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Post Transplant Cyclophosphamide (PTCY) as Sole Graft Versus Host Disease (GVHD) Prophylaxis for Matched Allotransplant: CYRIC

NCT03263767 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2022-07-15

No results posted yet for this study

Summary

Acute or chronic graft versus host disease is still the major complication of stem cells transplantation regarding morbidity and mortality.

Recently, high dose cyclophosphamide utilization early after post-transplantation (day+ 3 and +4) not only for patients with HLA- haploidentical donor but also for patients with Human Leukocyte Antigen (HLA)-compatible donor, showed a great control of graft versus host disease after transplantation, allowing to consider stopping immunosuppressive treatment after the transplantation (Neoral=cyclosporine, cell-cept=mycophenolate mofetil). Indeed, this step has already been completed in myeloablative transplantation in adult patients.

This approach could enable to avoid in the end several complications related to long term immunosuppressive drugs administration, while promoting quicker immunity recovery.

Conditions

Interventions

DRUG

Fludarabine

30 mg/m² Intravenous 5 days from Day-6 to Day-2

DRUG

Clofarabine

30 mg/m² Intravenous 5 days from Day-6 to Day-2

RADIATION

Full body irradiation

2 grays at Day-1

DRUG

Cyclophosphamide

14 mg/kg intravenous 2 days at Day - 6 and day -5

DRUG

Cyclophosphamide

50 mg/kg intravenous 2 days at day +3 and day +4

OTHER

stem cell transplantation

at D0 intraveinous Depending on donor : the stem cells will be extracted from blood (CD34+) or from bone marrow (CD34+ and nuclear cells)

OTHER

nuclear cells

CD3+ cells if needed after transplantation

DRUG

Thymoglobulin Injectable Product

At day -2 2.5 mg/kg for patients inclued after 14 dec 2020

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-15
Primary Completion
2021-10-21
Completion
2022-06-21

Countries

  • France

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03263767 on ClinicalTrials.gov