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| ID | Type | Description | Link |
|---|---|---|---|
| 000633-C |
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Background:
Non-Hodgkin lymphomas are blood cancers that can be difficult to treat. They can also return after treatment. Examples include diffuse large B-cell lymphoma (DLBCL) and peripheral T-cell lymphoma (PTCL). More effective treatments are needed for these diseases.
Objective:
To test the safety of a study drug (Enitociclib (VIP152) in combination with other drugs used to treat people with aggressive blood cancers.
Eligibility:
People aged 18 years or older diagnosed with DLBCL, PTCL, or related blood cancers. The cancers must have either not responded to treatment or returned after treatment.
Design:
Participants will undergo screening. They will have a physical exam with scans and blood and urine tests. They will have imaging scans and tests of their heart function. They may also provide a bone marrow aspiration or biopsy.
Participants may provide a saliva sample for deoxyribonucleic acid (DNA) testing.
Participants will receive study treatment in cycles. Each cycle is 21 days.
Participants will take two drugs by mouth at home once a day on days 1-10 of each cycle.
On days 2 and 9 they will come to the clinic to receive VIP152. This drug will be administered through a small plastic tube with a needle placed in a vein.
On day 11, participants will receive a fourth medication as an injection under the skin. They will rest and recover on days 12-21.
Screening tests will be repeated periodically throughout the study period.
Treatment will continue for up to 24 cycles.
Participants will have follow-up visits for up to 5 years.
Background:
Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1/Phase 1: Arm 1 Dose Escalation | Experimental | Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax. |
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| Cohort 2/Phase 2: Arm 2 Dose Expansion | Experimental | Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at the recommended phase II dose (RP2D) with prednisone at fixed doses. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vysis LSI MYC Break Apart Rearrangement Probe Kit | Device | MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 2: Complete Response (CR) Rate | CR rate is defined as the percentage of participants who meet criteria for complete response (CR) as measured by the Lugano Classification Response Criteria for Non-Hodgkin lymphoma (NHL). Complete response is defined as target nodes/nodal masses that regress to <1.5 cm in longest transverse diameter of a lesion (LDi). | 24 cycles (i.e., 72 weeks) |
| Phase 1: Number of Solicited and/or Non-solicited Non-serious Adverse Events (AE's) With Grade | Number of non-serious adverse events (AE's) with grade was assessed by the CTCAEv5.0. A non-serious adverse event is any untoward medical occurrence that does not meet seriousness criteria. Grade 1 is mild. Grade 2 is moderate. Grade 3 is serious. Grade 4 if life-threatening. | Up to 18 weeks. |
| Phase 1: Number of Solicited and/or Unsolicited Serious Adverse Events (SAE's) With Grade | Number of serious adverse events (SAE's) with grade was assessed by the CTCAEv5.0. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is fatal. | Up to 18 weeks. |
| Phase 1: Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) | The MTD/RP2D is the dose level at which no more than 1 of up to 6 participants experience dose limiting toxicity (DLT) during the DLT evaluation window(s), or the dose below that at which at least 2 (of ≤6) participants have DLT. A DLT (dose-limiting toxicity) is defined as a grade 3 or higher adverse event (AE) that occurs in the dose-escalation cohort within the first 22 days after initiation of VVIP (i.e., Cycle 1, Day 1 to Cycle 2, Day 1 pre-dose) and is considered related to study drug (i.e., VIP152, venetoclax, and/or prednisone) or a treatment delay of cycle 2 of > 7 days for hematologic or nonhematologic toxicities. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Progression-free Survival (PFS) | PFS is defined as the duration of time from the date of study enrollment until the date of disease relapse, disease progression, death, or last follow-up, whichever occurs first, using the Kaplan-Meier method. Response was assessed by the Lugano Classification Response Criteria for Non-Hodgkin lymphoma (NHL). Disease progression is defined as an increase of ≥ 50% from the product of the perpendicular diameter (PPD) nadir and an increase in longest transverse diameter of a lesion (LDi) or shortest axis perpendicular diameter (SDi) from nadir of >0.5 cm for lesions <2 cm or >1.0 cm for lesions >2 cm. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
INCLUSION CRITERIA:
Participants must have a histologically or cytologically confirmed lymphoid malignancy as listed below, confirmed by the Laboratory of Pathology, National Cancer Institute (NCI), as follows:
Relapsed and/or refractory disease, as defined below:
Must have evaluable disease by clinical exam (i.e., palpable lymphadenopathy, measurable skin lesions, etc.), laboratory assessment (i.e., disease involvement of bone marrow or peripheral blood by morphology, cytology or flow cytometry), and/or imaging (measurable lymph nodes, masses, or bony lesions on computed tomography (CT) or magnetic resonance imaging (MRI) and/or evaluable FD-Gavid lesions on positron emission tomography (PET).
