Clinical Trial for Lymphoma: 05-C-0252: 1.888.NCI.1937

Phase III Randomized Study of R-CHOP Versus Dose-Adjusted EPOCH-R With Molecular Profiling in Untreated De Novo Diffuse Large B-Cell Lymphomas

Protocol # 05-C-0252

Why is this trial important?
Who is eligible for this trial?
What types of drugs or therapies are being used?
What is the study outline?
What is the frequency and duration of the visits?
What are the costs?
Who is the Principal Investigator?
Where is this trial taking place?
Who are the contacts for this trial?
Where can additional information be found?

Why is this trial important?

This study aims to compare two different treatment approaches for diffuse large B-cell lymphoma: R-CHOP, the standard therapy, versus dose-adjusted EPOCH-R, a regimen developed from studies on drug schedule and resistance and pharmacokinetics that had promising results in phase 2 studies. This study also will assess multiple biological factors, employing molecular profiling, proteomics, and genomics with an aim toward understanding the biological basis of response and tumor biology.

Who is eligible for this trial? (PDQ)

Histologically confirmed de novo B-cell non-Hodgkin's lymphoma (NHL) of one 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

Stage I primary mediastinal (thymic) OR stage II-IV disease
CD20-positive disease
No underlying low-grade lymphoma
No known lymphomatous CNS involvement; lumbar puncture required unless there are no neurological symptoms
No prior rituximab; no concurrent epoetin cytokines
No prior chemotherapy for other malignancies; no prior cytotoxic chemotherapy; no other concurrent chemotherapy
Prior short course (< 10 days) glucocorticoids allowed for an urgent local disease complication at diagnosis; no concurrent hormonal therapy except steroids for adrenal failure or hormones for non-disease-related conditions; no concurrent dexamethasone or other steroidal antiemetics
Prior limited field radiotherapy allowed for an urgent local disease complication at diagnosis; no concurrent radiotherapy except for isolated CNS lesions
No active bleeding unrelated to NHL
No active ischemic heart disease; no congestive heart failure
No active uncontrolled bacterial or viral infection unrelated to NHL; HIV negative

What types of drugs or therapies are being used?

Rituximab
Etoposide
Prednisone
Vincristine
Adriamycin
Cyclophosphamide
Neupogen

What is the study outline? (PDQ)

Patients are randomized to one of two treatment arms:

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

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 6-17 or until blood counts recover
Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity

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

What is the frequency and duration of the visits?

This is an outpatient protocol, unless patients need to be admitted for medical reasons. If patients receive R-CHOP, they will be here for 1-2 days every 21 days. If patients receive EPOCH-R, they will need to be here for 6 days every 21 days.

What are the costs?

There is no charge for medical care received at the National Institutes of Health (NIH) Clinical Center. Patients will be responsible for travel costs for their initial screening visits. In most cases, once patients are enrolled in a trial, the National Cancer Institute (NCI) will pay the transportation costs for all subsequent trial-related visits for patients who do not live in the local area. In addition, these patients will receive a small per diem to help offset the costs of meals and lodging if they are being treated as outpatients.

It will be important to maintain your current insurance plan to cover all medical care that is provided away from the NIH Clinical Center.

No U.S. citizen or permanent U.S. resident residing in the U.S. who otherwise meets the eligibility requirements will be denied enrollment in clinical research protocols because of their inability to pay the costs of travel and subsistence.

Who is the Principal Investigator?

Dr. Wyndham H. Wilson received his B.A. and M.S. degrees in biology from Stanford University in 1975. In 1981, he received his Ph.D. in neurobiology and M.D. from Stanford, completing his residency training in internal medicine at Stanford in 1984. From 1984 to 1987, he was a clinical associate in the Medicine Branch, NCI, where he completed a fellowship in medical oncology. Dr. Wilson was special assistant to the director, Division of Cancer Treatment, NCI, from 1988 to 1995. In 1995, he joined the former Medicine Branch as a senior oncologist.

Where is this trial taking place?

NIH Clinical Center
National Institutes of Health
NCI Metabolism Branch
10 Center Drive
Bethesda, Maryland 20892

Who are the contacts for this trial?

Wyndham H. Wilson, M.D., Ph.D.
Principal Investigator
Phone: 301-435-2415
wilsonw@mail.nih.gov

Referrals:

Therese White, R.N.
Research Nurse
Phone: 301-402-5886
whiteth@mail.nih.gov

Peggy Shovlin, R.N., B.S.N.
Research Nurse
Phone: 301-594-6597
mshovlin@mail.nih.gov