Phase 2 Study of Rituximab-ABVD in Classical Hodgkin Lymphoma

NCT00369681 | Completed Phase 2 Results

• 3 other identifiers: J0615P30CA006973NA_00002473
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 4

Brief Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with newly diagnosed stage II, stage III, or stage IV Hodgkin's lymphoma.

Conditions

Lymphoma

Keywords

stage II adult Hodgkin lymphoma; stage III adult Hodgkin lymphoma; stage IV adult Hodgkin lymphoma; adult lymphocyte depletion Hodgkin lymphoma; adult mixed cellularity Hodgkin lymphoma; adult nodular sclerosis Hodgkin lymphoma

Outcome Measures

Primary Outcomes (2)

• Effect of Rituximab on EBV(+) Tumors

  Number of relapses among participants who had tumors positive for Epstein-Barr virus (EBV).

  Up to 56 months

• Relationship Between Marker Detection and Clinical Outcome

  Number of relapses for participants who did and did not have re-emergence of clonal CD27(+) ALDH(+) B cells after completing study intervention.

  3 years

Secondary Outcomes (2)

• Event-free Survival

  3 years

• Addition of Information to Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) by Plasma DNA Biomarkers

  5 years

Study Arms (1)

R-ABVD

EXPERIMENTAL

ABVD (doxorubicin; vinblastine; bleomycin; dacarbazine) given as standard for 6-8 cycles. Rituximab given 375 mg/m\^2 Cycle 1 Days -6, 1, 8, 15, and 22. Rituximab given 375 mg/m\^2 Cycles 2, 4, and 6 Day 1.

Drug: Bleomycin; Biological: Rituximab; Drug: Dacarbazine; Drug: Doxorubicin; Drug: Vinblastine

Interventions

Bleomycin DRUG

Also known as: Blenoxane

R-ABVD

Rituximab BIOLOGICAL

Also known as: Rituxan

R-ABVD

Dacarbazine DRUG

Also known as: DTIC, DTIC-Dome

R-ABVD

Doxorubicin DRUG

Also known as: Adriamycin

R-ABVD

Vinblastine DRUG

Also known as: Velban, Alkaban

R-ABVD

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed classical Hodgkin's lymphoma * No lymphocyte-predominant histology * Stage II, III, or IV disease * Newly diagnosed disease PATIENT CHARACTERISTICS: * Performance status 0-2 * Creatinine \< 2.0 mg/dL * Bilirubin \< 5 mg/dL * Not pregnant or nursing * No HIV positivity * Hepatitis B surface antigen negative * No active concurrent malignancy except for superficial nonmelanoma skin cancer or cervical carcinoma in situ PRIOR CONCURRENT THERAPY: * No prior chemotherapy or radiotherapy for Hodgkin's lymphoma * Steroids allowed if medically required before chemotherapy initiation

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242-1009, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Kasamon YL, Jacene HA, Gocke CD, Swinnen LJ, Gladstone DE, Perkins B, Link BK, Popplewell LL, Habermann TM, Herman JM, Matsui WH, Jones RJ, Ambinder RF. Phase 2 study of rituximab-ABVD in classical Hodgkin lymphoma. Blood. 2012 May 3;119(18):4129-32. doi: 10.1182/blood-2012-01-402792. Epub 2012 Feb 16.

  PMID: 22343727 BACKGROUND

MeSH Terms

Conditions

Lymphoma; Hodgkin Disease

Interventions

Bleomycin; Rituximab; Dacarbazine; Doxorubicin; Vinblastine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Results Point of Contact

• Title: Dr. Yvette Kasamon
• Organization: Johns Hopkins University

ykasamon@jhmi.edu

410-955-8839

Study Officials

• Yvette L. Kasamon, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2006
• First Posted: August 29, 2006
• Study Start: May 1, 2006
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: August 27, 2018
• Results First Posted: July 3, 2015

Record last verified: 2018-07

Locations

US (4)