SL-401 in Combination With Azacitidine or Azacitidine/Venetoclax in Acute Myeloid Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS) or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
Phase 1 Study of SL-401 in Combination With Azacitidine and Venetoclax in Relapsed/Refractory Acute Myeloid Leukemia (AML) and in Treatment-Naive Subjects With AML Not Eligible for Standard Induction and in Subjects With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) or SL-401 in Combination With Azacitidine in Subjects With High-Risk Myelodysplastic Syndrome (MDS)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
This research study is studying a drug as a possible treatment for diagnosis of AML, BPDCN and high-risk MDS. The interventions involved in this study are: * SL-401 * Azacitidine * Venetoclax
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
Inclusion Criteria: Histologically confirmed diagnosis of acute myeloid leukemia (AML) \[Cohort B\] or myelodysplastic syndrome (MDS) \[Cohort A\] or BPDCN \[Cohort C\] per 2016 WHO criteria CD123 / IL3RA expression on the subject's AML or MDS blasts or BPDCN cells 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) \[Cohort B\] OR Age \>= 18 years with treatment-naïve AML who decline intensive induction chemotherapy or who are unfit due to co-morbidity or other factors (see APPENDIX A for unfitness definitions) (hydroxyurea is not considered a prior treatment regimen) \[Cohort B\] OR Age \>= 18 years with MDS and \> 10% myeloblasts in the bone marrow \[Cohort A\] OR Age \>= 18 years with relapsed or refractory BPDCN (hydroxyurea is not considered a prior treatment regimen) \[Cohort C\] 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 \< 1.5x ULN (if thought to be \> 1.5x 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 \[Cohorts B and C\] WBC \< 20,000 / uL on day of first therapy, cytoreduction may be achieved using hydroxyurea 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 protocol treatment. 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 protocol treatment. Exclusion Criteria: Prior treatment with venetoclax \[Cohorts B or C\], unless it was last taken \>2 months before protocol therapy Diagnosis of acute promyelocytic leukemia Received treatment with chemotherapy, radiation, or biologic cancer therapy within 14 days of first protocol treatment, except for intrathecal chemotherapy. Prior and concurrent hydroxyurea is permitted. Hematopoietic stem cell transplantation (HSCT) within 60 days of screening or active graft versus-host-disease Active CNS involvement by AML or BPDCN. Screening lumbar puncture (LP) required for patients with BPDCN. If history of treated CNS involvement, must have had two consecutive negative LPs since last CNS involvement, which may include the screening LP 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, azacitidine, and venetoclax (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, azacitidine, and venetoclax. Patients with uncontrolled infection shall not be enrolled until infection is treated and brought under control. Patients with active infection are permitted to enroll provided that the infection is controlled \[Cohorts B and C\] Patients with gastrointestinal (GI) tract disease causing the inability to take oral medication, malabsorption syndrome, a requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's disease, ulcerative colitis) \[Cohorts B and C\] Patients on strong CYP3A inducers within 7 days of first dose of study treatment.
Study sites (3)
CA
- City of Hope · Duarte, CA 91010Anthony Stein, MD · Study contact · 626-359-8111 · AStein@coh.orgAnthony Stein, MD · Principal investigatorMore trials in Duarte
MA
- Dana Farber Cancer Institute · Boston, MA 02215Andrew Lane, MD, PhD · Study contact · andrew_lane@dfci.harvard.eduVeronica Zehnder · Study contact · veronica_zehnder@dfci.harvard.eduAndrew Lane, MD, PhD · Principal investigatorMore trials in Boston
TX
- MD Anderson Cancer Center · Houston, TX 77030Naveen Pemmaraju, MD · Study contact · 713-792-4956 · npemmaraju@mdanderson.orgNaveen Pemmaraju, MD · Principal investigatorMore trials in Houston