Participant flow

Comparison of Two Combination Chemotherapy Regimens With Either Vincristine or Vinblastine in Treating Patients With Advanced Anaplastic Large Cell Lymphoma · Source last updated 2014-09-22

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

groups

1. description

   In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV over 15 minutes, vincristine sulfate (1.5 mg/m2 (maximum dose 2 mg)) IV, and methotrexate intrathecally (age-adjusted dosing) (IT) on day 1 and oral prednisone (40 mg/m2/day) three times daily and oral mercaptopurine (225 mg/m2) once daily on days 1-5. In courses 4 and 5, patients receive doxorubicin (30 mg/m2), vincristine sulfate (1.5 mg/m2 (Maximum dose 2 mg)), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3. In courses 6-15, patients receive vincristine sulfate (1.5 mg/m2), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3 and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.

   id

   FG000

   title

   Standard (APO) With Vincristine (Arm I)

2. description

   In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV, methotrexate (age adjusted dosing) IT, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) IV over 1 minute on days 1, 8, and 15. In courses 4 and 5, patients receive doxorubicin hydrochloride (30 mg/m2) IV, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) as in arm II (courses 1-3). In courses 6-15, patients receive prednisone (120 mg/m2/day) and mercaptopurine (225 mg/m2) as in arm I, vinblastine sulfate (4 mg/m2) IV as in arm II (courses 1-3), and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.

   id

   FG001

   title

   Consolidation (Includes Vinblastine) (Arm II)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         5

      type

      Lack of Efficacy

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      type

      Physician Decision

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         6

      type

      Withdrawal by Subject

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         3

      type

      Ineligible

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         65

      2. group Id

         FG001

         num Subjects

         64

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         53

      2. group Id

         FG001

         num Subjects

         47

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         17

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Randomization occurs at the time of enrollment with all participants receiving Standard Induction of Doxorubicin, Prednisone and Vincristine (APO) and are evaluated at week 6 for continuation therapy.

recruitment Details

This is a multi-center, phase III, randomized trial for newly diagnosed children with advanced-stage anaplastic large cell lymphoma (ALCL). The study was activated on November 3, 2003 and the first date of enrollment was January 13, 2004.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Independent clinical review pending · Not medical advice