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Cladribine in Patients With Mantle Cell Lymphoma

NCT ID: NCT00002879

Last Updated: 2016-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-11-30

Study Completion Date

2008-12-31

Brief Summary

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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effects of cladribine in previously treated or untreated patients with mantle cell lymphoma.

Detailed Description

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OBJECTIVES: I. Determine the efficacy of cladribine (2-chlorodeoxyadenosine; 2-CdA) as treatment for mantle cell lymphoma (MCL) either as initial therapy or for relapsed/refractory disease. II. Determine by flow cytometry immunophenotyping of blood lymphocytes the number of patients with peripheral blood involvement at the time of diagnosis and compare the presence or absence of peripheral blood involvement with response data. III. Detect rearrangements involving the bcl-1 gene and immunoglobulin heavy chain locus by molecular techniques (e.g., polymerase chain reaction, Southern blotting, or in situ hybridization), and compare these results with immunohistochemical demonstration of bcl-1 protein expression. VI. Determine the proliferative rate of MCL by immunohistochemistry and DNA content flow cytometry. V. Summarize the toxic effects associated with this treatment.

OUTLINE: Patients receive cladribine (2-chlorodeoxyadenosine; 2-CdA) daily for 5 days every 4 weeks for a maximum of 6 courses; response is assessed after every 2 courses. Patients in complete remission or with stable disease discontinue treatment and are followed; those with disease progression at any time are removed from study. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and annually for 2 years.

Conditions

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Lymphoma

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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cladribine

Patients receive cladribine (2-chlorodeoxyadenosine; 2-CdA) daily for 5 days every 4 weeks for a maximum of 6 courses; response is assessed after every 2 courses. Patients in complete remission or with stable disease discontinue treatment and are followed; those with disease progression at any time are removed from study. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and annually for 2 years.

Group Type EXPERIMENTAL

cladribine

Intervention Type DRUG

Interventions

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cladribine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed mantle cell lymphoma (MCL) requiring therapy NCCTG pathology review required - Repeat biopsy is required for previously treated patients with previously biopsy proven MCL who relapse after achieving a partial or complete remission - Rebiopsy is not required for patients with: Progression of previously biopsy proven MCL who have not received therapy since the diagnostic biopsy OR Previously biopsy proven MCL who progress or achieve less than a partial remission following initial therapy Measurable or evaluable disease

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: Bilirubin normal AST no greater than 3 times normal (5 times normal with liver involvement) Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No uncontrolled hypertension No unstable angina No active congestive heart failure No myocardial infarction within 6 months No serious uncontrolled arrhythmia Other: No active or uncontrolled infection No HIV antibody No medical or psychiatric condition that precludes participation No malignancy in the past 5 years, except carcinoma in situ of the cervix, resected basal cell or squamous cell carcinomas of the skin, or prostate cancer that is in remission following a radical retropubic prostatectomy or radiation therapy No pregnant or nursing women Negative pregnancy test required of fertile women within 7 days prior to entry Effective contraception required of fertile patients throughout study and at least 30 days thereafter

PRIOR CONCURRENT THERAPY: Recovered from any reversible acute toxic effects of previous therapy Biologic therapy: Not specified Chemotherapy: At least 4 weeks since chemotherapy (8 weeks since nitrosoureas or mitomycin) No prior fludarabine, pentostatin, or cladribine Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to greater than 25% of bone marrow Surgery: Not specified
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David J. Inwards, MD

Role: STUDY_CHAIR

Mayo Clinic

Locations

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CCOP - Scottsdale Oncology Program

Scottsdale, Arizona, United States

Site Status

CCOP - Illinois Oncology Research Association

Peoria, Illinois, United States

Site Status

CCOP - Carle Cancer Center

Urbana, Illinois, United States

Site Status

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, United States

Site Status

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, United States

Site Status

Siouxland Hematology-Oncology

Sioux City, Iowa, United States

Site Status

CCOP - Wichita

Wichita, Kansas, United States

Site Status

CCOP - Ochsner

New Orleans, Louisiana, United States

Site Status

CCOP - Ann Arbor Regional

Ann Arbor, Michigan, United States

Site Status

CCOP - Duluth

Duluth, Minnesota, United States

Site Status

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Site Status

CentraCare Clinic

Saint Cloud, Minnesota, United States

Site Status

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, United States

Site Status

Quain & Ramstad Clinic, P.C.

Bismarck, North Dakota, United States

Site Status

CCOP - Merit Care Hospital

Fargo, North Dakota, United States

Site Status

Altru Health Systems

Grand Forks, North Dakota, United States

Site Status

CCOP - Toledo Community Hospital Oncology Program

Toledo, Ohio, United States

Site Status

CCOP - Geisinger Clinical and Medical Center

Danville, Pennsylvania, United States

Site Status

Rapid City Regional Hospital

Rapid City, South Dakota, United States

Site Status

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, United States

Site Status

Saskatchewan Cancer Agency

Regina, Saskatchewan, Canada

Site Status

Countries

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United States Canada

References

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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 Jul 1;113(1):108-16. doi: 10.1002/cncr.23537.

Reference Type BACKGROUND
PMID: 18470909 (View on PubMed)

Inwards D, Brown D, Fonseca R, et al.: NCCTG Phase II trial of 2-chlorodeoxyadenosine (2-CDA) as initial therapy for mantle cell lymphoma. A well-tolerated treatment with promising activity. Blood 94(10 suppl 1): A-2930, 660a, 1999.

Reference Type RESULT

Other Identifiers

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NCI-2012-02249

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000065179

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCCTG-958053

Identifier Type: -

Identifier Source: org_study_id