Clinical Trial Details

NCT ID: NCT02520011
Date Last Changed: October 5, 2017

Overview

Research Study Summary

A clinical trial to evaluate treatments using Alvocidib, Cytarabine and Mitoxantrone for patients with Acute Myeloid Leukemia (AML)

Research Study Title

A Phase 2, Randomized, Biomarker-driven, Clinical Study on Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With an Exploratory Arm in Patients With Newly Diagnosed High-Risk AML

Purpose

The purpose of this two-stage Phase 2 study is to assess the clinical response (Complete Remission) to FLAM compared to AM treatment in refractory or relapsed AML patients with demonstrated NOXA BH3 priming of ≥ 40% by mitochondrial profiling in bone marrow.

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Recruitment Details

Phase
2
Gender
All
Age
18 to 65 Years
Overall Status
Recruiting
Lead Sponsor
Tolero Pharmaceuticals, Inc.
Duration
27 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years to 65 Years

Inclusion Criteria:

  1. Be between the ages of ≥18 and ≤65 years

  2. Have an established, pathologically confirmed diagnoses of AML by World Health Organization (WHO) criteria excluding acute promyelocytic leukemia (APL-M3) with a bone marrow of > 5% blasts based on histology or flow cytometry

  3. Be in first relapse (within 24 months of CR) or have primary refractory AML (refractory to initial induction therapy using 1 or 2 cycles of intensive anthracycline/cytarabine ± etoposide or cladribine induction) or have newly diagnosed high-risk AML as defined in this protocol.

  4. Demonstrate NOXA BH3 priming of ≥40% by mitochondrial profiling in bone marrow or 30 - 39% for NOXA Exploratory Arm.

  5. Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2

  6. Have a serum creatinine level ≤1.8 mg/dL

  7. Have an alanine aminotransferase (ALT)/aspartate aminotransferase (AST) level ≤5 times upper limit of normal (ULN)

  8. Have a total bilirubin level ≤2.0 mg/dL (unless secondary to Gilbert syndrome, hemolysis, or leukemia)

  9. Have a left ventricular ejection fraction (LVEF) > 45% by echocardiogram (ECHO) or multigated acquisition (MUGA) scan

  10. Be nonfertile or agree to use an adequate method of contraception. Sexually active patients and their partners must use an effective method of contraception associated with a low failure rate during and for 6 months after completion of study therapy.

  11. Be able to comply with the requirements of the entire study.

  12. Provide written informed consent prior to any study related procedure.

Exclusion Criteria:

  1. Received more than 2 cycles of induction therapy for AML. Investigational agents as part of front-line therapy for AML may by acceptable following discussion with the Medical Monitor. Hydroxyurea is permitted (see #5 below).

  2. Received any previous treatment with alvocidib or any other CDK inhibitor

  3. Received a hematopoietic stem cell transplant within the previous 2 months

  4. Have clinically significant graft versus host disease (GVHD), or GVHD requiring initiation or escalation of treatment within the last 21 days

  5. Require concomitant chemotherapy, radiation therapy, or immunotherapy. Hydroxyurea is allowed up to the evening before starting (but not within 12 hours) of starting treatment on either arm.

  6. Received > 360 mg/m2 equivalents of daunorubicin

  7. Have a peripheral blast count of > 30,000/mm3 (may use hydroxyurea as in #5 above)

  8. Received antileukemic therapy within the last 3 weeks (with the exception of hydroxyurea or if the patient has definite refractory disease). Refractory patients who received therapy within the last 3 weeks may be eligible with prior approval of the Medical Monitor.

  9. Diagnosed with acute promyelocytic leukemia (APL, M3)

  10. Have active central nervous system (CNS) leukemia

  11. Have evidence of uncontrolled disseminated intravascular coagulation

  12. Have an active, uncontrolled infection

  13. Have other life-threatening illness

  14. Have other active malignancies or diagnosed with other malignancies within the last 6 months, except nonmelanoma skin cancer or cervical intraepithelial neoplasia

  15. Have mental deficits and/or psychiatric history that may compromise the ability to give written informed consent or to comply with the study protocol.

  16. Are pregnant and/or nursing

  17. Have received any live vaccine within 14 days prior to first study drug administration.

Site Locations (10)

Country State City Zip Facility and Contact
United States Georgia Atlanta 30342 Northside Hospital
Nancy Shegda
404-845-5929
nancy.mccarthy@Northside.com

Lawrence Morris, MD
Principal Investigator
United States Iowa Iowa City 52242 University of Iowa
Karen Parrott, RN, BSN
319-353-6347
karen-parrott@uiowa.edu

Carlos Vigil, MD
Principal Investigator
United States Kansas Westwood 66205 University of Kansas Medical Center
Kerry Hepler
913-945-7552
ctnursenav@kumc.edu

Tara Lin, MD
Principal Investigator
United States Louisiana New Orleans 70121 Ochsner Clinic Foundation
Amanda Woolery
504-842-0275
Amanda.woolery@ochsner.org

Andrew Dalovisio, MD
Principal Investigator
United States Maryland Baltimore 21287 Sidney Kimmel Cancer Center at Johns Hopkins
Seanna Coffin
410-614-2023
scoffin1@jhmi.edu

B. Douglas Smith, MD
Principal Investigator
United States New York New York 10032 Columbia University Medical Center
Sarah Leach
212-304-5585
sl3971@cumc.columbia.edu

Mark Frattini, MD
Principal Investigator
United States North Carolina Chapel Hill 27599 University of North Carolina
Jack Zhang
jack_zhang@med.unc.edu

Joshua Zeidner, MD
Principal Investigator
United States Texas Dallas 75246 Baylor Sammons Cancer Center
Amy Solis
214-820-8685
amy.solis@bswhealth.org

Moshe Levy, MD
Principal Investigator
United States Texas Houston 77030 MD Anderson Cancer Center
Carol Bivins
713-794-4460
cbibins@mdanderson.org

Jorge Cortes, MD
Principal Investigator
Canada Ontario Toronto M5G 2M9 Princess Margaret Cancer Center
Deborah Sanfelice, RN
416-946-4501 ext. 2867
karen.yee@uhn.ca

Karen Yee, MD
Principal Investigator

Contact

Judy Costas, BSN
3616499176
E-mail:

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