Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Chemotherapy Plus Rituximab in Treating Patients With Mantle Cell Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 to 69	NCI	SWOG-S0213 S0213, NCT00041132

Objectives

1. Determine the 1-year progression-free survival probability in patients with previously untreated mantle cell lymphoma treated with courses of rituximab and cyclophosphamide, doxorubicin, vincristine, and dexamethasone alternating with courses of rituximab and high-dose cytarabine and methotrexate with leucovorin calcium.
2. Determine the response rate (complete unconfirmed and complete and partial responses) and survival of patients treated with this regimen.
3. Determine the toxicity of this regimen in these patients.
4. Correlate chromosomal breakpoints, translocated immunoglobulin regulatory sequences, and cyclins D1, D2, and D3 with response and progression-free survival in patients treated with this regimen.
5. Correlate gene expression (measured by DNA microarray analysis) with response and progression-free survival in patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Histologically proven stage III/IV or bulky stage II mantle cell lymphoma of one of the following histologic subtypes:
  • Nodular
  • Diffuse
  • Mantle zone
  • Blastic



• Newly diagnosed and previously untreated disease



• Bidimensionally measurable disease

Prior/Concurrent Therapy:

Biologic therapy:

• No prior monoclonal antibody therapy

Chemotherapy:

• No prior chemotherapy for lymphoma

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy for lymphoma

Surgery:

• Not specified

Patient Characteristics:

Age:

• 18 to 69

Performance status:

• Zubrod 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,000/mm³
• Platelet count at least 100,000/mm³ (50,000/mm³ if marrow involvement present)

Hepatic:

• Bilirubin no greater than 1.5 mg/dL (5.0 mg/dL if hepatic involvement present)

Renal:

• Creatinine no greater than 2.0 mg/dL
• Creatinine clearance greater than 50 mL/min

Cardiovascular:

• Ejection fraction at least 50% by MUGA or 2-D echocardiogram
• No significant abnormalities by EKG

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception
• Willing to receive blood product transfusions
• No known sensitivity to E. coli-derived proteins
• No known AIDS syndrome or HIV-associated complex
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

Expected Enrollment

Approximately 50 patients will be accrued for this study within 25 months.

Outcomes

Response rate
Progression-free survival at 1 year
Toxicity
Correlation of chromosomal breakpoints, translocated immunoglobulin regulatory sequences, anc cyclins D1, D2, and D3 with response and progression-free survival
Correlation of gene expression with response and progression-free survival

Outline

This is a pilot, multicenter study.

• Courses 1, 3, 5, and 7: Patients receive rituximab IV on day 1 (courses 1, 3, and 5 only); cyclophosphamide IV over 3 hours twice a day on days 2-4; doxorubicin IV over 24 hours on days 5-7; vincristine IV on days 5 and 12; dexamethasone orally or IV four times a day on days 2-5 and 12-15; and filgrastim (G-CSF) subcutaneously (SC) daily beginning on day 8 and continuing until blood counts recover.



• Courses 2, 4, 6, and 8: Patients receive rituximab IV on day 1 (courses 2, 4, and 6 only); high-dose methotrexate IV over 24 hours on day 2; high-dose cytarabine IV over 2 hours twice a day on days 3-4; oral leucovorin calcium 4 times a day on days 3-10; and G-CSF SC daily beginning on day 5 and continuing until blood counts recover.

Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed within 30 days, every 3 months for 2 years, and then every 6 months for 3 years. Patients with disease progression are followed annually for up to 5 years from study entry.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Elliot Epner, MD, PhD, Protocol chair		Ph: 503-494-1551; 800-494-1234

Registry Information
Official Title		Pilot Trial of Hyper-CVAD and Methotrexate/ARA C Plus Rituximab in Patients with Previously Untreated Mantle Cell Lymphoma
Trial Start Date		2002-09-30
Registered in ClinicalTrials.gov		NCT00041132
Date Submitted to PDQ		2002-05-16
Information Last Verified		2006-08-16
NCI Grant/Contract Number		CA32102

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