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Plerixafor/G-CSF as Additional Agents for Conditioning Before HSCT in CGD Patients

NCT ID: NCT03547830

Last Updated: 2019-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-13

Study Completion Date

2023-01-01

Brief Summary

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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

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Detailed Description

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Severe primary or secondary graft dysfunction is one of major problem in patients with Chronic granulomatous disease (CGD). In this study the hypothesis is that the use of plerixafor and G-CSF as additional agents in conditioning regimen would offers advantages. The effect is based on mobilizing bone marrow stem cells into the peripheral blood and blocking CXCR4 chemokine receptors to prevent stem cell homing. Thus, some have hypothesized that plerixafor and G-CSF make free stromal space of the bone marrow available for donor stem cell engraftment. Moreover, stem cell release probably leads to liberation of host stem cells from the anti-apoptotic effects of the BM stroma for the more powerful effect of chemotherapy. Thus, the purpose of this study is to evaluate the safety and efficiency of myeloablative conditioning with Plerixafor and G-CSF as additional agents for prevention of graft failure after stem cell transplantation in patients with chronic granulomatous disease.

Conditions

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Chronic Granulomatous Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Plerixafor/G-CSF

Plerixafor/G-CSF for HSCT conditioning Myeloablative conditioning regimen with Plerixafor as addition agent before stem cell transplantation in CGD patients

Group Type EXPERIMENTAL

Plerixafor

Intervention Type DRUG

Plerixafor for Conditioning before HSCT.

Gcsf

Intervention Type DRUG

GCSF for Conditioning before HSCT.

Interventions

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Plerixafor

Plerixafor for Conditioning before HSCT.

Intervention Type DRUG

Gcsf

GCSF for Conditioning before HSCT.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients aged ≥ 1 months and \< 25 years Patients diagnosed with CGD eligible for an allogeneic transplantation Signed written informed consent

Exclusion Criteria

Lack of informed consent.
Minimum Eligible Age

1 Month

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal Research Institute of Pediatric Hematology, Oncology and Immunology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology

Moscow, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Dmitry Balashov, MD

Role: CONTACT

[email protected]
+79265791817

Svetlana Kozlovskaya, MD

Role: CONTACT

[email protected]
+79165587891

Facility Contacts

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Zhanna Shekhovtsova, MD

Role: primary

[email protected]
4956647078 ext. 7538

Eugene Pashanov, PhD

Role: backup

[email protected]
+79262205578

References

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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.

Reference Type BACKGROUND
PMID: 29550630 (View on PubMed)

Other Identifiers

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NCPHOI-2018-02

Identifier Type: -

Identifier Source: org_study_id

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