Trial · NCT00448201
Reduced-Intensity Busulfan and Fludarabine With or Without Antithymocyte Globulin Followed by Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Disease
NCT00448201, Phase 2, Completed, UNC Lineberger Comprehensive Cancer Center; results first posted 2017-05-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Reduced-Intensity Busulfan and Fludarabine With or Without Antithymocyte Globulin Followed by Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Disease. Trials, record NCT00448201. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00448201
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Reduced-Intensity Busulfan and Fludarabine With or Without Antithymocyte Globulin Followed by Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Disease
- NCT number
- NCT00448201
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 71 participants, actual
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Conditions
- Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes
- Interventions
anti-thymocyte globulin, sargramostim, therapeutic allogeneic lymphocytes, busulfan, fludarabine phosphate, methotrexate, tacrolimus, nonmyeloablative allogeneic hematopoietic stem cell transplantation, peripheral blood stem cell transplantation
- First posted
- 2007-03-16
- Last updated
- 2017-05-30
- Results first posted
- 2017-05-30
- Limitations and caveats
Per the protocol, non-serious adverse events were not captured as this was a high-dose transplant study and grades 1,2, and 3 adverse events were expected. No unexpected toxicities were seen beyond those reported in the Serious Adverse Event section.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment-related Mortality | 6 months | Treatment related mortality for first 6 months. Defined as the number of treatment related deaths excluding deaths due to disease relapse. |
| Secondary | Complete Response at 6 and 12 Months Post-transplant | 6 and 12 months | |
| Secondary | Complete or Mixed Donor Chimerism at 30, 60, and 90 Days Post-transplant | Days 30, 60, and 90 | Complete chimerism is defined as 100% donor cells detected, suggesting complete hematopoietic replacement. Mixed donor chimerism means host cells are detected in particular cells like lymphocytes. Five to 90% donor cells set the criteria for mixed chimerism (MC). Chimerism was not tabulated on day 30. |
| Secondary | 5-year Disease-free Survival | Year 5 | The length of time post-transplant that the patient survives without any signs or symptoms of that cancer. |
| Secondary | Graft-vs-host Disease at 6 Months Post-transplant | 6 Months | Graft-vs-host disease (GVHD) can be mild, moderate or severe depending on the differences in tissue type between patient and donor. Its symptoms can include: * Rashes, which include burning and redness, that erupt on the palms or soles and may spread to the trunk and eventually to the entire body * Blistering, causing the exposed skin surface to flake off in severe cases * Nausea, vomiting, abdominal cramps, diarrhea and loss of appetite, which can indicate that the gastrointestinal (digestive) tract is affected * Jaundice, or a yellowing of the skin, which can indicate liver damage * Excessive dryness of the mouth and throat, leading to ulcers * Dryness of the lungs, vagina and other surfaces Acute GVHD - Can occur soon after the transplanted cells begin to appear in the recipient. Acute GVHD ranges from mild, moderate or severe, and can be life-threatening if its effects are not controlled. Extensive chronic GVHD - Usually occurs at about three months post-transplant. |
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 | Treatment-related Mortality | 6 months | percentage of participants | NUMBER | |
| SECONDARY | Complete Response at 6 and 12 Months Post-transplant | 6 and 12 months | Complete response was not calculated at 6 and 12 months because the majority of patients had complete response at the time of transplant. | ||
| SECONDARY | Complete or Mixed Donor Chimerism at 30, 60, and 90 Days Post-transplant | Days 30, 60, and 90 | percentage of patients | NUMBER | |
| SECONDARY | 5-year Disease-free Survival | Year 5 | percentage of participants | NUMBER | |
| SECONDARY | Graft-vs-host Disease at 6 Months Post-transplant | 6 Months | percentage of participants | NUMBER |
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 |
|---|---|---|---|---|---|
| Treatment-related Mortality | All Trial Participants | 8.4 | percentage of participants | ||
| Complete or Mixed Donor Chimerism at 30, 60, and 90 Days Post-transplant | Day 60 | Complete Donor | 82 | percentage of patients | |
| Complete or Mixed Donor Chimerism at 30, 60, and 90 Days Post-transplant | Day 90 | Complete Donor | 87 | percentage of patients | |
| Complete or Mixed Donor Chimerism at 30, 60, and 90 Days Post-transplant | Day 60 | Mixed Donor | 18 | percentage of patients | |
| Complete or Mixed Donor Chimerism at 30, 60, and 90 Days Post-transplant | Day 90 | Mixed Donor | 13 | percentage of patients | |
| 5-year Disease-free Survival | All Trial Participants | 31 | percentage of participants | ||
| Graft-vs-host Disease at 6 Months Post-transplant | All Trial Participants | Acute GVHD | 13 | percentage of participants | |
| Graft-vs-host Disease at 6 Months Post-transplant | All Trial Participants | Extensive Chronic GVHD | 30 | percentage of participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | All Trial Participants | 71 | |
| Overall Study | COMPLETED | All Trial Participants | 71 | |
| Overall Study | NOT COMPLETED | All Trial Participants | 0 |
Source ClinicalTrials.gov
Adverse events16
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 |
|---|---|---|---|---|---|---|
| serious | hypoxemia | Blood and lymphatic system disorders | All Trial Participants | 1 | 71 | |
| serious | graft failure | Blood and lymphatic system disorders | All Trial Participants | 1 | 71 | |
| serious | liver toxicity/hyperbilirubinemia | Hepatobiliary disorders | All Trial Participants | 1 | 71 | |
| serious | Graft vs host disease grade 4 | Gastrointestinal disorders | All Trial Participants | 3 | 71 | |
| serious | CMV viremia | Infections and infestations | All Trial Participants | 1 | 71 | |
| serious | subdural hematoma | Vascular disorders | All Trial Participants | 1 | 71 | |
| serious | Fever | Infections and infestations | All Trial Participants | 2 | 71 | |
| serious | Failure to thrive | General disorders | All Trial Participants | 1 | 71 | |
| serious | elevated lipase | Gastrointestinal disorders | All Trial Participants | 1 | 71 | |
| serious | CMV pneumonia | Infections and infestations | All Trial Participants | 1 | 71 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Trial Participants | 44 | 71 |
| Total, other adverse events | All Trial Participants | 0 | 0 |
| Total, serious adverse events | All Trial Participants | 7 | 71 |
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 |
|---|---|---|---|---|---|
| P30CA016086 | Cancer Center Support Grant | FERRIS, ROBERT L. | UNIV OF NORTH CAROLINA CHAPEL HILL | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
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/NCT00448201
GET https://conductscience.org/api/trials/v1/NCT00448201/registered