Allogeneic Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Acute Myeloid Leukemia+2 MoreAllogeneic Hematopoietic Stem Cell Transplantation - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

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 With Excess Blasts-2 (MDS-EB-2)
  • Myeloid Neoplasm

Treatment Effectiveness

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to 5 years post-randomization

Year 5
Relapse-free survival
Year 5
Frequencies of the types of transplantation received
Overall survival
Rate of transplantation

Trial Safety

Trial Design

2 Treatment Groups

Arm A (alloHCT)
1 of 2
Arm B (CPX-351, alloHCT)
1 of 2

Active Control

Experimental Treatment

1 Total Participants · 2 Treatment Groups

Primary Treatment: Allogeneic Hematopoietic Stem Cell Transplantation · No Placebo Group · Phase 2

Arm B (CPX-351, alloHCT)Experimental Group · 2 Interventions: Allogeneic Hematopoietic Stem Cell Transplantation, Liposome-encapsulated Daunorubicin-Cytarabine · Intervention Types: Procedure, Drug
Arm A (alloHCT)
Procedure
ActiveComparator Group · 1 Intervention: Allogeneic Hematopoietic Stem Cell Transplantation · Intervention Types: Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1280
Daunorubicin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years post-randomization

Who is running the clinical trial?

Jazz PharmaceuticalsIndustry Sponsor
218 Previous Clinical Trials
30,268 Total Patients Enrolled
Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
149,090 Total Patients Enrolled
Fred Hutchinson Cancer CenterLead Sponsor
530 Previous Clinical Trials
1,303,766 Total Patients Enrolled
Filippo MilanoPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
6 Previous Clinical Trials
450 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
in the patient, were removed from heparinized blood samples by density gradient centrifugation, and the isolated cells were stained with monoclonal antibodies to CD45 and CD34 and analyzed by flow cytometry The abnormal cells, which were present at a frequency of between 0% and 5% of total nucleated cells, were removed from heparinized blood samples by density gradient centrifugation
This includes (but is not limited to) the following genes: CBL (CDS), CSF3R (exons 14, 15, 17), EZH2 (exons 15-20), FBXW7 (CDS), FGFR1 (exons 4, 11-17, partial 18), FLT3 (p.D835H), GATA1 (exons 2-3), GATA2 (exons 3-5), HRAS (exon 1-2), IDH1(p.
People with acute myeloid leukemia (AML) who have not been diagnosed with acute promyelocytic leukemia (APL), myelodysplastic syndrome with excess blasts-2 (MDS-EB2), or another high-risk myeloid neoplasm (10% blasts or more in the blood or marrow), and who have completed at least one cycle of chemotherapy intended to induce remission are candidates for allogeneic hematopoietic stem cell transplantation (HSCT).
A regimen including cytarabine and an anthracycline is effective at killing leukemia cells.
Definition of abnormal karyotype: an abnormal chromosome set, present in any number of metaphase cells.
The doctor thinks that the abnormal fluorescence in the cells is due to the presence of malignant cells.
The intensive chemotherapy for this study will include the regimens listed below
A regimen including cytarabine and a purine analog is recommended.
is an important quality criterion for enrolling subjects in clinical trials
The person has a life expectancy of less than one year due to another illness.