A Study of Idasanutlin with Cytarabine versus Cytarabine plus Placebo in Patients with Relapsed or Refractory Acute Myeloid Leukemia.

Phase 1

• Conditions: Relapsed or refractory acute myeloid leukemia.; MedDRA version: 18.1Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-003065-15-FR
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-14
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 440

Inclusion Criteria

- Age >=18 years
- Documented/confirmed 1st/2nd refractory/relapsed AML using World Health Organization classification, except acute promyelocytic leukemia
- No more than 2 prior induction regimens (excl. prior HSCT) and one must have included cytarabine with an anthracycline (or anthracenedione)
- Eastern Cooperative Oncology Group performance status of 0 to 1
- Patient should be a potential candidate for allogeneic HSCT
- Adequate hepatic and renal function.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 176
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 264

Exclusion Criteria

- Patients with CR1 duration of >1 year AND age <60 years
- Patients with AML with myelodysplasia related changes, or AML that has developed as a consequence of an AHD
- AML secondary to any prior chemotherapy unrelated to leukemia
- Patients who have received more than two prior cytarabine containing induction regimens for AML
- Patients who have relapsed within 90 days after therapy with intermediate-dose cytosine arabinoside (IDAC) or high-dose cytosine arabinoside (HiDAC) containing regimens
- Patients who have received allogeneic HSCT within 90 days prior to randomization
- Patients who have received immunosuppressive therapy for graft versus host disease (G versus HD) within 2 weeks prior to study start
- Prior treatment with a Murine Double Minute 2 (MDM2) antagonist
- Patients receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy
- Patients with a history of other malignancy within 5 years prior to screening
- Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
- Pregnant or breastfeeding patients.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified