Trial · NCT01850108
Non-Myeloablative Conditioning and Bone Marrow Transplantation
NCT01850108, Not applicable, Unknown, Vanderbilt-Ingram Cancer Center; results first posted 2024-01-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Non-Myeloablative Conditioning and Bone Marrow Transplantation. Trials, record NCT01850108. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01850108
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Non-Myeloablative Conditioning and Bone Marrow Transplantation
- NCT number
- NCT01850108
- Status
- Unknown
- Phases
- Not applicable
- Enrollment
- 26 participants, actual
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Conditions
- Sickle Cell Disease, Hemoglobinopathies
- Interventions
- Thymoglobulin, Fludarabine, Cyclophosphamide (CTX), Mesna, Sirolimus, Mycophenolate mofetil (MMF), Bone marrow transplantation, Total body irradiation
- First posted
- 2013-05-09
- Last updated
- 2024-01-10
- Results first posted
- 2024-01-10
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Transplant-related Mortality (TRM) | at 1 year after BMT | Defined as death in the absence of recurrent sickle cell disease or hemoglobinopathy |
| Secondary | Number of Patients Who Developed Grade I-IV Acute Graft-vs.-Host Disease | 2 years | GVHD Severity was graded using the established National Institutes of Health's consensus criteria \[36\]. |
| Secondary | Number of Patients With Donor Hematopoietic Chimerism in Peripheral Blood <95% at 6 Months After Mini-haploBMT | Up to approximately 180 after mini-haploBMT | Partially human leukocyte antigen (HLA)-mismatched bone marrow from first-degree relatives. Defined in percentages of donor cells in patient's peripheral blood, measured in 4 ways. * Mixed donor chimerism: \> 0% but \< 95% * Complete donor chimerism \> 95% Any amount of donor chimerism after day 60 will be considered as having engrafted |
| Secondary | Number of Participants With Hematologic and Non-hematologic Toxicities Following minihaploBMT | Day 60 after BMT | Hematologic toxicity: -Absolute neutrophil count (ANC): consecutive values of \< 500/µL on 3 different days after chemotherapy post-BMT Platelet count: consecutive values of \< 20,000 µL on 3 different days after chemotherapy post-BMT Non-hematologic toxicities: -Toxicities necessitating hospitalization Toxicities grade 4 or above Meets the criteria of the following SAE: * Relapse of underlying disease * Grade 3 ocular toxicity not related to ocular GVHD * Grade 3 related non-hematologic toxicity |
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 | Transplant-related Mortality (TRM) | at 1 year after BMT | participants in this study | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients Who Developed Grade I-IV Acute Graft-vs.-Host Disease | 2 years | Participants in this study with median follow-up of 16.7 months (IQR, 6.5-30.8 months) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With Donor Hematopoietic Chimerism in Peripheral Blood <95% at 6 Months After Mini-haploBMT | Up to approximately 180 after mini-haploBMT | Recipients of Haplo-BMT with PTCy and Thiotepa | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Hematologic and Non-hematologic Toxicities Following minihaploBMT | Day 60 after BMT | Recipients of Haplo-BMT with PTCy and Thiotepa | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Transplant-related Mortality (TRM) | Non-Myeloablative Conditioning and Bone Marrow Transplantation | 0 | Participants | ||
| Number of Patients Who Developed Grade I-IV Acute Graft-vs.-Host Disease | Non-Myeloablative Conditioning and Bone Marrow Transplantation | 2 | Participants | ||
| Number of Patients With Donor Hematopoietic Chimerism in Peripheral Blood <95% at 6 Months After Mini-haploBMT | Non-Myeloablative Conditioning and Bone Marrow Transplantation | 1 | Participants | ||
| Number of Participants With Hematologic and Non-hematologic Toxicities Following minihaploBMT | Non-Myeloablative Conditioning and Bone Marrow Transplantation | Mucositis | 1 | Participants | |
| Number of Participants With Hematologic and Non-hematologic Toxicities Following minihaploBMT | Non-Myeloablative Conditioning and Bone Marrow Transplantation | Hepatic vessel clot | 1 | Participants | |
| Number of Participants With Hematologic and Non-hematologic Toxicities Following minihaploBMT | Non-Myeloablative Conditioning and Bone Marrow Transplantation | veno-occlusive disease of the liver | 1 | Participants | |
| Number of Participants With Hematologic and Non-hematologic Toxicities Following minihaploBMT | Non-Myeloablative Conditioning and Bone Marrow Transplantation | posterior reversible encephalopathy syndrome | 1 | Participants | |
| Number of Participants With Hematologic and Non-hematologic Toxicities Following minihaploBMT | Non-Myeloablative Conditioning and Bone Marrow Transplantation | Platelet refractory thrombocytopenis | 1 | Participants | |
| Number of Participants With Hematologic and Non-hematologic Toxicities Following minihaploBMT | Non-Myeloablative Conditioning and Bone Marrow Transplantation | Invasive fungal infection | 1 | Participants | |
| Number of Participants With Hematologic and Non-hematologic Toxicities Following minihaploBMT | Non-Myeloablative Conditioning and Bone Marrow Transplantation | Mycophenolate mofetilinduced gastritis | 1 | Participants |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Non-Myeloablative Conditioning and Bone Marrow Transplantation | 26 | |
| Overall Study | COMPLETED | Non-Myeloablative Conditioning and Bone Marrow Transplantation | 18 | |
| Overall Study | NOT COMPLETED | Non-Myeloablative Conditioning and Bone Marrow Transplantation | 8 |
Source ClinicalTrials.gov
Adverse events21
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 | Duodenal hemorrhage | Gastrointestinal disorders | Non-Myeloablative Conditioning and Bone Marrow Transplantation | 1 | 26 | 1 |
| serious | Anaphylaxis | Nervous system disorders | Non-Myeloablative Conditioning and Bone Marrow Transplantation | 1 | 26 | 1 |
| serious | Reversible posterior leukoencephalopathy syndrome | Nervous system disorders | Non-Myeloablative Conditioning and Bone Marrow Transplantation | 2 | 26 | 2 |
| serious | Fever | General disorders | Non-Myeloablative Conditioning and Bone Marrow Transplantation | 2 | 26 | 2 |
| serious | Seizure | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-Myeloablative Conditioning and Bone Marrow Transplantation | 2 | 26 | 2 |
| serious | Fall | Injury, poisoning and procedural complications | Non-Myeloablative Conditioning and Bone Marrow Transplantation | 1 | 26 | 1 |
| serious | Hip fracture | Injury, poisoning and procedural complications | Non-Myeloablative Conditioning and Bone Marrow Transplantation | 1 | 26 | 1 |
| serious | Cognitive disturbancce | Nervous system disorders | Non-Myeloablative Conditioning and Bone Marrow Transplantation | 1 | 26 | 1 |
| serious | Kidney injury | Renal and urinary disorders | Non-Myeloablative Conditioning and Bone Marrow Transplantation | 2 | 26 | 2 |
| serious | Generalized weakness | General disorders | Non-Myeloablative Conditioning and Bone Marrow Transplantation | 1 | 26 | 1 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Non-Myeloablative Conditioning and Bone Marrow Transplantation | 1 | 26 |
| Total, other adverse events | Non-Myeloablative Conditioning and Bone Marrow Transplantation | 0 | 26 |
| Total, serious adverse events | Non-Myeloablative Conditioning and Bone Marrow Transplantation | 9 | 26 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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/NCT01850108
GET https://conductscience.org/api/trials/v1/NCT01850108/events?page=2