NOTE: Lesions that have been irradiated cannot be included in the tumor assessment unless unequivocal tumor progression has been documented in these lesions after radiation therapy.
Age >= 18 years
Eastern Cooperative Oncology Group (ECOG) performance status <= 2
Adequate organ and marrow function as defined below unless dysfunction is secondary to disease:
OR
--Creatinine clearance**** >= 40 mL/min/1.73 m^2 for participants with creatinine levels above 2 mg/dL
Creatinine clearance (Cr Cl) will be calculated with the use of the 24-hour creatinine clearance or modified
Cockcroft-Gault equation (eCCR; with the use of ideal body mass [IBM] instead of mass): (140 - Age) x IBM (kg) x [0.85 if female] / 72 x serum creatinine (mg/dL)
*Red blood cell (RBC) transfusions and use of granulocyte colony-stimulating factor (G-CSF) will be allowed in order to meet eligibility parameters.
Total bilirubin must be <= 3 X institutional ULN for eligibility even if secondary to disease.
AST(SGOT)/ALT(SGPT) must be <= 5 X institutional ULN for eligibility even if secondary to disease.
Creatinine clearance must be >= 30 mL/min for eligibility even if secondary to disease.
Negative serum or urine pregnancy test must be obtained within 7 days before the first dose of study drug in individuals of childbearing potential. Postmenopausal individuals, as defined below, are allowed to enroll without a pregnancy test:
--Age >50 years with amenorrhea for at least 12 months or
--Age <=50 years with 6 months of spontaneous amenorrhea and follicle stimulating hormone (FSH) level within postmenopausal range (>40 mIU/mL) OR
Individuals of reproductive potential must agree to use highly effective contraception when sexually active. This applies for the period between signing of the informed consent and 90 days after the last administration of study drug.
Highly effective contraception includes:
In addition, participants must agree to use condoms.
EXCLUSION CRITERIA:
-The following restrictions apply to current or prior anti-cancer treatment, prior to the first dose of study drug:
NOTE: Exceptions to this include events not considered to place the participant at unacceptable risk of participation in the opinion of the principal investigator (PI) (e.g., alopecia).
-Participants requiring the following agents within 14 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of venetoclax and VIP152 are excluded:
NOTE: Moderate CYP3A inhibitors and inducers should be used with caution for participants in the dose-expansion cohorts and an alternative medication used, whenever possible.
Known allergy to both xanthine oxidase inhibitors and rasburicase; or known hypersensitivity to any of the study drugs
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 2 weeks prior to first dose of study drug
HIV-positive participants
Active cytomegalovirus (CMV) infection as determined by a positive CMV polymerase chain reaction (PCR)
Active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection based on PCR assay; prior SARs-CoV-2 infection allowed if completely recovered from infection and negative PCR testing
Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis; as well as active infection with hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) except as noted above in inclusion criteria
Malabsorption syndrome or other condition that precludes enteral route of administration
History of other active malignancy requiring therapy that could affect compliance with the protocol or interpretation of results
Symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
Left ventricular ejection fraction (LVEF) < 45%
Clinically relevant findings on electrocardiogram (ECG) such as a second- or third-degree AV block or prolongation of the heart-rate corrected QT interval (Qtc) (Fridericia) over 470 msec (participants with atrioventricular (AV) block and pacemaker in place for >1 year and checked by a cardiologist within <6 months before the first dose of study drug, will not be excluded).
Uncontrolled intercurrent illness (including psychiatric) or social situations that may limit interpretation of results or that could increase risk to the participant
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| Name | Affiliation | Role |
|---|---|---|
| Christopher J Melani, M.D. | National Cancer Institute (NCI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | United States |
| 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. |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. In addition, all large-scale genomic sequencing data will be shared with subscribers to the database of Genotypes and Phenotypes (dbGaP).
