Combination Chemotherapy With or Without Rituximab in Treating

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

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

Clinical Trial Details

NCT number	NCT00654732
Study type	Interventional
Source	M.D. Anderson Cancer Center
Contact
Status	Completed
Phase	Phase 2
Start date	March 19, 2008
Completion date	September 5, 2018

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms