← Back to Search

Anti-tumor antibiotic

Allogeneic Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia

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 up to 5 years post-randomization

Awards & highlights

Study Summary

This trial is studying the effect of CPX-351 followed by donor stem cell transplantation compared to immediate donor stem cell transplantation in treating patients with high-grade myeloid cancers that still have some measureable disease.

Eligible Conditions

Acute Myeloid Leukemia
Myelodysplastic Syndrome
Myeloid Neoplasm

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years post-randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years post-randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years post-randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall survival

Secondary outcome measures

Frequencies of the types of transplantation received

Rate of transplantation

Relapse-free survival

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

~1200

Liposome-encapsulated Daunorubicin-Cytarabine

2016

Completed Phase 2

~100

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer Research CenterLead Sponsor

443 Previous Clinical Trials

148,244 Total Patients Enrolled

Fred Hutchinson Cancer CenterLead Sponsor

556 Previous Clinical Trials

1,343,267 Total Patients Enrolled

Jazz PharmaceuticalsIndustry Sponsor

248 Previous Clinical Trials

34,358 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants still being enrolled for this research project?

"The clinicaltrials.gov website reveals that this medical experiment is actively searching for participants, having first been advertised on August 9th 2021 and latest updated on September 8th 2022."

Answered by AI

What is the current enrollment capacity for this experiment?

"Yes, according to the clinicaltrials.gov registry, this medical trial is still actively searching for patients. The investigation was posted on August 9th 2021 and has been periodically updated until September 8th 2022. As of now, 130 individuals are required from a single site."

Answered by AI

What is the potential risk associated with Allogeneic Hematopoietic Stem Cell Transplantation?

"Although there is no clinical data showing efficacy, Allogeneic Hematopoietic Stem Cell Transplantation has been assigned a safety rating of 2 due to the Phase 2 nature of this trial."

Answered by AI

What are the most usual applications of Allogeneic Hematopoietic Stem Cell Transplantation?

"Allogeneic Hematopoietic Stem Cell Transplantation is often used to treat acute myelocytic leukemia. Additionally, this medical procedure can be of help with other maladies such as blast phase chronic myelocytic leukemia, lymphoma, and the prevention of meningeal leukemia."

Answered by AI

What past attempts have been made to assess the efficacy of Allogeneic Hematopoietic Stem Cell Transplantation?

"At present, 260 investigational clinical trials are underway to evaluate Allogeneic Hematopoietic Stem Cell Transplantation. 65 of these studies have advanced to Phase 3 and the majority originate from New york City; however, they span 12359 sites around the globe."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "CPX-351 Versus Immediate Stem Cell Transplantation for the Treatment of High-Grade Myeloid Cancers With Measurable Residual Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04526288.