Clinical data will be available during the study and indefinitely. Genomic data will be available once genomic data are uploaded per protocol Genomic Data Sharing (GDS) plan for as long as database is active.
Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI). Genomic data will be made available via the database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 1 Enitociclib (VIP152) 15 mg & Venetoclax 600 mg | Enitociclib (VIP152), Venetoclax and prednisone (VVIP)-VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax. Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study. Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL), R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 20, 2025 |
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| Venetoclax | Drug | Dose Escalation: Administered orally, days 1-10, per specified dose level; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity. Dose Expansion: Administered orally, days 1-10, at the recommended phase 2 dose (RP2D); every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity |
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| VIP152 | Drug | Dose Escalation: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity. Dose Expansion: Administered intravenously, days 2 and 9, at the recommended phase 2 dose (RP2D); every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity. |
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| Prednisone | Drug | Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity |
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| PET | Diagnostic Test | Screening, pre-cycle 7, pre-cycle 13, and at end-of-treatment (post-cycle 24). |
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| EKG | Diagnostic Test | Screening |
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| ECHO | Diagnostic Test | Screening |
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| CT neck chest, abdomen, and pelvis | Diagnostic Test | Screening, pre-cycle 2, pre-cycle 3, pre-cycle 5, pre-cycle 7, pre-cycle 9, pre-cycle 11, pre-cycle 13, pre-cycle 15, pre-cycle 17, pre-cycle 19, pre-cycle 21, pre-cycle 23, and at end-of-treatment (post cycle 24). |
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| MRI | Diagnostic Test | As indicated. Screening, pre-cycle 2, pre-cycle 3, pre-cycle 5, pre-cycle 7, pre-cycle 9, pre-cycle 11, pre-cycle 13, pre-cycle 15, pre-cycle 17, pre-cycle 19, pre-cycle 21, pre-cycle 23, and at end-of-treatment (post cycle 24). |
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| Bone marrow aspiration/Biopsy | Procedure | Baseline, post-cycle 6, post-cycle 12, and at end-of-treatment (post-cycle 24). |
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| First 22 days (i.e., cycle 1, day 1 to cycle 2, day 1 pre-dose) |
| Phase 1: Number of Participants With Grade 4 Neutropenia Dose-Limiting Toxicity (DLT) | A DLT (dose-limiting toxicity) is defined as a grade 3 or higher adverse event (AE) that occurs in the dose-escalation cohort within the first 22 days after initiation of VVIP (i.e., Cycle 1, Day 1 to Cycle 2, Day 1 pre-dose) and is considered related to study drug (i.e., VIP152, venetoclax, and/or prednisone) or a treatment delay of cycle 2 of > 7 days for hematologic or nonhematologic toxicities. | First 22 days (i.e., cycle 1, day 1 to cycle 2, day 1 pre-dose) |
| Assessed from date of study enrollment until time of disease relapse, disease progression, death, or last follow-up, whichever comes first, up to 8 months |
| Phase 1: Time to Response (TTR) | TTR is defined as the time from the start of the treatment until time of first objective response using the Kaplan-Meier method. Median, assessed during therapy and after completion of therapy from initiation of therapy to first response every (q)3, 4, 6 and 12 months for post-treatment years 1, 2, 3, and 4-5, respectively, for up to 5 years after the last participant has enrolled on study. Response was measured by the Lugano Classification Response Criteria for Non-Hodgkin lymphoma (NHL). Complete response is target nodes/nodal masses that regress to <1.5 cm in longest transverse diameter of a lesion. Partial response is ≥ 50% decrease in sum of the product of the perpendicular diameters for multiple lesions (SPD) of up to 6 target measurable nodes and extranodal sites. Disease progression is an increase by ≥ 50% from progressive disease progression (PPD) nadir and an increase in longest transverse diameter of a lesion (LDi) or shortest axis perpendicular diameter (SDi) from nadir. | Time from the date of study enrollment during therapy, after completion of therapy from initiation of therapy to first response, up to 5 months |
| Phase 1: Duration of Response (DOR) | DOR is defined as the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented using the Kaplan-Meier method. Response was measured by the Lugano Classification Response Criteria for Non-Hodgkin lymphoma (NHL). Complete response is target nodes/nodal masses that regress to <1.5 cm in longest transverse diameter of a lesion (LDi). Partial response is ≥ 50% decrease in sum of the product of the perpendicular diameters for multiple lesions (SPD) of up to 6 target measurable nodes and extranodal sites. Disease progression is an increase by ≥ 50% from progressive disease progression (PPD) nadir and an increase in longest transverse diameter of a lesion (LDi) or shortest axis perpendicular diameter (SDi) from nadir of >0.5 cm for lesions <2 cm or >1.0 cm for lesions >2 cm. | Time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 months |
