Rituximab and Combination Chemotherapy in Treating Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00118209
First received: July 8, 2005
Last updated: February 13, 2013
Last verified: February 2013
  Purpose

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. It is not yet known which combination chemotherapy regimen is more effective when given with rituximab in treating diffuse large B-cell non-Hodgkin's lymphoma. Imaging procedures, such as fludeoxyglucose F 18 positron emission tomography (FDG-PET)/computed tomography (CT), may help diagnose if recurrent disease is likely.

PURPOSE: This randomized phase III trial is studying rituximab when given together with two different combination chemotherapy regimens to compare how well they work in treating patients with diffuse large B-cell non-Hodgkin's lymphoma.


Condition Intervention Phase
Lymphoma
Biological: filgrastim
Biological: rituximab
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: prednisone
Drug: vincristine sulfate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Randomized Study of R-CHOP V. Dose-Adjusted EPOCH-R With Molecular Profiling in Untreated De Novo Diffuse Large B-Cell Lymphomas

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Event-free survival 5 years after completion of study treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • R-CHOP and DA-EPOCH-R molecular predictors of outcome as measured by cDNA microarray 5 years after completion of study treatment [ Designated as safety issue: No ]

Estimated Enrollment: 523
Study Start Date: May 2005
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I (R-CHOP)
Patients receive rituximab IV, cyclophosphamide IV, doxorubicin IV over 3-5 minutes, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Biological: rituximab
Given IV
Drug: cyclophosphamide
Prednisone given orally; all others given IV
Drug: doxorubicin hydrochloride
Prednisone given orally; all others given IV
Drug: prednisone
Prednisone given orally; all others given IV
Drug: vincristine sulfate
Prednisone given orally; all others given IV
Experimental: Arm II (EPOCH-R)
Patients receive rituximab IV on day 1, doxorubicin IV, etoposide IV, and vincristine IV continuously over 96 hours on days 1-4, cyclophosphamide IV on day 5, and oral prednisone twice daily on days 1-5. Patients also receive filgrastim (G-CSF) once daily on days 2-11 or until blood counts recover. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Biological: filgrastim
No administration information available
Biological: rituximab
Given IV
Drug: cyclophosphamide
Prednisone given orally; all others given IV
Drug: doxorubicin hydrochloride
Prednisone given orally; all others given IV
Drug: etoposide
Given IV
Drug: prednisone
Prednisone given orally; all others given IV
Drug: vincristine sulfate
Prednisone given orally; all others given IV

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed* de novo B-cell non-Hodgkin's lymphoma (NHL) of 1 of the following WHO histologic subtypes:

    • Diffuse large cell lymphoma, including any of the following morphologic variants:

      • Centroblastic
      • Immunoblastic
      • T-cell/histiocyte rich
      • Anaplastic
    • Mediastinal (thymic) large cell lymphoma
    • Intravascular large cell lymphoma NOTE: *Fine needle aspirates or core biopsies must not be the only diagnostic material
  • Stage I primary mediastinal (thymic) OR stage II-IV disease
  • CD20-positive disease
  • No underlying low-grade lymphoma (e.g., transformed lymphoma or low-grade lymphoma in the bone marrow)
  • No known lymphomatous CNS involvement

    • Lumbar puncture required unless there are no neurological symptoms
  • As of July 1, 2012, the PET/CT imaging companion study CALGB-580603 will be required of all patients enrolling onto the treatment study CALGB-50303 NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,000/mm^3^*
  • Platelet count ≥ 100,000/mm^3^*
  • No active bleeding unrelated to NHL NOTE: *Unless due to NHL

Hepatic

  • Bilirubin ≤ 2 mg/dL* NOTE: *Unless due to NHL or Gilbert's disease

Renal

  • Creatinine ≤ 1.5 mg/dL^* OR
  • Creatinine clearance ≥ 50 mL/min^* NOTE: *Unless due to NHL

Cardiovascular

  • No active ischemic heart disease
  • No congestive heart failure

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No active uncontrolled bacterial or viral infection unrelated to NHL
  • No other active medical process unrelated to NHL

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior rituximab

Chemotherapy

  • No prior chemotherapy for other malignancies
  • No prior cytotoxic chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy

  • Prior short course (< 10 days) glucocorticoids allowed for an urgent local disease complication (e.g., cord compression or superior vena cava syndrome) at diagnosis
  • No concurrent hormonal therapy except steroids for adrenal failure or hormones for non-disease related conditions (e.g., insulin for diabetes)
  • No concurrent dexamethasone or other steroidal antiemetics

