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This study will evaluate the response rate to treatment with pentostatin in steroid-refractory acute graft versus host disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pentostatin | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the response rate (complete and partial) to treatment with pentostatin in steroid-refractory acute GVHD (graft-versus-host disease). | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Investigate the pharmacokinetics of pentostatin in patients with acute GVHD to correlate the response with area under the curve (AUC). | up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Craig Hofmeister, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23588536 | Result | 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. |
| Label | URL |
|---|---|
| Jamesline | View source |
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| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D015649 | Pentostatin |
| ID | Term |
|---|---|
| D003070 | Coformycin |
| D005573 | Formycins |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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|
|
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |