ClinicalTrials.gov
ClinicalTrials.gov Menu

Randomized Study of CX-01 Combined With Standard Induction Therapy for Newly Diagnosed Acute Myeloid Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02873338
Recruitment Status : Recruiting
First Posted : August 19, 2016
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
Cantex Pharmaceuticals

Brief Summary:
The purpose of this study is to determine whether CX-01 when given together with standard induction and consolidation therapy for acute myeloid leukemia (AML) will increase the effectiveness of the induction/consolidation therapy. Two different doses of CX-01 will be studied and safety and tolerability will be assessed.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: CX-01 Drug: Idarubicin Drug: Cytarabine Phase 2

Detailed Description:
This randomized open-label study is designed to evaluate whether the addition of either or both different dose levels of CX-01 to standard induction therapy and consolidation therapy has a beneficial effect in newly diagnosed AML patients (60 years of age or older) when compared to patients receiving standard induction and consolidation chemotherapy alone. 75 patients will be randomized to one of 3 treatment groups to receive standard induction/consolidation therapy alone or standard induction/consolidation therapy with CX-01 at one of 2 different dose levels (lower and higher). Patients will receive up to 2 induction cycles and up to 2 consolidation cycles and will participate in the study for up to 18 months. Clinical laboratory tests will be conducted routinely, and bone marrow aspirates and biopsies will be performed during the induction cycles. Safety will be monitored through adverse events and clinical laboratory results.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Phase II Study of CX-01 Combined With Standard Induction Therapy for Newly Diagnosed Acute Myeloid Leukemia
Study Start Date : August 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : November 2018


Arm Intervention/treatment
Active Comparator: Idarubicin + Cytarabine

Induction:

Idarubicin - 12 mg/m2/day slow IV injection for 3 days;

Cytarabine - 100 mg/m2/day continuous 24-hour IV infusion for 7 days

Re-induction - same as above or:

Idarubicin - 12 mg/m2/day slow IV injection for 2 days;

Cytarabine - 100 mg/m2/day continuous 24-hour IV infusion for 5 days

Consolidation:

Cytarabine - 1.0 g/m2 IV infusion over 3 hours, q12h every other day for 3 days

Drug: Idarubicin
12 mg/m2/day by slow (10 to 15 minutes) IV injection daily on days 1, 2 and 3 of induction therapy, and on days 1 and 2 of re-induction therapy
Other Name: Idamycin

Drug: Cytarabine

100 mg/m2/day by continuous IV infusion on days 1 through 7 of induction therapy, and on days 1 through 5 of re-induction therapy

1.0 g/m2 IV infusion given over 3 hours every 12 hours on days 1, 3, and 5 of consolidation therapy


Experimental: Idarubicin+Cytarabine+lower dose CX-01

Induction:

Idarubicin - 12 mg/m2/day slow IV injection for 3 days;

Cytarabine - 100 mg/m2/day continuous 24-hour IV infusion for 7 days;

CX-01 - 4 mg/kg IV bolus followed by CX-01 0.125 mg/kg/hr as a continuous 24-hour IV infusion for 7 days

Re-induction - same as above or:

Idarubicin - 12 mg/m2/day slow IV injection for 2 days;

Cytarabine - 100 mg/m2/day continuous 24-hour IV infusion for 5 days

CX-01 - 4 mg/kg IV bolus followed by CX-01 0.125 mg/kg/hr as a continuous 24-hour IV infusion for 5 days

Consolidation:

Cytarabine - 1.0 g/m2 IV infusion over 3 hours, q12h every other day for 3 days

CX-01 - 4 mg/kg IV bolus followed by CX-01 0.125 mg/kg/hr as a continuous 24-hour IV infusion for 5 days

Drug: CX-01
4 mg/kg IV bolus followed by doses of 0.125, or 0.25 mg/kg/hr given on days 1 through 7 with standard induction therapy, on days 1 through 5 or 7 with standard re-induction therapy, and on days 1, 3 and 5 with standard consolidation therapy
Other Names:
  • 2-O, 3-O desulfated heparin
  • ODSH
  • PGX-100

Drug: Idarubicin
12 mg/m2/day by slow (10 to 15 minutes) IV injection daily on days 1, 2 and 3 of induction therapy, and on days 1 and 2 of re-induction therapy
Other Name: Idamycin

Drug: Cytarabine

100 mg/m2/day by continuous IV infusion on days 1 through 7 of induction therapy, and on days 1 through 5 of re-induction therapy

1.0 g/m2 IV infusion given over 3 hours every 12 hours on days 1, 3, and 5 of consolidation therapy


Experimental: Idarubicin+Cytarabine+higher dose CX-01

Induction:

Idarubicin: 12 mg/m2/day slow IV injection for 3 days;

Cytarabine: 100 mg/m2/day continuous 24-hour IV infusion for 7 days;

CX-01: 4 mg/kg IV bolus followed by CX-01 0.25 mg/kg/hr as a continuous 24-hour IV infusion for 7 days

Re-Induction - same as above or:

Idarubicin - 12 mg/m2/day slow IV injection for 2 days;

Cytarabine - 100 mg/m2/day continuous 24-hour IV infusion for 5 days;

