Acute Myeloid Leukemia Clinical Trial
A Study of Idasanutlin With Cytarabine Versus Cytarabine Plus Placebo in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML)
Summary
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) 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.
Eligibility Criteria
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 2
Adequate hepatic and renal function
White blood cell (WBC) count at randomization less than or equal to (=) 50000 cells 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 or for engraftment syndrome after autologous stem cell transplantation 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 except for malignancy that has been in remission without treatment for at least 2 years prior to randomization
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
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There are 82 Locations for this study
Great Neck New York, 11021, United States
Hawthorne New York, 10532, United States
New York New York, 10029, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19107, United States
Dallas Texas, 75204, United States
Houston Texas, 77030, United States
Canberra Australian Capital Territory, 2605, Australia
Sydney New South Wales, 2139, Australia
Adelaide South Australia, 5000, Australia
Geelong Victoria, 3220, Australia
Melbourne Victoria, 3004, Australia
Graz , 8036, Austria
Haine-Saint-Paul , 7100, Belgium
Liège , 4000, Belgium
Roeselare , 8800, Belgium
Hamilton Ontario, L8V 5, Canada
Helsinki , 00290, Finland
Tampere , 33521, Finland
Angers Cedex 9 , 49933, France
Lille , 59037, France
Marseille , 13273, France
Nantes , 44093, France
Paris , 75475, France
Paris , 75571, France
Pessac , 33604, France
Pierre Benite , 69495, France
Toulouse , 31059, France
Vandoeuvre Les Nancy , 54511, France
Aachen , 52074, Germany
Bonn , 53127, Germany
Braunschweig , 38114, Germany
Chemnitz , 09113, Germany
Dresden , 01307, Germany
Hannover , 30625, Germany
Köln , 50937, Germany
Mainz , 55131, Germany
Marburg , 35043, Germany
Jerusalem , 91031, Israel
Jerusalem , 91120, Israel
Petach Tikva , 49414, Israel
Tel Aviv , 64239, Israel
Napoli Campania, 80131, Italy
Bologna Emilia-Romagna, 40138, Italy
Meldola Emilia-Romagna, 47014, Italy
Ravenna Emilia-Romagna, 48100, Italy
Udine Friuli-Venezia Giulia, 33100, Italy
Roma Lazio, 00133, Italy
Genova Liguria, 16132, Italy
Bergamo Lombardia, 24127, Italy
Milano Lombardia, 20132, Italy
Milano Lombardia, 20162, Italy
Orbassano (TO) Piemonte, 10043, Italy
Torino Piemonte, 10126, Italy
Firenze Toscana, 50135, Italy
Pisa Toscana, 56100, Italy
Busan , 49241, Korea, Republic of
Jeollanam-do , 58128, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06591, Korea, Republic of
Amsterdam , 1105 , Netherlands
Maastricht , 6202 , Netherlands
Auckland , 1023, New Zealand
Bergen , 5021, Norway
Oslo , 0372, Norway
Panama City , 0824, Panama
Moscow , 12516, Russian Federation
Saint-Petersburg , 19702, Russian Federation
Sankt-Petersburg , 19734, Russian Federation
Barcelona , 08025, Spain
Barcelona , 08036, Spain
Madrid , 28041, Spain
Sevilla , 41013, Spain
Valencia , 46026, Spain
Basel , 4031, Switzerland
Zürich , 8091, Switzerland
Birmingham , B9 5S, United Kingdom
Cardiff , CF14 , United Kingdom
London , EC1M , United Kingdom
Manchester , M20 4, United Kingdom
Sutton , SM2 5, United Kingdom
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