CompletedPhase 2

506U78 in Treating Patients With Lymphoma

United States74 participantsStarted 2000-05

Plain-language summary

Phase II trial to study the effectiveness of 506U78 in treating patients who have lymphoma that has not been treated previously or that has not responded to previous treatment. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die

Who can participate

Age range

69 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.

Inclusion Criteria: * Histologically documented cutaneous T-cell lymphoma (CTCL) or noncutaneous peripheral T-cell lymphoma (PTCL) (needle aspirate or core biopsy of tissue or marrow as the sole means of diagnosis is not acceptable), confirmed by immunophenotyping, including: * Mycosis fungoides/Sezary syndrome * Peripheral T-Cell lymphomas (medium, mixed medium-large, large cell) * Variants of peripheral T-Cell lymphoma * Angioimmunoblastic T-Cell lymphoma (AILD); angiocentric lymphoma; intestinal T-Cell Lymphoma; adult T-Cell lymphoma/leukemia (ATLL); anaplastic Large Cell (CD30+) lymphoma, T-cell type Failure to submit pathology slides within 60 days of patient registration will result in patient being declared ineligible; Note: patients diagnosed more than one year prior to entry on this protocol must have a repeat lymph node biopsy. In the event of rapid tumor growth, rising LDH, or the onset of B symptoms in a period of time less than one year a rebiopsy is also required * Biopsy and immunophenotyping should be performed to document relapse after prior treatment * CTCL patients may have received one prior course of single-agent systemic chemotherapy for CTCL, but may not have received a multi-agent chemotherapy regimen; patients may have received prior local, topical, radiation- or electron beam-based, or chemotherapy-based treatment; examples of the latter would include, but not be limited to, cytokines such as interferon, retinoids, monoclonal antibodies, an…

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.

1This trial tested a drug called 506U78 specifically in T-cell lymphomas like mycosis fungoides and anaplastic large cell lymphoma — since it's a completed Phase 2 study, can you tell me what the remission rates actually looked like, and whether those results are relevant to my specific type and stage?
2Because this was a Phase 2 trial focused on measuring both remission and toxicity using formal NCI criteria, what kinds of side effects showed up in the data, and how do they compare to what I might expect from standard treatment options available to me today?
3Since this trial has already been completed, is the drug 506U78 — also known as nelarabine — now available as an approved or standard treatment for my diagnosis, or would I need to look for a different active trial to access it?
4My condition is listed among several subtypes in this trial, ranging from early Stage I to Stage IV — does the data from this study apply equally across all those stages, or were the results stronger for certain patients that might be more like my situation?
5Given that this trial is completed and not enrolling, what current treatment path would you recommend for me, and is there a more recent study building on this 506U78 research that might be worth considering alongside standard care?

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

Remission rate (complete and partial remission)

Timeframe: Up to 2 years

Remission duration

Timeframe: From the time of first reported complete or partial response (later confirmed) until time of documented relapse, assessed up to 2 years

Toxicity as assessed by the NCI Common Toxicity Criteria (CTC) version 2.0

Timeframe: Up to 2 years

Trial details

NCT IDNCT00005080

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2006-01

View on ClinicalTrials.gov More Anaplastic Large Cell Lymphoma trials

Who can participate

Age range

69 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.

What they're measuring

Remission rate (complete and partial remission)

Timeframe: Up to 2 years

Remission duration

Timeframe: From the time of first reported complete or partial response (later confirmed) until time of documented relapse, assessed up to 2 years

Toxicity as assessed by the NCI Common Toxicity Criteria (CTC) version 2.0

Timeframe: Up to 2 years