Selinexor in Combination With Fludarabine and Cytarabine in Patients With Refractory or Relapsed Acute Myeloid Leukemia

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT03071276
Phase
PHASE2
Status
Terminated

Conditions

  • Acute Myeloid Leukemia (AML)

Eligibility Criteria

Sex
ALL
Age
N/A - 24 Years
Healthy Volunteers
Not accepted

Interventions

  • Selinexor — DRUG
    Given orally on days 1,3,8,10,22 and 24 of each cycle
  • Fludarabine — DRUG
    Will be given intravenously (IV) over 30 minutes daily on days 16 through 20. Fludarabine may be given prior to day 16 if it is determined to be in the participant's best interest based on disease progression. Chemotherapy may be delayed by 1-3 days if clinically indicated.
  • Cytarabine — DRUG
    Will be given IV over 4 hours daily on days 16 through 20. Cytarabine may be given prior to day 16 if it is determined to be in the participant's best interest based on disease progression. Chemotherapy may be delayed by 1-3 days if clinically indicated.
  • methotrexate/hydrocortisone/cytarabine — DRUG
    Intrathecal (IT) triples will be given prior to cycle 1: IT cytarabine, IT methotrexate, and IT methotrexate/hydrocortisone/cytarabine (MHA) are acceptable. Patients without evidence of central nervous system (CNS) leukemia will receive no further IT therapy during cycle 1. Patients with CNS disease will receive weekly ITMHA until the cerebrospinal fluid becomes free of leukemia (minimum of 4 doses).

Study Details

This study will be done in two parts: Phase I (NCT02212561) has been completed and published. The goal of the Phase I portion of this study was to find the highest tolerable dose of selinexor (KPT-330) that can be given to patients with leukemia or myelodysplastic syndrome (MDS), when it is combined with fludarabine and cytarabine. The Phase II portion of the protocol is reflected in this registration. The goal of the Phase II portion of this protocol is to give the highest dose of selinexor (KPT-330) in combination with fludarabine/cytarabine that was found in Phase I to be safe for children with acute myeloid leukemia (AML). The investigators will examine the effect of this combination treatment.

Key Dates

Start date
Jan 14, 2016
Status verified
May 2020
Primary completion
Apr 30, 2019
Completion
Apr 30, 2019

Study Design

Enrollment
37 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm
    Interventions: Selinexor, Fludarabine, and Cytarabine. Methotrexate/hydrocortisone/cytarabine (intrathecal triples) will be given prior to cycle 1.

Primary Outcome Measure

The Overall Response (OR) Rate (Complete Response + Incomplete Count Recovery + Partial Response) [ Time Frame: Between days 28 and 35 of cycle 1 (cycle length is 42-56 days) ]

Locations (7)

FacilityCityStateZIPSite coordinators
Phoenix Children's HospitalPhoenixArizona85016-
Lucile Packard Children's Hospital Stanford UniversityPalo AltoCalifornia94304-
University of ChicagoChicagoIllinois60637-
Children's Hospital of MichiganDetroitMichigan48201-
Duke University Medical CenterDurhamNorth Carolina27710-
St. Jude Children's Research HospitalMemphisTennessee38105-
Cook Children's Medical CenterFort WorthTexas76104-

Find similar trials in Phoenix, AZ

By research site
Phoenix Children's Hospital· Phoenix, AZLucile Packard Children's Hospital Stanford University· Palo Alto, CAUniversity of Chicago· Chicago, ILChildren's Hospital of Michigan· Detroit, MIDuke University Medical Center· Durham, NCSt. Jude Children's Research Hospital· Memphis, TN

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