NCT00654732

Combination Chemotherapy With or Without Rituximab in Treating Participants With Stage III-IV Classic Hodgkin Lymphoma

A Randomized Phase II Study of Rituximab With ABVD Versus Standard ABVD for Patients With Advanced-Stage Classical Hodgkin Lymphoma With Poor Risk Features (IPS Score > 2)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well combination chemotherapy with or without rituximab works in treating participants with stage III-IV classic Hodgkin lymphoma. Monoclonal antibodies, such as rituximab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving rituximab with combination chemotherapy may work better in treating participants with classic Hodgkin lymphoma.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the event free survival (EFS) following therapy with rituximab plus adriamycin (doxorubicin hydrochloride), bleomycin, vinblastine, and dacarbazine (ABVD) or standard ABVD in patients with newly diagnosed classical Hodgkin lymphoma who have poor prognosis defined as International prognostic score (IPS) of \> 2. SECONDARY OBJECTIVES: I. To compare the effect of the two treatment arms on positron emission tomography (PET) scan results after 2 cycles of therapy. II. To compare the effect of the two treatment arms on the level of circulating malignant Hodgkin stem cells. OUTLINE: Participants are randomized to 1 of 2 arms. ARM A: Participants receive rituximab intravenously (IV) over 7 hours on days 1, 8, 15, and 22 of course 1 and on days 1 and 8 of course 2. Participants also receive doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine IV over 1 hour on days 1 and 15. Treatment with ABVD repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. ARM B: Participants receive doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine as in Arm A. After completion of study treatment, participants are followed up every 3 months for the first year, every 4 months for the second year, every 6 months for years 3-5, and then annually thereafter.

Conditions

• Classic Hodgkin Lymphoma
• Lugano Classification Stage III Hodgkin Lymphoma AJCC v8
• Lugano Classification Stage IV Hodgkin Lymphoma AJCC v8

Interventions

Type	Name	Description
DRUG	Bleomycin	Given IV
DRUG	Dacarbazine	Given IV
DRUG	Doxorubicin Hydrochloride	Given IV
BIOLOGICAL	Rituximab	Given IV
DRUG	Vinblastine	Given IV

Timeline

• Start date: 2008-03-19
• Primary completion: 2018-09-05
• Completion: 2018-09-05
• First posted: 2008-04-09
• Last updated: 2020-02-28
• Results posted: 2020-02-28

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study