Mode
Text Size
Log in / Sign up
Phase 2 N=29 Treatment

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

Leukemia · Lymphoma · Small Intestine Cancer

Enrolled (actual)
29
Serious AEs
65.5%
Results posted
May 2022
Primary outcome: Primary: Maximum Tolerated Dose — 20 mg/m2 of clofarabine

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
clofarabine (Drug)
Age
Pediatric, Adult, Older Adult · 2+ yrs
Sex
All
Sponsor
Memorial Sloan Kettering Cancer Center
Primary completion
Mar 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Maximum Tolerated Dose
20
PRIMARY
Response Rate for Participants With Non-Hodgkin's Lymphoma
0; 1; 1; 1; 0; 0
SECONDARY
Participants Evaluated for Toxicity
1; 3; 4; 17; 4

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00416351). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search