Selinexor With Fludarabine and Cytarabine for Treatment of Refractory or Relapsed Leukemia or Myelodysplastic Syndrome

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT02212561
Phase
PHASE1
Status
Completed

Conditions

  • Acute Lymphoblastic Leukemia (ALL)
  • Acute Myeloid Leukemia (AML)
  • Mixed Phenotype Acute Leukemia (MPAL)
  • Myelodysplastic Syndrome (MDS)

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

The purpose of this study is to test the safety of selinexor (KPT-330) and to find the highest dose of selinexor (KPT-330) that can be given safely when it is combined with two chemotherapy drugs (fludarabine and cytarabine). This study will be done in two parts: Phase I and Phase II. The goal of Phase I is to find the highest tolerable dose of selinexor (KPT-330) that we can give to patients with leukemia or MDS, when it is combined with fludarabine and cytarabine. The goal of the subsequent Phase II portion of the study (insert NCT ID of SELHEM-2) 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 leukemia or MDS. The investigators will examine the effect of this combination treatment. PRIMARY OBJECTIVE: * Determine a tolerable combination of selinexor, fludarabine, and cytarabine in pediatric patients with relapsed or refractory hematologic malignancies included acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), mixed phenotype acute leukemia (MPAL) and myelodysplastic syndrome (MDS). SECONDARY OBJECTIVES: * To characterize the pharmacokinetics of selinexor, when administered in tablet form, after the first dose and at steady-state, as well as in combination with fludarabine and cytarabine * To estimate the overall response rate of selinexor given with fludarabine and cytarabine in patients with relapsed or refractory hematologic malignancies

Key Dates

Start date
Aug 31, 2014
Status verified
Feb 2017
Primary completion
Dec 31, 2015
Completion
Dec 31, 2015

Study Design

Enrollment
19 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

Maximum tolerated dose (MTD) of combination selinexor, fludarabine and cytarabine [ Time Frame: MTD will be determined at the end of cycle 1 (day 35 of therapy) ]

Locations (6)

FacilityCityStateZIPSite coordinators
Phoenix Children's HospitalPhoenixArizona85016-
Lucile Packard Children's Hospital Stanford UniversityPalo AltoCalifornia94304-
University of ChicagoChicagoIllinois60637-
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, ILDuke University Medical Center· Durham, NCSt. Jude Children's Research Hospital· Memphis, TNCook Children's Medical Center· Fort Worth, TX

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