A Study of Idasanutlin With Cytarabine Versus Cytarabine Plus Placebo in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML)

Status:	Recruiting
Conditions:	Blood Cancer, Blood Cancer, Hematology
Therapuetic Areas:	Hematology, Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	3/13/2019
Start Date:	December 30, 2015
End Date:	May 26, 2021
Contact:	Reference Study ID Number: WO29519 www.roche.com/about_roche/roche_worldwide.htm
Email:	global-roche-genentech-trials@gene.com
Phone:	888-662-6728 (U.S. and Canada)

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase III Study of Idasanutlin, an MDM2 Antagonist, With Cytarabine Versus Cytarabine Plus Placebo in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

This is a multicenter, double-blind, randomized, placebo-controlled study designed to compare
overall survival in participants with relapsed or refractory AML treated with idasanutlin in
combination with cytarabine versus participants treated with placebo and cytarabine.
Participants will receive induction treatment with idasanutlin/placebo and cytarabine (Cycle
1). Responding participants may continue to receive a maximum of further two cycles of
consolidation (Cycle 2 and Cycle 3). Complete remission (CR), CR with incomplete platelet
count recovery (CRp), overall remission rate (ORR), event-free survival (EFS), leukemia-free
survival (LFS) and percentage of participants with an allogeneic hematopoietic stem cell
transplant (HSCT) will also be compared between treatment arms. This study will include
participants with and without TP53 wild type (TP53 WT) mutations.

Inclusion Criteria:

- Documented/confirmed first/second refractory/relapsed AML using World Health
Organization classification, except acute promyelocytic leukemia

- No more than 2 prior induction regimens (excluding prior HSCT) in their first line
treatment and one must have included cytarabine with an anthracycline (or
anthracenedione)

- Eastern Cooperative Oncology Group performance status of 0 to 1

- Adequate hepatic and renal function

- White blood cell (WBC) count at randomization less than or equal to ( per cubic millimeter (/mm^3)

Exclusion Criteria:

- First relapsed participants aged less than (<) 60 years with first CR duration greater
than (>) 1 year

- Participants with prior documented antecedent hematological disorder (AHD)

- AML secondary to any prior chemotherapy unrelated to leukemia

- Participants who are either refractory to or relapsed within 90 days of receiving a
regimen containing a cumulative dose of greater than or equal to (>/=) 18 g/m^2 of
cytarabine

- Participants who have received allogeneic HSCT within 90 days prior to randomization

- Participants who have received immunosuppressive therapy for graft versus host disease
within 2 weeks prior to randomization

- Prior treatment with an Murine Double Minute 2 (MDM2) antagonist

- Participants receiving any other investigational or commercial agents or therapies
administered with the intention to treat their malignancy within 30 days from first
receipt of study drug

- Participants with a history of other malignancy within 5 years prior to screening

- Participants who have any severe and/or uncontrolled medical conditions or other
conditions that could affect their participation in the study

- Participants with extramedullary AML with no evidence of systemic involvement

- Pregnant or breastfeeding participants

We found this trial at

sites

Baylor University Medical Center

3500 Gaston Avenue
Dallas, Texas 75246

1.800.422.9567