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New treatment option for Blastic Plasmacytoid Dendritic Cell Neoplasm
Official title Venetoclax, SL-401, and Chemotherapy for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm
ClinicalTrials.gov ID: NCT04216524
What this study is testing
What is Cyclophosphamide?
Cyclophosphamide is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for blastic plasmacytoid dendritic cell neoplasm.
Also referred to as (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate.
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 phase II trial studies how well venetoclax, SL-401, and chemotherapy works in treating patients with blastic plasmacytoid dendritic cell neoplasm. Venetoclax may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
- Phase 2: a mid-size study of how well it works
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
- Treatment naïve or relapsed refractory patients with histologically confirmed diagnosis of blastic plasmacytoid dendritic cell neoplasm (BPDCN) per...
- Front line participants may have received emergent chemotherapy prior to study enrollment:
- One prior cycle of SL-401, or other BPDCN-directed therapy, will be allowed prior to entering the study.
- Prior or concomitant doses of ARA-C (cytarabine) or Hydroxyurea are allowed on before or during the study for proliferative disease due to BPDCN.
- Relapsed/refractory participants may have received at least one prior cycle of therapy.
You likely can't join if
- Participants is pregnant or breastfeeding
- Known active hepatitis B or C infection, or known seropositivity for human immunodeficiency virus (HIV)
- Major surgery or radiation therapy within 14 days prior to the first study dose
- Symptomatic or untreated leptomeningeal disease or spinal cord compression
- Participants with active heart disease (New York Heart Association (NYHA) class 3-4 as assessed by history and physical examination, unstable...
- Malabsorption syndrome or other conditions that preclude enteral route of administration
See the full eligibility criteria
- Treatment naïve or relapsed refractory patients with histologically confirmed diagnosis of blastic plasmacytoid dendritic cell neoplasm (BPDCN) per 2016 WHO criteria
- Front line participants may have received emergent chemotherapy prior to study enrollment:
- One prior cycle of SL-401, or other BPDCN-directed therapy, will be allowed prior to entering the study.
- Prior or concomitant doses of ARA-C (cytarabine) or Hydroxyurea are allowed on before or during the study for proliferative disease due to BPDCN.
- Relapsed/refractory participants may have received at least one prior cycle of therapy.
- Age ≥ 18 years
- ECOG performance status 0, 1, or 2 (see APPENDIX B)
- 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 but \< 3x ULN, and thought to be elevated due to Gilbert's disease or the patient's BPDCN, the subject may be eligible but must discuss with the PI)
- 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 and men enrolled on this protocol must agree to use adequate contraception for the duration of study participation and for 2 months after completion VEN administration. Acceptable birth...
- Birth control pills or injections
- Intrauterine devices (IUDs)
- Double-barrier methods for example condom in combination with spermicide. Males should not donate sperm while on study and for at least 8 weeks after the last dose of SL-401.
- Left ventricular ejection fraction ≥ institutional lower limit of normal by MUGA scan or echocardiogram within 30 days of first protocol treatment.
- Participants is pregnant or breastfeeding
- Known active hepatitis B or C infection, or known seropositivity for human immunodeficiency virus (HIV)
- Major surgery or radiation therapy within 14 days prior to the first study dose
- Symptomatic or untreated leptomeningeal disease or spinal cord compression
- Participants with active heart disease (New York Heart Association (NYHA) class 3-4 as assessed by history and physical examination, unstable angina/stroke/myocardial infarction within the last 6 months)
- Malabsorption syndrome or other conditions that preclude enteral route of administration
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risk associated with study participation or investigational product...
The study team makes the final eligibility decision.
Where it's taking place
- 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 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.