A Phase II Study of Selinexor Plus Cytarabine and Idarubicin in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML)

Conditions

• Acute Myeloid Leukemia (Relapsed/Refractory)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Selinexor — DRUG
  Patients receive Selinexor as specified in arm/group description (8 doses of 40 mg/m\^2 or 6 doses of 60 mg per induction cycle).
• Idarubicin — DRUG
  Infusion, iv, 10 mg/m\^2, on days 1,3,5 in cycle 1, on days 1,3 in cycle 2
• Cytarabine — DRUG
  Continuous infusion day 1 to 7, 100 mg/m\^2, iv,

Study Details

Acute Myeloid Leukemia (AML) is currently treated with chemotherapy by combining several drugs with different ways of inhibiting the cell growth. In this trial, standard chemotherapeutics that have proven their effectiveness for years, Ara-C and Idarubicin, will be combined with a new drug called Selinexor. Selinexor inhibits the growth of cancer cells by keeping certain proteins in the nucleus which control the cell growth.

Key Dates

Start date

Sep 30, 2014

Status verified

Aug 2021

Primary completion

Jul 31, 2018

Completion

Jul 31, 2018

Study Design

Enrollment

42 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1 / Selinexor 40 mg/m^2 in combination with cytarabine and idarubicin
  All enrolled patients are treated with cytarabine at a dose of 100 mg/m² continuous infusion (day 1-7) and idarubicin at a dose of 10 mg/m\^2 iv (day 1,3,5) every 4 weeks and selinexor for up to 2 induction cycles. If a second cycle is applied idarubicin is only given on day 1 and 3. Selinexor is administered at a dose of 40 mg/m\^2 twice weekly orally starting on day 2 (total of 8 doses per induction cycle).
• Experimental: Cohort 2 / Selinexor 60 mg flat dose in combination with cytarabine and idarubicin
  All enrolled patients are treated with cytarabine at a dose of 100 mg/m\^2 continuous infusion (day 1-7) and idarubicin at a dose of 10 mg/m\^2 iv (day 1,3,5) every 4 weeks and selinexor for up to 2 induction cycles. If a second cycle is applied idarubicin is only given on day 1 and 3. Selinexor is administered at a flat dose of 60 mg twice weekly orally in weeks 1-3 of a 4-week cycle starting on day 2 (total of 6 doses per induction cycle).

Primary Outcome Measure

Number of Participants With CR/CRi = Overall Reponse Rate [ Time Frame: 1-2 induction cycles (4 - 8 weeks) ]