Trial · NCT00301834
Alemtuzumab, Fludarabine, and Busulfan Followed By Donor Stem Cell Transplant in Treating Young Patients With Hematologic Disorders
NCT00301834, Phase 2, Completed, University of California, San Francisco; results first posted 2013-05-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Alemtuzumab, Fludarabine, and Busulfan Followed By Donor Stem Cell Transplant in Treating Young Patients With Hematologic Disorders. Trials, record NCT00301834. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00301834
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Alemtuzumab, Fludarabine, and Busulfan Followed By Donor Stem Cell Transplant in Treating Young Patients With Hematologic Disorders
- NCT number
- NCT00301834
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 35 participants, actual
- Lead sponsor
- University of California, San Francisco
- Conditions
- Congenital Amegakaryocytic Thrombocytopenia, Diamond-blackfan Anemia, Leukemia, Myelodysplastic Syndromes, Severe Congenital Neutropenia
- Interventions
alemtuzumab, busulfan, cyclosporine, fludarabine phosphate, methotrexate, methylprednisolone, allogeneic bone marrow transplantation, allogeneic hematopoietic stem cell transplantation, peripheral blood stem cell transplantation, umbilical cord blood transplantation
- First posted
- 2006-03-13
- Last updated
- 2017-09-28
- Results first posted
- 2013-05-16
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Achieving Durable Engraftment (Presence of Donor Cells) at 6 Weeks Post Transplantation | 6 weeks post-transplant | Peripheral blood chimerism studies were performed by quantitative real time polymerase chain reaction (qPCR) evaluation of differential short tandem repeat DNA sequences |
| Secondary | Treatment-related Mortality at 100 Days and 1 Year Post Transplantation | 100 days and 1 year | |
| Secondary | Toxicity Grade ≥ 3 From Start of Conditioning Through the First Year Post Transplantation | 1 year post-transplantation | |
| Secondary | Cytomegalovirus (CMV) Viral Infection and Disease Symptoms | Up to one year post-transplant | polymerase chain reaction testing for presence of CMV weekly until at least day +100 then every 2 weeks until T-cell reconstitution as defined by cluster of differentiation 4 (CD4) \> 200 cells/mm3. Median time to T-cell reconstitution was 6 months. |
| Secondary | Disease-free Survival With Correction of Disease at One Year Post Transplantation | 1 year post-transplantation | Patients deemed "alive and well" at follow-up timepoint later than 1-year post-transplantation |
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 | Number of Participants Achieving Durable Engraftment (Presence of Donor Cells) at 6 Weeks Post Transplantation | 6 weeks post-transplant | Participants evaluable for engraftment 6 weeks post-transplant; 1 patient died of transplant-related hemorrhage prior to 6 weeks and was not evaluated for this outcome | participants | NUMBER |
| SECONDARY | Treatment-related Mortality at 100 Days and 1 Year Post Transplantation | 100 days and 1 year | participants | NUMBER | |
| SECONDARY | Toxicity Grade ≥ 3 From Start of Conditioning Through the First Year Post Transplantation | 1 year post-transplantation | participants | NUMBER | |
| SECONDARY | Cytomegalovirus (CMV) Viral Infection and Disease Symptoms | Up to one year post-transplant | 4 participants were incapable of producing Ab or CMV testing result was indeterminate | participants | NUMBER |
| SECONDARY | Disease-free Survival With Correction of Disease at One Year Post Transplantation | 1 year post-transplantation | participants | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Achieving Durable Engraftment (Presence of Donor Cells) at 6 Weeks Post Transplantation | Single Arm - Transplant Pre-conditioning Per Study Protocol | 31 | participants | ||
