Phase 2
Completed N=8
Study of VIP152, Venetoclax, and Prednisone (VVIP) in Relapsed/Refractory Lymphoid Malignancies
Source: ClinicalTrials.gov NCT05371054 ↗Enrolled (actual)
8
Serious AEs
25.0%
Results posted
Apr 2025
Primary outcomePrimary: Phase 2: Complete Response (CR) Rate
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase 2: Complete Response (CR) Rate |
— | — |
| PRIMARY Phase 1: Number of Solicited and/or Non-solicited Non-serious Adverse Events (AE's) With Grade |
0; 0; 1; 2; 4; 1 | — |
| PRIMARY Phase 1: Number of Solicited and/or Unsolicited Serious Adverse Events (SAE's) With Grade |
0; 1; 0; 0; 0; 1 | — |
| PRIMARY Phase 1: Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) |
NA | — |
| PRIMARY Phase 1: Number of Participants With Grade 4 Neutropenia Dose-Limiting Toxicity (DLT) |
0; 0; 1 | — |
| SECONDARY Phase 1: Progression-free Survival (PFS) |
1.48; 4.14; 4.11 | — |
| SECONDARY Phase 1: Time to Response (TTR) |
3.45; 0.69; NA | — |
| SECONDARY Phase 1: Duration of Response (DOR) |
NA; NA; NA; 4.37; 3.45; NA | — |
| SECONDARY Phase 1: Overall Response Rate (ORR) |
0; 0; 0; 0.3333; 1.000; 0 | — |
| SECONDARY Phase 1: Overall Survival (OS) |
NA; 17.17; 2.13 | — |
| SECONDARY Phase 1: Event-free Survival (EFS) |
1.48; 4.14; 1.59 | — |
Eligibility Criteria
- 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:
- Refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/High-grade B-cell lymphoma (HGBCL) (MYC aberration must be confirmed by NCI Laboratory of Pathology to enroll)
- R/R non-germinal center B-cell (non-GCB) DLBCL without MYC-rearrangement (Cell of origin (COO) and non-MYC aberration must be confirmed by NCI Laboratory of Pathology to enroll. COO determination at enrollment will utilize immunohistochemistry and Han's algorithm)
- R/R Peripheral T-cell lymphoma (PTCL-not otherwise specified (NOS), PTCL-T follicular helper (TFH), follicular T-cell lymphoma (TCL), angioimmunoblastic T-cell lymphoma (AITL), adult T-cell leukemia/lymphoma (ATLL), anaplastic lymphoma kinase (ALK)+ anaplastic large-cell lymphoma (ALCL) and ALK- ALCL per 2016 World Health Organization (WHO) classification)
- Relapsed and/or refractory disease, as defined below:
- Aggressive B-cell lymphoma: relapsed after and/or refractory to at least 2 prior systemic therapies, 1 or more which includes an anthracycline and anti-cluster of differentiation 20 (CD20) targeting agent
- PTCL: relapsed after and/or refractory to at least 2 prior systemic therapies, 1 or more which includes an anthracycline (and a brentuximab vedotin-containing regimen for participants with ALK+ or ALK- ALCL)
- 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 =1,000/mcL
- Hemoglobin* >=8 g/dL
- Platelets >=75,000/mcL
- International normalized ratio (INR) = 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 = 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 40 mIU/mL) OR
- Permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, uterine ablation)
- 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:
- Established use of oral, injected or implanted hormonal methods of contraception
- Placement of certain intrauterine devices (IUD) or intrauterine systems (IUS)
- Hysterectomy, oophorectomy, salpingectomy or vasectomy of the partner (provided that partner is the sole sexual partner of the individual of childbearing potential trial participant and that the vasectomized partner has received
Data sourced from ClinicalTrials.gov (NCT05371054). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.