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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 CenterNew York, New York  10021
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642