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Allogeneic hematopoietic cell transplantation from HLA-matched donor after Flu-Mel-PTCy versus Flu-Mel-ATG reduced-intensity conditioning: a phase II randomized study from the Belgian Hematology Society (BHS)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518568-11-00
Acronym
TJB1703
Enrollment
114
Registered
2024-10-23
Start date
2019-02-04
Completion date
Unknown
Last updated
2025-07-01

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

Conditions

- ALL in CR; - Multiple myeloma; - CLL; - Non-Hodgkin’s lymphoma (aggressive NHL should have chemosensitive disease); - Hodgkin’s disease with chemosensitive disease or responding to checkpoint inhibitors., Hematological malignancies confirmed histologically: - AML in morphological CR or not in morphological CR but not rapidly progressing (i.e. no need to give treatments such as hydroxyurea to maintain WBC count < 10 000 x109/mL); - MDS; - CML in CP or AP; - MPD not in blast crisis, - MDS/MPD overlap

Brief summary

To assess the current GVHD-free, relapse-free survival (cGRFS) for patients conditioned with FM-PTCy or FM-ATG

Detailed description

1. To assess cGRFS for patients conditioned with FM-PTCy or FM-ATG separately in those transplanted with a related or an unrelated donor., 2. To assess the relapse/progression rate for patients conditioned with FM-PTCy or FM-ATG., 3. To assess the rates of grade II-IV and III-IV acute (at 6 months) and moderate/severe cGVHD (at 24 months) in patients conditioned with FM-PTCy or FM-ATG., 4. To assess the rates of NRM as well as LFS and OS in patients conditioned with FM-PTCy or FM-ATG., 5. To assess the proportion of patients alive without active disease and without systemic immunosuppression 1, 2, 3, 4, 5, 7, 10 and 15-years after transplantation in patients conditioned with FM-PTCy or FM-ATG.

Interventions

DRUGEndoxan 500 mg - poudre pour solution injectable
DRUGTHYMOGLOBULINE 5 mg/ml poudre pour solution pour perfusion

Sponsors

Centre Hospitalier Universitaire De Liege
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
To assess the current GVHD-free, relapse-free survival (cGRFS) for patients conditioned with FM-PTCy or FM-ATG

Secondary

MeasureTime frame
1. To assess cGRFS for patients conditioned with FM-PTCy or FM-ATG separately in those transplanted with a related or an unrelated donor., 2. To assess the relapse/progression rate for patients conditioned with FM-PTCy or FM-ATG., 3. To assess the rates of grade II-IV and III-IV acute (at 6 months) and moderate/severe cGVHD (at 24 months) in patients conditioned with FM-PTCy or FM-ATG., 4. To assess the rates of NRM as well as LFS and OS in patients conditioned with FM-PTCy or FM-ATG., 5. To assess the proportion of patients alive without active disease and without systemic immunosuppression 1, 2, 3, 4, 5, 7, 10 and 15-years after transplantation in patients conditioned with FM-PTCy or FM-ATG.

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026