Radiotherapy

  • Prior limited field radiotherapy allowed for an urgent local disease complication (e.g., cord compression or superior vena cava syndrome) at diagnosis
  • No concurrent radiotherapy except for isolated CNS lesions

Surgery

  • Not specified

Other

  • No other concurrent investigational or commercial agents or therapies for NHL
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00118209

  Hide Study Locations
Locations
United States, California
Rebecca and John Moores UCSD Cancer Center Recruiting
La Jolla, California, United States, 92093-0658
Contact: Clinical Trials Office - Rebecca and John Moores UCSD Cancer    858-822-5354    cancercto@ucsd.edu   
Camino Medical Group - Treatment Center Recruiting
Mountain View, California, United States, 94040
Contact: Peter P. Yu, MD    408-524-5814      
Palo Alto Medical Foundation Recruiting
Palo Alto, California, United States, 94301
Contact: David S. Leibowitz    650-321-4121      
Saint Helena Hospital Recruiting
Saint Helena, California, United States, 94574
Contact: Gregory B. Smith    707-963-3611      
Naval Medical Center - San Diego Recruiting
San Diego, California, United States, 92134
Contact: Preston S. Gable, MD, FACP    619-532-7319      
United States, Connecticut
Eastern Connecticut Hematology and Oncology Associates Recruiting
Norwich, Connecticut, United States, 06360
Contact: Dennis E. Slater, MD    860-886-8362      
United States, Delaware
CCOP - Christiana Care Health Services Recruiting
Newark, Delaware, United States, 19713
Contact: Clinical Trial Office - CCOP - Christiana Care Health Services    302-623-4450      
United States, Illinois
University of Illinois Cancer Center Recruiting
Chicago, Illinois, United States, 60612-7243
Contact: Clinical Trial Office - University of Illinois Cancer Center    312-355-3046      
Creticos Cancer Center at Advocate Illinois Masonic Medical Center Recruiting
Chicago, Illinois, United States, 60657
Contact: Clinical Trials Office - Creticos Cancer Center at Advocate Il    773-296-5360      
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Recruiting
Chicago, Illinois, United States, 60611-3013
Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer    312-695-1301    cancer@northwestern.edu   
Cardinal Bernardin Cancer Center at Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Clinical Trials Office - Cardinal Bernardin Cancer Center    708-226-4357      
United States, Maryland
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital Recruiting
Baltimore, Maryland, United States, 21215
Contact: Roberto F. Martinez    410-601-4734      
National Naval Medical Center Recruiting
Bethesda, Maryland, United States, 20889-5600
Contact: David C. Van Echo    301-295-5706      
NIH - Warren Grant Magnuson Clinical Center Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Clinical Trials Office - NIH - Warren Grant Magnuson Clinical    800-411-1222      
United States, Michigan
Providence Cancer Institute at Providence Hospital - Southfield Campus Recruiting
Southfield, Michigan, United States, 48075
Contact: Howard R. Terebelo, DO    248-552-0620      
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Nancy L. Bartlett, MD    314-362-5654      
United States, New Hampshire
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care Recruiting
Concord, New Hampshire, United States, 03301
Contact: Douglas J. Weckstein, MD    603-622-6484      
New Hampshire Oncology - Hematology, PA - Hooksett Recruiting
Hooksett, New Hampshire, United States, 03106
Contact: Douglas J. Weckstein, MD    603-622-6484      
United States, New York
Charles R. Wood Cancer Center at Glens Falls Hospital Recruiting
Glens Falls, New York, United States, 12801
Contact: Clinical Trials Office - Charles R. Wood Cancer Center at Glen    518-926-6700      
New York Weill Cornell Cancer Center at Cornell University Recruiting
New York, New York, United States, 10021
Contact: Clinical Trials Office - New York Weill Cornell Cancer Center    212-746-1848      
James P. Wilmot Cancer Center at University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Jonathan W. Friedberg    585-275-5345      
United States, North Carolina
Presbyterian Cancer Center at Presbyterian Hospital Recruiting
Charlotte, North Carolina, United States, 28233-3549
Contact: Clinical Trials Office - Presbyterian Cancer Center at Presbyt    704-384-5369      
Kinston Medical Specialists Recruiting
Kinston, North Carolina, United States, 28501
Contact: Peter R. Watson, MD    252-559-2200ext.201      
Iredell Memorial Hospital Recruiting
Statesville, North Carolina, United States, 28677
Contact: Ruby A. Grimm, MD    704-873-2219      
