Trial · NCT02282904
Haploidentical Transplant for People With Chronic Granulomatous Disease Using Post Transplant Cyclophosphamide
NCT02282904, Phase 1, Phase 2, Terminated, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2020-05-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Haploidentical Transplant for People With Chronic Granulomatous Disease Using Post Transplant Cyclophosphamide. Trials, record NCT02282904. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02282904
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Haploidentical Transplant for People With Chronic Granulomatous Disease Using Post Transplant Cyclophosphamide
- NCT number
- NCT02282904
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Chronic Granulomatous Disease
- Interventions
- Sirolimus, Donor peripheral blood stem cells., Cyclophosphamide post transplant, Total body 200cGy, Cyclophosphamide, Fludarabine, Busulfan
- First posted
- 2014-11-05
- Last updated
- 2020-05-12
- Results first posted
- 2020-05-01
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To Determine the Efficacy of This Allogeneic Transplant Approach in Reconstituting Normal Hematopoiesis and Reversing the Clinical Phenotype of CGD | 5 years | Patient will have donor chimerism of greater than 20% and resolution of infection or autoimmunity at end of follow up |
| Secondary | To Determine the Safety of This Allogeneic HSCT Approach in Patients With CGD Including Transplant Related Toxicity, the Incidence of Acute and Chronic Graft-versus-host Disease, Immune Reconstitution, Overalland Disease-free Survival. | 1 year post transplant | 1\. Stable chimerism as indicated by 30-50% myeloid engraftment and 50% lymphoid engraftment as assessed by 1 year post transplant. 2. Immune reconstitution levels with DHR as a marker of normal neutrophil function by 1 year post transplant. 3. GvHD grades of less than 3. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | To Determine the Efficacy of This Allogeneic Transplant Approach in Reconstituting Normal Hematopoiesis and Reversing the Clinical Phenotype of CGD | 5 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | To Determine the Safety of This Allogeneic HSCT Approach in Patients With CGD Including Transplant Related Toxicity, the Incidence of Acute and Chronic Graft-versus-host Disease, Immune Reconstitution, Overalland Disease-free Survival. | 1 year post transplant | Participants | COUNT_OF_PARTICIPANTS |
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 |
|---|---|---|---|---|---|
| To Determine the Efficacy of This Allogeneic Transplant Approach in Reconstituting Normal Hematopoiesis and Reversing the Clinical Phenotype of CGD | CGD Recipient | Greater than 20% donor chimerism | 7 | Participants | |
| To Determine the Efficacy of This Allogeneic Transplant Approach in Reconstituting Normal Hematopoiesis and Reversing the Clinical Phenotype of CGD | CGD Recipient | Resolution of inflammation or infection | 7 | Participants | |
To Determine the Safety of This Allogeneic HSCT Approach in Patients With CGD Including Transplant Related Toxicity, the Incidence of Acute and Chronic Graft-versus-host Disease, Immune Reconstitution, Overalland Disease-free Survival. | CGD Recipient | Number of patients with stable chimerism at 1 year | 6 | Participants | |
To Determine the Safety of This Allogeneic HSCT Approach in Patients With CGD Including Transplant Related Toxicity, the Incidence of Acute and Chronic Graft-versus-host Disease, Immune Reconstitution, Overalland Disease-free Survival. | CGD Recipient | Patients with normal DHR at 1 year | 6 | Participants | |
To Determine the Safety of This Allogeneic HSCT Approach in Patients With CGD Including Transplant Related Toxicity, the Incidence of Acute and Chronic Graft-versus-host Disease, Immune Reconstitution, Overalland Disease-free Survival. | CGD Recipient | Patients with Acute (Grade 3 or higher) GvHD | 3 | Participants | |
To Determine the Safety of This Allogeneic HSCT Approach in Patients With CGD Including Transplant Related Toxicity, the Incidence of Acute and Chronic Graft-versus-host Disease, Immune Reconstitution, Overalland Disease-free Survival. | CGD Recipient | Patients with Chronic GvHD | 0 | Participants | |
To Determine the Safety of This Allogeneic HSCT Approach in Patients With CGD Including Transplant Related Toxicity, the Incidence of Acute and Chronic Graft-versus-host Disease, Immune Reconstitution, Overalland Disease-free Survival. | CGD Recipient | Overall Survival | 5 | Participants | |
To Determine the Safety of This Allogeneic HSCT Approach in Patients With CGD Including Transplant Related Toxicity, the Incidence of Acute and Chronic Graft-versus-host Disease, Immune Reconstitution, Overalland Disease-free Survival. | CGD Recipient | Disease Free Survival | 5 | 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 | CGD Recipient | 7 | |
| Overall Study | COMPLETED | CGD Recipient | 7 | |
| Overall Study | NOT COMPLETED | CGD Recipient | 0 |
Source ClinicalTrials.gov
Adverse events4
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 | Mild GvHD | Immune system disorders | CGD Recipient | 7 | 7 | 7 |
| serious | Severe Acute GvHD | Immune system disorders | CGD Recipient | 3 | 7 | 3 |
| serious | Hemorrhagic Cystitis | Renal and urinary disorders | CGD Recipient | 1 | 7 | 1 |
| serious | Post transplant lymphoproliferative disease | Blood and lymphatic system disorders | CGD Recipient | 1 | 7 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CGD Recipient | 2 | 7 |
| Total, other adverse events | CGD Recipient | 7 | 7 |
| Total, serious adverse events | CGD Recipient | 3 | 7 |
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/NCT02282904
GET https://conductscience.org/api/trials/v1/NCT02282904/registered