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

December 5, 2016 updated by: Alliance for Clinical Trials in Oncology

Phase II Trial of Rituximab and 2-Chlorodeoxyadenosine (2-CDA) in Newly Diagnosed Mantle Cell Lymphoma (MCL)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rituximab + cladribine

Patients receive 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.

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.
Drug: cladribine
Biological: rituximab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete remission (CR) and complete remission unconfirmed (CRu) rate at the close of study therapy assessment (after 2, 4, or 6 courses)
Time Frame: Up to 4 years
Up to 4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression at any time after therapy
Time Frame: Up to 4 years
Up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: David J. Inwards, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

January 27, 2003

First Submitted That Met QC Criteria

January 27, 2003

First Posted (Estimate)

January 28, 2003

Study Record Updates

Last Update Posted (Estimate)

December 7, 2016

Last Update Submitted That Met QC Criteria

December 5, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCTG-N0189
  • NCI-2012-02510 (Registry Identifier: NCI-2012-02510 CTRP (Clinical Trials Reporting System))
  • CDR0000269055 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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