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

Sponsor:	North Central Cancer Treatment Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00053027

Purpose

RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy such as cladribine work in different ways to stop cancer cells from dividing so they stop growing or die. Combining rituximab with cladribine may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving rituximab together with cladribine works in treating patients with newly-diagnosed mantle cell lymphoma.

Condition	Intervention	Phase
Lymphoma	Biological: rituximab Drug: cladribine	Phase II

Study Type:	Interventional
Study Design:	Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Trial of Rituximab and 2-Chlorodeoxyadenosine (2-CDA) in Newly Diagnosed Mantle Cell Lymphoma (MCL)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Rituximab Cladribine

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Complete remission (CR) and complete remission unconfirmed (CRu) rate at the close of study therapy assessment (after 2, 4, or 6 courses) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression at any time after therapy [ Designated as safety issue: No ]

Study Start Date:	February 2003
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

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

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.

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

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/mm^3
Platelet count at least 100,000/mm^3

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

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00053027

Sponsors and Collaborators

North Central Cancer Treatment Group

National Cancer Institute (NCI)

Investigators

Study Chair:

David J. Inwards, MD

Mayo Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Inwards DJ, Fishkin PA, Hillman DW, Brown DW, Ansell SM, Kurtin PJ, Fonseca R, Morton RF, Veeder MH, Witzig TE. 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. 2008 May 9; [Epub ahead of print]

ClinicalTrials.gov Identifier:	NCT00053027 History of Changes
Other Study ID Numbers:	CDR0000269055, NCCTG-N0189
Study First Received:	January 27, 2003
Last Updated:	December 2, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

contiguous stage II mantle cell lymphoma
noncontiguous stage II mantle cell lymphoma
stage I mantle cell lymphoma
stage III mantle cell lymphoma
stage IV mantle cell lymphoma

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

Rituximab
Cladribine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 12, 2012