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)
3 other identifiers
interventional
58
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2008
Longer than P75 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 19, 2008
CompletedFirst Submitted
Initial submission to the registry
April 3, 2008
CompletedFirst Posted
Study publicly available on registry
April 9, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 5, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 5, 2018
CompletedResults Posted
Study results publicly available
February 28, 2020
CompletedFebruary 28, 2020
February 1, 2020
10.5 years
April 3, 2008
February 4, 2020
February 17, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Arm A (rituximab, combination chemotherapy)
EXPERIMENTALParticipants 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 (combination chemotherapy)
ACTIVE COMPARATORParticipants receive doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine as in Arm A.
Interventions
Given IV
Given IV
Given IV
Given IV
Given IV
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (4)
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Hun Ju Lee, Associate Professor, Lymphoma/Myeloma
- Organization
- UT MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Hun Lee
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2008
First Posted
April 9, 2008
Study Start
March 19, 2008
Primary Completion
September 5, 2018
Study Completion
September 5, 2018
Last Updated
February 28, 2020
Results First Posted
February 28, 2020
Record last verified: 2020-02