CAMELLIA: Anti-CD47 Antibody Therapy in Haematological Malignancies
Atslēgvārdi
Abstrakts
Datumi
| Pēdējoreiz pārbaudīts: | 01/31/2019 |
| Pirmais iesniegtais: | 01/26/2016 |
| Paredzētā reģistrācija iesniegta: | 02/03/2016 |
| Pirmais izlikts: | 02/08/2016 |
| Pēdējais atjauninājums iesniegts: | 02/18/2019 |
| Pēdējā atjaunināšana ievietota: | 02/20/2019 |
| Faktiskais studiju sākuma datums: | 10/31/2015 |
| Paredzamais primārās pabeigšanas datums: | 10/31/2018 |
| Paredzamais pētījuma pabeigšanas datums: | 01/31/2019 |
Stāvoklis vai slimība
Iejaukšanās / ārstēšana
Drug: Hu5F9-G4
Fāze
Roku grupas
| Roka | Iejaukšanās / ārstēšana |
|---|---|
| Experimental: Hu5F9-G4 Dose Escalation: CD47 blocking antibody Hu5F9-G4 | Drug: Hu5F9-G4 |
Atbilstības kritēriji
| Vecums, kas piemērots studijām | 18 Years Uz 18 Years |
| Dzimumi, kas ir piemēroti studijām | All |
| Pieņem veselīgus brīvprātīgos | Jā |
| Kritēriji | 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 |
Rezultāts
Primārie rezultāti
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]
