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Chemotherapy With or Without Additional Chemotherapy and/or Radiation Therapy in Treating Children With Newly Diagnosed Hodgkin's Disease · Source last updated 2017-04-12

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

groups

1. description

   Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin sulfate IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, oral prednisone 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Prednisone: Given orally Vincristine Sulfate Liposome: Given IV

   id

   FG000

   title

   Arm I (Patients Off-therapy Before Callback-Induction Only)

2. description

   Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR undergo IFRT approximately 3 weeks after the last day of ABVE course 4. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Involved-Field Radiation Therapy: Undergo IFRT Prednisone: Given orally Vincristine Sulfate Liposome: Given IV

   id

   FG001

   title

   Arm II (RER With CR [ABVE-PC, IFRT])

3. description

   Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR are randomized to receive no further treatment. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Prednisone: Given orally Vincristine Sulfate Liposome: Given IV

   id

   FG002

   title

   Arm III (RER With CR [ABVE-PC])

4. description

   Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with VGPR, PR or SD undergo IFRT approximately 3 weeks after the last day of ABVE-PC course 4 for 5 days a week. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Involved-Field Radiation Therapy: Undergo IFRT Prednisone: Given orally Vincristine Sulfate Liposome: Given IV

   id

   FG003

   title

   Arm IV (RER With Less Than CR [ABVE-PC, IFRT])

5. description

   Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients with PD are taken off therapy. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Prednisone: Given orally Vincristine Sulfate Liposome: Given IV

   id

   FG004

   title

   Arm V (RER With PD)

6. description

   Patients receive dexamethasone IV over 15 minutes, etoposide IV over 3 hours, \& cytarabine IV over 3 hours on days 1-2. Patients receive 2 drops of dexamethasone ophthalmic solution every 6 hours on days 1, 2 \& 3. Patients also receive cisplatin PO or IV over 12 hours as pre-hydration followed by continuous IV over 6 hours on day 1 \& G-CSF SC beginning on day 3 \& continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then receive 2 additional courses of ABVE-PC chemotherapy. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy. Bleomycin Sulfate: Given IV or SC Cisplatin: Given IV Cyclophosphamide: Given IV Cytarabine: Given IV Dexamethasone: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Involved-Field Radiation Therapy: Undergo IFRT Pre

   id

   FG005

   title

   Arm VI (SER [DECA, ABVE-PC, IFRT])

7. description

   Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive 2 additional courses of ABVE-PC. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy. Bleomycin Sulfate: Given IV or SC Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Filgrastim: Given SC Involved-Field Radiation Therapy: Undergo IFRT Prednisone: Given orally Vincristine Sulfate Liposome: Given IV

   id

   FG006

   title

   Arm VII (SER [ABVE-PC, IFRT])

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         3

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         1

      7. group Id

         FG006

         num Subjects

         2

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         46

      3. group Id

         FG002

         num Subjects

         60

      4. group Id

         FG003

         num Subjects

         78

      5. group Id

         FG004

         num Subjects

         11

      6. group Id

         FG005

         num Subjects

         30

      7. group Id

         FG006

         num Subjects

         38

      type

      Lack of Efficacy

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         9

      3. group Id

         FG002

         num Subjects

         13

      4. group Id

         FG003

         num Subjects

         13

      5. group Id

         FG004

         num Subjects

         1

      6. group Id

         FG005

         num Subjects

         3

      7. group Id

         FG006

         num Subjects

         1

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         5

      5. group Id

         FG004

         num Subjects

         4

      6. group Id

         FG005

         num Subjects

         2

      7. group Id

         FG006

         num Subjects

         1

      type

      Physician Decision

   5. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         2

      6. group Id

         FG005

         num Subjects

         1

      7. group Id

         FG006

         num Subjects

         3

      type

      Protocol Violation

   6. reasons

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         27

      3. group Id

         FG002

         num Subjects

         6

      4. group Id

         FG003

         num Subjects

         14

      5. group Id

         FG004

         num Subjects

         11

      6. group Id

         FG005

         num Subjects

         8

      7. group Id

         FG006

         num Subjects

         3

      type

      Withdrawal by Subject

   7. reasons

      1. group Id

         FG000

         num Subjects

         14

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         6

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         1

      type

      Ineligible

   8. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         1

      6. group Id

         FG005

         num Subjects

         7

      7. group Id

         FG006

         num Subjects

         2

      type

      Randomization error

   9. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      type

      Adverse Event

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         52

      2. group Id

         FG001

         num Subjects

         381

      3. group Id

         FG002

         num Subjects

         382

      4. group Id

         FG003

         num Subjects

         571

      5. group Id

         FG004

         num Subjects

         42

      6. group Id

         FG005

         num Subjects

         153

      7. group Id

         FG006

         num Subjects

         153

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         292

      3. group Id

         FG002

         num Subjects

         301

      4. group Id

         FG003

         num Subjects

         457

      5. group Id

         FG004

         num Subjects

         6

      6. group Id

         FG005

         num Subjects

         101

      7. group Id

         FG006

         num Subjects

         102

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         45

      2. group Id

         FG001

         num Subjects

         89

      3. group Id

         FG002

         num Subjects

         81

      4. group Id

         FG003

         num Subjects

         114

      5. group Id

         FG004

         num Subjects

         36

      6. group Id

         FG005

         num Subjects

         52

      7. group Id

         FG006

         num Subjects

         51

      type

      NOT COMPLETED

   title

   Overall Study

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Preserved source evidence · Not medical advice