Participant flow

Chemotherapy in Treating Patients With Myelodysplastic Syndrome Before Donor Stem Cell Transplant · Source last updated 2024-02-15

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

groups

1. description

   Patients receive decitabine or azacitidine IV or SC per standard of care. Treatment repeats per standard of care, every 28 days for 4 cycles of decitabine or 6 cycles of azacitidine in the absence of disease progression or unacceptable toxicity. Azacitidine (AZC): Given IV or SC Decitabine: Given IV or SC Quality-of-Life Assessment: Ancillary studies

   id

   FG000

   title

   Arm A (Decitabine or Azacitidine)

2. description

   Patients receive physician choice of standard of care or other experimental protocol using induction-like chemotherapy regimen. No one specific regimen is required. Several regimens are listed in the protocol for example only. Quality-of-Life Assessment: Ancillary studies

   id

   FG001

   title

   Arm B (Induction-like Chemotherapy Regimen)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Persistent Disease

   2. reasons

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         11

      type

      Not transplanted

   3. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         3

      type

      Transplanted died prior to 18-months post-transplant follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Screen Failure

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         25

      2. group Id

         FG001

         num Subjects

         25

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         10

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         19

      2. group Id

         FG001

         num Subjects

         15

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

This study is a multi-center, open-label randomized study of intensive chemotherapy versus hypomethylating agent-based therapy as the initial pre-transplant cytoreductive therapy in patients with myelodysplastic syndrome. Patients will be randomized to receive treatment with either hypomethylating agent therapy or intensive chemotherapy; they will not receive both.

recruitment Details

Participants were recruited based on physician referral at 3 academic medical centers between April 2013 to March 2022. The first participant was enrolled on August 19, 2013 and the last participant was enrolled in September 24, 2021.

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Preserved source evidence · Not medical advice