Study of CLAG + Selinexor in Relapsed or Refractory Acute Myeloid Leukemia

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT02416908
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Selinexor — DRUG
  • Cladribine — DRUG
  • G-CSF — DRUG
  • Cytarabine — DRUG
  • Bone marrow biopsy — PROCEDURE

Study Details

Selinexor has shown single-agent activity in a current phase I study enrolling patients with relapsed/refractory AML with durable complete remissions (CR), complete remissions with incomplete hematologic recovery (CRi), partial remissions (PR), and stable disease (SD) observed. Furthermore, common toxicities included nausea, fatigue, and anorexia and were manageable with supportive care agents. Additionally, CLAG chemotherapy has proven activity in relapsed and refractory AML, and has been shown to be a relatively well tolerated regimen without significant non-hematologic toxicity. Given the established role of CLAG chemotherapy, the single agent activity of selinexor, and their non-overlapping toxicities, the investigators propose a phase I/II open label study of selinexor in combination with CLAG for the treatment of patients with relapsed/refractory AML.

Key Dates

Start date
Jun 16, 2015
Status verified
Mar 2020
Primary completion
Jun 21, 2019
Completion
Jun 21, 2019

Study Design

Enrollment
40 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I Schedule A (selinexor)
    * Selinexor will be dosed on Days 1, 5, 10, and 12 of the 28-day cycle. All doses will be 60 mg each PO. * Single agent selinexor maintenance may be given at 60 mg on Days 1, 8, 15, and 22 (4 doses per 28 day cycle). * Cladribine will be given 5 mg/m\^2/day IV once daily on Days 4-8. * G-CSF will be given 300 mcg SC once daily on Days 3-8. * Cytarabine will be given 2000 mg/m\^2/day IV once daily on Days 4-8. * Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response.
  • Experimental: Phase I Schedule B (selinexor)
    * Selinexor will be dosed on Days 1, 5, 10, 12, 17, and 19 of the 28-day cycle. All doses will be 60 mg each PO. * Single agent selinexor maintenance may be given at 60 mg on Days 1, 8, 15, and 22 (4 doses per 28 day cycle). * Cladribine will be given 5 mg/m\^2/day IV once daily on Days 4-8. * G-CSF will be given 300 mcg SC once daily on Days 3-8. * Cytarabine will be given 2000 mg/m\^2/day IV once daily on Days 4-8. * Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response.
  • Experimental: Phase II (selinexor)
    * Selinexor will be given at the schedule as determined in Phase 1. * Single agent selinexor maintenance may be given at 60 mg on Days 1, 8, 15, and 22 (4 doses per 28 day cycle). * Cladribine will be given 5 mg/m\^2/day IV once daily on Days 4-8. * G-CSF will be given 300 mcg SC once daily on Days 3-8. * Cytarabine will be given 2000 mg/m\^2/day IV once daily on Days 4-8. * Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response.

Primary Outcome Measure

Safety and Tolerability of Treatment as Measured by Incidence of Grade 3-4 Adverse Events Occurring in >5% of Participants [ Time Frame: From start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever came first (41 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110-

Find similar trials in St Louis, MO

By condition
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By research site
Washington University School of Medicine· St Louis, MO

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