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Treatment of Graft Failure After Hematopoietic Stem Cell Transplantation

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ClinicalTrials.gov Identifier: NCT02161783
Recruitment Status : Recruiting
First Posted : June 12, 2014
Last Update Posted : April 21, 2022
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Tracking Information
First Submitted Date June 10, 2014
First Posted Date June 12, 2014
Last Update Posted Date April 21, 2022
Study Start Date October 2014
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 10, 2014)
Rate of donor engraftment [ Time Frame: day 42 ]
Rate of sustained donor engraftment at day 42 post this transplant.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 10, 2014)
  • Rate of treatment related mortality [ Time Frame: day 100 ]
    Rate of treatment related mortality (TRM) at day 100
  • Rate of survival [ Time Frame: Day 100 ]
    Rate of survival by day 100.
  • Rate of survival [ Time Frame: 1 year ]
    Rate of survival at 1 year
  • Incidence of acute graft-versus-host disease [ Time Frame: Day 100 ]
    Incidence of acute graft-versus-host disease by day 100
  • Incidence of chronic graft-versus-host disease [ Time Frame: 1 year ]
    Incidence of chronic graft-versus-host disease at 1 year.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Treatment of Graft Failure After Hematopoietic Stem Cell Transplantation
Official Title Treatment of Graft Failure After Hematopoietic Stem Cell Transplantation
Brief Summary

This is a guideline for the treatment of graft failure after hematopoietic stem cell transplant (HSCT). This regimen, consisting of cyclophosphamide and fludarabine with low dose total body irradiation (TBI) is designed to promote donor engraftment by day 42 after initial graft failure.

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 Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Graft failure for
Condition
  • Primary Graft Failure
  • Secondary Graft Failure
Intervention
  • Drug: Fludarabine
    Fludarabine 30 mg/m2 IV over 1 hour given on days -6 through -2 of transplant.
    Other Name: Fludara
  • Drug: 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.
  • Radiation: Total Body Irradiation
    TBI 200cGy in a single fraction on day -1 from transplant.
    Other Name: TBI
  • Biological: Hematopoietic stem cell infusion
    Hematopoietic stem cell infusion given on day 0.
    Other Name: HSCT
Study Groups/Cohorts Treatment
This regimen consists of cyclophosphamide and fludarabine with low dose total body irradiation (TBI), followed by hematopoietic stem cell infusion.
Interventions:
  • Drug: Fludarabine
  • Drug: Cyclophosphamide
  • Radiation: Total Body Irradiation
  • Biological: Hematopoietic stem cell infusion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 10, 2014)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2022
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with primary or secondary graft failure, as defined below, may receive a second transplant:

    • 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:

  • Uncontrolled infection at the time of transplant.
  • Patients with Fanconi Anemia or other DNA breakage syndromes.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Timothy Krepski 612-273-2800 tkrepsk1@fairview.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02161783
Other Study ID Numbers 2013OC003
MT2013-06C ( Other Identifier: University of Minnesota Blood and Marrow Transplant Program )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Masonic Cancer Center, University of Minnesota
Original Responsible Party Same as current
Current Study Sponsor Masonic Cancer Center, University of Minnesota
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Troy C Lund, MD, PhD University of Minnesota
PRS Account Masonic Cancer Center, University of Minnesota
Verification Date April 2022