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

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Trial Conditions
  • Lymphoma
What is the purpose of this trial?

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective when given with rituximab in treating diffuse large B-cell non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying rituximab when given together with two different combination chemotherapy regimens to compare how well they work in treating patients with diffuse large B-cell non-Hodgkin's lymphoma.

Date & Status

Recruiting

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

DISEASE CHARACTERISTICS:

- Histologically confirmed* de novo B-cell non-Hodgkin's lymphoma (NHL) of 1 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 NOTE: *Fine needle aspirates or core biopsies
must not be the only diagnostic material

- Stage I primary mediastinal (thymic) OR stage II-IV disease

- CD20-positive disease

- No underlying low-grade lymphoma (e.g., transformed lymphoma or low-grade lymphoma in
the bone marrow)

- No known lymphomatous CNS involvement

- Lumbar puncture required unless there are no neurological symptoms NOTE: A new
classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ.
The terminology of "indolent" or "aggressive" lymphoma will replace the former
terminology of "low", "intermediate", or "high" grade lymphoma. However, this
protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count ≥ 1,000/mm^3^*

- Platelet count ≥ 100,000/mm^3^*

- No active bleeding unrelated to NHL NOTE: *Unless due to NHL

Hepatic

- Bilirubin ≤ 2 mg/dL* NOTE: *Unless due to NHL or Gilbert's disease

Renal

- Creatinine ≤ 1.5 mg/dL^* OR

- Creatinine clearance ≥ 50 mL/min^* NOTE: *Unless due to NHL

Cardiovascular

- No active ischemic heart disease

- No congestive heart failure

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

- No active uncontrolled bacterial or viral infection unrelated to NHL

- No other active medical process unrelated to NHL

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior rituximab

Chemotherapy

- No prior chemotherapy for other malignancies

- No prior cytotoxic chemotherapy

- No other concurrent chemotherapy

Endocrine therapy

- Prior short course (< 10 days) glucocorticoids allowed for an urgent local disease
complication (e.g., cord compression or superior vena cava syndrome) at diagnosis

- No concurrent hormonal therapy except steroids for adrenal failure or hormones for
non-disease related conditions (e.g., insulin for diabetes)

- No concurrent dexamethasone or other steroidal antiemetics

Radiotherapy

- Prior limited field radiotherapy allowed for an urgent local disease complication
(e.g., cord compression or superior vena cava syndrome) at diagnosis

- No concurrent radiotherapy except for isolated CNS lesions

Surgery

- Not specified

Other

- No other concurrent investigational or commercial agents or therapies for NHL

Gender: Both
Steward Physician(s)
  • Wyndham H. Wilson, MD, PhD
  • Andrew D. Zelenetz, MD, PhD
Facilities
  • St. Elizabeth's Medical Center - Recruiting
Trial Interventions
Biological
  • filgrastim
  • rituximab
Drug
  • cyclophosphamide
  • doxorubicin hydrochloride
  • etoposide
  • prednisone
  • vincristine sulfate
For more information about this trial, contact

Uma Narayanasami

Phone: 617-789-3000

Uma Narayanasami

Phone: (617) 789-3000


Physician Researcher

Investigator Name:

  • Wyndham H. Wilson, MD, PhD
  • Andrew D. Zelenetz, MD, PhD

Other Information

Sponsor: Cancer and Leukemia Group B
Phase: Phase 3
Trial ID: NCT00118209
Volunteers:  Not Accepting Healthy Volunteers

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