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

Classic Hodgkin Lymphoma Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00654732
• Other study ID #: 2007-0144
• Secondary ID: NCI-2018-0185520
• Status: Completed
• Phase: Phase 2
• Start date: March 19, 2008
• Est. completion date: September 5, 2018

Study information

• Verified date: February 2020
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: September 5, 2018
• Est. primary completion date: September 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

• Previously untreated patient with classical Hodgkin's lymphoma patients with stage III and IV

• International Prognostic Score of > 2 (patient must have > 2 of the following risk features: Male, >= 45 years of age, stage IV, albumin < 4, white blood cell count [WBC] >= 15, lymphocytes < 8% or < 600, hemoglobin [Hgb] < 10.5)

• Must sign a consent form

• Absolute neutrophil count (ANC) >= 1,500/microL

• Platelet > 100,000/microL

• Left ventricular ejection fraction (LVEF) >= 50% by multigated acquisition (MUGA) scan or echocardiogram

• Serum creatinine < 2 mg/dl

• Serum bilirubin < 2 mg/dl

• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2 x upper limit of normal (ULN)

• Bi-dimensionally measurable disease

Exclusion Criteria:

• Lymphocyte predominant Hodgkin's lymphoma

• Known human immunodeficiency virus (HIV) infection

• Pregnant women and women of child bearing age who are not practicing adequate contraception

• Prior chemotherapy or radiation therapy

• Severe pulmonary disease as judged by the principal investigator (PI) including chronic obstructive pulmonary disease (COPD) and asthma

• Active infection requiring treatment with intravenous therapy

• Presence of central nervous system (CNS) lymphoma

• Concomitant malignancies or previous malignancies within the last 5 years (exception made for adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of cervix)

• Active hepatitis B or C infection

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

Intervention

Drug:
• Bleomycin
Given IV
• Dacarbazine
Given IV
• Doxorubicin Hydrochloride
Given IV

Biological:
• Rituximab
Given IV

Drug:
• Vinblastine
Given IV

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois
United States	M D Anderson Cancer Center	Houston	Texas
United States	University of Miami Miller School of Medicine-Sylvester Cancer Center	Miami	Florida
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-free Survival (EFS) Rate	EFS will be estimated using the Kaplan-Meier method. The log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be utilized to include multiple covariates in the time-to-event analysis. Logistic regression will be utilized to assess the effect of patient prognostic factors on the response rate.	From the start of study treatment up to 3 years

External Links

•   MD Anderson Cancer Center Website