A randomized placebo-controlled trial comparing cyclosporine plus steroids with or without Myfortic as primary treatment for extensive chronic graft-versus host disease

Phase 3

Completed

• Conditions: allogene hematopoetische stamceltransplantatie bij diverse maligniteiten; chronic graft versus host disease; chronic rejection

• Registration Number: NL-OMON30458
• Lead Sponsor: European cooperative group for Blood and Marrow Transplantation (EBMT)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

• Age 18 - 60
• Any primary diagnosis requiring treatment by hematopoietic stem cell transplantation (HSCT)
• Recipient of a single allogeneic stem cell transplant (bone marrow or peripheral blood stem cells, or cord blood) minimum 80 days ago
• Transplant from a related or unrelated donor
• Conditioning regimen: Myeloablative (MA) or non-myeloablative (NMA)
• Patients with a first episode of extensive chronic GvHD, without recurrent disease
• The diagnosis of chronic GvHD as defined by the NIH diagnostic and scoring system:
-With clear distinction from acute GvHD
-With presence of at least one diagnostic clinical sign of chronic GvHD or presence of at least 1 distinctive manifestation confirmed bypertinent biopsy or other relevant diagnostic tests
-Exclusion of other possible diagnoses
• Receiving a standard prophylaxis regimen for acute GvHD: CsA alone, CsA plus methotrexate or CsA+MMF for NMA, or a T-cell depleted transplantation (Patients may be started on CsA + steroids pre randomisation but may not be on treatment for more than 3 days pre randomisation)
• Negative pregnancy test in females of child-bearing potential - see section 5.4
• Patient gives written informed consent prior to randomisation

Exclusion Criteria

• Age less than 18 or over 60 years old
• GvHD prophylaxis by tacrolimus plus methotroxate
• Delayed onset acute GvHD following NMA or DLI
• Second allogeneic stem cell transplant
• Not the first episode of chronic GvHD needing systemic immunosuppressive therapy
• Limited chronic GvHD (Seattle criteria)
• MMF used to prevent or treat GvHD in the previous 4 weeks
• Neutropenia (<1.0 x 109/l)
• Uncontrolled systemic infection which in the opinion of the investigator is associated with an increased risk of the patient*s death
within 1 week of randomisation
• In the opinion of the investigator, if the patient has significant medical or psychosocial problems or unstable disease status
• Pregnant or lactating females, - see section 5.4

Study & Design

• Study Type: Interventional
• Study Design: Not specified