Clinical trial · Interventional
Clofarabine in Treating Patients With T-Cell or Natural Killer-Cell Non-Hodgkin's Lymphoma That Has Relapsed or Not Responded to Previous Treatment
A Phase I/II Study of Clofarabine in Patients With Relapsed T-Cell and NK-Cell Lymphomas
NCT00416351CI-TRIAL-00058530completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Small Intestine Cancer | Small Intestinal Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| clofarabine | Drug | Clofarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Clofarabine
- 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.
- interventionNames
- Drug: clofarabine
Primary outcomes (2)
- measure
- Maximum Tolerated Dose
- timeFrame
- 2 years
- measure
- Response Rate for Participants With Non-Hodgkin's Lymphoma
- timeFrame
- 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)
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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 therapyReferences
Publications (0)
Data not yet available
No reference posted for this study.