A Study of Idasanutlin With Cytarabine Versus Cytarabine Plus Placebo in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML)
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Leukemia, Myeloid, Acute
In brief
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.
Key facts
- Study ID
- NCT02545283
- Run by
- Hoffmann-La Roche
- People needed
- 447
- Starts
- 2015-12-30
- Expected to finish
- 2020-04-24
- Last updated by the study team
- 2022-01-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- 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
- Geelong Hospital; Andrew Love Cancer Centre — Geelong, Victoria, Australia
- Alfred Hospital; Clinical Haematology and Bone Marrow Transplantation — Melbourne, Victoria, Australia
- Lkh-Univ. Klinikum Graz; Klin. Abt. Für Hämatologie — Graz, Austria
- CH Jolimont - Lobbes (Jolimont) — Haine-Saint-Paul, Belgium
- CHU Sart-Tilman — Liège, Belgium
- AZ Delta (Campus Rumbeke) — Roeselare, Belgium
- Juravinski Cancer Clinic; Clinical Trials Department — Hamilton, Ontario, Canada
- Helsinki University Central Hospital; Hematology — Helsinki, Finland
- Tampere University Hospital; Hematology — Tampere, Finland
- Centre Hospitalier Uni Ire; Service Des Maladies Du Sang — Angers, France
- Hopital Claude Huriez; Hematologie — Lille, France
- Institut J Paoli I Calmettes; Onco Hematologie 2 — Marseille, France
- Hopital Hotel Dieu Et Hme;Hopital De Jour — Nantes, France
- Hopital Saint Louis; Oncologie Medicale — Paris, France
- HOPITAL SAINT ANTOINE;Hematologie Clinique — Paris, France
- Northwell Health — Great Neck, New York, United States
Full record on ClinicalTrials.gov
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