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 range
2 Years – 120 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum Tolerated Dose
Timeframe: 2 years
2
Response Rate for Participants With Non-Hodgkin's Lymphoma