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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00416351
Recruitment Status : Active, not recruiting
First Posted : December 28, 2006
Last Update Posted : August 4, 2017
National Cancer Institute (NCI)
University of Rochester
The Cleveland Clinic
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Leukemia Lymphoma Small Intestine Cancer Drug: clofarabine Phase 1 Phase 2

Detailed Description:



  • 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  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Clofarabine in Patients With Relapsed T-Cell and NK-Cell Lymphomas
Study Start Date : June 2006
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

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

Primary Outcome Measures :
  1. Maximum tolerated dose (Phase I) [ Time Frame: 2 years ]
  2. 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) [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Toxicity as defined by NCI Common Terminology Criteria for Adverse Events v 3.0 [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00416351

United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
University of Rochester
The Cleveland Clinic
Principal Investigator: Steven M. Horwitz, MD Memorial Sloan Kettering Cancer Center

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center Identifier: NCT00416351     History of Changes
Other Study ID Numbers: 06-065
P30CA008748 ( U.S. NIH Grant/Contract )
First Posted: December 28, 2006    Key Record Dates
Last Update Posted: August 4, 2017
Last Verified: August 2017

Keywords provided by Memorial Sloan Kettering Cancer Center:
anaplastic large cell lymphoma
angioimmunoblastic T-cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent adult T-cell leukemia/lymphoma
recurrent mycosis fungoides/Sezary syndrome
adult nasal type extranodal NK/T-cell lymphoma
prolymphocytic leukemia
childhood nasal type extranodal NK/T-cell lymphoma
recurrent childhood lymphoblastic lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
small intestine lymphoma

Additional relevant MeSH terms:
Intestinal Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents