Clofarabine in Treating Patients With T-Cell or Natural Killer-Cell Non-Hodgkin's Lymphoma That Has Relapsed or Not Responded to Previous Treatment

April 25, 2022 updated by: Memorial Sloan Kettering Cancer Center

A Phase I/II Study of Clofarabine in Patients With Relapsed T-Cell and NK-Cell Lymphomas

RATIONALE: Drugs used in chemotherapy, such as clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase I/II trial is studying the side effects and best dose of clofarabine and to see how well it works in treating patients with T-cell or natural killer-cell lymphoma that has relapsed or not responded to previous treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose of clofarabine in patients with relapsed or refractory T-cell or natural killer-cell lymphoma.
  • Determine the toxicity of this drug in these patients.
  • Determine, preliminarily, the efficacy of this drug, in terms of response rate, in these patients.

OUTLINE: This is a phase I, non-randomized, dose-escalation study followed by an open-label, phase II study.

  • Phase I: Patients receive clofarabine IV over 1 hour once daily on days 1-3. Treatment repeats every 21 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or partial response (PR) or complete response (CR) may receive 2 additional courses of treatment. Patients with PR or CR after completing 4 courses of therapy may receive 2 additional courses.

Cohorts of 1-6 patients receive escalating doses of clofarabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.

  • Phase II: Patients receive clofarabine as in phase I at the MTD determined in phase I.

After completion of study treatment, patients are followed every 3 months for 2 years.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • Rochester, New York, United States, 14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Taussig Cancer Center

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

2 years to 120 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed T-cell or natural killer (NK)-cell lymphoma, including any of the following subtypes:

    • Blastic NK-cell lymphoma
    • T/NK-cell lymphoma/leukemia
    • Adult T-cell lymphoma/leukemia
    • T-cell prolymphocytic leukemia
    • T-lymphoblastic lymphoma
    • Peripheral T-cell lymphoma, not otherwise specified
    • Angioimmunoblastic T-cell lymphoma
    • Anaplastic large cell lymphoma
    • Transformed mycosis fungoides
    • Subcutaneous panniculitis-like T-cell lymphoma
    • Nasal T/NK-cell lymphoma
    • Enteropathy-type T-cell lymphoma
    • Hepatosplenic gamma/delta T-cell lymphoma

  • Relapsed or refractory disease, meeting both of the following criteria:

    • Must have been treated with prior cytotoxic chemotherapy and/or monoclonal antibody therapy

    • No standard curative treatment exists

      • Allogeneic bone marrow transplantation is not considered standard curative treatment
  • Evaluable disease (Phase I)

  • Measurable disease, defined as any nodal site or mass lesion ≥ 1.5 cm in longest transverse diameter on physical exam or CT scan OR a measurable extranodal site > 1 cm (Phase II)

    • Patients with evaluable blood- or marrow-based disease are eligible

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Absolute neutrophil count ≥ 1,500/mm³ (Phase I)
  • Absolute neutrophil count ≥ 500/mm³ (Phase II)
  • Platelet count ≥ 100,000/mm³ (Phase I)
  • Platelet count ≥ 50,000/mm³ (Phase II)
  • Creatinine < 2.0 mg/dL*
  • Bilirubin ≤ 2.0 times upper limit of normal (ULN)*
  • AST and ALT ≤ 2.5 times ULN*
  • No active infection requiring antibiotics
  • No New York Heart Association class III or IV congestive heart failure
  • No known HIV positivity
  • No other active malignancy requiring therapy
  • No other serious or life-threatening condition deemed unacceptable by the principal investigator
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception NOTE: *Unless due to lymphoma and patients are entering to the phase II portion of the study

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

  • At least 3 weeks since prior therapy, including any of the following:

    • Interferon
    • Antibody therapy
    • Retinoids
    • Other non-chemotherapeutic treatment
  • Concurrent stable-dose corticosteroids allowed
  • No colony-stimulating factor therapy during the first course of study therapy

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Clofarabine
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
Drug: clofarabine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Tolerated Dose
Time Frame: 2 years
2 years
Response Rate for Participants With Non-Hodgkin's Lymphoma
Time Frame: 2 years
Response rate as defined by complete remission, complete remission unconfirmed, partial remission, positron emission tomography (PET)-negative partial remission, stable disease, and progressive disease (Phase II)
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants Evaluated for Toxicity
Time Frame: 2 years
Toxicity as defined by NCI Common Terminology Criteria for Adverse Events v 3.0
2 years

Collaborators and Investigators

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

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)
The Cleveland Clinic
University of Rochester

Investigators

  • Principal Investigator: Steven M. Horwitz, MD, Memorial Sloan Kettering Cancer Center

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.

Helpful Links

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 (ACTUAL)

June 27, 2006

Primary Completion (ACTUAL)

March 1, 2021

Study Completion (ACTUAL)

March 1, 2021

Study Registration Dates

First Submitted

December 27, 2006

First Submitted That Met QC Criteria

December 27, 2006

First Posted (ESTIMATE)

December 28, 2006

Study Record Updates

Last Update Posted (ACTUAL)

May 17, 2022

Last Update Submitted That Met QC Criteria

April 25, 2022

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-065
  • P30CA008748 (U.S. NIH Grant/Contract)
  • MSKCC-06065

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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