg IV over 1-2 hours given on days -6 and -5 from transplant. And Cyclophosphamide 50 mg/kg IV over 2 hours given on days +3 and +4 from transplant.
Total Body Irradiation
TBI 200cGy in a single fraction on day -1 from transplant.
Hematopoietic stem cell infusion
Hematopoietic stem cell infusion given on day 0.
Interventions
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Fludarabine
Fludarabine 30 mg/m2 IV over 1 hour given on days -6 through -2 of transplant.
Cyclophosphamide
Cyclophosphamide 14.5 mg/kg IV over 1-2 hours given on days -6 and -5 from transplant. And Cyclophosphamide 50 mg/kg IV over 2 hours given on days +3 and +4 from transplant.
Total Body Irradiation
TBI 200cGy in a single fraction on day -1 from transplant.
Hematopoietic stem cell infusion
Hematopoietic stem cell infusion given on day 0.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Primary graft failure is defined as not achieving an ANC ≥0.5x10\^9/L for three consecutive days by day 35 - 42 following the first transplant.
* Secondary graft failure is defined as achieving an ANC ≥0.5x10\^9/L for three consecutive days by day 35 - 42, but subsequently drops below 0.5x10\^9/L without recovery.
* Loss of chimerism is defined as achieving an ANC ≥0.5x10\^9/L for three consecutive, but with less than 10% CD15+ donor cells in the marrow or peripheral blood.
* Recipients should have acceptable organ function defined as:
* Renal: creatinine \< 2.0 (adults) and creatinine clearance \> 30. For creatinine clearance \< 70, consultation with a BMT pharmacist is necessary for chemotherapy dose adjustments.
* Hepatic: bilirubin, AST/ALT, ALP \< 10 x upper limit of normal
* Cardiac: left ventricular ejection fraction \> 40%
Exclusion Criteria
* Patients with Fanconi Anemia or other DNA breakage syndromes.
ALL
No
Sponsors
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Masonic Cancer Center, University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Troy C Lund, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Locations
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University of Minnesota Medical Center, Fairview
Minneapolis, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Timothy Krepski
Role: primary
Other Identifiers
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MT2013-06C
Identifier Type: OTHER
Identifier Source: secondary_id
2013OC003
Identifier Type: -
Identifier Source: org_study_id