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Lymphoma

Combination Chemotherapy With or Without Rituximab in Non-Hodgkin's Lymphoma

Sponsored by NCIC Clinical Trials Group

About this trial

Last updated 5 years ago

Study ID

LY9

Status

Completed

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

18-75 Years
18 to 60 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 11 years ago

What is this trial about?

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without rituximab in treating patients with non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying four different combination chemotherapy regimens and rituximab to see how well they work compared to four different combination chemotherapy regimens alone in treating patients with non-Hodgkin's lymphoma.

What are the Participation Requirements?

DISEASE CHARACTERISTICS:

- Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma according to REAL
classification

- Diagnosed within the past 6 weeks

- CD20+ disease

- Ann Arbor stage II, III, or IV disease or stage I bulky disease

- International Prognostic Index (IPI) score of 0 or 1

- Score 0 defined by all of the following:

- Stage I or II disease

- ECOG performance status of 0 or 1

- Lactic dehydrogenase (LDH) no greater than upper limit of normal (ULN)

- Score 1 defined by 1 of the following:

- Stage I or II disease; ECOG performance status of 0 or 1; and LDH greater
than ULN

- Stage I or II disease; ECOG performance status 2 or 3; and LDH no greater
than ULN

- Stage III or IV disease; ECOG performance status 0 or 1; and LDH no greater
than ULN

- Previously untreated disease

- Mediastinal B-cell lymphoma allowed

- No secondary lymphoma after prior chemotherapy or radiotherapy for other malignancies

- No transformed lymphoma

- No primary CNS lymphoma

- No primary gastrointestinal (MALT) lymphoma

- No post-transplant lymphoproliferative disorder

PATIENT CHARACTERISTICS:

Age

- 18 to 60

Performance status

- See Disease Characteristics

- ECOG 0-3

Life expectancy

- At least 3 months

Hematopoietic

- Not specified

Hepatic

- Bilirubin no greater than 2.0 mg/dL*

- Transaminases no greater than 3 times normal*

- No active chronic hepatitis B or C infection NOTE: *Unless related to lymphoma

Renal

- Creatinine no greater than 2 times normal* NOTE: *Unless related to lymphoma

Cardiovascular

- No myocardial infarction within the past 6 months

- No uncompensated heart failure

- No dilatative cardiomyopathy

- No coronary heart disease with ST segment depression on ECG

- No severe uncompensated hypertension

Pulmonary

- No chronic lung disease with hypoxemia

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

- No known allergic reactions against foreign proteins

- No other prior malignancy except basal cell skin cancer or carcinoma in situ of the
cervix

- No concurrent disease that would preclude study treatment

- No active infections requiring systemic antibiotics or antiviral medications

- No severe uncompensated diabetes mellitus

- No clinical signs of cerebral dysfunction

- No severe psychiatric disease

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior murine antibodies

Chemotherapy

- No other concurrent anticancer chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- No concurrent response-adapted (slow response or unconfirmed complete response)
radiotherapy

Surgery

- Not specified

Other

- No prior lymphoma-specific treatment

- More than 12 weeks since prior participation in another clinical trial

- No prior participation in this study

- No other concurrent study medication

Locations

Location

Status