Loading clinical trials...

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

TERMINATEDPHASE3

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

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)

NCT02545283•Hoffmann-La Roche

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+2 more criteria

Locations (82)

Northwell Health

Great Neck, New York, United States

New York Medical College

Hawthorne, New York, United States

Ichan School of Medicine at Mount Sinai

New York, New York, United States

Abramson Cancer Center; Univ of Pennsylvania

Philadelphia, Pennsylvania, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Baylor University Medical Center

Dallas, Texas, United States

M.D. Anderson Cancer Center; Department of Hematology

Houston, Texas, United States

Canberra Hospital; Haematology Department

Canberra, Australian Capital Territory, Australia

Concord Repatriation General Hospital; Haematology

Sydney, New South Wales, Australia

Royal Adelaide Hospital; Haematology Clinical Trials

Adelaide, South Australia, Australia

Key Dates

Start Date

December 30, 2015

Primary Completion Date

April 24, 2020

Completion Date

April 24, 2020

Last Updated

January 11, 2022

Enrollment

447

ACTUAL participants

Conditions

Leukemia, Myeloid, Acute

Interventions

Cytarabine

DRUG

Idasanutlin

DRUG

Placebo

OTHER

A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

NCT06852222

Leukemia, Myeloid, Acute

View study

RECRUITING

Toxicity Genetic Determinants and Response to Azacitidine and Venetoclax in AML

NCT06580106

Leukemia, Myeloid, Acute

View study

RECRUITINGPHASE1

A Study of BH-30236 in Relapsed/ Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 11, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

Toxicity Genetic Determinants and Response to Azacitidine and Venetoclax in AML

A Study of BH-30236 in Relapsed/ Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome

A Study Comparing Venetoclax and Azacitidine Plus Cusatuzumab to Venetoclax and Azacitidine in Newly Diagnosed AML Ineligible for Intensive Therapy

DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia

Interest of Light Therapy in Hematology - The PHOTO-TREAT Study