Venetoclax, SL-401, and Chemotherapy for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm
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| ClinicalTrials.gov Identifier: NCT04216524 |
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Recruitment Status :
Recruiting
First Posted : January 2, 2020
Last Update Posted : December 2, 2021
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Sponsor:
M.D. Anderson Cancer Center
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
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Brief Summary:
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. SL-401 is a recombinant protein consisting of IL-3 linked to a toxic agent called DT. IL-3 attaches to IL-3 receptors on tumor cells in a targeted way and delivers DT to kill them. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax and SL-401 with chemotherapy may be an effective treatment for patients with blastic plasmacytoid dendritic cell neoplasm.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Blastic Plasmacytoid Dendritic Cell Neoplasm | Drug: Cyclophosphamide Drug: Cytarabine Drug: Dexamethasone Drug: Doxorubicin Drug: Mercaptopurine Drug: Methotrexate Drug: Methylprednisolone Drug: Prednisone Biological: Rituximab Biological: Tagraxofusp-erzs Drug: Venetoclax Drug: Vincristine | Phase 2 |
Show detailed description
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 40 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase 2 Clinical Trial for Comprehensive Treatment Program for Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN): Tagraxofusp (SL-401) in Combination With HCVAD/Mini-CVD and VENETOCLAX |
| Actual Study Start Date : | May 29, 2020 |
| Estimated Primary Completion Date : | December 31, 2026 |
| Estimated Study Completion Date : | December 31, 2026 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Venetoclax
| Arm | Intervention/treatment |
|---|---|
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Experimental: Treatment (SL-401, venetoclax, chemotherapy)
See detailed description.
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Drug: Cyclophosphamide
Given IV
Other Names:
Drug: Cytarabine Given IT or IV
Other Names:
Drug: Dexamethasone Given PO or IV
Other Names:
Drug: Doxorubicin Given IV
Other Names:
Drug: Mercaptopurine Given PO
Other Names:
Drug: Methotrexate Given IT, IV, or PO
Other Names:
Drug: Methylprednisolone Given IV
Other Names:
Drug: Prednisone Given PO
Other Names:
Biological: Rituximab Given IV
Other Names:
Biological: Tagraxofusp-erzs Given IV
Other Names:
Drug: Venetoclax Given PO
Other Names:
Drug: Vincristine Given IV
Other Names:
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Primary Outcome Measures :
- Progression free survival (PFS) [ Time Frame: Up to 6 years ]The median PFS time will be estimated by Bayesian posterior estimates. Estimated using the Kaplan-Meier method.
- Incidence of adverse events [ Time Frame: Up to 6 years ]Will be reported by type, frequency and severity. Highest toxicity grades per patient per course will be tabulated for selected adverse events and laboratory measurements.
- Overall response rate [ Time Frame: Up to 6 years ]Overall response rate along with complete remission and complete remission with incomplete hematologic recovery will be estimated along with 95% confidence interval.
- Rate of stem cell transplant [ Time Frame: Up to 6 years ]The response rate will be compared between subgroups (e.g. minimal residual disease negativity, etc.) by Fisher's exact test, and Wilcoxon rank test will be used to compare the patient clinical information (e.g., protein expression) between subgroups such as response and non-response.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically confirmed diagnosis of blastic plasmacytoid dendritic cell neoplasm (BPDCN) per 2016 World Health Organization (WHO) criteria
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Patients 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 aspacytarabine (ARA-C [cytarabine]) or hydroxyurea are allowed on before or during the study for proliferative disease due to BPDCN
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Albumin >= 3.2 g/dL (in the absence of receipt of intravenous albumin in the previous 72 hours)
- Serum creatinine < 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x ULN
- Total bilirubin < 1.5 x ULN (if total bilirubin is > 1.5 x but < 3 x 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 principal investigator [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 control methods allowed to be used while on study include: 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 multi-gated acquisition (MUGA) scan or echocardiogram within 30 days of first protocol treatment
Exclusion Criteria:
- Patient 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
- Systemic chemotherapy/radiotherapy/investigational therapy within 14 days (with the exception of hydroxyurea and/or dexamethasone, or one dose of cytarabine) prior to starting therapy
- Symptomatic or untreated leptomeningeal disease or spinal cord compression
- Patients 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)
- Prior treatment with VEN
- 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 administration or may interfere with the interpretation of study results and/or would make the patient inappropriate for enrollment into this study
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04216524
Contacts
| Contact: Naveen Pemmaraju | 713-792-4956 | npemmaraju@mdanderson.org |
Locations
| United States, Texas | |
| M D Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Naveen Pemmaraju 713-792-4956 npemmaraju@mdanderson.org | |
| Principal Investigator: Naveen Pemmaraju | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Naveen Pemmaraju | M.D. Anderson Cancer Center |
Additional Information:
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT04216524 |
| Other Study ID Numbers: |
2019-0587 NCI-2019-08358 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 2019-0587 ( Other Identifier: M D Anderson Cancer Center ) P30CA016672 ( U.S. NIH Grant/Contract ) |
| First Posted: | January 2, 2020 Key Record Dates |
| Last Update Posted: | December 2, 2021 |
| Last Verified: | November 2021 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Neoplasms Cytarabine Dexamethasone Dexamethasone acetate Prednisone Methylprednisolone Methylprednisolone Acetate Methylprednisolone Hemisuccinate Prednisolone Prednisolone acetate Cortisone Cyclophosphamide Rituximab Doxorubicin Liposomal doxorubicin |
Methotrexate Vincristine Daunorubicin Venetoclax Mercaptopurine Antineoplastic Agents, Immunological Antibodies Immunoglobulins Antibodies, Monoclonal Prednisolone hemisuccinate Prednisolone phosphate BB 1101 Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |