Last updated on February 2019

Study of MEN1112 Intravenous Infusion in Relapsed or Refractory Acute Myeloid Leukemia

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Recurrent Adult Acute Myeloid Leukemia | Acute Myeloid Leukemia | in Relapse
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Male or female patients aged 18 years.
  • Documented definitive diagnosis of AML (according to WHO criteria, 2008) that is relapsed/refractory to standard treatment, for which no standard therapy is available or the patient refuses standard therapy.
  • WBC count 10 x 109/L at Visit 1 (Day 1); hydroxyurea is allowed to lower WBC count.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at Visit 1 (Day 1).
  • Life expectancy of at least 2 months.
  • Adequate renal and hepatic laboratory assessments: Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) 3.0 ULN, unless considered due to leukemic organ involvement, Total Bilirubin 2.0 ULN, Serum creatinine 2.0 ULN.
  • Able to give written informed consent before any study related procedure

Exclusion Criteria:

  • Acute promyelocytic leukaemia (French-American-British M3 classification).
  • Active central nervous system involvement.
  • Haematopoietic stem cell transplantation (HSCT) performed within 3 months prior to Screening Visit.
  • Active infection requiring intravenous antibiotics.
  • Life-threatening illnesses other than AML, uncontrolled medical conditions or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety or interfere with the patient's ability to comply with the study activities.
  • Anti-tumour therapy within 14 days of study Visit 1 (Day 1, excluding hydroxyurea).
  • Prior participation in an investigational study (procedure or device) within 21 days of study Visit 1 (Day 1).
  • Radiotherapy within 28 days prior to study Visit 1 (Day 1) or scheduled along the study conduct.
  • Known history of human immunodeficiency virus (HIV) or active infection with hepatitis C virus (HCV) or hepatitis B virus (HBV).
  • Other active malignancies. History of malignancy in the last 12 months (except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast or non-melanoma skin cancer).

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

Volunteer Sign-up

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.