Clofarabine in Treating Patients With T-Cell or Natural Killer-Cell Non-Hodgkin's Lymphoma That H… (NCT00416351) | Clinical Trial Compass
CompletedPhase 1/2
Clofarabine in Treating Patients With T-Cell or Natural Killer-Cell Non-Hodgkin's Lymphoma That Has Relapsed or Not Responded to Previous Treatment
United States29 participantsStarted 2006-06-27
Plain-language 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.
Who can participate
Age range2 Years – 120 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Maximum Tolerated Dose
Timeframe: 2 years
2
Response Rate for Participants With Non-Hodgkin's Lymphoma