Trial comparing treatments for AML - Acute Myeloid Leukemia
Official title Evaluation of Treosulfan Versus Melphalan Conditioning Followed by PTCy in Patients With AML and MDS Undergoing Allogeneic Transplantation
ClinicalTrials.gov ID: NCT07025824
What this study is testing
What is Treosulfan (Treo)?
Treosulfan (Treo) is an investigational medicine, given as an IV infusion (through a vein), being studied as a potential treatment for aml - acute myeloid leukemia.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Main
- 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...
You likely can't join if
- 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
- Planned TBI as part of conditioning
- Serum bilirubin \> 1.5 × ULN (if not considered Gilbert-syndrome) or
See the full eligibility criteria
- Main
- 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)
- MDS according to WHO
- Patients aged ≥ 50 years at transplant and/or
- HCT-CI \> 2 and/or
- AML or MDS scheduled for 2nd allogeneic HCT from different donor with minimum of 12 months after 1st allogeneic HCT
- Matched sibling donor (MSD) or
- matched unrelated donor (MUD, 10/10 HLA) or
- mismatched unrelated donor (MMUD, single allele or antigen mismatch at HLA-A, -B, -C, or -DRB1 and no concurrent -DQB1 mismatch (9/10) shown by confirmatory typing) or
- haploidentical family donor
- Planned GvHD prophylaxis with standard PTCy (with 50mg/kg body weight on days +3 and +4)
- No history of cardiac disease that preclude allogeneic HCT and absence of active symptoms, otherwise, documented left ventricular ejection fraction
- 40 %.
- No need for supplementary oxygen on day of randomization Main
- 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
- Planned TBI as part of conditioning
- Serum bilirubin \> 1.5 × ULN (if not considered Gilbert-syndrome) or
- ALAT or ASAT \> 5 × ULN
- Uncontrolled infection at the time of randomization.
- Active viral hepatitis unless serology demonstrates clearance of infection. Occult or prior hepatitis B virus (HBV) infection, defined as negative hepatitis B surface antigen and positive total hepatitis core...
- Pregnant or breastfeeding women
The study team makes the final eligibility decision.
Where it is enrolling
- Aachen, Germany
- Augsburg, Germany
- Berlin, Germany
- Chemnitz, Germany
- Cologne, Germany
- Dresden, Germany
- Frankfurt am Main, Germany
- Greifswald, Germany
- Halle, Germany
- Jena, Germany
- Kiel, Germany
- Leipzig, Germany
- Münster, Germany
- Nuremberg, Germany
- Rostock, Germany
- Stuttgart, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Aachen, Germany; Augsburg, Germany; Berlin, Germany; Chemnitz, Germany; Cologne, Germany; Dresden, Germany and 10 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.