CAMELLIA: Anti-CD47 Antibody Therapy in Haematological Malignancies
Sleutelwoorden
Abstract
Datums
| Laatst geverifieerd: | 01/31/2019 |
| Eerste ingediend: | 01/26/2016 |
| Geschatte inschrijving ingediend: | 02/03/2016 |
| Eerst geplaatst: | 02/08/2016 |
| Laatste update ingediend: | 02/18/2019 |
| Laatste update geplaatst: | 02/20/2019 |
| Werkelijke startdatum van het onderzoek: | 10/31/2015 |
| Geschatte primaire voltooiingsdatum: | 10/31/2018 |
| Geschatte voltooiingsdatum van het onderzoek: | 01/31/2019 |
Conditie of ziekte
Interventie / behandeling
Drug: Hu5F9-G4
Fase
Armgroepen
| Arm | Interventie / behandeling |
|---|---|
| Experimental: Hu5F9-G4 Dose Escalation: CD47 blocking antibody Hu5F9-G4 | Drug: Hu5F9-G4 |
Geschiktheidscriteria
| Leeftijden die in aanmerking komen voor studie | 18 Years Naar 18 Years |
| Geslachten die in aanmerking komen voor studie | All |
| Accepteert gezonde vrijwilligers | Ja |
| Criteria | Key Inclusion Criteria: - Pathologically confirmed relapsed or refractory (primary refractory and relapsed refractory) Acute Myeloid Leukemia (AML) (defined by World Health Organization (WHO) criteria) for which no further conventional therapy is suitable for the patient, or confirmed myelodysplastic syndrome defined according to WHO classification, with an International Prognostic Scoring System (IPSS) risk category of intermediate-2 or high risk, that is relapsed, refractory or intolerant to conventional therapy within 3 weeks of registration. - Male or female, Age ≥ 18 years. - Eastern Cooperative Oncology Group (ECOG) performance score of 0‐1 - Willing to undergo blood transfusions as deemed clinically necessary. - Adequate hematological, liver, and kidney function Key Exclusion Criteria: - Females: Pregnant or breast‐feeding women, or women of childbearing potential unless effective method of contraception is used during and for 3 months after the trial. Males: unless an effective method of contraception is used during and for 3 months after the trial. - Any prior exposure to Hu5F9‐G4 or other CD47 targeting agents. - Treatment with any other investigational agent within 28 days prior to enrolment. - Previous allogeneic stem cell transplant within 6 months prior to enrolment, active graft vs host disease (GVHD), or requiring transplant-related immunosuppression - Evidence for active CNS involvement by leukaemia - Clinical evidence or known history of cardiopulmonary disease |
Resultaat
Primaire uitkomstmaten
1. Maximum tolerated dose (MTD) of Hu5F9‐G4, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (Part A) [Up to 28 days]
