Using Sorafenib to Prevent Relapse After Stem Cell Transplantation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of sorafenib as a relapse prophylaxis in patients with high-risk myeloid malignancies following allogeneic hematopoietic stem cell transplantation (HCT) using a post-transplantation bendamustine and cyclophosphamide regimen. It is a single-center, randomized, open-label phase II trial that compares the outcomes of patients receiving sorafenib against those under observation after achieving complete remission post-engraftment. The study aims to address the high relapse rates in patients with refractory acute myeloid leukemia and other high-risk myeloid conditions, where traditional HCT approaches have shown limited success. Participants will be monitored for relapse rates and overall survival to determine the efficacy of the intervention.

Why it matters

Who can join: the full rules

Inclusion 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

Exclusion Criteria:

* 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 months before inclusion
* 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

Where it's running

• RM Gorbacheva Research Institute
  Saint Petersburg, Russia Recruiting

Study contacts

• Study coordinator: Ivan S Moiseev
• Email: moisiv@mail.ru
• Phone: +78123386265

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Optimizing post-transplant bendamustine plus cyclophosphamide for high‑risk myeloid cancers with a partially mismatched donor

  This trial tests whether giving bendamustine plus cyclophosphamide after transplant (with possible abatacept or ruxolitinib) can reduce dangerous cytokine release and graft‑versus‑host disease for people with high‑risk myeloid malignancies who have a partially HLA‑mismatched donor.

  Recruiting Phase 2 St. Petersburg State Pavlov Medical University · Saint Petersburg · NCT07238712

• Vedolizumab with post-transplant cyclophosphamide and short-course tacrolimus to prevent graft-versus-host disease after reduced-intensity allogeneic stem cell transplant

  This trial tests whether adding vedolizumab to post-transplant cyclophosphamide and a short course of tacrolimus can prevent graft-versus-host disease in adults getting reduced-intensity allogeneic stem cell transplants for leukemias or related blood disorders.

  Recruiting Phase 2 City of Hope Medical Center · Duarte, California · NCT06815003

• Intensity-modulated total marrow irradiation for high-risk blood cancers

  This study is testing a new type of radiation treatment combined with standard chemotherapy to see if it helps people with high-risk blood cancers feel better after receiving stem cell transplants.

  Recruiting Phase 2 University of Illinois Chicago · Chicago, Illinois · NCT06802315

• Vitamin A and D supplementation for patients undergoing allogeneic hematopoietic transplantation

  This study is testing if giving high doses of vitamins A and D before a stem cell transplant can help patients with certain blood cancers have fewer complications like infections and graft-versus-host disease.

  Recruiting Phase 2 St. Petersburg State Pavlov Medical University · Saint Petersburg · NCT06508099

• Comparing two conditioning regimens for haploidentical stem cell transplantation

  This study is testing two different treatment plans for patients getting stem cell transplants from partially matched donors to see which one works better in preventing complications like graft failure and relapse.

  Recruiting Phase 2 St. Petersburg State Pavlov Medical University · Saint Petersburg · NCT06477549

• Using post-transplant cyclophosphamide and ATG for blood cancer transplants

  This study is testing whether using post-transplant cyclophosphamide and ATG can help prevent graft-versus-host disease in patients with blood cancers who are getting stem cell transplants.

  Recruiting Phase 1/2 Instituto Nacional de Cancer, Brazil · Rio de Janeiro, Rio de Janeiro · NCT06299462

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.