Trial · NCT00823797
Bendamustine Hydrochloride in Treating Patients With Recurrent or Progressive Anaplastic Glioma
NCT00823797, Phase 2, Completed, University of Washington; results first posted 2017-05-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Bendamustine Hydrochloride in Treating Patients With Recurrent or Progressive Anaplastic Glioma. Trials, record NCT00823797. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00823797
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bendamustine Hydrochloride in Treating Patients With Recurrent or Progressive Anaplastic Glioma
- NCT number
- NCT00823797
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 45 participants, actual
- Lead sponsor
- University of Washington
- Conditions
- Adult Anaplastic Astrocytoma, Adult Anaplastic Oligodendroglioma, Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Neoplasm
- Interventions
- Bendamustine Hydrochloride, Quality-of-Life Assessment
- First posted
- 2009-01-16
- Last updated
- 2017-07-07
- Results first posted
- 2017-05-19
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | PFS-6 | At 6 months | Defined as the proportion of patients who remain alive and free of any disease progression at 6 months. PFS over time will be estimated using the Kaplan-Meier method with standard errors estimated using Greenwood's formula. |
| Secondary | PFS | Up to progression or death, whichever came first, assessed up to 108 months | Defined as the time from date of initial therapy to first objective documentation of tumor progression or death. |
| Secondary | Toxic Death | Up to 30 days after completion of study treatment | Defined as death that is possibly, probably, or definitely attributed to bendamustine hydrochloride. |
| Secondary | Overall Survival | Until death or last reported survival | \*inclusive of subjects still alive at time of last reporting. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | PFS-6 | At 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | PFS | Up to progression or death, whichever came first, assessed up to 108 months | months | MEDIAN | |
| SECONDARY | Toxic Death | Up to 30 days after completion of study treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Survival | Until death or last reported survival | months | MEDIAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| PFS-6 | Treatment (Bendamustine Hydrochloride) for Glioblastoma | 1 | Participants | ||
| PFS-6 | Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma | 8 | Participants | ||
| PFS | Treatment (Bendamustine Hydrochloride) for Glioblastoma | 1.0 | 95% Confidence Interval -0.5 to 2.6 | months | |
| PFS | Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma | 2.6 | 95% Confidence Interval -1.0 to 6.3 | months | |
| Toxic Death | Treatment (Bendamustine Hydrochloride) for Glioblastoma | 0 | Participants | ||
| Toxic Death | Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma | 0 | Participants | ||
| Overall Survival | Treatment (Bendamustine Hydrochloride) for Glioblastoma | 18.3 | 95% Confidence Interval 8.2 to 28.4 | months | |
| Overall Survival | Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma | 45.6 | 95% Confidence Interval 33.6 to 57.7 | months |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma | 29 | |
| Overall Study | STARTED | Treatment (Bendamustine Hydrochloride) for Glioblastoma | 16 | |
| Overall Study | COMPLETED | Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma | 29 | |
| Overall Study | COMPLETED | Treatment (Bendamustine Hydrochloride) for Glioblastoma | 16 | |
| Overall Study | NOT COMPLETED | Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma | 0 | |
| Overall Study | NOT COMPLETED | Treatment (Bendamustine Hydrochloride) for Glioblastoma | 0 |
Source ClinicalTrials.gov
Adverse events4
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 | Lymphopenia | Blood and lymphatic system disorders | Treatment (Bendamustine Hydrochloride) | 36 | 45 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Treatment (Bendamustine Hydrochloride) | 9 | 45 | |
| serious | Pneumonia | Respiratory, thoracic and mediastinal disorders | Treatment (Bendamustine Hydrochloride) | 2 | 45 | 2 |
| serious | Allergic Reaction | Immune system disorders | Treatment (Bendamustine Hydrochloride) | 1 | 45 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Bendamustine Hydrochloride) | ||
| Total, other adverse events | Treatment (Bendamustine Hydrochloride) | 45 | 45 |
| Total, serious adverse events | Treatment (Bendamustine Hydrochloride) | 3 | 45 |
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 |
|---|---|---|---|---|---|
| P30CA015704 | Cancer Center Support Grant | LYNCH, THOMAS JAMES | FRED HUTCHINSON CANCER CENTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Treatment (Bendamustine Hydrochloride) for Glioblastoma vs Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma: Toxic Death | Trial comparisons |
| Treatment (Bendamustine Hydrochloride) for Glioblastoma vs Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma: PFS-6 | Trial comparisons |
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/NCT00823797
GET https://conductscience.org/api/trials/v1/NCT00823797/registered