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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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28315
Enrollment
500
Registered
2010-03-15
Start date
2010-03-26
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Randomization 1: Patients planned to undergo an allogeneic SCT for malignant hematological disorders and with a related or unrelated 8/8 HLA matched donor.

Interventions

Patients planned to undergo an allogeneic SCT for malignant hematological disorders and with a related or unrelated 8/8 HLA matched donor will be randomized to either standard immunosuppression (arm 1

Sponsors

Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON) P/a HOVON Data Center Erasmus MC - Daniel den Hoed Postbus 5201 3008 AE Rotterdam Tel: 010 7041560 Fax: 010 7041028 e-mail: hdc@erasmusmc.nl
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Randomization 1: 1. Age 18-65 inclusive; 2. AML, MDS, ALL, MM, CML, CLL, NHL, HL, or a myeloproliferative disease (MPD); 3. Planned allogeneic stem cell transplantation; 4. Related or unrelated donor with a 8/8 HLA match (HLA A, B, C, DRB1); 5. WHO performance status 0-2; 6. Written Informed Consent; 7. Negative pregnancy test (if applicable); 8. Patients who are willing and capable to use adequate contraception during Myfortic treatment (all pre-menopausal women).

Exclusion criteria

Exclusion criteria: Randomization 1: 1. Renal dysfunction (serum creatinine > 150 µmol/L or clearance 5% marrow blasts in case of AML, ALL, CML; 7. Patients with EMD in case of AML, ALL, CML.

Design outcomes

Primary

MeasureTime frame
Randomization 1: 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.—

Secondary

MeasureTime frame
Randomization 1: 1. Time to acute GVHD grade I, II, III, IV; 2. Cumulative incidence of progression; 3. Progression-free survival (defined as time from randomization 1 until progression or death, whichever occurs first); 4. Cumulative incidence of non-relapse mortality; 5. Overall survival (cause of death should be defined according to Appendix F); 6. Time to chronic GVHD limited and extensive; 7. Adverse events; 8. ƒ{ƒnQuality of life as defined by the EORTC QLQ-C30 and the FACT-BMT definitions.—

Contacts

Public ContactA.E.C. Broers

Erasmus MC, Daniel Department of Hematology Postbus 5201

a.broers@erasmusmc.nl+31 (0)10 7041367

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)