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Slow enrollment
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Determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of VIP152 as monotherapy or in combination with a BTKi in patients with Chronic Lymphocytic Leukemia (CLL) or Richter Syndrome
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monotherapy of VIP152 | Experimental | Investigating VIP152 in a monotherapy cohort in patients with high-risk CLL and Richter Syndrome |
|
| VIP152 in combination with BTKi | Experimental | Investigating VIP152 in combination with a BTKi in patients with CLL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIP152 | Drug | Weekly IV infusion for 28 day cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | Number of participants with adverse events as a measure safety and tolerability of high risk CLL and RS in monotherapy | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | Tumor response evaluation based on the response criteria as applicable for CLL and Richter Syndrome | Up to 3 years |
| Duration of Response | Time at Which Response Criteria are Met for Complete Response or Partial Response (Whichever Occurs First) Until the First Date of Recurrence, Progression or Death per applicable response criteria |
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Inclusion Criteria:
PART1
or
PART2
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vincerx Study Director | Vincerx Pharma, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45219 | United States | ||
| The Ohio State University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37882668 | Derived | Frigault MM, Mithal A, Wong H, Stelte-Ludwig B, Mandava V, Huang X, Birkett J, Johnson AJ, Izumi R, Hamdy A. Enitociclib, a Selective CDK9 Inhibitor, Induces Complete Regression of MYC+ Lymphoma by Downregulation of RNA Polymerase II Mediated Transcription. Cancer Res Commun. 2023 Nov 9;3(11):2268-2279. doi: 10.1158/2767-9764.CRC-23-0219. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 10, 2024 | |
| Reset | Oct 2, 2024 | |
| Release | Nov 1, 2024 |
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| BTKi | Drug | Taken per local prescribing information |
|
| Up to 3 years |
| Progression Free Survival | Number of Participants Without Disease Progression per iwCLL guidelines for CLL & Lugano Classification for NHL | Up to 3 years |
| Assessment of pharmacokinetics (PK) of VIP152 | Maximum observed drug concentration in measured administration (Cmax) of VIP152 | Cycle 1 Day 1 through Cycle 2 Day 1 |
| Time To Next Treatment | time from first dose to the initiation of next dose or death | Up to 3 years |
| Columbus |
| Ohio |
| 43210 |
| United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | United States |
| Pratia MCM Krakow | Krakow | 30-510 | Poland |
| Reset | Dec 13, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 10, 2024 | Oct 2, 2024 | |||
| Nov 1, 2024 | Dec 13, 2024 |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D006402 | Hematologic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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