Graft-Versus-Host DiseasePhase 2NCT00201786
Phase II Trial of Pentostatin in Steroid Refractory Acute Graft Versus Host Disease
A Phase 2 study testing Pentostatin in people with Graft-Versus-Host Disease, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This study will evaluate the response rate to treatment with pentostatin in steroid-refractory acute graft versus host disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graft-Versus-Host Disease
- What is being tested?
- Pentostatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Jul 2013
- Phase
- Phase 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have biopsy proven grade II-IV acute GVHD refractory to systemic corticosteroids
- No chronic GVHD
- Age ≥ 18 years
- Evidence of myeloid engraftment (ANC ≥ 0.5 x 109/l)
- Performance status 0-3
Who cannot join
- Patients on mechanical ventilation or who have resting O2 saturation <90% by pulse-oximetry.
- Patients on renal dialysis or who have an estimated creatinine clearance of < 30 ml/min/1.73 m2.
- Patients with documented clinical infection (progressive symptoms despite antibiotics or continued fever) cannot be enrolled on study until infection is controlled.
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the response rate to treatment with pentostatin in steroid-refractory acute graft versus host disease.
- Conditions
- Graft-Versus-Host Disease
- Being tested
- Pentostatin
- Keywords
- Corticosteroids
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PentostatinDrug
Also called (Nipent®, Supergen)
Pentostatin is given at a dose of 1.5 mg/m2/day IV x 3 consecutive days. Each IV infusion of pentostatin will be administered over 20-30 minutes in 100-250 ml of D5W or NS. To prevent nephrotoxicity, patients will also receive 500 ml normal saline as pre- and post drug hydration (total 1000 ml).
| Study group | Role | What they receive |
|---|---|---|
| Pentostatin | Experimental | Pentostatin is given at a dose of 1.5 mg/m2/day IV x 3 consecutive days. Each IV infusion of pentostatin will be administered over 20-30 minutes in 100-250 ml of D5W or NS. Receives: Drug: Pentostatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the response rate (complete and partial) to treatment with pentostatin in steroid-refractory acute GVHD (graft-versus-host disease).
Measured: up to 2 years
Secondary outcomes (1)
Investigate the pharmacokinetics of pentostatin in patients with acute GVHD to correlate the response with area under the curve (AUC).
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJul 2003
- Primary completionOct 2007
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Graft-Versus-Host DiseaseStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Craig Hofmeister, Ohio State University Comprehensive Cancer Center
- Investigators
- Craig Hofmeister, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00201786
- Sponsor's protocol ID
- OSU-0301
- Status last verified
- Apr 2016
- First submitted
- 12 Sep 2005
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Poi MJ, Hofmeister CC, Johnston JS, Edwards RB, Jansak BS, Lucas DM, Farag SS, Dalton JT, Devine SM, Grever MR, Phelps MA. Standard pentostatin dose reductions in renal insufficiency are not adequate: selected patients with steroid-refractory acute graft-versus-host disease. Clin Pharmacokinet. 2013 Aug;52(8):705-12. doi: 10.1007/s40262-013-0064-7.
PubMed 23588536
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Pentostatin in Steroid Refractory Acute Graft Versus Host Disease
- ClinicalTrials.gov ID
- NCT00201786
- Acronym / sponsor ID
- OSU-0301
- Conditions
- Graft-Versus-Host Disease
- Keywords
- Corticosteroids
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Jul 2003
- Primary completion
- Oct 2007 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 20 Sep 2005 (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.
This study will evaluate the response rate to treatment with pentostatin in steroid-refractory acute graft versus host disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pentostatin | Experimental | Drug: PentostatinPentostatin is given at a dose of 1.5 mg/m2/day IV x 3 consecutive days. Each IV infusion of pentostatin will be administered over 20-30 minutes in 100-250 ml of D5W or NS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must have biopsy proven grade II-IV acute GVHD refractory to systemic corticosteroids
- No chronic GVHD
- Age ≥ 18 years
- Evidence of myeloid engraftment (ANC ≥ 0.5 x 109/l)
- Performance status 0-3
Key exclusion criteria (3 listed)
- Patients on mechanical ventilation or who have resting O2 saturation <90% by pulse-oximetry.
- Patients on renal dialysis or who have an estimated creatinine clearance of < 30 ml/min/1.73 m2.
- Patients with documented clinical infection (progressive symptoms despite antibiotics or continued fever) cannot be enrolled on study until infection is controlled.
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 |
|---|---|---|
| PentostatinAlso: (Nipent®, Supergen)Pentostatin is given at a dose of 1.5 mg/m2/day IV x 3 consecutive days. Each IV infusion of pentostatin will be administered over 20-30 minutes in 100-250 ml of D5W or NS. To prevent nephrotoxicity, patients will also receive 500 ml normal saline as pre- and post drug hydration (total 1000 ml). | Drug | Pentostatin |
Primary outcome
Evaluate the response rate (complete and partial) to treatment with pentostatin in steroid-refractory acute GVHD (graft-versus-host disease).
Time frame: up to 2 years
1 secondary outcome
Investigate the pharmacokinetics of pentostatin in patients with acute GVHD to correlate the response with area under the curve (AUC).
Time frame: up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2016.
- Results publication: PubMed 23588536Poi MJ, Hofmeister CC, Johnston JS, Edwards RB, Jansak BS, Lucas DM, Farag SS, Dalton JT, Devine SM, Grever MR, Phelps MA. Standard pentostatin dose reductions in renal insufficiency are not adequate: selected patients with steroid-refractory acute graft-versus-host disease. Clin Pharmacokinet. 2013 Aug;52(8):705-12. doi: 10.1007/s40262-013-0064-7.
- JameslineLink provided by the sponsor.
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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.
Craig Hofmeister, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pentostatin in people with Graft-Versus-Host Disease, run by Ohio State University Comprehensive Cancer Center 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 3 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: finished, as of the sponsor's last update on 27 Apr 2016. 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 phase mean?
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Evaluate the response rate (complete and partial) to treatment with pentostatin in steroid-refractory acute GVHD (graft-versus-host disease). (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00201786, which also lists 1 linked publication.
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 27 Apr 2016.