Combination Chemotherapy in Treating Young Male Patients With Hodgkin's Lymphoma
Pilot Study for Therapy Optimising for Hodgkin's Lymphoma in Childhood and Adolescence; Optimising Therapy for Boys With Hodgkin's Lymphoma in Intermediate and Advanced Stages. Safety and Efficacy Study for Drug Combination VECOPA
Sponsor: Christine Mauz-Körholz
A PHASE2 clinical study on Lymphoma, this trial is completed. The trial is conducted by Christine Mauz-Körholz and has accumulated 7 data snapshots since 2005. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Study Description(click to expand)OBJECTIVES: * Determine the safety and efficacy of combination chemotherapy comprising vincristine, etoposide, cyclophosphamide, vinblastine, prednisone, and doxorubicin hydrochloride (VECOPA) in pediatric male patients with previously untreated stage II-IV classic Hodgkin's lymphoma. * Compare the effects of VECOPA vs cyclophosphamide, vincristine, procarbazine hydrochloride, and prednisone (COPP) in these patients. OUTLINE: This is a pilot, multicenter study. Patients are stratified according to disease stage (IA/B\[E\], IIA\[E\], IIB, or IIIA vs IIB\[E\], IIIA/B\[E\], IIIB, or IVA/B). * Stratum 1 (stages IA/B\[E\], IIA\[E\], IIB, or IIIA): Patients receive oral prednisone on days 1-15, vincristine IV on days 1, 8, and 15, doxorubicin hydrochloride IV over 4 hours on days 1 and 15, and etoposide IV over 2 hours on days 2-6 (OEPA). Treatment repeats every 4 weeks for 2 courses. Beginning at week 9, patients receive VECOPA chemotherapy comprising oral prednisone on days 1-14 and 21-34, etoposide IV over 2 hours on days 1-3, doxorubicin hydrochloride IV over 2 hours on day 21, vinblastine IV and cyclophosphamide IV over 1 hour on days 1 and 21, and vincristine IV on days 8 and 29. Patients then undergo radiotherapy. * Stratum 2 (stages IIB\[E\], IIIA/B\[E\], IIIB, or IVA/B): Patients receive 2 courses of OEPA...
OBJECTIVES:
* Determine the safety and efficacy of combination chemotherapy comprising vincristine, etoposide, cyclophosphamide, vinblastine, prednisone, and doxorubicin hydrochloride (VECOPA) in pediatric male patients with previously untreated stage II-IV classic Hodgkin's lymphoma. * Compare the effects of VECOPA vs cyclophosphamide, vincristine, procarbazine hydrochloride, and prednisone (COPP) in these patients.
OUTLINE: This is a pilot, multicenter study. Patients are stratified according to disease stage (IA/B\[E\], IIA\[E\], IIB, or IIIA vs IIB\[E\], IIIA/B\[E\], IIIB, or IVA/B).
* Stratum 1 (stages IA/B\[E\], IIA\[E\], IIB, or IIIA): Patients receive oral prednisone on days 1-15, vincristine IV on days 1, 8, and 15, doxorubicin hydrochloride IV over 4 hours on days 1 and 15, and etoposide IV over 2 hours on days 2-6 (OEPA). Treatment repeats every 4 weeks for 2 courses. Beginning at week 9, patients receive VECOPA chemotherapy comprising oral prednisone on days 1-14 and 21-34, etoposide IV over 2 hours on days 1-3, doxorubicin hydrochloride IV over 2 hours on day 21, vinblastine IV and cyclophosphamide IV over 1 hour on days 1 and 21, and vincristine IV on days 8 and 29. Patients then undergo radiotherapy. * Stratum 2 (stages IIB\[E\], IIIA/B\[E\], IIIB, or IVA/B): Patients receive 2 courses of OEPA as in stratum 1 followed by 2 courses of VECOPA (6-week courses). Patients then undergo radiotherapy.
After completion of study treatment, patients are followed periodically for at least 6 years.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Status Flow
Change History
7 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE2
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Sep 2024 — Sep 2025 [monthly]
Completed PHASE2
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
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Jan 2021 — Jul 2024 [monthly]
Completed PHASE2
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Apr 2020 — Jan 2021 [monthly]
Completed PHASE2
▶ Show 2 earlier versions
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Jun 2018 — Apr 2020 [monthly]
Completed PHASE2
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Jan 2017 — Jun 2018 [monthly]
Completed PHASE2
First recorded
Jun 2005
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Christine Mauz-Körholz
- Martin-Luther-Universität Halle-Wittenberg
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Augsburg, Germany , Berlin, Germany , Cologne, Germany , Erlangen, Germany , Frankfurt, Germany , Halle, Germany , Hanover, Germany , Leipzig, Germany , Munich, Germany , Münster, Germany and 2 more locations