Phase III Study of CPX-351 Versus 7+3 in Patients 60-75 Years Old With Untreated High Risk (Secondary) Acute Myeloid Leukemia (301)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Celator Pharmaceuticals
Sponsor:
Collaborator:
The Leukemia and Lymphoma Society
Information provided by (Responsible Party):
Celator Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01696084
First received: September 26, 2012
Last updated: September 5, 2014
Last verified: September 2014

September 26, 2012
September 5, 2014
November 2012
December 2014   (final data collection date for primary outcome measure)
Overall Survival [ Time Frame: Dec 2016 ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT01696084 on ClinicalTrials.gov Archive Site
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Phase III Study of CPX-351 Versus 7+3 in Patients 60-75 Years Old With Untreated High Risk (Secondary) Acute Myeloid Leukemia
Phase III, Multicenter, Randomized, Trial of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection Versus Cytarabine and Daunorubicin in Patients 60-75 Years of Age With Untreated High Risk (Secondary) AML

To confirm the efficacy of CPX-351 compared to 7+3 as first line therapy in elderly patients (60-75 yrs) with high risk (secondary) Acute Myeloid Leukemia. The primary efficacy endpoint will be overall survival.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
High Risk Acute Myeloid Leukemia
  • Drug: CPX-351
  • Drug: 7+3 (cytarabine and daunorubicin)
    Other Name: cytarabine and daunorubicin
  • Experimental: Arm A (CPX-351)
    Study drug will be given intravenously at 100u/m2 on days 1, 3 and 5 by approximately 90 minute infusion.
    Intervention: Drug: CPX-351
  • Active Comparator: Arm B (7+3)
    Therapy will be administered intravenously with 100mg/m2/day of cytarabine administered by continuous infusion for 7 days and 60mg/m2 of daunorubicin given on days 1, 2 and 3.
    Intervention: Drug: 7+3 (cytarabine and daunorubicin)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
December 2016
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Ability to understand and voluntarily give informed consent
  • Age 60-75 years at the time of diagnosis of AML
  • Pathological diagnosis of AML according to WHO criteria (with at least 20% blasts in the peripheral blood or bone marrow)
  • Confirmation of:

    • Therapy related AML: t-AML must have a documented history of prior cytotoxic therapy or ionizing radiotherapy for an unrelated disease
    • AML with a history of myelodysplasia: MDSAML must have bone marrow documentation of prior MDS
    • AML with a history of CMMoL: CMMoLAML must have bone marrow documentation of prior CMMoL
    • De novo AML with karyotypic abnormalities characteristic of MDS: de novoAML must have cytogenetics with abnormalities per WHO.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Able to adhere to the study visit schedule and other protocol requirements
  • Laboratory values fulfilling the following:

    • Serum creatinine < 2.0 mg/dL
    • Serum total bilirubin < 2.0 mg/dL, patients with Gilbert's Syndrome should contact the medical monitor
    • Serum alanine aminotransferase or aspartate aminotransferase < 3 times the ULN Note: If elevated liver enzymes, above the ULN, are related to disease; contact medical monitor to discuss.
  • Cardiac ejection fraction ≥ 50% by echocardiography or MUGA
  • Patients with second malignancies in remission may be eligible if there is clinical evidence of disease stability for a period of greater than 6 months off cytotoxic chemotherapy, documented by imaging, tumor marker studies, etc., at screening. Patients maintained on long-term non-chemotherapy treatment, e.g., hormonal therapy, are eligible.
  • Except for CMMoL, patients with history of myeloproliferative neoplasms (MPN) (defined as a history of essential thrombocytosis or polycythemia vera, or idiopathic myelofibrosis prior to the diagnosis of AML) or combined MDS/MPN are not eligible.
  • Acute promyelocytic leukemia [t(15;17)] or favorable cytogenetics, including t(8;21) or inv16 if known at the time of randomization.
  • Clinical evidence of active CNS leukemia
  • Patients with active (uncontrolled, metastatic) second malignancies are excluded.
  • Prior treatment intended for induction therapy of AML; only hydroxyurea is permitted for control of blood counts. For example, a patient with MDS that changes HMA dose and schedule after the diagnosis of AML is excluded. AML-type therapy, such as cytarabine alone (>1g/m2/day) or cytarabine plus an anthracycline as well as prior HSCT are also excluded.
  • Administration of any therapy for MDS (conventional or investigational) must be completed by 2 weeks prior to of the first dose of study drug; in the event of rapidly proliferative disease use of hydroxyurea is permitted until 24 hours before the start of study treatment. Toxicities associated with prior MDS therapy must have recovered to grade 1 or less prior to start of treatment.
  • Any major surgery or radiation therapy within four weeks.
  • Patients with prior cumulative anthracycline exposure of greater than 368 mg/m2 daunorubicin (or equivalent).
  • Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent obtaining informed consent
  • Patients with myocardial impairment of any cause (e.g. cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, and congestive heart failure) resulting in heart failure by New York Heart Association Criteria (Class III or IV staging)
  • Active or uncontrolled infection. Patients with an infection receiving treatment (antibiotic, antifungal or antiviral treatment) may be entered into the study but must be afebrile and hemodynamically stable for ≥72 hrs.
  • Current evidence of invasive fungal infection (blood or tissue culture); patients with recent fungal infection must have a subsequent negative cultures to be eligible; known HIV (new testing not required) or evidence of active hepatitis B or C infection (with rising transaminase values)
  • Hypersensitivity to cytarabine, daunorubicin or liposomal products
  • History of Wilson's disease or other copper-metabolism disorder
Both
60 Years to 75 Years
No
Contact: Arthur C Louie, MD 609-243-0123 alouie@celatorpharma.com
Contact: Kim H Paulsen 609-243-6235 kpaulsen@celatorpharma.com
United States,   Canada
 
NCT01696084
CLTR0310-301
Yes
Celator Pharmaceuticals
Celator Pharmaceuticals
The Leukemia and Lymphoma Society
Not Provided
Celator Pharmaceuticals
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP