Neoplasms

Blood and Lymph Conditions

All Conditions

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Recurrence

Neoplasms by Histologic Type

Hematologic Diseases

Disease Attributes

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Cytarabine

Daunorubicin

First induction: 100 units/m2 on Days 1, 3, and 5 by 90-minute IV infusion Second induction: 100 units/m2 on Days 1 and 3 by 90-minute IV infusion Consolidation(s): 100 units/m2 on Days 1 and 3 by 90-minute IV infusion

First induction: Investigator's choice salvage therapy administered according to local practice Second induction: Investigator's choice salvage therapy administered according to local practice Consolidation(s): Investigator's choice consolidation therapy administered according to local practice

CPX-351

Intensive Salvage Therapy

Jonathan Kolitz, MD

The study investigates if CPX-351 will be a) more effective than the standard intensive salvage AML treatment and b) more tolerable than the standard intensive salvage treatment regimens.

The study compares the investigational product CPX-351 vs the standard intensive salvage treatment for first relapse AML patients.

This study is a randomized, open-label, parallel-arm, fixed-dose, standard therapy controlled Phase IIB trial. Study enrollment duration is expected to be approximately 12-18 months. On entry, patients are randomized to receive either CPX-351 or intensive first salvage treatment.

Patients are stratified to balance the likelihood of obtaining a CR and the duration of CR between the two arms.

Trial of CPX-351 in Adult Patients With First Relapse Acute Myeloid Leukemia (AML)

Phase IIB, Multicenter, Randomized, Open-Label Trial Of CPX-351 (Cytarabine : Daunorubicin) Liposome Injection Versus Intensive Salvage Therapy In Adult Patients ≤ 65 Years Old With AML In First Relapse Following An Initial CR > 1 Month Duration

The proportion of subjects surviving at 1 year was evaluated separately for each arm by the number of subjects alive at 1 year divided by the total number of subjects.

Remission duration was measured from the time the criteria for CR were first met until the first date that disease relapse was objectively documented or until subject death.

Number of patients transferred for stem cell transplant

The Leukemia and Lymphoma Society

Jazz Pharmaceuticals

Safety Population: All randomized participants who received at least one dose of study medication.

Salvage Therapy

Total

Age, Continuous

Sex: Female, Male

Safety Analysis Set

One subject in the Salvage Therapy arm was randomized and withdrew consent prior to treatment, and therefore was excluded from the analysis

Associate Director, Clinical Trial Disclosure & Transparency

Efficacy Evaluable Analysis Set - All randomized participants who received at least one dose of study medication.

Proportion of Subjects Surviving at 1 Year

Efficacy Evaluable Analysis Set: All randomized participants who received at least one dose of study medication.

Spots Global Cancer Trial Database for intensive salvage therapy