Participant flow

A Trial of Temsirolimus With Etoposide and Cyclophosphamide in Children With Relapsed Acute Lymphoblastic Leukemia and Non-Hodgkins Lymphoma · Source last updated 2023-07-27

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

groups

1. description

   This is the starting dose of temsirolimus at 7.5 mg/m\^2 given IV. First dose of temsirolimus will be administered on Day 1, followed immediately by the first dose of IV etoposide and IV cyclophosphamide. Etoposide and cyclophosphamide are continued for the next four days (Day 1-5). A second dose of temsirolimus is given on Day 8. Temsirolimus: Dose will be assigned at study entry. Give IV over 30 minutes on days 1 and 8. Etoposide: 100 mg/m2 IV over 1-2 hours daily x 5 on Days 1-5. Cyclophosphamide: 440 mg/m2 IV daily x 5 on Days 1-5 given over 30-60 minutes.

   id

   FG000

   title

   Dose Level 1

2. description

   If Dose Level 1 is tolerated, the study will escalate to Dose Level 2 following the dose escalation schedule. Dose Level 2 will be administered via IV at 10 mg/m\^2. First dose of temsirolimus will be administered on Day 1, followed immediately by the first dose of IV etoposide and IV cyclophosphamide. Etoposide and cyclophosphamide are continued for the next four days (Day 1-5). A second dose of temsirolimus is given on Day 8. Temsirolimus: Dose will be assigned at study entry. Give IV over 30 minutes on days 1 and 8. Etoposide: 100 mg/m2 IV over 1-2 hours daily x 5 on Days 1-5. Cyclophosphamide: 440 mg/m2 IV daily x 5 on Days 1-5 given over 30-60 minutes.

   id

   FG001

   title

   Dose Level 2

3. description

   If Dose Level 2 is tolerated, the study will escalate to Dose Level 3 following the dose escalation schedule. Dose Level 3 will be administered via IV at 15 mg/m\^2. First dose of temsirolimus will be administered on Day 1, followed immediately by the first dose of IV etoposide and IV cyclophosphamide. Etoposide and cyclophosphamide are continued for the next four days (Day 1-5). A second dose of temsirolimus is given on Day 8. Temsirolimus: Dose will be assigned at study entry. Give IV over 30 minutes on days 1 and 8. Etoposide: 100 mg/m2 IV over 1-2 hours daily x 5 on Days 1-5. Cyclophosphamide: 440 mg/m2 IV daily x 5 on Days 1-5 given over 30-60 minutes.

   id

   FG002

   title

   Dose Level 3

4. description

   If Dose Level 3 is tolerated, the study will escalate to Dose Level 4 following the dose escalation schedule. Dose Level 4 will be administered via IV at 25 mg/m\^2. First dose of temsirolimus will be administered on Day 1, followed immediately by the first dose of IV etoposide and IV cyclophosphamide. Etoposide and cyclophosphamide are continued for the next four days (Day 1-5). A second dose of temsirolimus is given on Day 8. Temsirolimus will not be escalated beyond Dose Level 4. Temsirolimus: Dose will be assigned at study entry. Give IV over 30 minutes on days 1 and 8. Etoposide: 100 mg/m2 IV over 1-2 hours daily x 5 on Days 1-5. Cyclophosphamide: 440 mg/m2 IV daily x 5 on Days 1-5 given over 30-60 minutes.

   id

   FG003

   title

   Dose Level 4

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         6

      4. group Id

         FG003

         num Subjects

         3

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         6

      4. group Id

         FG003

         num Subjects

         3

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Overall Study

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Preserved source evidence · Not medical advice