| Phase 1: Overall Response Rate (ORR) | ORR is defined as the proportion of participants who meet criteria for complete response (CR) or partial response (PR) as measured by the Lugano Classification Response Criteria for Non-Hodgkin lymphoma (NHL). Complete response is target nodes/nodal masses that regress to <1.5 cm in longest transverse diameter of a lesion (LDi). Partial response is ≥ 50% decrease in sum of the product of the perpendicular diameters for multiple lesions (SPD) of up to 6 target measurable nodes and extranodal sites. | 24 cycles (i.e., 72 weeks) |
| Phase 1: Overall Survival (OS) | OS is defined as the time from the date of study enrollment until death from any cause, or last follow-up, whichever occurs first, assessed using the Kaplan-Meier method. | Assessed from the date of study enrollment until death from any cause, or last follow-up, whichever occurs first, up to a maximum of 32 months. |
| Phase 1: Event-free Survival (EFS) | EFS is defined as the time from the date of study enrollment until time of disease relapse, disease progression, alternative therapy for lymphoma given (such as radiation), death, or last follow-up, whichever occurs first, assessed using the Kaplan-Meier method. Disease progression is an increase by ≥ 50% from progressive disease progression (PPD) nadir and an increase in longest transverse diameter of a lesion (LDi) or shortest axis perpendicular diameter (SDi) from nadir of >0.5 cm for lesions <2 cm or >1.0 cm for lesions >2 cm as assessed by the Lugano Classification Response Criteria for Non-Hodgkin lymphoma (NHL). | Assessed from the date of study enrollment until time of disease relapse, disease progression, alternative therapy for lymphoma given (such as radiation), death, or last follow-up, whichever occurs first, assessed up to 8 months |
| 24 cycles (i.e., 72 weeks) |
| FG001 | Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 2 Enitociclib(VIP152) 22.5 mg & Venetoclax 600 mg | Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax. Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study. Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL) |
| FG002 | Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 3 Enitociclib (VIP152) 30 mg & Venetoclax 600 mg | Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax. Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study. Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL) |
| FG003 | Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 4 Enitociclib (VIP152) 30mg & Venetoclax 800mg | No participants were enrolled in cohort 1/phase 1:Arm 1 dose escalation dose level 4. VIP152, Venetoclax, & prednisone-Enitociclib(VIP152) & venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose & recommended phase II dose of VIP152 & venetoclax. Vysis LSI MYC Break Apart Rearrangement Probe Kit:MYC rearrangement fluorescence in situ hybridization testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research, National Cancer Institute. This kit is not Food and Drug Administration approved. It is being used as a treatment determining in-vitro diagnostic device in this study. Venetoclax:Administered orally, days 1-10, per specified dose level;every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity. VIP152:Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity. Prednisone:Administered orally, days 1-10, at a dose of 100mg;every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity. Cohort 1 Dose Escalation:participants with either refractory/relapsed (R/R)MYC-rearranged diffuse large B-cell lymphoma/high-grade B-cell lymphoma, R/R non-germinal center B-Cell diffuse large B-cell lymphoma(no MYC rearrangement) &/or R/R peripheral T-cell lymphoma. |
| FG004 | Cohort 2/Phase 2: Arm 2 Dose Expansion With Enitociclib (VIP152) & Venetoclax | No participants were enrolled in cohort 2/phase 2: Arm 2 dose expansion. Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at the recommended phase II dose (RP2D) with prednisone at fixed doses. Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study. Venetoclax: Administered orally, days 1-10, at the recommended phase 2 dose (RP2D); every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity VIP152: Administered intravenously, days 2 and 9, at the recommended phase 2 dose (RP2D); every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity Participants with refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL) for Phase 2 dose expansion. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 1 Enitociclib (VIP152) 15 mg & Venetoclax 600 mg | Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax. Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study. Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL), R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL) |
| BG001 | Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 2 Enitociclib(VIP152) 22.5 mg & Venetoclax 600 mg | Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax. Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study. Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL) |
