Evaluation of the Clinical Outcome of Cyclosporine Short Infusion Versus Continuous Infusion Post Allogenic Stem Cell Transplantation

NCT04575779 | Completed

• 1 other identifier: 70
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This study focuses on the basis for current immunosuppressive strategies in patients undergoing allogeneic haematopoietic stem cell transplantation at the bone marrow transplantation unit in Ain Shams university hospitals. It discusses whether there is room for improving both the monitoring and the delivery of pharmacologically mediated immunosuppression in this population of patients. Our study will try to determine whether CsA administration at a daily dose of 3 mg/kg/day intravenously (IV) in 2 hrs (short infusion) twice-daily will achieve C2 blood levels of at least 800 mg/l and whether it will be feasible and safe or not.

Conditions

Allogenic Bone Marrow Transplantation

Outcome Measures

Primary Outcomes (2)

• Recording the occurrence of graft-versus-host disease (GvHD) events [Safety and tolerability]

  To compare between the administration of twice-daily cyclosporin infusion over two hours versus continuous cyclosporin infusion via recording the occurrence of graft-versus-host disease (GvHD) events

  Three months following transplantation date

• Recording the occurrence of cyclosporine toxicity adverse events [Safety and tolerability]

  To compare between the administration of twice-daily cyclosporin infusion over two hours versus continuous cyclosporin infusion via recording the occurrence of cyclosporine toxicity adverse events

  Three months following transplantation date

Secondary Outcomes (2)

• Recording the achievement of C2 (The drug concentration level determined 2 hours after the administration) blood levels of at least 800 mg/l. [Efficacy]

  From Transplantation date till 3 months afterward

• Correlation with the the area under the concentration-time curve in the first 4 hours after the drug administration (AUC0-4)

  From Transplantation date till day 8 afterward

Study Arms (2)

Group A

Cyclosporin of a daily dose of 3 mg/kg/day intravenously over 2 h (short infusion) every 12 h

Drug: Cyclosporin with a daily dose of 3 mg/kg/day intravenously over 2 h (short infusion) every 12 h

Group B

Administer cyclosporin daily dose of 3 mg/kg/day in a continuous infusion over 23 h every 24 h.

Drug: Cyclosporin with a daily dose of 3 mg/kg/day intravenously over 2 h (short infusion) every 12 h

Interventions

Cyclosporin with a daily dose of 3 mg/kg/day intravenously over 2 h (short infusion) every 12 h DRUG

To determine whether administering CsA at a dailydose of 3 mg/kg/day intravenously(i.v.) in 2 hrs (short infusion) twice-daily will achieve C2 blood levels of at least 800 mg/l and whether it will be feasible and safe or not.

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with related allogeneic stem cell transplantation

You may qualify if:

• Adult ages \>18 years.
• Patients undergoing allogeneic stem cell transplantation, matched or mismatched related donors.
• Had never been exposed to cyclosporin before.

You may not qualify if:

• Patients with a hypersensitivity to cyclosporin or to any of the ingredients of the formulation.
• Patient with abnormal hepatic functions.
• Patient with abnormal renal functions with elevated serum creatinine levels in excess of 220 mmol/l at study entry.
• Patient receiving systemically active azoles within 2 weeks before Hematopoietic Stem Cell Transplantation (HSCT) patients.
• Patient with body mass index (BMI) above 30 kg/m2.

Sponsors & Collaborators

• Shaymaa Mohammed El-Awady: lead

Study Sites (1)

Shaymaa Mohammed Mohammed Youssef El-Awady

Cairo, Egypt

Location

Related Publications (1)

• El-Awady SMM, El Afifi AM, Afifi R, Sabri NA, Ahmed MA. Evaluation of the Clinical Outcomes of Cyclosporine Short Infusion Versus Continuous Infusion Postallogenic Stem Cell Transplantation. Eur J Drug Metab Pharmacokinet. 2025 Jan;50(1):53-64. doi: 10.1007/s13318-024-00927-y. Epub 2024 Nov 27.

  PMID: 39601981 DERIVED

MeSH Terms

Interventions

Cyclosporine

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 19, 2020
• First Posted: October 5, 2020
• Study Start: July 10, 2018
• Primary Completion: April 4, 2021
• Study Completion: May 30, 2022
• Last Updated: February 1, 2023

Record last verified: 2023-01

Locations

EG (1)