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
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 April 23, 2014