Patients will be randomly assigned to one of two groups. Patients in group one will receive a 1-hour infusion of cisplatin on day 1, dexamethasone by infusion or by mouth on days 1-4, and an infusion of gemcitabine on days 1 and 8. Patients in group two will receive a 24-hour continuous infusion of cisplatin on day 1, dexamethasone as in group one, and a 3-hour infusion of cytarabine twice on day 2. Treatment in both groups may be repeated every 3 weeks for up to three courses. Some patients may then have stem cells collected and will undergo autologous stem cell transplantation. They may then be randomly assigned to one of two groups. Beginning 4 weeks after transplantation, patients in group one will receive an infusion of rituximab every 2 months for up to 1 year. Patients in group two will undergo observation. Quality of life will be assessed periodically. Patients will be evaluated every 1-6 months for approximately 2 years and once a year thereafter.

Condition	Treatment or Intervention	Phase
Lymphoma	Drug: dexamethasone and cisplatin with gemcitabine  Drug: dexamethasone and cisplatin with cytarabine	Phase III

Ages Eligible for Study:  16 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Histologically confirmed aggressive non-Hodgkin's lymphoma of 1 of the following subtypes: * Diffuse large cell lymphoma (includes primary mediastinal B-cell lymphoma and T-cell-rich B-cell lymphoma) * Prior indolent lymphoma (e.g., follicular center cell lymphoma; marginal zone lymphoma, including extranodal mucosa-associated lymphoid tissue [MALT] lymphoma; and lymphoplasmacytoid lymphoma) with transformation to diffuse large B-cell lymphoma at relapse * Peripheral T-cell lymphoma * Anaplastic large cell lymphoma * Small noncleaved Burkitt-like lymphoma
• T-cell or B-cell lineage confirmed by immunohistochemistry
• Previously treated with 1, and only 1, chemotherapy regimen including an anthracycline and excluding cisplatin, cytarabine, and gemcitabine

Exclusion Criteria:

• Prior or concurrent malignancy except adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix, unless the prior malignancy was diagnosed at least five years previously and there is no evidence of recurrence.
• Uncontrolled central nervous system involvement by lymphoma.
• Prior treatment with gemcitabine, cytarabine, or cisplatin.
• Prior treatment with high dose chemotherapy and stem cell transplantation
• Pregnant or lactating woman

There may be multiple sites in this clinical trial.      1-877-CTLILLY (1-877-285-4559 

Arkansas
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Springdale,  Arkansas,  United States; Recruiting
New Jersey
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Hackensack,  New Jersey,  United States; Recruiting
North Carolina
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Durham,  North Carolina,  United States; Recruiting

Study ID Numbers:  7581
Record last reviewed:  April 2005
Last Updated:  April 4, 2005
Record first received:  August 13, 2004
ClinicalTrials.gov Identifier:  NCT00089817
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08