TerminatedPhase 1/2

Dose-finding Study Using Pentostatin for Injection in the Treatment of Steroid-refractory aGvHD

United States36 participantsStarted 2002-01-30

Plain-language summary

To determine a safe and effective dose of pentostatin in steroid-refractory aGvHD and to identify the minimal effective dose of pentostatin defined as the lowest dose that produces a response in 20% or more of patients while producing treatment failure (defines as death, grade 3/4 toxicity, or progressive disease) in 40% or less of patients.

Who can participate

Age range

6 Months

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: * Patients 6 months of age with grade 2 GVHD that is steroid-refractory * Must be engrafted with ANC 1000/mL, may still be transfusion dependent for platelets and PRBC * Time post stem cell infusion \< 100 days * Written informed consent * Must have adequate renal function (creatinine clearance 40 mL/min/1.73 m2) Exclusion: * Post-transplant lymphoproliferative disease * Uncontrolled infection * Mental illness or other condition preventing full cooperation with the treatment and monitoring requirements of the study * ATG within the previous 14 days * Other immunosuppressive agents (including monoclonal antibodies) when initiated within the previous 7 days

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.

Trial details

NCT IDNCT00032773

SponsorAstex Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2005-11-03

View on ClinicalTrials.gov More Acute Graft Versus Host Disease trials