Genes in Predicting Outcome of Patients With DLBCL Treated With Rituximab and Combination Chemotherapy (R-CHOP)

NCT ID: NCT00450385

Last Updated: 2017-06-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-24
• Study Completion Date: 2016-05-31

Brief Summary

The investigators hypothesize that survival of newly diagnosed DLBCL (diffuse large B-cell lymphoma) patients treated with R-CHOP can be predicted by RNA or protein gene expression or by presence of biomarkers associated with the anti-tumor effects of Rituximab.

Detailed Description

In this phase II multi-institutional trial, the investigators will identify genes associated with either good or bad outcome in DLBCL patients treated with R-CHOP, will construct a robust predictive models based on RNA extracted from or paraffin specimens as well on immunohistochemistry and will examine the predictive power of new biomarkers associated with the anti-tumor effects of rituximab. The acquisition of fixed tissue as a component of this uniformly treated prospective study will also afford future studies with this informative dataset.

Conditions

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

R-CHOP

Patients will receive R-CHOP for 6 to 8 cycles:

• Rituximab 375 mg/m2 on day 1
• Cyclophosphamide 750 mg/m2 IV on day 1
• Doxorubicin 50 mg/m2 on day 1
• Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1
• Prednisone 100 mg orally days 1-5, repeated every 21 days.

Group Type: EXPERIMENTAL

Rituximab

Intervention Type: DRUG

Rituximab 375 mg/m2 on day 1 for 6 to 8 cycles

Cyclophosphamide

Intervention Type: DRUG

Cyclophosphamide 750 mg/m2 IV on day 1 for 6 to 8 cycles

Doxorubicin

Intervention Type: DRUG

Doxorubicin 50 mg/m2 on day 1 for 6 to 8 cycles

Prednisone

Intervention Type: DRUG

Prednisone 40 mg/m2 orally days 1-5, repeated every 21 days for 6 to 8 cycles.

Vincristine

Intervention Type: DRUG

Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1 for 6 to 8 cycles

Interventions

Rituximab

Rituximab 375 mg/m2 on day 1 for 6 to 8 cycles

Intervention Type: DRUG

Cyclophosphamide

Cyclophosphamide 750 mg/m2 IV on day 1 for 6 to 8 cycles

Intervention Type: DRUG

Doxorubicin

Doxorubicin 50 mg/m2 on day 1 for 6 to 8 cycles

Intervention Type: DRUG

Prednisone

Prednisone 40 mg/m2 orally days 1-5, repeated every 21 days for 6 to 8 cycles.

Intervention Type: DRUG

Vincristine

Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1 for 6 to 8 cycles

Intervention Type: DRUG

Other Intervention Names

Rituxan; Cytoxan; Adriamycin; Deltasone; Oncovin

Eligibility Criteria

Inclusion Criteria

• 1. Diagnosis of diffuse large B-cell lymphoma, CD20-positive, according to the World Health Organization Classification, stages II-IV or limited stage I disease that is bulky (more than 10 cm) or with International Prognostic Index (IPI) score > 1.
• 2. Patients must not have had prior chemotherapy, radiotherapy or immunotherapy. A short course (< 2 weeks) of corticosteroids is allowed.
• 3. Adequate paraffin-embedded tumor specimen must be available for gene expression analysis and immunohistochemistry prior to initiation of therapy. (If the specimen is deemed inadequate, the subject can be retroactively screen failed, as this does not change the treatment regimen).
• 4. Baseline measurements and evaluation must be obtained within 4 weeks before first treatment.
• 5. Age >18 years.
• 6. Eastern Cooperative Oncology Group (ECOG) performance status 0-3.
• 7. Adequate organ function:

• White Blood Cells count (WBC) >2500/µL
• Absolute Neutrophil Count (ANC) > 1000/µL (unless due to disease in marrow)
• platelet count >100,000/µL (unless due to disease in marrow)
• creatinine < 2.0 mg/dL,
• bilirubin < 1.5 mg/dL (may be 1.5-3.0 mg/dl if due to liver involvement by lymphoma)
• Serum Glutamic Oxaloacetic Transaminase (SGOT)/ Serum Glutamic Pyruvic Transaminase (SGPT) <3 x upper limit of normal.
• 8. Female patients must not be pregnant or breast feeding.
• 9. Women of childbearing potential and men must be strongly advised to use an accepted and effective method of contraception.
• 10. Patients must have left ventricular ejection fraction of >45%.
• 11. Provision of written informed consent.

Exclusion Criteria

• 1. Patients with a second malignancy other than basal cell carcinoma of the skin or in situ carcinoma of the cervix unless the tumor was treated with curative intent at least two years previously; and; the patient continue to be free of evidence of recurrence.
• 2. Patients with HIV infection as these patients are managed on dedicated protocols.
• 3. Patients with active central nervous system (CNS) lymphoma.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Izidore Lossos

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Izidore S. Lossos, MD

Role: STUDY_CHAIR

University of Miami

Locations

Stanford University

Stanford, California, United States

University of Miami

Miami, Florida, United States

University of Rochester Medical Center - Wilmot Cancer Institute

Rochester, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

SCCC-2006069

Identifier Type: OTHER

Identifier Source: secondary_id

WIRB-20070073

Identifier Type: OTHER

Identifier Source: secondary_id

20061138

Identifier Type: -

Identifier Source: org_study_id