Participant flow

Reduced-Intensity Regimen Before Donor Bone Marrow Transplant in Treating Patients With Myelodysplastic Syndromes · Source last updated 2023-06-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses. Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient. Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD.

   id

   FG000

   title

   Arm I

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         6

      type

      Lack of Efficacy

   2. reasons

      1. group Id

         FG000

         num Subjects

         3

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         3

      type

      Death

   4. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      site error

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         17

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         17

      type

      Eligible and Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         3

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         14

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

This trial was open to accrual on May 18, 2005 with the first patient accrued on October 24, 2006. By September 23, 2009, 17 patients were enrolled to the trial and the first 15 patients were included in the interim analysis. This trial did not meet pre-defined criteria to continue to the second stage. In the end, a total of 17 patients were enrolled to the trial from 7 participating institutions.

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Preserved source evidence · Not medical advice