Health TrialsbyHealthPanel

Optimization of Post-transplantation Benadamustine and Cyclophosphamide in Patients With High-risk Myeloid Malignancies and a Partially Mismatched Donor

ConditionsAcute Myeloid Leukemia (AML)Chronic Myeloid LeukemiaMyelodysplastic Syndromes (MDS)Myeloprolipherative NeoplsmAtypical Chronic Myeloid Leukemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSt. Petersburg State Pavlov Medical University

About this trial

Optimization of bendamustine-containg graft-versus-host disease (GVHD) prophylaxis to reduce the incidence of secondary haemophagocytic lymphohistiocytosis and GVHD

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with indication for allogeneic hematopoietic stem cell transplantation

Patients with <10/10 HLA-matched related or unrelated donor available. The donor and recipient must be identical by the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1.

Peripheral blood stem cells or bone marrow as a graft source

Disqualifiers

Patients with indication for allogeneic hematopoietic stem cell transplantation

Patients with <10/10 HLA-matched related or unrelated donor available. The donor and recipient must be identical by the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1.

Peripheral blood stem cells or bone marrow as a graft source

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ruxolitinib

    Drug

    ; Days -1 through +21: ruxolitinib 10 mg/kg/day p.o.

  • Abatacept (Orencia)

    Drug

    Days -1,+5, +14, +21 abatacept 10 mg/kg/day i.v.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Experimental: Test cohort 1 - ruxolitinibExperimental treatment 1 intervention
Group B: Test cohort 2 - abataceptExperimental treatment 1 intervention
Group C: Experimental: Expansion cohortExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall survival analysis

Measure: Kaplan-Meier estimate of death from all causes

Time frame
2 years

Secondary outcomes

1

Incidence of secondary hemophagocytic lymphohistiocytosis

Based on H-score diagnostic criteria.

Time frame
100 days
2

Incidence of HSCT-associated adverse events (safety and toxicity)

Toxicity assessment is based on NCI CTC AE 6.0 grades. Veno-occlusive disease incidence and severity assessment is based on EBMT criteria 2016. Transplant-associated microangiopathy incidence assessment is based on Schoettler et al. criteria. All toxicity measurements will be aggregated as severity scores.

Time frame
100 days
3

Infectious complications, including analysis of severe bacterial, fungal and viral infections incidence

Proportion of patients, requiring systemic treatment for bacterial, viral and fungal disease

Time frame
100 days
4

Incidence of acute GVHD grade II-IV

Cumulative incidence of patients with acute GVHD II-IV grade

Time frame
180 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

St. Petersburg State Pavlov Medical University

Lead sponsor

Source ClinicalTrials.gov
Apply now