Clinical Trials Logo

Clinical Trial Summary

This phase I trial studies the side effects and best dose of selinexor when given after stem cell transplant in treating patients with acute myeloid leukemia that is at intermediate or high risk of spreading or coming back (intermediate- or high-risk), or myelodysplastic syndrome that is at high risk of spreading or coming back (high-risk). Selinexor works to stop cancer growth by blocking an enzyme, which may cause cancer cells to die and also kill cells that cause the cancer to grow, which commonly do not respond to regular chemotherapy.

Clinical Trial Description


I. To determine the maximum tolerated dose (MTD) of selinexor in patients with hematologic malignancies, especially acute myeloid leukemia (AML)/myelodysplastic syndrome (MDS), after allogeneic (allo)-stem cell transplant (SCT).


I. To evaluate the toxicities of selinexor as maintenance treatment after allo-SCT.

II. To determine the incidence of non-relapse mortality. III. To determine 2 years post SCT progression-free survival (PFS) and overall survival rates.

IV. To determine the incidence of acute and chronic graft-versus-host disease (GVHD).

V. To assess lymphoid and myeloid chimerism post transplantation.


I. To analyze donor immune re-constitution after allo-SCT with selinexor maintenance.

II. To monitor minimal residual disease (MRD) by Wilms tumor 1 (WT1) polymerase chain reaction (PCR) during selinexor treatment in AML/MDS patients.

III. To characterize the physiopathology of the leukemia initiating cells (LIC) at the time of disease relapse on selinexor maintenance and compare that at initial diagnosis of the disease.

OUTLINE: This is a dose-escalation study.

Beginning on day 60-100 after allo-SCT without evidence of GVHD above grade 1 and disease relapse with stable hematopoietic recovery, patients receive selinexor orally (PO) on day 1 of each week or on days 1 and 3 of weeks 1-3. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 1 year. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT02485535
Study type Interventional
Source University of Chicago
Status Active, not recruiting
Phase Phase 1
Start date September 4, 2015
Completion date November 2018

See also
  Status Clinical Trial Phase
Recruiting NCT03197714 - Clinical Trial of OPB-111077 in Patients With Relapsed or Refractory Acute Myeloid Leukaemia Phase 1
Recruiting NCT03224819 - Study of AMG 673 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia Early Phase 1
Recruiting NCT03665480 - The Effect of G-CSF on MRD After Induction Therapy in Newly Diagnosed AML Phase 2/Phase 3
Recruiting NCT02882321 - Study of IACS-010759 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia (AML) Phase 1
Recruiting NCT02771197 - Lymphodepletion and Anti-PD-1 Blockade to Reduce Relapse in AML Patient Not Eligible for Transplant Phase 2
Recruiting NCT02933333 - G-CSF Alone or Combination With GM-CSF on Prevention and Treatment of Infection in Children With Malignant Tumor Phase 4
Recruiting NCT03214562 - Study of the BCL-2 Inhibitor Venetoclax in Combination With Standard Intensive Acute Myeloid Leukemia (AML) Induction/Consolidation Therapy With FLAG-IDA in Patients With Newly Diagnosed or Relapsed/Refractory Acute Myeloid Leukemia (AML) Phase 1/Phase 2
Recruiting NCT03298984 - Ph I Study of Alvocidib and Cytarabine/Daunorubicin (7+3) in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML). Phase 1
Recruiting NCT03256071 - Low Dose Decitabine + Modified BUCY Conditioning Regimen for High Risk Acute Myeloid Leukemia Undergoing Allo-HSCT Phase 2/Phase 3
Recruiting NCT02975869 - A Collaborative Palliative and Oncology Care Model for Patients With Acute Myeloid Leukemia N/A
Recruiting NCT02909972 - Safety Study of ALRN-6924 in Patients With Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome Phase 1
Recruiting NCT02668653 - Quizartinib With Standard of Care Chemotherapy and as Maintenance Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML) Phase 3
Active, not recruiting NCT02899286 - Efficacy and Safety Study of Recombinant Human Arginase 1 in Patients With Relapsed or Refractory Acute Myeloid Leukemia Phase 2
Recruiting NCT02483312 - A Study of (Interleukin-12) IL-12 in Patients With Acute Myelogenous Leukemia (AML) Phase 1
Recruiting NCT02400255 - Crenolanib Maintenance Following Allogeneic Stem Cell Transplantation in FLT3-positive Acute Myeloid Leukemia Patients Phase 2
Recruiting NCT02229266 - Randomised Controlled Phase-2 Trial to Determine the Efficacy of Adoptive Immunotherapy With NK Cells in High-risk AML Phase 2
Recruiting NCT02543879 - Study of a Novel BET Inhibitor FT-1101 in Patients With Relapsed or Refractory Hematologic Malignancies Phase 1
Recruiting NCT02502968 - BL-8040 Addition to Consolidation Therapy in AML Patients Phase 2
Active, not recruiting NCT02400281 - Study of Crenolanib Combined With Chemotherapy in FLT3-mutated Acute Myeloid Leukemia Patients Phase 1/Phase 2
Completed NCT02544438 - Study Evaluating the Safety and Efficacy of Astarabine in Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia Phase 1/Phase 2