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Evaluation of Treosulfan Versus Melphalan Conditioning Followed by PTCy in Patients With AML and MDS Undergoing Allogeneic Transplantation

ConditionsAML - Acute Myeloid LeukemiaMDS (Myelodysplastic Syndrome)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTechnische Universität Dresden

About this trial

The aim of this study is to compare the effectiveness and tolerability of two conditioning chemotherapies prior to allogeneic stem cell transplantation.

The following will also be investigated:

* Survival * Remission and Relapse rate * Engraftment or graft failure * Graft versus Host Disease (GvHD)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Informed consent signed by the patient capable of giving

Patient scheduled for allogeneic transplantation within the next 3 weeks

Age ≥ 18 years

AML in first or second complete remission (CR) or complete remission with incomplete hematologic recovery (CRi/CRh) or morphologic leukemia-free state (MLFS)

Disqualifiers

Patients with acute promyelocytic leukemia with t(15;17)(q22;q12)

Patients with graft failure after previous allogeneic HCT

Patients with scheduled 2nd allogeneic HCT within 12 months after 1st allogeneic HCT

Pretreatment with either melphalan or treosulfan within the last 12 months prior to randomization

Trial design

Design model

Parallel

Treatments tested in this trial

  • Treosulfan (Treo)

    Drug

    10 g/m2 intravenous

  • Melphalan (Mel)

    Drug

    140 mg/m2 intravenous

  • Fludarabine (Flud)

    Drug

    30 mg/m2 intravenous

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: Treo - ArmExperimental treatment 2 interventions
Group B: MEL - ArmActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

overall survival (OS)

Time frame
2 years after randomization

Secondary outcomes

1

non-relapsed mortality (NRM)

Time frame
2 years after randomization
2

relapse-free survival (RFS)

Time frame
2 years after randomization
3

-Cumulative incidences of acute and chronic GvHD

Time frame
2 years after randomization
4

Rates of AEs/SAEs/AESI

Time frame
56 days after allogeneic stem cell transplantation

Other outcomes

Sponsors and contacts

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

Technische Universität Dresden

Lead sponsor

medac GmbH

Collaborator

Source ClinicalTrials.gov
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