Phase II Clinical Trial to optimize the dose of an anti-NKG2A monoclonal antibody (humZ270 mAb, IPH2201) for patients with acute myeloid leukemia or myelodysplastic syndrome undergoing haploidentical transplantation with posttransplantation cyclophosphamide. - ONC-2020-001

IRCCS ISTITUTO CLINICO HUMANITAS0 sites42 target enrollmentJune 8, 2021

ConditionsPatients with acute myeloid leukemia or myelodysplastic syndrome undergoing haploidentical transplantation with posttransplantation cyclophosphamide.MedDRA version: 21.1Level: PTClassification code 10000880Term: Acute myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10028533Term: Myelodysplastic syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Patients with acute myeloid leukemia or myelodysplastic syndrome undergoing haploidentical transplantation with posttransplantation cyclophosphamide.
Sponsor: IRCCS ISTITUTO CLINICO HUMANITAS
Enrollment: 42
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 8, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

IRCCS ISTITUTO CLINICO HUMANITAS

Eligibility Criteria

Inclusion Criteria

•1\) Patients capable of providing informed consent according to ICH/ GCP, and national/local regulations and be willing to comply with all study\-related procedures.
•2\) Adult patients aged \=18 years and \=70 years old, without any restriction of gender and race.
•3\) Patients with a hematologic malignancy represented either by Acute Myeloid Leukemia or Myelodysplastic Syndrome (MDS).
•4\) Patients lacking a human leukocyte antigen (HLA) identical donor and receiving Haplo\-SCT with GVHD/host versus graft (HVG) prophylaxis consisting of Cyclophosphamide: 50 mg/kg/day, day \+3 and \+4, Cyclosporine A: 3 mg/kg/day from day \+5, Mycophenolate mofetil: 45 mg/kg/day, from day \+5 to day \+35\.
•5\) Patient who have received Haplo\-SCT with a myeloablative (MA) or reduced intensity (RIC) or non\-myeloblative (NMA) conditioning followed either by a bone marrow or a peripheral blood stem cell (PBSC) graft.
•6\) Negative beta\-human chorionic gonadotropin (ß\-HCG) pregnancy test within 7 days prior to start of study drug for women of childbearing potential.
•7\) Women of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least 52 weeks after the last dose of study therapy.
•Men with female partners who are of childbearing potential must agree that they will use a highly effective method of contraception from the time of giving informed consent until at least 52 weeks after the patient receives his last dose of study therapy contraception.
•Are the trial subjects under 18? no
•Number of subjects for this age range:

Exclusion Criteria

•1\) Patients aged \< 18 or \> 70 years old.
•2\) Active uncontrolled infections.
•3\) Central nervous system (CNS) involvement of AML disease.
•4\) Karnofsky performance status (KPS) \<60% or severe organ dysfunction, including a left ventricular ejection fraction \<40%, DLCO \<50% or creatinine clearance \<50 ml/min (as per transplant eligibility).
•5\) Pregnant or breast\-feeding or intending to become pregnant during the study.
•6\) Patients who rapidly relapse after allogenic\-SCT before day 30 after Haplo\-SCT.
•7\) Patients who experience acute GVHD before day \+30 after Haplo\-SCT.
•8\) Patients treated with a second allogeneic Allo\-SCT.