Participant flow

Nilotinib and Imatinib Mesylate After Donor Stem Cell Transplant in Treating Patients With ALL or CML · Source last updated 2017-08-10

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

groups

1. description

   Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO QD until day 80 and then nilotinib PO BID on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO BID beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.

   id

   FG000

   title

   Single Arm Nilotinib Relapse Prophylaxis

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         6

      type

      Progressive leukemia

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Critically ill

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Corrected QT interval (QTc) >450 msec

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Myocardial infarction

   5. reasons

      1. group Id

         FG000

         num Subjects

         4

      type

      ANC<1500, plts<20K or hyperbilirubinemia

   6. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Miscellaneous (unanticipated) other

   milestones

   1. achievements

      1. comment

         57 agreed to participate and completed informed consent (= the 1st "intention to treat" population)

         group Id

         FG000

         num Subjects

         57

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         17

      type

      Ineligible for Study Drug

   3. achievements

      1. comment

         40 of 57 originally consented subjects remained eligible at engraftment (= the 2nd ITT population)

         group Id

         FG000

         num Subjects

         40

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         17

      type

      NOT COMPLETED

   title

   From Consent to Engraftment

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         11

      type

      Failed pre-1st dose criteria

   2. reasons

      1. group Id

         FG000

         num Subjects

         4

      type

      Relapse (1 Central Nervous System, 3 BM)

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Non-compliance

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Adenocarcinoma

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Liver GVHD

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Suicide

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Acute respiratory distress syndrome

   8. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Dyspnea (unrelated to nilotinib)

   9. reasons

      1. group Id

         FG000

         num Subjects

         5

      type

      Toxicity attributed to Nilotinib

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         40

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         27

      type

      Patient Drop-outs

   3. achievements

      1. group Id

         FG000

         num Subjects

         13

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         27

      type

      NOT COMPLETED

   title

   From Engraftment to Study Completion

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice