Plerixafor/G-CSF as Additional Agents for Conditioning Before HSCT in CGD Patients
A Clinical Trial of Plerixafor With G-CSF as Additional Agents in Conditioning Regimen for Prevention of Graft Failure in Patients With Chronic Granulomatous Disease
1 other identifier
interventional
17
1 country
1
Brief Summary
Treatment Study to assess of safety and efficiency of conditioning with Plerixafor and G-CSF as additional agents for prevention of graft failure after transplantation in patients with chronic granulomatous disease
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2019
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2018
CompletedFirst Posted
Study publicly available on registry
June 6, 2018
CompletedStudy Start
First participant enrolled
April 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2023
CompletedSeptember 17, 2019
September 1, 2019
3.7 years
May 24, 2018
September 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Event free survival
The EFS probability compared with historical control. We mean event as primary (non-engraftment) and secondary (rejection) graft dysfunction.
1 year
Secondary Outcomes (5)
1. Overall survival
1 year
Proportion of patients with full/mixed donor chimerism
30 days
3. Transplant related mortality
1 year
4. Acute Graft Versus Host Diseases
100 days
5. Incidence of Plerixafor related toxicity
100 days
Study Arms (1)
Plerixafor/G-CSF
EXPERIMENTALPlerixafor/G-CSF for HSCT conditioning Myeloablative conditioning regimen with Plerixafor as addition agent before stem cell transplantation in CGD patients
Interventions
Eligibility Criteria
You may qualify if:
- Patients aged ≥ 1 months and \< 25 years Patients diagnosed with CGD eligible for an allogeneic transplantation Signed written informed consent
You may not qualify if:
- Lack of informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology
Moscow, 117997, Russia
Related Publications (1)
Balashov D, Laberko A, Shcherbina A, Trakhtman P, Abramov D, Gutovskaya E, Kozlovskaya S, Shelikhova L, Novichkova G, Maschan M, Rumiantsev A, Maschan A. A Conditioning Regimen with Plerixafor Is Safe and Improves the Outcome of TCRalphabeta+ and CD19+ Cell-Depleted Stem Cell Transplantation in Patients with Wiskott-Aldrich Syndrome. Biol Blood Marrow Transplant. 2018 Jul;24(7):1432-1440. doi: 10.1016/j.bbmt.2018.03.006. Epub 2018 Mar 14.
PMID: 29550630BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2018
First Posted
June 6, 2018
Study Start
April 13, 2019
Primary Completion
January 1, 2023
Study Completion
January 1, 2023
Last Updated
September 17, 2019
Record last verified: 2019-09