Umbilical Cord Blood Transplantation From Unrelated Donors

Part of paid clinical trials in Rochester, New York.

Sponsor
University of Rochester
Study ID
NCT03016806
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
2 Months - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Total Body Irradiation 1200 cGy — RADIATION
    Total Body Irradiation 1200 cGy in 8 fractions
  • Total Body Irradiation 200 cGy — RADIATION
    Total Body Irradiation 200 cGy in one fraction
  • Cyclophosphamide — DRUG
    50 mg/kg or 60 mg/kg
  • Mesna — DRUG
    50 mg/kg or 60 mg/kg plus 10% loading dose
  • Cord Blood Infusion — PROCEDURE
    Intravenous infusion of cord blood stem cells
  • Busulfan — DRUG
    0.8 mg/kg x 16 doses
  • Fludarabine — DRUG
    30 mg/m2/day x 5 or 40 mg/m2/day x 5
  • Melphalan — DRUG
    140 mg/m2

Study Details

This study is being done to determine how long it takes for the engraftment (recovery of blood cell counts) of umbilical cord stem cells and also how often engraftment of umbilical cord stem cells transplanted from an unrelated donor fails. Another purpose will be to document the rate of disease-free survival and the rate of relapse (a return of your disease or syndrome) as well as the incidence and severity of graft versus host disease (GvHD) following cord blood stem cell transplantation. GvHD is a complication of stem cell transplants in which white blood cells from the transplanted tissue (graft) attack the transplant recipient's body (host).

Key Dates

Start date
Jun 30, 2015
Status verified
Oct 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: Full Intensity, TBI-based Conditioning
    Full Intensity TBI-based Conditioning Total Body Irradiation 1200 cGy in fractions of 150 cGy days -8 or -7 to -4 Cyclophosphamide 60 mg/kg/day x 2 doses days -3 and -2 Mesna 60 mg/kg/day with 20% loading dose with first Cyclophosphamide followed by continuous infusion over 24 hours x 2 doses \[to be completed 24 hours after final Cyclophosphamide dose\] followed by Cord Blood Infusion Other names: TBI/Cy
  • Arm: Full Intensity, Chemo-based Conditioning
    Full Intensity, Chemotherapy Conditioning Busulfan days -7 to -4 Recipients \<5 years - 1 mg/kg/dose x 16 doses every 6 hours Recipients \>/= 5 years - 0.8 mg/kg/dose x 16 doses every 6 hours Cyclophosphamide 60 mg/kg/day x 2 doses days -3 and -2 Mesna 60 mg/kg/day with 20% loading dose with first Cyclophosphamide followed by continuous infusion over 24 hours x 2 doses \[to be completed 24 hours after final Cyclophosphamide dose\] followed by Cord Blood Infusion Other names: Bu/Cy
  • Arm: Reduced Intensity Chemotherapy
    Reduced Intensity Chemotherapy Fludarabine 30 mg/m2/day x 5 doses days -6 to -2 Melphalan 140 mg/m2/day x 1 dose day -2 Cord Blood Infusion Other names: Flu/Mel
  • Arm: Non-Myeloablative Conditioning
    Fludarabine 40 mg/m2/day x 5 doses days -6 to -2 Cyclophosphamide 50 mg/kg/day x 1 dose day -6 Mesna 50 mg/kg/day with 20% loading dose with Cyclophosphamide dose followed by continuous infusion over 24 hours x 1 dose \[to be completed 24 hours after Cyclophosphamide dose\] Total Body Irradiation 200 cGy in a single fraction day -1 Cord Blood Infusion Other names: Flu/Cy/TBI

Primary Outcome Measure

Engraftment of ANC and Platelets [ Time Frame: 42 days following the infusion of stem cells for ANC [If engraftment of ANC does not occur within 42 days, a subsequent transplant will be performed if a donor is available.] ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wilmot Cancer InstituteRochesterNew York14642
Omar Aljitawi, MD
[email protected]
585-275-4099

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