Participant flow

Total Therapy Study XVI for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia · Source last updated 2022-08-23

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

groups

1. description

   Patients randomized on the first day of continuation phase to receive 3500 units/m\^2 dose of PEG-asparaginase

   id

   FG000

   title

   PEG 3500 Units/m^2

2. description

   Patients randomized on the first day of continuation phase to receive 2,500 units/m\^2 dose of PEG-asparaginase

   id

   FG001

   title

   PEG 2500 Units/m^2

3. description

   Patients who came off study prior to randomization

   id

   FG002

   title

   Not Randomized

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         13

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         4

      type

      Physician Decision

   3. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         4

      type

      Bone Marrow (BM) or Extramedullary Relapse

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      type

      Failure to achieve Complete Remission (CR)

   5. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         5

      type

      Participant/Family Withdraw

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Second Malignancy

   7. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         18

      type

      Transplant

   8. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         6

      type

      Unacceptable Toxicity

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         206

      2. group Id

         FG001

         num Subjects

         208

      3. group Id

         FG002

         num Subjects

         184

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         194

      2. group Id

         FG001

         num Subjects

         188

      3. group Id

         FG002

         num Subjects

         133

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         20

      3. group Id

         FG002

         num Subjects

         51

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Two (2) were later found ineligible and excluded. Of the 598 eligible patients, 414 patients were randomized to the two treatment arms, 184 were not randomized for various reasons: * Not Eligible for Randomization (n=41) * Death (n=5) * Transplant (n=13) * Withdrawal of Consent (n=3) * Down's Syndrome (n=12) * Poor Organ Function (n=8) * Parent/Patient Decision (n=70) * Attending Physician Decision (n=4) * Enrollment after Completion of Randomization (n=69)

recruitment Details

Between October 29, 2007 and March 26, 2017, 600 patients younger than 19 years of age with newly diagnosed Acute Lymphoblastic Leukemia (ALL) were enrolled.

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Preserved source evidence · Not medical advice