Wake Forest University Comprehensive Cancer Center Recruiting
Winston-Salem, North Carolina, United States, 27157-1096
Contact: Clinical Trials Office - Wake Forest University Comprehensive    336-713-6771      
United States, North Dakota
Altru Cancer Center at Altru Hospital Recruiting
Grand Forks, North Dakota, United States, 58201
Contact: Clinical Trails Office - Altru Cancer Center at Altru Hospital    701-780-6520      
United States, Ohio
Mercy Cancer Center at Mercy Medical Center Recruiting
Canton, Ohio, United States, 44708
Contact: Mitchell Haut, MD    330-453-9993      
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210-1240
Contact: Ohio State University Cancer Clinical Trial Matching Service    866-627-7616    Jamesline@osumc.edu   
United States, Pennsylvania
Geisinger Cancer Institute at Geisinger Health Recruiting
Danville, Pennsylvania, United States, 17822-0001
Contact: Clinical Trials Office - Geisinger Cancer Institute    570-271-5251      
Easton Regional Cancer Center at Easton Hospital Recruiting
Easton, Pennsylvania, United States, 18042
Contact: Rajen P. Oza    610-250-4567      
Geisinger Hazleton Cancer Center Recruiting
Hazleton, Pennsylvania, United States, 18201
Contact: Edward J. Gorak, II    570-459-2901      
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033-0850
Contact: Clinical Trials Office - Penn State Hershey Cancer Institute a    717-531-3779    CTO@hmc.psu.edu   
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15224-1791
Contact: John Lister    412-578-5000      
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Recruiting
Wilkes-Barre, Pennsylvania, United States, 18711
Contact: Clinical Trials Office - Frank M. and Dorothea Henry Cancer Ce    570-271-5251      
United States, Vermont
Mountainview Medical Recruiting
Berlin, Vermont, United States, 05602
Contact: Emiliano N. G. Mugnaini    802-223-6196      
United States, Virginia
Virginia Commonwealth University Massey Cancer Center Recruiting
Richmond, Virginia, United States, 23298-0037
Contact: Clinical Trials Office -Virginia Commonwealth University Masse    804-628-1939      
United States, Washington
Madigan Army Medical Center - Tacoma Recruiting
Tacoma, Washington, United States, 98431
Contact: Anthony J. Fadell    206-968-1110      
United States, West Virginia
Mary Babb Randolph Cancer Center at West Virginia University Hospitals Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Mehdi Hamadani    304-293-4500      
United States, Wisconsin
Marshfield Clinic - Marshfield Center Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Clinical Trials Office - Marshfield Clinic - Marshfield Center    800-782-1581 ext. 94457      
Saint Joseph's Hospital Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Ali W. Bseiso, MD    715-387-5416      
Marshfield Clinic - Lakeland Center Recruiting
Minocqua, Wisconsin, United States, 54548
Contact: Ali W. Bseiso, MD    715-387-5416      
Ministry Medical Group at Saint Mary's Hospital Recruiting
Rhinelander, Wisconsin, United States, 54501
Contact: Ali W. Bseiso, MD    715-387-5416      
Marshfield Clinic - Indianhead Center Recruiting
Rice Lake, Wisconsin, United States, 54868
Contact: Ali W. Bseiso, MD    715-387-5416      
Saint Michael's Hospital Cancer Center Recruiting
Stevens Point, Wisconsin, United States, 54481
Contact: Ali W. Bseiso, MD    715-387-5416      
Marshfield Clinic at Saint Michael's Hospital Recruiting
Stevens Point, Wisconsin, United States, 54481
Contact: Ali W. Bseiso, MD    715-387-5416      
Marshfield Clinic - Weston Center Recruiting
Weston, Wisconsin, United States, 54476
Contact: Ali W. Bseiso, MD    715-387-5416      
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Wyndham H. Wilson, MD, PhD National Cancer Institute (NCI)
Investigator: Andrew D. Zelenetz, MD, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Monica M. Bertagnolli, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier: NCT00118209     History of Changes
Obsolete Identifiers: NCT00234351
Other Study ID Numbers: CDR0000433265, CALGB-50303, ECOG-50303, NCI-05-C-0252
Study First Received: July 8, 2005
Last Updated: February 13, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage I adult diffuse large cell lymphoma
contiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
stage III adult diffuse large cell lymphoma
stage IV adult diffuse large cell lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Rituximab
Liposomal doxorubicin
Etoposide phosphate
Doxorubicin
Etoposide
Prednisone
Vincristine
Lenograstim
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists

ClinicalTrials.gov processed this record on August 28, 2014