Trial · NCT05463133
Allogeneic Hematopoietic Stem Cell Transplantation for Chronic Granulomatous Disease (CGD) With an Alemtuzumab, Busulfan and TBI-based Conditioning Regimen Combined With Cytokine (IL-6, +/- IFN-gamma) Antagonists
NCT05463133, Phase 1, Phase 2, Recruiting, National Institute of Allergy and Infectious Diseases (NIAID)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Allogeneic Hematopoietic Stem Cell Transplantation for Chronic Granulomatous Disease (CGD) With an Alemtuzumab, Busulfan and TBI-based Conditioning Regimen Combined With Cytokine (IL-6, +/- IFN-gamma) Antagonists. Trials, record NCT05463133. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05463133
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Allogeneic Hematopoietic Stem Cell Transplantation for Chronic Granulomatous Disease (CGD) With an Alemtuzumab, Busulfan and TBI-based Conditioning Regimen Combined With Cytokine (IL-6, +/- IFN-gamma) Antagonists
- NCT number
- NCT05463133
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 50 participants, estimated
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Chronic Granulomatous Disease
- Interventions
- Sirolimus, Cyclophosphamide, Alemtuzumab, Busulfan, Pheripheral blood stem cells, Emapalumab-Izsg, Tociluzumab, Total Body Irradiation
- First posted
- 2022-07-18
- Last updated
- 2026-10-13
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | 1 years post-transplant. | Alive at 1 years post-transplant. |
| Secondary | To assess the infection rates in the setting of Alemtuzumab (Campath-1H) and post-transplant cyclophosphamide with the addition of an Il-6 antagonist and TNF inhibitor. | Day 100, 6 months, 1 and/or 2 years post BMT | Any documented viral, bacterial, fungal, or parasitic infection. |
| Secondary | To assess kinetics of engraftment | Day +14, +30, +60, +100, 6 month and 1 year post transplant | Measurement of chimerism, lymphocyte phenotype (TBNK/SCID/TVB), and cytokine analysis laboratory values and research cytokine, alemtuzumab, and CXCL9 levels |
| Secondary | Improve eligibility for allogeneic transplantation. | Eligibility determination for protocol enrollment | Subject eligible to enroll in the protocol. |
| Secondary | Engraftment without GvHD | Day 100, 6 months, and/or 1 year post BMT | As defined by a \>10-20% myeloid engraftment of donor neutrophils. Will be assess as event-free survival (EFS) |
| Secondary | Decreased engraftment syndrome. | 30 days post transplant. | Engraftment syndrome symptoms such as fever, erythrodermal rash, noncardiogenic pulmonary edema, hepatic dysfunction, renal insufficiency, weight gain and transient encephaopathy that is responsive to steroids and/or tocilizumab, and does not require ICU admission or lead to death. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT05463133
GET https://conductscience.org/api/trials/v1/NCT05463133/registered