Plerixafor/G-CSF as Additional Agents for Conditioning Before HSCT in CGD Patients
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|ClinicalTrials.gov Identifier: NCT03547830|
Recruitment Status : Recruiting
First Posted : June 6, 2018
Last Update Posted : September 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Granulomatous Disease||Drug: Plerixafor Drug: Gcsf||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||April 13, 2019|
|Estimated Primary Completion Date :||January 1, 2023|
|Estimated Study Completion Date :||January 1, 2023|
Plerixafor/G-CSF for HSCT conditioning Myeloablative conditioning regimen with Plerixafor as addition agent before stem cell transplantation in CGD patients
Plerixafor for Conditioning before HSCT.
GCSF for Conditioning before HSCT.
- Event free survival [ Time Frame: 1 year ]The EFS probability compared with historical control. We mean event as primary (non-engraftment) and secondary (rejection) graft dysfunction.
- 1. Overall survival [ Time Frame: 1 year ]The OS probability compared with historical control
- Proportion of patients with full/mixed donor chimerism [ Time Frame: 30 days ]Evaluation of the percentage of patients with the full/mixed donor chimerism (whole blood and CD3+ lineage). In addition, patients will be divided in accordance with % of donors cells: >95%; 50%-95%; 10%-49%; <10%. All data will be compared with historical control
- 3. Transplant related mortality [ Time Frame: 1 year ]The TRM probability compared with historical control.
- 4. Acute Graft Versus Host Diseases [ Time Frame: 100 days ]Cumulative Incidence of aGVHD
- 5. Incidence of Plerixafor related toxicity [ Time Frame: 100 days ]severity, features, incidence
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03547830
|Contact: Dmitry Balashov, MDfirstname.lastname@example.org|
|Contact: Svetlana Kozlovskaya, MDemail@example.com|
|Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology||Recruiting|
|Moscow, Russian Federation, 117997|
|Contact: Zhanna Shekhovtsova, MD 4956647078 ext 7538 firstname.lastname@example.org|
|Contact: Eugene Pashanov, PhD +79262205578 email@example.com|
|Principal Investigator: Dmitry Balashov, MD|