NCT01804101

Brief Summary

This randomized clinical trial studies liposomal cytarabine-daunorubicin CPX-351 in treating patients with untreated myelodysplastic syndrome or acute myeloid leukemia. Drugs used in chemotherapy, such as liposomal cytarabine-daunorubicin CPX-351, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

May 7, 2013

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2017

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

May 25, 2018

Completed
Last Updated

May 25, 2018

Status Verified

April 1, 2018

Enrollment Period

3.7 years

First QC Date

March 1, 2013

Results QC Date

January 11, 2018

Last Update Submit

April 27, 2018

Conditions

Acute Biphenotypic LeukemiaAcute Myeloid LeukemiaMyelodysplastic SyndromeUntreated Adult Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

  • Treatment-related Mortality Rate. (TRM)

    Estimate whether the 32 units/m2 or the 64 units/m2 or both dose levels of CPX-351 are likely to improve treatment-related mortality (TRM) rate while keeping the CR rate constant in patients with untreated high-risk MDS or non-APL AML at high risk of TRM.

    Up to 1 month after completion of study treatment

Secondary Outcomes (1)

  • Overall Remission Rate (CR+CRp)

    Up to day 28

Study Arms (2)

Arm I (lower-dose liposomal cytarabine-daunorubicin CPX-351)

EXPERIMENTAL

INDUCTION/RE-INDUCTION: Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRp continue on to consolidation. CONSOLIDATION: Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1 and 3. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Other: Laboratory Biomarker AnalysisDrug: Liposomal Cytarabine-Daunorubicin CPX-351

Arm II (closed to accrual effective 4/21/14)

EXPERIMENTAL

INDUCTION/RE-INDUCTION: Patients receive higher-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRp continue on to consolidation. CONSOLIDATION: Patients receive higher-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1 and 3. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Other: Laboratory Biomarker AnalysisDrug: Liposomal Cytarabine-Daunorubicin CPX-351

Interventions

Laboratory Biomarker AnalysisOTHER

Correlative studies

Arm I (lower-dose liposomal cytarabine-daunorubicin CPX-351)Arm II (closed to accrual effective 4/21/14)
Liposomal Cytarabine-Daunorubicin CPX-351DRUG

Given IV

Also known as: CPX-351, Cytarabine-Daunorubicin Liposome for Injection, Liposomal AraC-Daunorubicin CPX-351
Arm I (lower-dose liposomal cytarabine-daunorubicin CPX-351)Arm II (closed to accrual effective 4/21/14)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of untreated "high-risk" MDS (\>= 10% blasts) or AML other than acute promyelocytic leukemia (APL) with t(15;17)(q22;q12) or variants according to the 2008 World Health Organization (WHO) classification; patients with biphenotypic AML are eligible; outside diagnostic material is acceptable as long as peripheral blood and/or bone marrow slides are reviewed at the study institution and cytogenetic/molecular information is available
  • Prior hydroxyurea for AML is permitted but should be discontinued prior to start of CPX-351 treatment
  • Azacitidine, decitabine, lenalidomide, and growth factors are permitted for low-risk MDS (\< 10% blasts); all treatments for MDS should be discontinued prior to start of CPX-351 treatment
  • Treatment-related mortality (TRM) score \>= 13.1 as calculated with simplified model
  • Bilirubin \< 2.0 mg/mL x upper limit of normal; this requirement reflects the excretion of CPX-351 by the liver
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \< 4.0 x upper limit of normal; this requirement reflects the excretion of CPX-351 by the liver
  • Left ventricular ejection fraction (LVEF) \>= 40%, assessed within 28 days prior to registration, e.g. by multi gated acquisition (MUGA) scan or echocardiography, or other appropriate diagnostic modality
  • Patients with symptoms/signs of hyperleukocytosis or white blood cell (WBC) \> 100,000/uL can be treated with leukapheresis prior to enrollment
  • Provide signed written informed consent

You may not qualify if:

  • Refractory/relapsing blast crisis of chronic myelogenous leukemia (CML)
  • Concomitant illness associated with a likely survival of \< 1 year
  • Active systemic fungal, bacterial, viral, or other infection, unless under treatment with anti-microbials and controlled/stable, as defined as being afebrile and hemodynamically stable for 24-48 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Stanford Cancer Institute

Palo Alto, California, 94304, United States

Location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Leukemia, Biphenotypic, AcuteLeukemia, Myeloid, AcuteMyelodysplastic Syndromes

Interventions

CPX-351Injections

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, MyeloidBone Marrow Diseases

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Results Point of Contact

Title
Dr. Roland B. Walter
Organization
Fred Hutchinson Cancer Center
rwalter@fredhutch.org
206-667-3599

Study Officials

  • Roland Walter

    Fred Hutch/University of Washington Cancer Consortium

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 1, 2013

First Posted

March 5, 2013

Study Start

May 7, 2013

Primary Completion

January 10, 2017

Study Completion

January 10, 2017

Last Updated

May 25, 2018

Results First Posted

May 25, 2018

Record last verified: 2018-04

Locations

US(2)