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Phase II Study to Establish Gene Expression Models Predicting Survival of Diffuse Large B-Cell Lymphoma Patients Treated With R-CHOP


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

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Trial Information

Phase II Study to Establish Gene Expression Models Predicting Survival of Diffuse Large B-Cell Lymphoma Patients Treated With R-CHOP


OBJECTIVES:

Primary

- Determine a list of genes and construct a survival prediction model(s) that will
predict the overall survival at 30 months of patients with diffuse large B-cell
lymphoma treated with rituximab, cyclophosphamide, doxorubicin hydrochloride,
vincristine, and prednisone.

- Determine the usefulness of biomarkers associated with the antitumor effects of
rituximab (e.g., immunoglobulin G Fc receptor genotypes, CD20 protein expression, and
gene expression profiles) in predicting overall survival of patients treated with this
regimen.

- Compare the ability of constructed survival models to predict survival of these
patients.

Secondary

- Determine the ability of the models and/or biomarkers associated with the antitumor
effects of rituximab to predict 24-month time to treatment failure, defined as disease
progression, death, or initiation of new treatment.

- Determine the overall response rate (complete and partial response rate) at the end of
study therapy.

- Collect a series of fixed tissue samples with annotated clinical information and state
of the art therapy for future studies.

OUTLINE: This is a prospective study.

Patients receive rituximab IV over 4-8 hours, cyclophosphamide IV over 2 hours, doxorubicin
hydrochloride IV, and vincristine IV on day 1 and oral prednisone on days 1-5. Treatment
repeats every 21 days for up to 4 courses in the absence of disease progression or
unacceptable toxicity. Patients with responding disease after completion of course 4 receive
4 additional courses of therapy.

Paraffin-embedded tissue blocks and immunohistochemical slides are collected at baseline for
RNA-based gene array studies, real-time polymerase chain reaction gene expression studies,
polymorphism analysis, tissue-array immunohistochemical studies, and immunoglobulin G Fc
receptor genotypes determination.

After completion of study treatment, patients are followed every 3 months for 2 years, every
6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 213 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of diffuse large B-cell lymphoma, meeting 1 of the following staging
criteria:

- Limited stage I disease that is bulky (i.e., more than 10 cm) or with
International Prognostic Index > 1

- Stage II-IV disease

- CD20-positive disease

- Paraffin-embedded tumor specimen must be available

- No active CNS lymphoma

PATIENT CHARACTERISTICS:

- ECOG performance status 0-3

- WBC > 2,500/mm³

- Absolute neutrophil count > 1,000/mm³ (unless due to disease in marrow)

- Platelet count > 100,000/mm³ (unless due to disease in marrow)

- Creatinine < 2.0 mg/dL

- Bilirubin < 1.5 mg/dL (1.5-3.0 mg/dL if due to liver involvement by lymphoma)

- AST and ALT < 3 times upper limit of normal

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- LVEF > 45%

- No HIV positivity

- No other malignancy except for basal cell carcinoma of the skin or in situ carcinoma
of the cervix (unless the tumor was treated with curative intent ≥ 2 years ago and
the patient continues to be free of evidence of recurrence)

PRIOR CONCURRENT THERAPY:

- No prior chemotherapy, radiotherapy, or immunotherapy

- A prior short course (i.e., < 2 weeks) of corticosteroids allowed

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival at 30 months

Outcome Time Frame:

At study completion

Safety Issue:

No

Principal Investigator

Izidore S. Lossos, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Miami Sylvester Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

EPROST-20061138

NCT ID:

NCT00450385

Start Date:

February 2007

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent adult diffuse large cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • contiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • stage I adult diffuse large cell lymphoma
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

Name

Location

Stanford UniversityStanford, California  94305
University of Miami Sylvester Comprehensive Cancer Center - MiamiMiami, Florida  33136