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NCT02629120

High Dose Peripheral Blood Stem Cell Transplantation With Post Transplant Cyclophosphamide for Patients With Chronic Granulomatous Disease

Active, enrolled Phase 1, PHASE2 Last updated 1 April 2026
What this trial tests

Phase 1, PHASE2 trial testing Alemtuzumab in Chronic Granulomatous Disease Transplant in 45 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
17 December 2015
Primary endpoint
30 December 2027
30 December 2028

Quick facts

Lead sponsorNational Institute of Allergy and Infectious Diseases (NIAID)
PhasePhase 1, PHASE2
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment45
Start date17 December 2015
Primary completion30 December 2027
Estimated completion30 December 2028
Sites1 location across United States

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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

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Other trials of Alemtuzumab

Trials testing the same drug.

Other National Institute of Allergy and Infectious Diseases (NIAID) trials

Trials by the same sponsor.

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Data sources for this page

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