CPX-351 Versus Immediate Stem Cell Transplantation for the Treatment of High-Grade Myeloid Cancers With Measurable Residual Disease

Phase 2

Waitlist Available

Led By Filippo Milano

Research Sponsored by Fred Hutchinson Cancer Research Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the time of randomization up to 2 years post-randomization. for descriptive purposes, we shall also report survival and relapse-free survival from time of transplant up to 2 years post-transplant among patients who receive a transplant.

Awards & highlights

No Placebo-Only Group

Summary

This trial studies whether giving a specific type of chemotherapy before a stem cell procedure is more effective than doing the procedure immediately for patients with certain severe blood cancers. The chemotherapy aims to reduce cancer cells and prepare the body for new healthy cells. This newer treatment has shown promising results in improving intensive chemotherapy for a type of blood cancer.

Eligible Conditions

Acute Myeloid Leukemia
Myeloid Neoplasm

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the time of randomization up to 2 years post-randomization. for descriptive purposes, we shall also report survival and relapse-free survival from time of transplant up to 2 years post-transplant among patients who receive a transplant.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the time of randomization up to 2 years post-randomization. for descriptive purposes, we shall also report survival and relapse-free survival from time of transplant up to 2 years post-transplant among patients who receive a transplant.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time of randomization up to 2 years post-randomization. for descriptive purposes, we shall also report survival and relapse-free survival from time of transplant up to 2 years post-transplant among patients who receive a transplant. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival

Secondary study objectives

Frequencies of the Types of Transplantation Received

Rate of Transplantation

Relapse-free Survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm B (CPX-351, alloHCT)Experimental Treatment2 Interventions

Patients receive CPX-351 IV over 90 minutes on days 1, 3, and 5. Treatment may repeat for an additional cycle for a total of 2 cycles (on days 1 and 3 only of cycle 2) in the absence of disease progression or unacceptable toxicity. Within 60 days after completion of CPX-351, patients undergo alloHCT.

Group II: Arm A (alloHCT)Active Control1 Intervention

Patients undergo alloHCT.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Allogeneic Hematopoietic Stem Cell Transplantation

2012

Completed Phase 2

~1240

Liposome-encapsulated Daunorubicin-Cytarabine

2017