Acute Graft Versus Host DiseasePhase 1/2NCT00032773
Dose-finding Study Using Pentostatin for Injection in the Treatment of Steroid-refractory aGvHD
A Phase 1/2 study testing pentostatin for injection in people with Acute Graft Versus Host Disease, run by Astex Pharmaceuticals, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Acute Graft Versus Host Disease
- What is being tested?
- pentostatin for injection
- Type of treatment
- Injection or infusion
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2002to 3 Nov 2005
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Sequentially Adaptive, Open Label, Dose-finding, Phase I/II Trial of Pentostatin in the Treatment of Steroid-refractory Acute Graft Versus Host Disease (aGvHD)
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.
- Conditions
- Acute Graft Versus Host Disease
- Being tested
- pentostatin for injection
- Keywords
- acute graft versus host disease, aGVHD, allogeneic hematopoietic stem cell transplantation, peripheral blood stem cell transplantation, cord blood transplant, pentostatin, Nipent, deoxycoformycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pentostatin for injectionDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2002 (estimated)
- Study start30 Jan 2002
- Primary completion3 Nov 2005
- Study completion3 Nov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Graft Versus Host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants
Sponsor and investigators
- Lead sponsor
- Astex Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00032773
- Sponsor's protocol ID
- SGI-NIP-010
- Other IDs
- NIP-010
- Status last verified
- Aug 2024
- First submitted
- 2 Apr 2002
- Last updated
- 2 Aug 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sequentially Adaptive, Open Label, Dose-finding, Phase I/II Trial of Pentostatin in the Treatment of Steroid-refractory Acute Graft Versus Host Disease (aGvHD)
- ClinicalTrials.gov ID
- NCT00032773
- Acronym / sponsor ID
- SGI-NIP-010
- Conditions
- Acute Graft Versus Host Disease
- Keywords
- acute graft versus host disease, aGVHD, allogeneic hematopoietic stem cell transplantation, peripheral blood stem cell transplantation, cord blood transplant, pentostatin, Nipent, deoxycoformycin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 36 participants
- Lead sponsor
- Astex Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jan 2002 (actual)
- Primary completion
- 3 Nov 2005 (actual)
- Study completion
- 3 Nov 2005 (actual)
- First posted
- 4 Apr 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pentostatin for injection | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing pentostatin for injection in people with Acute Graft Versus Host Disease, run by Astex Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.