Clinical Trial 17865

Cancer Type: Malignant Hematology
Interventions:SL-401

Study Type: Treatment
Phase of Study: Phase I/II
Investigators:

  • Kendra Sweet

Overview

Study Title

SL-401 in Patients with Acute Myeloid Leukemia or Blastic Plasmacytoid Dendritic Cell Neoplasm

Summary

The goal of this research study is to find the safest highest dose of SL-401 that can be given to patients with AML or BPDCN. This study will also look at how SL-401 stops or slows leukemia or BPDCN growth and how SL-401 enters and leaves your body. This study will also look at certain proteins in your blood and bone marrow and how the amounts of them might change after receiving SL-401, or might be related to how well SL-401 does or does not function against the cancer.

Objective

Primary Objectives: The primary objectives are to determine the maximum tolerated dose (MTD), or the maximum tested dose where multiple dose-limiting toxicities (DLTs) are not observed, of SL-401, and to characterize the safety profile of SL-401 at the MTD or maximum tested dose. Secondary Objectives: The secondary objectives are to characterize the anti-tumor activity, pharmacokinetics (PK), and immunogenicity of SL-401.

Inclusion Criteria

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  • Diagnosis of AML or BPDCN according to WHO classification (AML; excluding acute promyelocytic leukemia [APL, FAB M3]) or confirmed by hematopathology (BPDCN)
  • Must meet one of the following (a) or (b) or (c): (a) Has evidence of persistent or recurrent AML in the peripheral blood and/or bone marrow that is refractory to, or has relapsed from, their most recent prior line of treatment. (b) Has previously untreated AML and is considered to be at high risk for disease progression and/or is unlikely to derive more than transient benefit from standard therapy by having at least one of the following: Treatment-related AML, except if it is associated with favorable cytogenetics and not a candidate for SCT in their current disease site; AML with antecedent hematological disease and not a candidate for SCT. (c) Has histological and/or cytological evidence of BPDCN.
  • ≥ 18 years old.
  • Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 0-2.
  • Have adequate baseline organ function, including cardiac, renal, and hepatic function.
  • Women of child bearing potential (WOCBP), have had a negative serum or urine pregnancy test within 1 week prior to treatment.
  • Has signed informed consent prior to initiation of any study-specific procedures or treatment.
  • Able to adhere to the study visit schedule and other protocol requirements, including follow-up for survival assessment.
  • Males and females agree to use acceptable contraceptive methods for the duration of time on the study, and continue to use acceptable contraceptive methods for 2 months after the last infusion of SL-401.

  • Exclusion Criteria

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  • Diagnosis of APL-(FAB M3).
  • Have persistent clinically significant toxicities Grade ≥ 2 from previous chemotherapy (excluding alopecia, nausea, fatigue, and liver function tests.
  • Have received treatment with chemotherapy, wide-field radiation, or biologic therapy within 14 days of study entry.
  • Have received treatment with another investigational agent within 14 days of study entry.
  • Previously received treatment with SL-401.
  • Have an active malignancy and/or cancer history (excluding AML, BPDCN, or antecedent MDS) that may confound the assessment of the study endpoints. Patients with a past cancer history (within 2 years of entry) with substantial potential for recurrence and/or ongoing active malignancy must be discussed with the Sponsor before study entry. Patients with the following neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ, cervical intraepithelial neoplasia, organ-confined prostate cancer with no evidence of progressive disease.
  • Clinically significant cardiovascular disease (e.g., uncontrolled or any NYHA Class 3 or 4 congestive heart failure, uncontrolled angina, history of myocardial infarction, unstable angina or stroke within 6 months prior to study entry, uncontrolled hypertension or clinically significant arrhythmias not controlled by medication).
  • Uncontrolled, clinically significant pulmonary disease (e.g., COPD, pulmonary hypertension) that in the opinion of the investigator would put the patient at significant risk for pulmonary complications during the study.
  • Known active or suspected CNS leukemia. If suspected, CNS leukemia should be ruled out with relevant imaging and/or examination of cerebrospinal fluid.
  • Receiving immunosuppressive therapy - with the exception of low-dose prednisone (≤ 10 mg/day) - for treatment or prophylaxis of graft-versus-host disease (GVHD). If the patient has been on immunosuppressive treatment or prophylaxis for GVHD, the treatment(s) must have been discontinued at least 14 days prior to study treatment and there must be no evidence of Grade ≥ 2 GVHD.
  • Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, disseminated intravascular coagulation, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant or breast feeding.
  • Known positive status for human immunodeficiency virus (HIV) active or chronic Hepatitis B or Hepatitis C.
  • Oxygen-dependent.
  • Any medical condition which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities.
  • The patient has AML and requires more than 1g per day of hydroxyurea. (Hydroxyurea is permitted at doses of 1g per day or less).