R-ABVD vs ABVD-RT in Early Stage Hodgkin's Lymphoma

• Status: Terminated
• Trial end date: 2019-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Combined modality therapy has then emerged as the standard of care for limited-stage Hodgkin's lymphoma and doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) chemotherapy that is devoid of alkylating agents and associated with a low potential for gonadal toxicity and leukemogenesis, is currently considered a gold standard. Nevertheless, the disadvantage to combine radiotherapy to ABVD is represented by late cardiovascular events (myocardial dysfunction and coronary or valvular disease), especially when the heart is within the radiation field; bleomycin pulmonary toxicity also is increased in conjunction with RT and secondary tumors, in particular in the RT fields. This study aims at treating patients with limited disease with multiagent chemotherapy alone, without irradiation, and using radiotherapy only for relapses.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondazione Michelangelo
• Treatments: Bleomycin; Dacarbazine; Doxorubicin; Liposomal doxorubicin; Rituximab; Vinblastine

Criteria

Inclusion Criteria:

• History of histologically confirmed classical Hodgkin lymphoma (cHL)

• Limited-stage disease defined as stage I or IIA with no areas of bulky disease

• Measurable disease according to the Cheson criteria

• Age >=18 years

• Adequate bone marrow reserve (ANC >= 1,500/uL, Platelet > 100,000/uL)

• LVEF >= 50% by MUGA scan or echocardiogram

• Serum creatinine < 2 mg/dl, serum bilirubin < 2 mg/dl, AST or ALT <2x ULN

• Bi-dimensionally measurable disease

• Use of effective means of contraception

• Signed informed consent form

Exclusion Criteria:

• Lymphocyte predominant HL

• Prior chemotherapy or radiation therapy

• Severe pulmonary disease as judged by the PI including COPD and asthma

• Presence of CNS lymphoma

• Concomitant malignancies or previous malignancies (exception made for adequately treated basal or squamous cell carcinoma of the skin)

• Active infection requiring treatment with intravenous therapy

• Known HIV infection

• Active hepatitis B or C

• Pregnancy or lactation and women of child bearing age who are not practicing adequate contraception