CX-01 - 4 mg/kg IV bolus followed by CX-01 0.25 mg/kg/hr as a continuous 24-hour IV infusion for 5 days

Consolidation:

Cytarabine - 1.0 g/m2 IV infusion over 3 hours, q12h every other day for 3 days

CX-01 - 4 mg/kg IV bolus followed by CX-01 0.25 mg/kg/hr as a continuous 24-hour IV infusion for 5 days

Drug: CX-01
4 mg/kg IV bolus followed by doses of 0.125, or 0.25 mg/kg/hr given on days 1 through 7 with standard induction therapy, on days 1 through 5 or 7 with standard re-induction therapy, and on days 1, 3 and 5 with standard consolidation therapy
Other Names:
  • 2-O, 3-O desulfated heparin
  • ODSH
  • PGX-100

Drug: Idarubicin
12 mg/m2/day by slow (10 to 15 minutes) IV injection daily on days 1, 2 and 3 of induction therapy, and on days 1 and 2 of re-induction therapy
Other Name: Idamycin

Drug: Cytarabine

100 mg/m2/day by continuous IV infusion on days 1 through 7 of induction therapy, and on days 1 through 5 of re-induction therapy

1.0 g/m2 IV infusion given over 3 hours every 12 hours on days 1, 3, and 5 of consolidation therapy





Primary Outcome Measures :
  1. Morphologic complete remission evaluated by IWG criteria (ANC >1000/microliter; platelet count >100,000, <5% blasts in bone marrow aspirate, no blasts with Auer rods, no evidence of extramedullary disease [ Time Frame: during induction and re-induction phases of treatment (up to 60 days after the start of each treatment cycle) ]

Secondary Outcome Measures :
  1. Event-free survival (length of time from randomization through treatment failure) [ Time Frame: every 3 months continuing until death or until 18 months after the last patient is randomized (whichever comes first) ]
    Treatment failure: failure to achieve composite complete morphological remission during the induction and re-induction phase of the study lasting up to 60 days, relapse from complete response or death from any cause, whichever occurs first)

  2. Leukemia-free survival (length of time from the date of randomization until disease relapse or patient death from any cause, whichever comes first, in patients who achieve complete remission only) [ Time Frame: every 3 months continuing until death or until 18 months after the last patient is randomized (whichever comes first) ]
  3. Overall survival (length of time from the date of randomization until death from any cause) [ Time Frame: every 3 months continuing until death or until 18 months after the last patient is randomized (whichever comes first) ]
  4. Composite complete remission rate (complete remission + complete remission with incomplete blood count recovery) [ Time Frame: during induction and re-induction phases of treatment (up to 60 days after the start of each treatment cycle) ]

    Complete remission: ANC >1000/microliter, platelet count >100,000, <5% blasts in bone marrow aspirate, no blasts with Auer rods, no evidence of extramedullary disease

    Complete remission with incomplete blood count recovery: ANC <1000/microliter and/or platelet count <100,000, <5% blasts in bone marrow aspirate, no blasts with Auer rods, no evidence of extramedullary disease


  5. Duration of morphologic complete remission (time from the achievement of complete response to the detection of relapse) [ Time Frame: every 3 months continuing until death or until 18 months after the last patient is randomized (whichever comes first) ]
    Relapse: reappearance of leukemia blasts in the peripheral blood; or >5% blasts in the bone marrow not attributable to another cause; or appearance or reappearance of extramedullary disease and the bone marrow blast percentage is >5% but < or equal to 20%, than a repeat bone marrow performed at least 7 days after the first marrow examination and documenting bone marrow blast percentage is >5% is necessary to establish relapse

  6. Neutrophil recovery - Time from date of randomization to ANC recovery (ANC > 1000/microliter) [ Time Frame: up to 60 days after the start of each treatment cycle ]
  7. Platelet recovery - Time from date of randomization to platelet recovery (platelet count >100,000/microliter) [ Time Frame: up to 60 days after the start of each treatment cycle ]
  8. 30-day mortality (rate of death) [ Time Frame: 30 days from the first day of induction treatment ]
  9. 60-day mortality (rate of death) [ Time Frame: 60 days from the first day of induction treatment ]
  10. 90-day mortality (rate of death) [ Time Frame: 90 days from the first day of induction treatment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed, de novo or secondary, previously untreated AML
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

Exclusion Criteria:

  • Acute promyelocytic leukemia
  • Prior chemotherapy for AML
  • Prior intensive chemotherapy or stem cell transplantation for the treatment of myelodysplastic syndrome
  • CNS leukemia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02873338


Contacts
Contact: Stephen Marcus, MD 954-315-3660 smarcus@cantex.com
Contact: Suzanne Balandis, PharmD 954-315-3660 sbalandis@cantex.com

  Show 24 Study Locations
Sponsors and Collaborators
Cantex Pharmaceuticals
Investigators
Study Director: Stephen Marcus, MD Cantex Pharmaceuticals. Inc.

Responsible Party: Cantex Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02873338     History of Changes
Other Study ID Numbers: CNTX-CX-01-2015-AML-1
First Posted: August 19, 2016    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Idarubicin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors