NCT00416351 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1, PHASE2
Status at capture: COMPLETED
Registry last update: 2022-05-17

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Maximum Tolerated Dose

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outcome · POSTED

Response Rate for Participants With Non-Hodgkin's Lymphoma

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outcome · POSTED

Participants Evaluated for Toxicity

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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
healthy Volunteers: false
maximum Age: 120 Years
minimum Age: 2 Years
sex: ALL
std Ages: CHILD
ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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.
intervention Names
Drug: clofarabine
label
Clofarabine
type
EXPERIMENTAL

interventions

arm Group Labels
Clofarabine
name
clofarabine
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 29
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

measure
Maximum Tolerated Dose
time Frame
2 years
description
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)
measure
Response Rate for Participants With Non-Hodgkin's Lymphoma
time Frame
2 years

secondary Outcomes

description
Toxicity as defined by NCI Common Terminology Criteria for Adverse Events v 3.0
measure
Participants Evaluated for Toxicity
time Frame
2 years

Full study description

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.
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.

Source references