| BG002 | Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 3 Enitociclib (VIP152) 30 mg & Venetoclax 600 mg | Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax. Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study. Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL) |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Phase 2: Complete Response (CR) Rate | CR rate is defined as the percentage of participants who meet criteria for complete response (CR) as measured by the Lugano Classification Response Criteria for Non-Hodgkin lymphoma (NHL). Complete response is defined as target nodes/nodal masses that regress to <1.5 cm in longest transverse diameter of a lesion (LDi). | This outcome measure was not done because no participants were enrolled in the phase 2 cohort. | Posted | Number | 95% Confidence Interval | Percentage of participants | 24 cycles (i.e., 72 weeks) |
|
| ||||||||||||||||
| Primary | Phase 1: Number of Solicited and/or Non-solicited Non-serious Adverse Events (AE's) With Grade | Number of non-serious adverse events (AE's) with grade was assessed by the CTCAEv5.0. A non-serious adverse event is any untoward medical occurrence that does not meet seriousness criteria. Grade 1 is mild. Grade 2 is moderate. Grade 3 is serious. Grade 4 if life-threatening. | Posted | Number | adverse events | Up to 18 weeks. |
| |||||||||||||||||||
| Primary | Phase 1: Number of Solicited and/or Unsolicited Serious Adverse Events (SAE's) With Grade | Number of serious adverse events (SAE's) with grade was assessed by the CTCAEv5.0. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is fatal. | Posted | Number | Adverse events | Up to 18 weeks. |
| |||||||||||||||||||
| Primary | Phase 1: Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) | The MTD/RP2D is the dose level at which no more than 1 of up to 6 participants experience dose limiting toxicity (DLT) during the DLT evaluation window(s), or the dose below that at which at least 2 (of ≤6) participants have DLT. A DLT (dose-limiting toxicity) is defined as a grade 3 or higher adverse event (AE) that occurs in the dose-escalation cohort within the first 22 days after initiation of VVIP (i.e., Cycle 1, Day 1 to Cycle 2, Day 1 pre-dose) and is considered related to study drug (i.e., VIP152, venetoclax, and/or prednisone) or a treatment delay of cycle 2 of > 7 days for hematologic or nonhematologic toxicities. | Posted | Number | mg | First 22 days (i.e., cycle 1, day 1 to cycle 2, day 1 pre-dose) |
|
| ||||||||||||||||||
| Primary | Phase 1: Number of Participants With Grade 4 Neutropenia Dose-Limiting Toxicity (DLT) | A DLT (dose-limiting toxicity) is defined as a grade 3 or higher adverse event (AE) that occurs in the dose-escalation cohort within the first 22 days after initiation of VVIP (i.e., Cycle 1, Day 1 to Cycle 2, Day 1 pre-dose) and is considered related to study drug (i.e., VIP152, venetoclax, and/or prednisone) or a treatment delay of cycle 2 of > 7 days for hematologic or nonhematologic toxicities. | Posted | Count of Participants | Participants | First 22 days (i.e., cycle 1, day 1 to cycle 2, day 1 pre-dose) |
| |||||||||||||||||||
| Secondary | Phase 1: Progression-free Survival (PFS) | PFS is defined as the duration of time from the date of study enrollment until the date of disease relapse, disease progression, death, or last follow-up, whichever occurs first, using the Kaplan-Meier method. Response was assessed by the Lugano Classification Response Criteria for Non-Hodgkin lymphoma (NHL). Disease progression is defined as an increase of ≥ 50% from the product of the perpendicular diameter (PPD) nadir and an increase in longest transverse diameter of a lesion (LDi) or shortest axis perpendicular diameter (SDi) from nadir of >0.5 cm for lesions <2 cm or >1.0 cm for lesions >2 cm. | Posted | Median | 95% Confidence Interval | Months | Assessed from date of study enrollment until time of disease relapse, disease progression, death, or last follow-up, whichever comes first, up to 8 months |
| ||||||||||||||||||
| Secondary | Phase 1: Time to Response (TTR) | TTR is defined as the time from the start of the treatment until time of first objective response using the Kaplan-Meier method. Median, assessed during therapy and after completion of therapy from initiation of therapy to first response every (q)3, 4, 6 and 12 months for post-treatment years 1, 2, 3, and 4-5, respectively, for up to 5 years after the last participant has enrolled on study. Response was measured by the Lugano Classification Response Criteria for Non-Hodgkin lymphoma (NHL). Complete response is target nodes/nodal masses that regress to <1.5 cm in longest transverse diameter of a lesion. Partial response is ≥ 50% decrease in sum of the product of the perpendicular diameters for multiple lesions (SPD) of up to 6 target measurable nodes and extranodal sites. Disease progression is an increase by ≥ 50% from progressive disease progression (PPD) nadir and an increase in longest transverse diameter of a lesion (LDi) or shortest axis perpendicular diameter (SDi) from nadir. | Posted | Median | 95% Confidence Interval | Months | Time from the date of study enrollment during therapy, after completion of therapy from initiation of therapy to first response, up to 5 months |
| ||||||||||||||||||
| Secondary | Phase 1: Duration of Response (DOR) | DOR is defined as the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented using the Kaplan-Meier method. Response was measured by the Lugano Classification Response Criteria for Non-Hodgkin lymphoma (NHL). Complete response is target nodes/nodal masses that regress to <1.5 cm in longest transverse diameter of a lesion (LDi). Partial response is ≥ 50% decrease in sum of the product of the perpendicular diameters for multiple lesions (SPD) of up to 6 target measurable nodes and extranodal sites. Disease progression is an increase by ≥ 50% from progressive disease progression (PPD) nadir and an increase in longest transverse diameter of a lesion (LDi) or shortest axis perpendicular diameter (SDi) from nadir of >0.5 cm for lesions <2 cm or >1.0 cm for lesions >2 cm. | Posted | Median | 95% Confidence Interval | Months | Time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 months |
