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. - HOVON 96 GVHD

• Conditions: Graft versus Host Disease; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2008-003540-11-BE
• Lead Sponsor: HOVON Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-22
• Last Update Posted: 18 August 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 500

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 genotypical 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)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 490
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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 clinical trial of medicinal product
• Study Design: Not specified