A phase II/III randomized, open-label study to compare the efficacy and safety of intravenous volasertib in combination with subcutaneous cytarabine versus investigator*s choice of anti-leukemic treatment in adult patients with relapsed or refractory acute myeloid leukemia with no established treatment options (POLO-AML 1)

Phase 2

Withdrawn

Conditions: Acute myeloid leukemia
10024324
leukemia

Registration Number: NL-OMON36189

Lead Sponsor: Boehringer Ingelheim

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 11

Inclusion Criteria

Adults with relapsed or refractory AML, considered not to benefit from / not to be eligible for standard intensive therapy and / or stem cell transplantation based on one of the following criteria:
a. AML patient 60 years of age or older failing to achieve complete remission after standard induction
b. Relapsed AML patient 60 years of age or older and at least one of the following:
- first complete remission duration <18 months.
- previous allogeneic stem cell transplant.
- adverse cytogenetics and/or molecular genetics.
- more than 1st relapse.
c. AML patient <60 years of age failing to achieve complete remission after induction.
d. Relapsed AML patient <60 years of age who has already received high-dose cytarabine salvage and/or allogeneic stem cell transplant.

Exclusion Criteria

- Previously untreated AML
- Acute promyelocytic leukemia
- Second malignancy currently requiring active therapy
- Current symptomatic leukemic CNS involvement.
- Clinically relevant QTcF prolongation
- Severe illness or organ dysfunction involving the heart, kidney, liver or other organ system
- Concomitant anti-leukemic treatment.
- Concomitant anti-infective therapy
- Uncontrolled systemic fungal, bacterial, viral, or other infection
- Female patients of childbearing potential who are sexually active and unwilling to use a medically acceptable method of contraception during the trial
- Pregnancy or breast feeding
- Recent treatment with any investigational drug

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Phase II part: percentage complete remission (CR)<br /><br>Phase III part: Overall Survival (OS)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Event free survival (EFS)<br /><br>Complete Remission with incomplete blood count recovery (CRi)<br /><br>Relapse Free Survival (RFS)<br /><br>Remission duration</p><br>