| ||||||||||||||||||
| Secondary | Phase 1: Overall Response Rate (ORR) | ORR is defined as the proportion of participants who meet criteria for complete response (CR) or partial response (PR) as measured by the Lugano Classification Response Criteria for Non-Hodgkin lymphoma (NHL). Complete response is target nodes/nodal masses that regress to <1.5 cm in longest transverse diameter of a lesion (LDi). Partial response is ≥ 50% decrease in sum of the product of the perpendicular diameters for multiple lesions (SPD) of up to 6 target measurable nodes and extranodal sites. | Posted | Number | 95% Confidence Interval | Proportion of participants | 24 cycles (i.e., 72 weeks) |
| ||||||||||||||||||
| Secondary | Phase 1: Overall Survival (OS) | OS is defined as the time from the date of study enrollment until death from any cause, or last follow-up, whichever occurs first, assessed using the Kaplan-Meier method. | Posted | Median | 95% Confidence Interval | Months | Assessed from the date of study enrollment until death from any cause, or last follow-up, whichever occurs first, up to a maximum of 32 months. |
| ||||||||||||||||||
| Secondary | Phase 1: Event-free Survival (EFS) | EFS is defined as the time from the date of study enrollment until time of disease relapse, disease progression, alternative therapy for lymphoma given (such as radiation), death, or last follow-up, whichever occurs first, assessed using the Kaplan-Meier method. Disease progression is an increase by ≥ 50% from progressive disease progression (PPD) nadir and an increase in longest transverse diameter of a lesion (LDi) or shortest axis perpendicular diameter (SDi) from nadir of >0.5 cm for lesions <2 cm or >1.0 cm for lesions >2 cm as assessed by the Lugano Classification Response Criteria for Non-Hodgkin lymphoma (NHL). | Posted | Median | Full Range | Months | Assessed from the date of study enrollment until time of disease relapse, disease progression, alternative therapy for lymphoma given (such as radiation), death, or last follow-up, whichever occurs first, assessed up to 8 months |
| ||||||||||||||||||
| Other Pre-specified | Phase 1: Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. | Posted | Count of Participants | Participants | 24 cycles (i.e., 72 weeks) |
|
All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1/Phase 1:Arm 1 Dose Escalation Dose Level 1 Enitociclib (VIP152) 15 mg and Venetoclax 600 mg | Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax. Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study. Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL), R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL) | 1 | 3 | 0 | 3 | 3 | 3 |
| EG001 | Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 2 Enitociclib(VIP152) 22.5 mg & Venetoclax 600 mg | Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax. Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study. Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL) | 2 | 3 | 1 | 3 | 3 | 3 |
| EG002 | Cohort 1/Phase 1:Arm 1 Dose Escalation Dose Level 3 Enitociclib (VIP152) 30 mg and Venetoclax 600 mg | Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax. Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study. Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL) | 1 | 2 | 1 | 2 | 2 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Lymph node pain | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Cytomegalovirus infection reactivation | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hyperphosphatemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other, Tinea corporis | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christopher J. Melani | National Cancer Institute | 240-760-6057 | christopher.melani@nih.gov |
| Jan 7, 2026 |
| Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 7, 2024 | Jan 3, 2025 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D008228 | Lymphoma, Non-Hodgkin |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| 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 |
| D009371 | Neoplasms by Site |
| D006402 | Hematologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C579720 | venetoclax |
| D011241 | Prednisone |
| D049268 | Positron-Emission Tomography |
| D004562 | Electrocardiography |
| D004452 | Echocardiography |
| D008279 | Magnetic Resonance Imaging |
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D004568 | Electrodiagnosis |
| D057791 | Cardiac Imaging Techniques |
| D014463 | Ultrasonography |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 2 Enitociclib(VIP152) 22.5 mg & Venetoclax 600 mg | Venitociclib (VIP152), venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax. Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study. Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL) |
| OG002 | Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 3 Enitociclib (VIP152) 30 mg & Venetoclax 600 mg | Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax. Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study. Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL) |
