Prevention of severe GVHD after allogeneic hematopoietic stem cell transplantation, applied as consolidation immunotherapy in patients with hematological malignancies. A prospective randomized phase III trial.

Phase 3

Completed

• Conditions: Graft versus Host Disease; 10018849

• Registration Number: NL-OMON47822
• Lead Sponsor: HOVO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 497

Inclusion Criteria

-Age 18-70 inclusive
-AML, MDS, ALL, MM, CML, CLL, NHL, HL, or a myeloproliferative disease (MPD)
-Planned allogeneic stem cell transplantation
-Related or unrelated donor with a 8/8 HLA match (HLA A, B, C, DRB1)
-WHO performance status 0-2
-Written Informed Consent
-Negative pregnancy test (if applicable)
-Patients who are willing and capable to use adequate contraception during
Myfortic treatment (all pre-menopausal women)

Exclusion Criteria

- Renal dysfunction (serum creatinine > 150 mmol/L or clearance < 50 ml/min)
- Patients with active, uncontrolled infection
- Cord Blood transplantation
- Patients receiving ATG pre-transplantation as part of the conditioning regimen
- Patients with progressive disease in case of MM, CLL, NHL, HL
- Patients with > 5% marrow blasts in case of AML, ALL, CML
- Patients with EMD in case of AML, ALL, CML

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Proportion of patients with non-severe GVHD (acute GVHD grade I, grade II<br /><br>without gut infiltration, or chronic GVHD not requiring systemic treatment)<br /><br>within D180 after randomization / registration.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- time to acute GVHD grade I, II, III, IV<br /><br>- cumulative incidence of progression<br /><br>- progression-free survival (defined as time from randomization 1 until<br /><br>progression or death, whichever occurs first)<br /><br>- cumulative incidence of non-relapse mortality<br /><br>- overall survival<br /><br>- time to chronic GVHD limited and extensive<br /><br>- adverse events<br /><br>- Quality of life (of randomized patients) as defined by the EORTC QLQ-C30 and<br /><br>the FACT-BMT definitions</p><br>