Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT06613035
NCT06613035Not yet recruitingPhase 3

Twice-per-week Selinexor, 2 Days Melphalan Plus BU2FLU3 Compared with BU3FLU5 for Elder High-risk Acute Myeloid Leukemia Undergoing Allogenic Hematopoietic Cell Transplantation: a Multi-center Randomized Phase 3 Trial

Institute of Hematology & Blood Diseases Hospital, China4 sites in 1 country126 target enrollmentStarted: September 30, 2024Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Enrollment
126
Locations
4
Primary Endpoint
1-year RFS
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Twice-per-week Selinexor, 2 days Melphalan plus BU2FLU3 compared with BU3FLU5 for elder high-risk acute myeloid leukemia undergoing allogenic hematopoietic cell transplantation: a multi-center randomized phase 3 trial

Detailed Description

Twice-per-week Selinexor, 2 days Melphalan plus BU2FLU3 compared with BU3FLU5 for elder high-risk acute myeloid leukemia undergoing allogenic hematopoietic cell transplantation: a multi-center randomized phase 3 trial Primary Objective The primary objective of this study is to compared 1-year RFS between Sel2Mel2BU2FLU3 and BU3FLU5 groups for elder AML in CRc undergoing allo-HCT.

Secondary Objective The secondary objective of this study is to compare leukemia relapse, engraftment, GVHD, OS, TRM, AEs and RRT between Sel2Mel2BU2FLU3 and BU3FLU5 groups

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
55 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients with high-risk acute myeloid leukemia (excluding acute promyelocytic leukemia).
  • •Recipients of allogeneic hematopoietic stem cell transplantation (including HLA-matched or mismatched allogeneic transplantation as well as unrelated donor transplantation).
  • •Age ≥ 55 years.
  • •Disease status prior to allogeneic transplantation must be complete remission (CRc), confirmed by bone marrow analysis within three days prior to randomization.
  • •Karnofsky Performance Score (KPS) of at least
  • •Informed consent must be signed prior to the commencement of the study procedures. If the patient's signature would be detrimental to their treatment due to their medical condition, the informed consent may be signed by a legal guardian or an immediate family member of the patient.
  • •Note: *High-risk AML: ① Patients classified as high-risk according to the ELN 2022 grading criteria. ② AML patients with persistent MRD positivity prior to transplantation. ③ Patients with refractory or relapsed AML.

Exclusion Criteria

  • •Previous history of hematopoietic stem cell transplantation.
  • •Active cardiac disease, defined as one or more of the following:
  • •History of uncontrolled or symptomatic angina.
  • •Myocardial infarction within the last 6 months prior to study enrollment.
  • •History of arrhythmias requiring medication or with clinically significant symptoms.
  • •Uncontrolled or symptomatic congestive heart failure (NYHA class > 2).
  • •Ejection fraction below the lower limit of the normal range.
  • •Respiratory failure (PaO2 ≤ 60 mmHg).
  • •Liver dysfunction (total bilirubin ≥ 3 mg/dL, transaminases > twice the upper limit of normal).
  • •Renal dysfunction (creatinine clearance rate < 30 mL/min).
  • •Presence of psychiatric disorders or other conditions that prevent cooperation with the study treatment and monitoring requirements.
  • •ECOG performance status of ≥
  • •Uncontrolled or active infection.
  • •Any condition that impairs the ability to provide informed consent.
  • •Any conditions deemed unsuitable for enrollment by the investigator prior to randomization.

Arms & Interventions

Patients in the BF group will receive the BU3FLU5 conditioning regimen

Experimental
  • Intravenous Busulfan (Bu): 3.2 mg/kg on days -9, -8, and -7.
  • Fludarabine (Flu): 30 mg/m² on days -6, -5, -4, -3, and -2.

Intervention: Fludarabine (Drug)

SMBF group will receive the following Sel2Mel2BU2FLU3 conditioning regimen

Experimental
  • Selinexor: 60 mg/day from days -9 to -5.
  • Melphalan: 60 mg/m² on days -8 and -7.
  • Intravenous Busulfan (Bu): 3.2 mg/kg on days -6 and -5.
  • Fludarabine (Flu): 30 mg/m² on days -4, -3, and -2.

Intervention: Selinexor (Drug)

SMBF group will receive the following Sel2Mel2BU2FLU3 conditioning regimen

Experimental
  • Selinexor: 60 mg/day from days -9 to -5.
  • Melphalan: 60 mg/m² on days -8 and -7.
  • Intravenous Busulfan (Bu): 3.2 mg/kg on days -6 and -5.
  • Fludarabine (Flu): 30 mg/m² on days -4, -3, and -2.

Intervention: Melphalan (Drug)

SMBF group will receive the following Sel2Mel2BU2FLU3 conditioning regimen

Experimental
  • Selinexor: 60 mg/day from days -9 to -5.
  • Melphalan: 60 mg/m² on days -8 and -7.
  • Intravenous Busulfan (Bu): 3.2 mg/kg on days -6 and -5.
  • Fludarabine (Flu): 30 mg/m² on days -4, -3, and -2.

Intervention: Intravenous Busulfan (Drug)

SMBF group will receive the following Sel2Mel2BU2FLU3 conditioning regimen

Experimental
  • Selinexor: 60 mg/day from days -9 to -5.
  • Melphalan: 60 mg/m² on days -8 and -7.
  • Intravenous Busulfan (Bu): 3.2 mg/kg on days -6 and -5.
  • Fludarabine (Flu): 30 mg/m² on days -4, -3, and -2.

Intervention: Fludarabine (Drug)

Patients in the BF group will receive the BU3FLU5 conditioning regimen

Experimental
  • Intravenous Busulfan (Bu): 3.2 mg/kg on days -9, -8, and -7.
  • Fludarabine (Flu): 30 mg/m² on days -6, -5, -4, -3, and -2.

Intervention: Intravenous Busulfan (Drug)

Outcomes

Primary Outcomes

1-year RFS

Time Frame: 1-year

The primary objective of this study is to compared 1-year RFS between Sel2Mel2BU2FLU3 and BU3FLU5 groups for elder AML in CRc undergoing allo-HCT.

Secondary Outcomes

  • 1-year OS(1-year)
  • 1-year GVHD(1-year)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

Loading locations...

Similar Trials

Active, not recruiting
Phase 3
Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced or Recurrent Endometrial CarcinomaEndometrial Cancer
NCT05611931Karyopharm Therapeutics Inc257
Withdrawn
Phase 2
Selinexor and Lenalidomide for Consolidation and Maintenance Treatment in Multiple Myeloma Post-transplantMyeloma-Associated AmyloidosisMultiple Myeloma
NCT05820763Washington University School of Medicine
Recruiting
Phase 2
The SABLe studyMultiple Myeloma
2024-512276-35-00Odense University Hospital50
Active, not recruiting
Phase 1
Selinexor with alternating bortezomib or lenalidomide plus dexamethasone in transplant ineligible newly diagnosed multiple myeloma patients (SABLe)MedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Multiple myeloma
EUCTR2020-006060-89-DKOdense University Hospital50
Terminated
Phase 1
A Study of Selinexor in Combination With Standard of Care Therapy for Newly Diagnosed or Recurrent GlioblastomaGlioblastoma Multiforme
NCT04421378Karyopharm Therapeutics Inc74