A Phase 2 interventional study of Sorafenib in Acute Myeloid Leukemia, in Relapse, Myelodysplastic Syndromes and Chronic Myeloid Leukemia, sponsored by St. Petersburg State Pavlov Medical University. Recruiting at 1 site in Russian Federation. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-08-01.
Sponsored by St. Petersburg State Pavlov Medical University · Phase 2, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 27 studies testing sorafenib in Leukemia, Myeloid, Acute — 2 open to participants now, 6 under way, 1 of them phase 3. Sorafenib · Leukemia, Myeloid, Acute.
Among the 27 studies testing sorafenib in Leukemia, Myeloid, Acute, this one is the 6th largest by planned enrollment, is the only one that started in 2024, is one of 9 in phase 2, and was the 26th registered.
3,668 studies on the registry are indexed under Leukemia, Myeloid, Acute; 816 are open to participants now.
Browse Leukemia, Myeloid, Acute studies →2 of the 27 studies testing sorafenib in Leukemia, Myeloid, Acute are open now, in 1 country. Recruiting first, the newest first:
Nanfang Hospital, Southern Medical University
Ages 18–65
By country, each count listing its studies:
Sorafenib: first FDA approval 2005 (NEXAVAR), first EMA approval 2006. What it is approved for, and how studies give it, is on its page →
Of the 625 Leukemia, Myeloid, Acute studies recruiting now, 363 (58%) set no upper age limit and 222 (36%) stop at 75 or younger; 145 take children under 18; 29 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
27 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 15 · Phase 2 16 · Phase 3 3
First in 2005; this study’s year is marked. 1 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 88 is above the median of 40 across 3,006 interventional studies indexed under Leukemia, Myeloid, Acute.
Median enrollment 48 across the 27 interventional studies. Of the 20 that completed or were terminated, 8 (40%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 27 has an industry lead sponsor. The 10 most frequent:
St. Petersburg State Pavlov Medical University is the lead sponsor of 52 studies on the registry; 17 are open to participants now.
St. Petersburg State Pavlov Medical University has 9 studies filed under Leukemia, Myeloid, Acute — fewer than ten, so there is no comparison to draw.
2 of the studies testing sorafenib in Leukemia, Myeloid, Acute that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07264010Phase 3Nanfang Hospital, Southern Medical UniversitySorafenib Combined With Venetoclax as Pre-emptive Therapy Strategy for MRD+ AML: a Prospective, Single-arm, Multicenter Clinical Study | 2026-12-30 |
| NCT06532084St. Petersburg State Pavlov Medical UniversitySorafenib Relapase Prophylaxis After HCT With PTBCy Regimen | 2027-05 |
Add all 2 to your calendar (.ics) → With an account.
Among the 27 studies testing sorafenib in Leukemia, Myeloid, Acute, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
Allogeneic hematopoietic stem cell transplantation (HCT) results steadily improve due to reduction of NRM. Standard risk patients now have the risk of HCT below 10% after matched donor transplantation. Nonetheless, there is limited improvement in CIR over time. Especially novel strategies to reduce relapse are needed for high-risk myeloid malignancies where standard HCT approaches result in relatively unfavorable outcomes. Among high-risk malignancies are refractory AML without hematological remission for HCT. In this group EFS rarely exceeds 15%. Some improvement in refractory AML was reported with intensified sequential conditioning regimens, but there use is limited to young and fit patients who comprise only around 20-30% of all refractory AML population. Also it was demonstrated that AML patients beyond CR2 have significantly worse prognosis than CR1 and CR2 patients. It is reported that long-term EFS in this group of patients is around 30%. The next adverse group of HCT recipients are patients with high-risk somatic mutations. It is reported in several studies that EFS in tp53-mutant AML even allografted in CR is 0%. Another adverse mutation is ASXL1, where also 0-10% EFS was demonstrated in large cohorts of patients. For therapy related myeloid malignancies it was also demonstrated that the CIR is higher and this group patients have even in CR have 30% EFS. Complex karyotype and monosomal karytope, involvement of chromosome 3 with EVI1 gene, which are common in this patients group, further exacerbate prognosis. Very high risk MDS was also reported to have dismal prognosis after allogeneic HCT. All these adverse groups were included in the study.
PTBCy GVHD prophylaxis provides augmented GVL and better disease control in high-risk myeloid malignancies, but GVL effect fades over time. While median relapse rate is significantly prolonged to 8 months against the previously reported in the literature 2-3 months, the relapse rate with long term follow up remains high. Thus this longer time to relapse gives enough time to initiate sorafenib prophylaxis which was shown to be one of the most promising agents for relapse prophylaxis. Given its immune modulatory properties the study hypothesis is that sorafenib with PTBCy GVHD prohylaxis will further augment GVL and facilitate better disease control.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients must have high-risk myeloid as an indication for transplantation defined as:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sorafenib 200 mg bid for 168 days starting before day+100 after HCT
Drug: Sorafenib
Usual care
Sorafenib 200 mg bid for 168 days starting in the time fram between engraftment with neutrophils \> 1.0 x 10\^9/L, white blood cells\> 1.5 x 10\^9/L, platelets\> 1.5 x 10\^9/L and day+100 after allogeneic hematopoietic cell trnaplantation
Event-free survival
Kaplan-Meier estimate of either relapse or secondary graft failure or death from all causes
Time frame: 2 years
Overall survival
Kaplan-Meier estimate of death from all causes
Time frame: 2 years
Cumulative incidence of primary and secondary graft failure
Cumulative secondary graft failure, competing risk is death and relapse
Time frame: 365 days
Incidence of HCT-associated adverse events
Toxicity assessment is based on presence of NCI CTC AE 5.0 event grades 3-5. Veno-occlusive disease incidence and severity assessment is based on EBMT criteria 2020. Transplant-associated microangiopathy incidence assessment is based on Harmonization criteria. All toxicity measurements will be aggregated as severity scores.
Time frame: 180 days
Infectious complications, including analysis of severe bacterial, fungal and viral infections incidence
proportion of patients, requiring systemic treatment for bacterial, viral and fungal diseases
Time frame: 180 days
Cumulative incidence of acute GVHD grade II-IV
125 days
Time frame: Cumulative incidence of patients with acute GVHD II-IV grade, competing risk is death, relapse and graft failure
Cumulative incidence of moderate and severe chronic GVHD
Cumulative incidence of patients with moderate and severe chronic GVHD according to NIH 2015 criteria, competing risk is death, relapse and primary graft failure
Time frame: 2 years
Non-relapse mortality analysis
Cumulative incidence of patients with mortality without hematological relapse of malignancy
Time frame: 2 years
GVHD-relapse-free survival analysis
Kaplan-Meier estimate of death, acute GVHD grade III-IV, severe chronic GVHD or relapse
Time frame: 2 years
Cumulative incidence of relapse
Cumulative incidence of patients with relapse, competing risk is non-relapse mortality
Time frame: 2 years
Plan to share: Yes — Upon written study proposal according to Pavlov University LEC SOPs.
Supporting information: Study protocol
Data sharing details ↗ · cloud.mail.ru
No publications or documents are linked to this record.
Started May 2024 (actual). Primary completion is estimated for May 2027, 36 months after the start.
Of 386 non-industry phase 2 interventional studies under Leukemia, Myeloid, Acute, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 108. This study's planned 36 months is below that.
Counting every sponsor, half of 443 studies reached it within 60 months; a quarter within 38 and three quarters within 104.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Sorafenib
St. Petersburg State Pavlov Medical University