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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 Chemoth...

Mise à jour : Il y a 4 ans
Référence : EUCTR2015-001611-12

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

Femme et Homme

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Extrait

Part A: The primary objectives of Part A of the study are to assess safety and to confirm the recommended Phase 2 dose (RP2D) of JNJ-56022473 monotherapy. Part B: The primary objectives of Part B of the study are to assess complete response (CR) rate and overall survival (OS) in patients with previously untreated AML who are not eligible for intense induction chemotherapy and who are randomly assigned to receive decitabine plus JNJ-56022473 at the RP2D or decitabine alone.

Critère d'inclusion

  • Acute Myeloid Leukemia (AML)

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