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| OG001 | Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 2 Enitociclib(VIP152) 22.5 mg & Venetoclax 600 mg | Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax. Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study. Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL) |
| OG002 | Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 3 Enitociclib (VIP152) 30 mg & Venetoclax 600 mg | Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax. Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study. Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL) |
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| OG001 | Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 2 Enitociclib(VIP152) 22.5 mg & Venetoclax 600 mg | Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax. Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study. Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL) |
| OG002 | Cohort 1/Phase 1:Arm 1 Dose Escalation Dose Level 3 Enitociclib (VIP152) 30 mg and Venetoclax 600 mg | Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax. Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study. Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL) |
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| OG001 | Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 2 Enitociclib(VIP152) 22.5 mg & Venetoclax 600 mg | Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax. Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study. Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL) |
| OG002 | Cohort 1/Phase 1:Arm 1 Dose Escalation Dose Level 3 Enitociclib (VIP152) 30 mg and Venetoclax 600 mg | Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax. Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study. Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL) |
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| OG001 | Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 2 Enitociclib(VIP152) 22.5 mg & Venetoclax 600 mg | Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax. Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study. Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL) |
| OG002 | Cohort 1/Phase 1:Arm 1 Dose Escalation Dose Level 3 Enitociclib (VIP152) 30 mg and Venetoclax 600 mg | Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax. Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study. Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL) |
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| OG001 | Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 2 Enitociclib(VIP152) 22.5 mg & Venetoclax 600 mg | Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax. Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study. Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL) |
| OG002 | Cohort 1/Phase 1:Arm 1 Dose Escalation Dose Level 3 Enitociclib (VIP152) 30 mg and Venetoclax 600 mg | Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax. Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study. Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL) |
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| OG001 | Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 2 Enitociclib(VIP152) 22.5 mg & Venetoclax 600 mg | Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax. Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study. Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL) |
| OG002 | Cohort 1/Phase 1:Arm 1 Dose Escalation Dose Level 3 Enitociclib (VIP152) 30 mg and Venetoclax 600 mg | Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax. Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study. Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL) |
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| OG001 | Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 2 Enitociclib(VIP152) 22.5 mg & Venetoclax 600 mg | Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax. Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study. Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL) |
| OG002 | Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 3 Enitociclib (VIP152) 30 mg & Venetoclax 600 mg | Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax. Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study. Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL) |
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| OG001 | Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 2 Enitociclib(VIP152) 22.5 mg & Venetoclax 600 mg | Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax. Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study. Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL) |
| OG002 | Cohort 1/Phase 1:Arm 1 Dose Escalation Dose Level 3 Enitociclib (VIP152) 30 mg and Venetoclax 600 mg | Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax. Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study. Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL) |
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| OG001 | Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 2 Enitociclib(VIP152) 22.5 mg & Venetoclax 600 mg | Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax. Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study. Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL) |
| OG002 | Cohort 1/Phase 1:Arm 1 Dose Escalation Dose Level 3 Enitociclib (VIP152) 30 mg and Venetoclax 600 mg | Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax. Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study. Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL) |
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