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

Alternate Title

Rituximab and Cladribine in Treating Patients With Newly Diagnosed Non-Hodgkin's Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	NCCTG-N0189 N0189, NCT00053027

Objectives

1. Determine whether rituximab and cladribine will increase the complete remission rate and the unconfirmed complete remission rate in patients with mantle cell lymphoma.
2. Determine the time to progression in patients treated with this regimen.
3. Determine the toxic effects of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed mantle cell lymphoma*



• Measurable or assessable disease defined as at least one of the following:
  • Lymph node or tumor mass that is 2.0 cm or more in at least one dimension by CT scan, MRI, or plain radiograph imaging OR greater than 1.5 cm in at least one dimension by physical exam
  • Splenic enlargement, if the spleen is palpable, at least 3 cm below the left costal margin
  • Diffuse infiltration of an organ such as the stomach, bone marrow, peripheral blood, liver, lungs, or bowel by lymphoma without a discrete mass would constitute assessable, but not measurable, disease



• No known CNS involvement

 [Note: *If tumor tissue is unavailable for biopsy, blood or bone marrow specimens may be used to establish patient eligibility provided fusion signals indicate the presence of t(11;14)(q13;q32) by fluorescence in situ hybridization using CCND1/IGH AND mantle cell lymphoma involvement is determined by morphology]

Prior/Concurrent Therapy:

Biologic therapy

• No prior biologic therapy for mantle cell lymphoma

Chemotherapy

• No prior chemotherapy for mantle cell lymphoma

Endocrine therapy

• No prior endocrine therapy for mantle cell lymphoma

Radiotherapy

• No prior radiotherapy

Surgery

• Prior splenectomy allowed (for diagnosis, cytopenia, or symptomatic splenomegaly)

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-3

Life expectancy

• At least 12 weeks

Hematopoietic

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic

• Total or direct bilirubin no greater than upper limit of normal (ULN) (with or without secondary liver involvement)
• SGOT no greater than 3 times ULN (5 times ULN if there is liver involvement)

Renal

• Creatinine no greater than 2.0 mg/dL

Cardiovascular

• No myocardial infarction within the past 6 months
• No uncontrolled high blood pressure
• No unstable angina
• No serious uncontrolled cardiac arrhythmia
• No active congestive heart failure

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 30 days after study participation
• HIV negative
• No other malignancy within the past 5 years except carcinoma in situ of the cervix, resected basal cell or squamous cell skin cancer, or prostate cancer that is in remission after a radical retropubic prostatectomy or radiotherapy
• No medical or psychiatric condition that makes the patient a poor risk for this study
• No active or uncontrolled infection
• No known hypersensitivity to rituximab or its components or to murine proteins

Expected Enrollment

A total of 31 patients will be accrued for this study within 21 months.

Outcomes

Complete remission (CR) and complete remission unconfirmed (CRu) rate at the close of study therapy assessment (after 2, 4, or 6 courses)

Progression at any time after therapy

Outline

This is a multicenter study.

An initial cohort of 6 patients at Mayo Clinic receives rituximab IV over 4-8 hours on day 1 and cladribine IV over 2 hours on days 4-8. If 2 or more patients experience unacceptable toxicity during the first course, the study is discontinued; otherwise, the study is opened for enrollment at all NCCTG sites. (The phase II study is open for enrollment as of 5/14/04.)

Treatment repeats every 28 days for a total of 2-6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually for 2 years.

Inwards DJ, Fishkin PA, Hillman DW, et al.: Long-term results of the treatment of patients with mantle cell lymphoma with cladribine (2-CDA) alone (95-80-53) or 2-CDA and rituximab (N0189) in the North Central Cancer Treatment Group. Cancer 113 (1): 108-16, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

David Inwards, MD, Protocol chair		Ph: 507-284-4101

Registry Information
Official Title		Phase II Trial of Rituximab and 2-Chlorodeoxyadenosine (2-CDA) in Newly Diagnosed Mantle Cell Lymphoma (MCL)
Trial Start Date		2003-02-11
Registered in ClinicalTrials.gov		NCT00053027
Date Submitted to PDQ		2002-11-12
Information Last Verified		2005-09-23
NCI Grant/Contract Number		U10-CA25224

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