Trial · NCT00003816
Combination Chemotherapy and Donor Stem Cell Transplant in Treating Patients With Aplastic Anemia or Hematologic Cancer
NCT00003816, Phase 2, Phase 3, Completed, Roswell Park Cancer Institute; results first posted 2021-08-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Combination Chemotherapy and Donor Stem Cell Transplant in Treating Patients With Aplastic Anemia or Hematologic Cancer. Trials, record NCT00003816. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00003816
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Chemotherapy and Donor Stem Cell Transplant in Treating Patients With Aplastic Anemia or Hematologic Cancer
- NCT number
- NCT00003816
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 361 participants, actual
- Lead sponsor
- Roswell Park Cancer Institute
- Conditions
Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases, Nonmalignant Neoplasm, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific
- Interventions
- anti-thymocyte globulin, busulfan, carboplatin, cyclophosphamide, etoposide, fludarabine phosphate, melphalan, thiotepa, total-body irradiation
- First posted
- 2003-01-27
- Last updated
- 2021-08-13
- Results first posted
- 2021-08-13
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | CR Rate | day 100 | Rate of Complete Remission by Day +100 |
| Secondary | Toxicity/TRM at Day 100 | Day +100 | Death due to treatment related causes before day +100 after BMT |
| Secondary | 4 Year PFS | 4 years | progression free survival estimate at 4 years post BMT (events are disease progression/relapse and death due to any cause) |
| Secondary | 4 yr OS | 4-year | Overall survival estimate at 4 years post BMT |
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 | CR Rate | day 100 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Toxicity/TRM at Day 100 | Day +100 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 4 Year PFS | 4 years | percentage of participants | NUMBER | |
| SECONDARY | 4 yr OS | 4-year | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| CR Rate | BuCy | 42 | Participants | ||
| CR Rate | CyTBI | 55 | Participants | ||
| CR Rate | FluMel | 134 | Participants | ||
| CR Rate | VpCyTBI | 18 | Participants | ||
| CR Rate | Other | 7 | Participants | ||
| Toxicity/TRM at Day 100 | BuCy | 3 | Participants | ||
| Toxicity/TRM at Day 100 | CyTBI | 4 | Participants | ||
| Toxicity/TRM at Day 100 | FluMel | 31 | Participants | ||
| Toxicity/TRM at Day 100 | VpCyTBI | 4 | Participants | ||
| Toxicity/TRM at Day 100 | Other | 4 | Participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BuCy | 55 | |
| Overall Study | STARTED | CyTBI | 69 | |
| Overall Study | STARTED | FluMel | 199 | |
| Overall Study | STARTED | VpCyTBI | 23 | |
| Overall Study | STARTED | Other | 15 | |
| Overall Study | COMPLETED | BuCy | 55 | |
| Overall Study | COMPLETED | CyTBI | 69 | |
| Overall Study | COMPLETED | FluMel | 199 | |
| Overall Study | COMPLETED | VpCyTBI | 23 | |
| Overall Study | COMPLETED | Other | 15 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events10
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 | acute graft-versus-host disease | Blood and lymphatic system disorders | BuCy | 25 | 55 | 25 |
| other | acute graft-versus-host disease | Blood and lymphatic system disorders | CyTBI | 35 | 69 | 35 |
| other | acute graft-versus-host disease | Blood and lymphatic system disorders | FluMel | 100 | 199 | 100 |
| other | acute graft-versus-host disease | Blood and lymphatic system disorders | VpCyTBI | 6 | 23 | 6 |
| other | acute graft-versus-host disease | Blood and lymphatic system disorders | Other | 9 | 15 | 9 |
| serious | 1 yr TRM | Investigations | BuCy | 11 | 55 | 11 |
| serious | 1 yr TRM | Investigations | CyTBI | 10 | 69 | 10 |
| serious | 1 yr TRM | Investigations | FluMel | 62 | 199 | 62 |
| serious | 1 yr TRM | Investigations | VpCyTBI | 6 | 23 | 6 |
| serious | 1 yr TRM | Investigations | Other | 4 | 15 | 4 |
Source ClinicalTrials.gov
Adverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BuCy | 30 | 55 |
| Total, all-cause mortality | CyTBI | 36 | 69 |
| Total, all-cause mortality | FluMel | 150 | 199 |
| Total, all-cause mortality | VpCyTBI | 19 | 23 |
| Total, all-cause mortality | Other | 9 | 15 |
| Total, other adverse events | BuCy | 25 | 55 |
| Total, other adverse events | CyTBI | 35 | 69 |
| Total, other adverse events | FluMel | 100 | 199 |
| Total, other adverse events | VpCyTBI | 6 | 23 |
| Total, other adverse events | Other | 9 | 15 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
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/NCT00003816
GET https://conductscience.org/api/trials/v1/NCT00003816/registered