An Efficacy and Safety Study of Decitabine (DACOGEN) Plus JNJ-56022473 (Anti CD123) Versus Decitabine (DACOGEN) alone in Participants with acute myeloid leukemia (AML) Ineligible for Intensive Chemotherapy.

Phase 1

• Conditions: Acute Myeloid Leukemia (AML); MedDRA version: 18.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-001611-12-ES
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-15
• Study Completion: 2018-01-25
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 326

Inclusion Criteria

- De novo or secondary acute myeloid leukemia (AML) according to WHO 2008 criteria
For Part A:
- Participants With AML: treatment naive or relapsed for whom experimental therapy is appropriate (as assessed by their treating physician)
For Part B:
- Previously untreated AML (except: emergency leukapheresis and/or hydroxyurea during the screening phase to control hyperleukocytosis); Of note: treatment with hydroxyurea has to be discontinued at least one day prior to start of study therapy
- Not eligible for standard intensive chemotherapy for induction and consolidation based on documented investigator assessment of disease- and patient characteristics as recorded in the electronic case report form (eCRF); these parameters include age, Eastern Cooperative Oncology Group (ECOG) performance status score, cytogenetic risk group, and comorbidities (cardiac, infectious, hepatic, diabetes-related, pulmonary, obesity-related, cerebrovascular accident-related, peptic-ulcer, and others)
- Not eligible for an allogeneic hematopoietic stem cell transplantation
- ECOG Performance Status score of 0, 1 or 2
- A woman must be either: Not of childbearing potential: postmenopausal (more than [>] 45 years of age with amenorrhea for at least 12 months; If, of childbearing potential must be practicing a highly effective method of birth control
- A woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) or urine pregnancy test at screening
- A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control eg, either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository for at least 3 months after last study treatment
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 6
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

- Acute promyelocytic leukemia with t(15;17), or its molecular equivalent (PML-RARalpha)
- For Part B only: Known leukemic involvement or clinical symptoms of leukemic involvement of the central nervous system
- In the case of AML from antecedent myelodysplastic syndrome (MDS), subjects who received prior treatment with a hypomethylating agent. For Part A, subjects with relapsed AML who received prior treatment with a hypomethylating agent
- For Part A only: Subjects who did not recover from all clinically significant toxicities (excluding alopecia and hematologic toxicities) of any previous surgery, radiotherapy, targeted therapy, or chemotherapy to less than or equal to Grade 1
- For Part A only: Subjects who did not recover from all clinically significant toxicities (excluding alopecia and hematologic toxicities) of any previous surgery, radiotherapy, targeted therapy, or chemotherapy to less than or equal to Grade 1
- Any active infection that is not responding to treatment

Study & Design

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