Genetic Determinations for Side Effects and Response Rate for Patients Receiving Chemotherapy With Diffuse Large Cell Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00590941
First received: December 28, 2007
Last updated: May 14, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to determine whether people have genes that make them more likely to respond to chemotherapy and/or have side effects from chemotherapy for diffuse large cell lymphoma.


Condition Intervention
Lymphoma
Diffuse Large Cell
Procedure: Blood draw

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Candidate Gene Polymorphisms and Response to Rituximab-CHOP in Patients With Diffuse Large Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Negative [F-18]fluorodeoxyglucose-positron emission tomography (FDG-PET) scan after 2 cycles of R-CHOP [ Time Frame: Approximately 42 days (2 cycles of R-CHOP) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response after six cycles of R-CHOP [ Time Frame: Approximately 126 days (6 Cycles of R-CHOP) ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Grade 3-4 toxicity [ Time Frame: Approximately 156 days ] [ Designated as safety issue: Yes ]

Enrollment: 52
Study Start Date: February 2005
Study Completion Date: April 2011
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: R-CHOP
Patients receiving R-CHOP via standard of care which consists of cyclophosphamide 750 mg/m2 IV day 1 of each 21 day cycle, doxorubicin 50 mg/m2 IV day 1 of each 21 day cycle, vincristine 1.4 mg/m2 IV day 1 of each 21 day cycle, prednisone 100 mg PO days 1-5 of each 21 day cycle, and rituximab 375 mg/m2 IV day 1 of each 21 day cycle.
Procedure: Blood draw
Sample Collection for Genotyping prior to cycle 1 treatment of R-CHOP, if patient is enrolled after cycle 1, sample for genotyping should be collected prior to cycle 2.

Detailed Description:

Upon enrollment in the study, patients will have a blood sample collected for genotyping of the FCGR3A gene (immunoglobulin Fc G receptor IIIa), the ABCB1 gene (ATP Binding Cassette Beta 1; also called MDR1), and other candidate genes. Patients will be treated with R-CHOP for six cycles, which is standard therapy for advanced stage DLCL. Response will be monitored by an FDG-PET scan performed after 2 cycles of R-CHOP and restaging exams performed upon completion of chemotherapy. Gene polymorphisms will be analyzed to establish which polymorphisms predict response to R-CHOP.

  Eligibility

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

Inclusion Criteria:

  • Histologically proven diffuse large B-cell non-Hodgkin's lymphoma according to the WHO classification, with measurable or evaluable disease
  • No prior therapy for NHL. Patient may be enrolled in this study after the first cycle of R-CHOP if all screening evaluations were performed prior to the first cycle of chemotherapy.
  • Ann Arbor stage 3 or 4
  • Age greater than or equal to 18 years
  • Patient must give written informed consent.
  • A patient enrolled in another clinical trial may also enroll in this study if the other trial has an R-CHOP treatment arm and the patient is randomized to the R-CHOP only arm. Registration to this study must occur after randomization in the other trial.

Exclusion Criteria:

  • CNS involvement
  • Known HIV positive
  • T-cell lymphoma or history of indolent NHL
  • Patients who will be treated with radiation therapy
  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: NCT00590941

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Amanda Cashen, MD Washington University School of Medicine
  More Information

Additional Information:
Publications:
Habermann TM, Weller EA et al. Phase III Trial of Rituximab-CHOP (R-CHOP) vs. CHOP with a Second Randomization to Maintenance Rituximab (MR) or Observation in Patients 60 Years of Age and Older with Diffuse Large B-Cell Lymphoma (DLBCL). Blood 102: abstract #8, 2003
Treon SP, Hansen M, et al. Polymorphisms in FcgRIIIA (CD16) Receptor Expression Are Associated with Clinical Response to Rituximab in Waldenstrom's Macroglobulinemia. Proc Am Soc Clin Onc 22(14S): 6556, 2004
Maloney DG, Pender-Smith B, et al. Fcg Receptor Polymorphisms Do Not Influence Progression Free Survival of Follicular NHL Patients Treated with CHOP Followed by Rituximab. ASH abstract # 2618, 2004
Boettcher S, Pott C, et al. Evidence for Fcg Receptor IIIA-Independent Rituximab Effector Mechanisms in Patients with Follicular Lymphoma Treated with Combined Immuno-Chemotherapy. ASH abstract #2953, 2004
Cheson BD, Horning SJ, et al. Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas. J. Clin. Onc. 17: 1244-1253, 1999

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00590941     History of Changes
Other Study ID Numbers: 05-0122, 05-0122
Study First Received: December 28, 2007
Last Updated: May 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Lymphoma
Rituximab
CHOP

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 20, 2014