| Treatment-related Mortality at 100 Days and 1 Year Post Transplantation | Single Arm - Transplant Pre-conditioning Per Study Protocol | Transplantation-related mortality 0-100 days | 2 | participants | |
| Treatment-related Mortality at 100 Days and 1 Year Post Transplantation | Single Arm - Transplant Pre-conditioning Per Study Protocol | Transplantation-related mortality 100-365 days | 1 | participants | |
| Toxicity Grade ≥ 3 From Start of Conditioning Through the First Year Post Transplantation | Single Arm | Grade 3-4 acute Graft-Versus-Host Disease | 2 | participants | |
| Toxicity Grade ≥ 3 From Start of Conditioning Through the First Year Post Transplantation | Single Arm | Grade 3-4 mucositis | 16 | participants | |
| Cytomegalovirus (CMV) Viral Infection and Disease Symptoms | CMV Seronegative Participants | Positive CMV Viral Load Assay | 1 | participants | |
| Cytomegalovirus (CMV) Viral Infection and Disease Symptoms | CMV Seropositive Participants | Positive CMV Viral Load Assay | 12 | participants | |
| Cytomegalovirus (CMV) Viral Infection and Disease Symptoms | CMV Seronegative Participants | Symptomatic CMV disease | 0 | participants | |
| Cytomegalovirus (CMV) Viral Infection and Disease Symptoms | CMV Seropositive Participants | Symptomatic CMV disease | 0 | participants | |
| Disease-free Survival With Correction of Disease at One Year Post Transplantation | Single Arm - Transplant Pre-conditioning Per Study Protocol | 22 | 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 | Single Arm - Transplant Pre-conditioning Per Study Protocol | 35 | |
| Overall Study | COMPLETED | Single Arm - Transplant Pre-conditioning Per Study Protocol | 34 | |
| Overall Study | NOT COMPLETED | Single Arm - Transplant Pre-conditioning Per Study Protocol | 1 |
Source ClinicalTrials.gov
Adverse events14
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 | Mucositis (All grades) | Gastrointestinal disorders | Single Arm - Transplant Pre-conditioning Per Study Protocol | 33 | 35 | 33 |
| other | aGVHD | General disorders | Single Arm - Transplant Pre-conditioning Per Study Protocol | 5 | 35 | 5 |
| other | cGVHD (Chronic graft-versus-host disease) | General disorders | Single Arm - Transplant Pre-conditioning Per Study Protocol | 2 | 35 | 2 |
| other | Infusion reaction to alemtuzumab | General disorders | Single Arm - Transplant Pre-conditioning Per Study Protocol | 19 | 35 | 19 |
| serious | aGVHD (acute Graft-Versus-Host Disease) | General disorders | Single Arm - Transplant Pre-conditioning Per Study Protocol | 1 | 35 | 1 |
| serious | Respiratory distress associated with Cytomegalovirus infection | Respiratory, thoracic and mediastinal disorders | Single Arm - Transplant Pre-conditioning Per Study Protocol | 1 | 35 | 1 |
| serious | Pancytopenia and splenomegaly | Blood and lymphatic system disorders | Single Arm - Transplant Pre-conditioning Per Study Protocol | 1 | 35 | 1 |
| serious | Repiratory failure following ideopathic pneumonia syndrome | Respiratory, thoracic and mediastinal disorders | Single Arm - Transplant Pre-conditioning Per Study Protocol | 1 | 35 | 1 |
| serious | Thrombocytopenia | Blood and lymphatic system disorders | Single Arm - Transplant Pre-conditioning Per Study Protocol | 1 | 35 | 1 |
| serious | Aspergillus pneumonia | Infections and infestations | Single Arm - Transplant Pre-conditioning Per Study Protocol | 1 | 35 | 1 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Single Arm - Transplant Pre-conditioning Per Study Protocol | ||
| Total, other adverse events | Single Arm - Transplant Pre-conditioning Per Study Protocol | 33 | 35 |
| Total, serious adverse events | Single Arm - Transplant Pre-conditioning Per Study Protocol | 7 | 35 |
Source ClinicalTrials.gov
Papers0
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/NCT00301834
GET https://conductscience.org/api/trials/v1/NCT00301834/registered