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NCT02629120
High Dose Peripheral Blood Stem Cell Transplantation With Post Transplant Cyclophosphamide for Patients With Chronic Granulomatous Disease
Phase 1, PHASE2 trial testing Alemtuzumab in Chronic Granulomatous Disease Transplant in 45 participants. Participants enrolled and being followed up; not accepting new ones.
30 December 2027
Quick facts
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 45 |
| Start date | 17 December 2015 |
| Primary completion | 30 December 2027 |
| Estimated completion | 30 December 2028 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Alemtuzumab (ALEMTUZUMAB) — full drug profile →
- Busulfan — full drug profile →
- Sirolimus (sirolimus) — full drug profile →
- Cyclophosphamide (cyclophosphamide) — full drug profile →
- Total Body Irradiation
- Peripheral blood stem cells
Conditions studied
- Chronic Granulomatous Disease Transplant — all drugs for Chronic Granulomatous Disease Transplant →
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Who can join
Adults 4 to 65, any sex, with Chronic Granulomatous Disease Transplant. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Chronic granulomatous disease (CGD) affects white blood cell function. Currently, the only curative treatment is bone marrow transplant to replace the abnormal stem cells with new ones (donor cells) capable of making a normal immune system. Transplant problems include graft versus host disease (GvHD) and graft rejection. With GvHD, donor cells attack the recipient s normal tissue. Researchers want to use preparation drugs and a high cell dose to increase graft success. They want to use 2 immunosuppressive drugs (cyclophosphamide and sirolimus) to lessen the risk of GvHD. ...
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Post-transplantation Cyclophosphamide: From HLA-Haploidentical to Matched-Related and Matched-Unrelated Donor Blood and Marrow Transplantation.
Williams L, Cirrone F, Cole K, Abdul-Hay M, et al · · 2020 · cited 32× · PMID 32373119 · DOI 10.3389/fimmu.2020.00636 -
Outcomes in hematopoetic cell transplantation in the setting of mold infections in patients with chronic granulomatous disease.
Kline A, Parta M, Cuellar-Rodriguez J, Gea-Banacloche J, et al · · 2025 · cited 3× · PMID 39496936 · DOI 10.1038/s41409-024-02389-x -
Febrile neutropenia management and outcomes in hematopoietic cell transplantation for chronic granulomatous disease.
Parta M, Cuellar-Rodriguez J, Gea-Banacloche J, Qin J, et al · · 2022 · cited 1× · PMID 35191140 · DOI 10.1111/tid.13815
Verify or expand the search:
- PubMed search for NCT02629120
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02629120 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID)
- Last refreshed: 1 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02629120.
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