Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin's Lymphoma

Recruiting in Palo Alto (17 mi)

+543 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Eastern Cooperative Oncology Group

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining more than one drug with radiation therapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is most effective in treating Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens and comparing how well they work, with or without radiation therapy, in treating patients with Hodgkin's lymphoma.

Eligibility Criteria

Inclusion Criteria

Histologically proven previously untreated classical Hodgkin's lymphoma

Locally extensive: Stage I-IIA/B with massive mediastinal adenopathy

Advanced: Stage III or IV

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Treatment Details

Interventions

Bleomycin (Anti-tumor antibiotic)
Cyclophosphamide (Alkylating agents)
Dacarbazine (Alkylating agents)
Doxorubicin (Topoisomerase II inhibitors)
Etoposide (Topoisomerase II inhibitors)
Mechlorethamine (Alkylating agents)
Prednisone (Corticosteroid)
Radiotherapy (Radiation)
Vinblastine (Vinca alkaloids)
Vincristine (Vinca alkaloids)

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A (ABVD)Experimental Treatment5 Interventions

Arm A (ABVD): Patients receive doxorubicin (25 mg/m²), bleomycin (10 u/m²), vinblastine (6 mg/m²), and dacarbazine (375 mg/m²) intravenously (IV) on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy.

Group II: Arm B (Stanford V)Active Control9 Interventions

Arm B (Stanford V): Patients receive Stanford V chemotherapy comprising doxorubicin (25 mg/m²) and vinblastine (6 mg/m²) IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine (1.4 mg/m²) and bleomycin (5 u/m²) IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine (6 mg/m²) IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide \[375 mg/m²\] IV); etoposide (60 mg/m²) IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone (40 mg/m²) every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy.

Bleomycin is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Bleomycin for: