Trial · NCT00074035
Pentostatin in Treating Patients With Refractory Chronic Graft-Versus-Host Disease
NCT00074035, Phase 2, Completed, Alliance for Clinical Trials in Oncology; results first posted 2017-03-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pentostatin in Treating Patients With Refractory Chronic Graft-Versus-Host Disease. Trials, record NCT00074035. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00074035
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pentostatin in Treating Patients With Refractory Chronic Graft-Versus-Host Disease
- NCT number
- NCT00074035
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 39 participants, actual
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Conditions
- Graft Versus Host Disease
- Interventions
- pentostatin
- First posted
- 2003-12-11
- Last updated
- 2021-11-03
- Results first posted
- 2017-03-15
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate | 3 months | Percentage of participants who had a complete or partial response defined by the Hopkins scoring system. A complete response is defined as the disappearance of signs and symptoms of chronic GVHD in all involved systems that is sustained for at lest 4 weeks. A partial response is an improvement by 2 or more points in at least one system score, which is sustained for at least 4 weeks, with no signs of worsening in others. |
| Secondary | Grade 3 or Higher Non-hematologic Adverse Events | Duration of treatment (up to 5 years) | Number of participants experiencing a grade 3, 4 or 5 clinically significant non-hematologic adverse events, at least possibly related to treatment. |
| Secondary | Overall Survival At 1 Year | 1 year | Percentage of patients who were alive at 1 year. |
| Secondary | Overall Survival At 2 Years | 2 year | Percentage of patients who were alive at 2 years. |
| Other | Pharmacokinetics Association Between Exposure and Response At 3 Months | 3 months | The individual PK parameters will be derived by using a noncompartmental analysis of the plasma-concentration-time data |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response Rate | 3 months | 3 patients died before the 3 month evaluation and were not evaluated for the primary endpoint | percentage of participants | NUMBER |
| SECONDARY | Grade 3 or Higher Non-hematologic Adverse Events | Duration of treatment (up to 5 years) | count of participants | NUMBER | |
| SECONDARY | Overall Survival At 1 Year | 1 year | percentage of participants | NUMBER | |
| SECONDARY | Overall Survival At 2 Years | 2 year | percentage of participants | NUMBER | |
| OTHER_PRE_SPECIFIED | Pharmacokinetics Association Between Exposure and Response At 3 Months | 3 months |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Rate | Pentostatin | 20 | percentage of participants | ||
| Grade 3 or Higher Non-hematologic Adverse Events | Pentostatin | Fatigue | 3 | count of participants | |
| Grade 3 or Higher Non-hematologic Adverse Events | Pentostatin | Renal failure | 4 | count of participants | |
| Grade 3 or Higher Non-hematologic Adverse Events | Pentostatin | Anorexia | 2 | count of participants | |
| Grade 3 or Higher Non-hematologic Adverse Events | Pentostatin | Infection | 10 | count of participants | |
| Grade 3 or Higher Non-hematologic Adverse Events | Pentostatin | CNS hemmorrhage | 1 | count of participants | |
| Grade 3 or Higher Non-hematologic Adverse Events | Pentostatin | Rash | 1 | count of participants | |
| Grade 3 or Higher Non-hematologic Adverse Events | Pentostatin | Personality/behavioral | 1 | count of participants | |
| Grade 3 or Higher Non-hematologic Adverse Events | Pentostatin | Pneumonitis | 1 | count of participants | |
| Overall Survival At 1 Year | Pentostatin | 53 | percentage of participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pentostatin | 38 | |
| Overall Study | COMPLETED | Pentostatin | 38 | |
| Overall Study | NOT COMPLETED | Pentostatin | 0 |
Source ClinicalTrials.gov
Adverse events233
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Pentostatin | 15 | 34 | 67 |
| other | Arrhythmia supraventricular | Cardiac disorders | Pentostatin | 1 | 34 | 2 |
| other | Atrial fibrillation | Cardiac disorders | Pentostatin | 1 | 34 | 2 |
| other | Cardiac disorder | Cardiac disorders | Pentostatin | 3 | 34 | 6 |
| other | Edema | Cardiac disorders | Pentostatin | 3 | 34 | 13 |
| other | Myocardial ischemia | Cardiac disorders | Pentostatin | 1 | 34 | 1 |
| other | Sinus tachycardia | Cardiac disorders | Pentostatin | 4 | 34 | 15 |
| other | Cushingoid | Endocrine disorders | Pentostatin | 1 | 34 | 8 |
| other | Cataract | Eye disorders | Pentostatin | 1 | 34 | 1 |
| other | Dry eye syndrome | Eye disorders | Pentostatin | 5 | 34 | 19 |
1 to 10 of 233Source ClinicalTrials.gov
See all 233 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pentostatin | ||
| Total, other adverse events | Pentostatin | 30 | 34 |
| Total, serious adverse events | Pentostatin | 14 | 34 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA031946 | Cancer and Leukemia Group B | BERTAGNOLLI, MONICA M | BRIGHAM AND WOMEN'S HOSPITAL | NATIONAL CANCER INSTITUTE | 1985 to 2013 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00074035
GET https://conductscience.org/api/trials/v1/NCT00074035/events?page=2