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.

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47822

Enrollment

497

Registered

2009-08-27

Start date

2010-04-12

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graft versus Host Disease

Interventions

Prevention of GvHD 3 regimens will be compared: a time-restricted immunosuppressive regimen (Myfortic for 28 days and Cyclosporine A for 84 days), a prolonged regimen (Myfortic for 84 days and Cyclo

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: - Renal dysfunction (serum creatinine > 150 mmol/L or clearance 5% marrow blasts in case of AML, ALL, CML - Patients with EMD in case of AML, ALL, CML

Design outcomes

Primary

Measure	Time frame
Proportion of patients with non-severe GVHD (acute GVHD grade I, grade II without gut infiltration, or chronic GVHD not requiring systemic treatment) within D180 after randomization / registration.	—

Secondary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)