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New treatment option for Acute Myeloid Leukemia, in Relapse
Official title Sorafenib Relapase Prophylaxis After HCT With PTBCy Regimen
ClinicalTrials.gov ID: NCT06532084
What this study is testing
What is Sorafenib?
Sorafenib is an investigational medicine, being studied as a potential treatment for acute myeloid leukemia, in relapse.
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
- This is a single-center randomized open-label phase II clinical trial to compare relapse prophylaxis with sorafenib and observation after graft-versus-host disease prophylaxis with post-transplantation bendamustine and cyclophosphamide in high-risk myeloid malignancies. This is an intention to treat study, where randomization is performed at first documentation of CR after engraftment.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients must undergo allogeneic hematopoietic stem cell transplantation with post-transplantation bendamustine AND cyclophosphamide from any donor.
- Patients must have high-risk myeloid malignancy as an indication for transplantation defined as:
- acute myeloid leukemia not in hematological remission prior to transplantation,
- ≥ 3 remission of acute myeloid leukemia,
- any myeloid malignancy with bi-allelic tp53 mutation,
You likely can't join if
- successfully treated relapse between transplantation and enrollment
- use of any other planned method for prophylaxis of relapse besides sorafenib
- donor lymphocyte infusion prior to randomization
- Second malignancy not in complete remission within 6 months prior to randomization
- Moderate or severe cardiac disease: ejection fraction \<50%, unstable angina, stable angina NYHA class III or IV, chronic heart failure NYHA class...
- Stroke within 3 months of inclusion, unless related to the underlying malignancy
See the full eligibility criteria
- Patients must undergo allogeneic hematopoietic stem cell transplantation with post-transplantation bendamustine AND cyclophosphamide from any donor.
- Patients must have high-risk myeloid malignancy as an indication for transplantation defined as:
- acute myeloid leukemia not in hematological remission prior to transplantation,
- ≥ 3 remission of acute myeloid leukemia,
- any myeloid malignancy with bi-allelic tp53 mutation,
- any myeloid malignancy with complex karyotype,
- therapy-related myeloid malignancy not in MRD-negative response
- myelodysplastic syndrome with very high IPSS-R risk
- any myeloid malignancy with monosomal or t(3;3) karyotype,
- any myeloid malignancy with ASXL1, bi-allelic tp53 or RUNX1 mutation, EVI1 overexpression
- MDS/NPM unclassified not in hematologic remission.
- Documented hematological remission in the bone marrow at the time of inclusion post-engraftment, measurable residual disease is allowed
- First 100 days after allogeneic hematopoietic stem cell transplantation
- successfully treated relapse between transplantation and enrollment
- use of any other planned method for prophylaxis of relapse besides sorafenib
- donor lymphocyte infusion prior to randomization
- Second malignancy not in complete remission within 6 months prior to randomization
- Moderate or severe cardiac disease: ejection fraction \<50%, unstable angina, stable angina NYHA class III or IV, chronic heart failure NYHA class III or IV, Lawn grade V arrhythmia, myocardial infarction within 3...
- Stroke within 3 months of inclusion, unless related to the underlying malignancy
- Severe decrease in pulmonary function: FEV1 \<50% or DLCO\<50% of predicted or respiratory distress or need for oxygen support;
- Severe organ dysfunction: AST or ALT \>10 upper normal limits, bilirubin \>2 upper normal limits, creatinine \>2 upper normal limits
- Creatinine clearance \< 30 mL/min
- Uncontrolled bacterial or fungal infection at the time of enrollment defined by CRP\> 70 mg/L
- Requirement for vasopressor support at the time of enrollment
- Requirement for positive-pressure oxygen at the time of enrollment
- Karnofsky index \<30%
- Pregnancy
- Somatic or psychiatric disorder making the patient unable to sign informed consent
The study team makes the final eligibility decision.
Where it's taking place
- Saint Petersburg, Russia
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 - 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saint Petersburg, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.