SL-401 in Combination With Azacitidine in Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)

Description

This research study is studying a drug as a possible treatment for diagnosis of AML and high-risk MDS. The interventions involved in this study are: - SL-401 - Azacitidine

Study Start Date

June, 26 2017

Estimated Completion Date

May 2023

Interventions

  • Drug: Azacitidine
  • Drug: SL-401

Study ID

Dana-Farber Cancer Institute -- 17-056

Status

Recruiting

Trial ID

NCT03113643

Study Type

Interventional

Trial Phase

Phase 1

Enrollment Quota

36

Sponsor

Dana-Farber Cancer Institute

Inclusion Criteria

  • Histologically confirmed diagnosis of acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) per 2016 WHO criteria
  • CD123 / IL3RA expression on the subject's AML, determined locally within 3 months of first protocol treatment
  • Age >= 18 years with relapsed or refractory AML (hydroxyurea is not considered a prior treatment regimen) OR --Age >= 18 years with treatment-na├»ve AML who decline intensive induction chemotherapy or who are unfit due to co-morbidity or other factor (hydroxyurea is not considered a prior treatment regimen) OR
  • Age > 18 years with MDS and >= 10% myeloblasts in the bone marrow
  • ECOG performance status 0, 1, or 2
  • Adequate organ function as defined by:
  • Albumin > 3.2 g/dL (in the absence of receipt of intravenous albumin in the previous 72 hours)
  • Serum creatinine < 1.5x ULN
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5x ULN
  • Total bilirubin < 2x ULN (if thought to be > 2x ULN due to Gilbert's disease or the patient's AML, must discuss with the PI)
  • Creatine phosphokinase (CPK) < 2.5x ULN
  • Left ventricular ejection fraction > institutional lower limit of normal by MUGA scan or echocardiogram within 30 days of first protocol treatment
  • Ability to understand and the willingness to sign a written informed consent document.
  • Able to adhere to study visit schedule and other protocol requirements including follow-up for survival assessment
  • Women of child-bearing potential must agree to use adequate contraception for the duration of study participation and for 2 months after completion of SL-401 and azacitidine administration. Men treated or enrolled on this protocol must also agree to use adequate contraception for the duration of study participation and 2 months after completion of SL-401 and azacitidine administration.

Exclusion Criteria

  • Prior treatment with a hypomethylating agent (including but not limited to azacitidine or decitabine)
  • Prior treatment with SL-401
  • Diagnosis of acute promyelocytic leukemia
  • Received treatment with chemotherapy, radiation, or biologic cancer therapy within 14 days of first protocol treatment. Prior and concurrent hydroxyurea is permitted.
  • Hematopoietic stem cell transplantation (HSCT) within 60 days of screening, or receipt of immunosuppressive therapy for graft-versus-host disease treatment or prophylaxis within 30 days of screening, or active graft-versus-host-disease
  • Known CNS involvement by AML
  • Known positive status for HIV infection
  • known active hepatitis B or hepatitis C infection
  • Clinically significant cardiopulmonary disease including uncontrolled or NYHA class 3 or 4 congestive heart failure, uncontrolled angina, uncontrolled hypertension, uncontrolled arrhythmia, myocardial infarction or stroke within 6 months of first protocol treatment, or QTc > 480 ms
  • Patients with known active advanced malignant solid tumors are excluded (except for basal or squamous skin cancers, or carcinomas in situ). Patients with additional hematologic malignancies that require treatment are excluded.
  • Pregnant women are excluded from this study because there is an unknown but potential risk for adverse events in the developing fetus with SL-401 and azacitidine (negative urine or serum pregnancy test required within 14 days of Cycle 1, Day 1). Because nursing infants have unknown potential for adverse events secondary to treatment of the mother, breastfeeding should be discontinued if the mother is treated with SL-401 and azacitidine.
  • Infection is a common feature of AML. Patients with active infection are permitted to enroll provided that the infection is controlled. Patients with uncontrolled infection shall not be enrolled until infection is treated and brought under control

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (12)

Study Location Distance Name Phone Email
Dana Farber Cancer Institute - Boston, Massachusetts 2.4 miles Andrew Lane MD PhD 617-632-4589 andrew_lane@dfci.harvard.edu
Dana Farber Cancer Institute - Boston, Massachusetts 2.4 miles Andrew Lane MD PhD 617-632-4589 andrew_lane@dfci.harvard.edu
Dana Farber Cancer Institute - Boston, Massachusetts 2.4 miles Andrew Lane MD PhD 617-632-4589 andrew_lane@dfci.harvard.edu
Dana Farber Cancer Institute - Boston, Massachusetts 2.4 miles Andrew Lane MD PhD 617-632-4589 andrew_lane@dfci.harvard.edu
Dana Farber Cancer Institute - Boston, Massachusetts 2.4 miles Andrew Lane MD PhD 617-632-4589 andrew_lane@dfci.harvard.edu
Dana Farber Cancer Institute - Boston, Massachusetts 2.4 miles Andrew Lane MD PhD 617-632-4589 andrew_lane@dfci.harvard.edu
City of Hope - Duarte, California 2,578.2 miles Anthony Stein MD 626-359-8111 AStein@coh.org
City of Hope - Duarte, California 2,578.2 miles Anthony Stein MD 626-359-8111 AStein@coh.org
City of Hope - Duarte, California 2,578.2 miles Anthony Stein MD 626-359-8111 AStein@coh.org
City of Hope - Duarte, California 2,578.2 miles Anthony Stein MD 626-359-8111 AStein@coh.org
City of Hope - Duarte, California 2,578.2 miles Anthony Stein MD 626-359-8111 AStein@coh.org
City of Hope - Duarte, California 2,578.2 miles Anthony Stein MD 626-359-8111 AStein@coh.org

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