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

Phase 1/Phase 2
2 Years
Open (Enrolling)
Leukemia, Lymphoma, Small Intestine Cancer

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Trial Information

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



- 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.

Inclusion Criteria


- 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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose (Phase I)

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Steven M. Horwitz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

June 2006

Completion Date:

July 2014

Related Keywords:

  • Leukemia
  • Lymphoma
  • Small Intestine Cancer
  • 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
  • Leukemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Duodenal Neoplasms
  • Ileal Neoplasms
  • Jejunal Neoplasms
  • Intestinal Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642