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New treatment option for Acute Myeloid Leukemia
Official title 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)
ClinicalTrials.gov ID: NCT03113643
What this study is testing
What is Azacitidine?
Azacitidine is an investigational medicine, being studied as a potential treatment for acute myeloid leukemia.
Also referred to as Vidaza.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically confirmed diagnosis of acute myeloid leukemia (AML) [Cohort B] or myelodysplastic syndrome (MDS) [Cohort A] or BPDCN [Cohort C] per...
- 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]
- Age \>= 18 years with treatment-naïve AML who decline intensive induction chemotherapy or who are unfit due to co-morbidity or other factors (see...
- Age \>= 18 years with MDS and \> 10% myeloblasts in the bone marrow [Cohort A]
You likely can't join if
- 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...
- 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...
- Known positive status for HIV infection; known active hepatitis B or hepatitis C infection
See the full eligibility 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]
- 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...
- Age \>= 18 years with MDS and \> 10% myeloblasts in the bone marrow [Cohort A]
- 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 due to Gilbert's disease or the patient's AML, must discuss with the PI) Creatine phosphokinase...
- [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.
- 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...
- 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...
- 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...
- 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...
- 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...
- [Cohorts B and C] Patients on strong CYP3A inducers within 7 days of first dose of study treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Boston, Massachusetts, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Boston, Massachusetts, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.