RECRUITING

Duvelisib and Venetoclax in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

Conditions

T-cell-prolymphocytic Leukemia Cutaneous T-Cell Lymphoma Refractory leukemia refractory relapsed

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is an open-label, phase I/II study of duvelisib in combination with Venetoclax for patients with relapsed/refractory NHL. Duvelisib is an FDA approved, marketed product used to treat certain patients with leukemia and lymphoma and Venetoclax, which is approved for treatment of certain patients with acute myeloid leukemia. The combination of these two drugs is experimental. Experimental means that it is not approved by the United States Food and Drug Administration (FDA). The researchers want to find out how safe it is to combine these drugs and how well this combination can work for your cancer.

Official Title

Phase I/II Study of Duvelisib and Venetoclax in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

Quick Facts

Study Start:2025-05-02

Study Completion:2031-06-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06810778

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Phase I: Histologically confirmed relapsed/refractory PTCL, except the following lymphoma subtypes: cutaneous T-cell lymphoma (CTCL) and T-cell-prolymphocytic leukemia (TPLL). * Phase II: same as phase I * Disease that has progressed during or relapsed after at least two previous therapies. * ECOG performance status ≤ 2 * Adequate hepatic function defined as: * Adequate renal function as defined by: * Patients must meet the following hematologic criteria at screening, unless they have significant bone marrow involvement confirmed on biopsy: * Absolute neutrophil count ≥ 1500 cells/mm3 (1.5 x 109/L) or ≥ 1000 cells/mm3 (1.5 x 109/L) with bone marrow involvement. Growth factor use is allowed in order to achieve this * Platelet count ≥ 50,000 cells/mm3 (50 x 109/L) independent of transfusion within 7 days of screening * Hemoglobin ≥8 g/dL (without transfusion support.)	* Phase I and Phase II: * Patients eligible for Hematopoietic stem cell transplantation (HSCT) * Cutaneous T-cell lymphoma (CTCL) and T-cell-prolymphocytic leukemia (TPLL) * Suspected and confirmed central nervous system involvement * Previous treatment with venetoclax or a PI3K inhibitor. * Active malignancy other than NHL requiring ongoing therapy, with the exception of hormonal therapy (i.e. castration-sensitive prostate cancer stable on testosterone blockade) * Patients receiving cancer therapy (i.e., chemotherapy, radiation therapy, immunotherapy, biologic therapy, surgery) within 2 weeks of Cycle 1/Day 1 with the following exceptions: * For patients on targeted therapies, a washout of least five half-lives is required * Patients who experience clinical deterioration may start therapy after a shorter washout period with prior approval by the PI * Corticosteroid therapy (prednisone or equivalent \<20 mg daily) is allowed * Patients with multiple basal cell carcinomas that undergo sequential Moh's excisions with interim observation * Allogeneic hematologic stem cell transplant within 6 months of starting study treatment or active graft vs. host disease (GVHD) requiring treatment or prophylaxis * Any active systemic infection requiring systemic antibiotics or other uncontrolled, active infections * Positive Human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) antibody test * Evidence of other clinically significant uncontrolled condition(s) including, but not limited to: * Uncontrolled and/or active systemic infection (viral, bacterial or fungal) * Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative-, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate * Uncontrolled, not disease-related autoimmune hemolytic anemia or ITP * History of stroke or intracranial hemorrhage * History of severe bleeding disorder (hemophilia A or B, von Willebrand disease (VWD)), history of spontaneous bleeding requiring blood transfusions or other medical intervention, history of life-threatening hemorrhage within 3 months of first dose. * Currently active gastrointestinal disease, including colitis, inflammatory bowel disease and diarrhea requiring therapy * Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to enrollment * Cardiac history of CHF requiring treatment or Ejection Fraction ≤ 50% or chronic stable angina * Use of Coumadin for anticoagulation (other anticoagulants permitted) * Lactating or pregnant * Unable to swallow capsules or malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction resulting in malabsorption or chronic diarrhea * Concurrent administration of medications or foods that are strong inhibitors or inducers of CYP3A (see Appendix D) * Treatment with any of the following within 7 days prior to the first dose of study drug: * Steroid therapy for anti-neoplastic intent (defined as prednisone or equivalent \>20 mg daily) * Moderate or strong cytochrome P450 3A (CYP3A) inhibitors (see Appendix D for examples) * Moderate or strong CYP3A inducers (see Appendix D for examples) * Administration or consumption of any of the following within 7 days prior to the first dose of study drug: * Grapefruit or grapefruit products * Seville oranges (including marmalade containing Seville oranges) * Star fruit

Inclusion Criteria

Exclusion Criteria

* Phase I: Histologically confirmed relapsed/refractory PTCL, except the following lymphoma subtypes: cutaneous T-cell lymphoma (CTCL) and T-cell-prolymphocytic leukemia (TPLL).
* Phase II: same as phase I
* Disease that has progressed during or relapsed after at least two previous therapies.
* ECOG performance status ≤ 2
* Adequate hepatic function defined as:
* Adequate renal function as defined by:
* Patients must meet the following hematologic criteria at screening, unless they have significant bone marrow involvement confirmed on biopsy:
* Absolute neutrophil count ≥ 1500 cells/mm3 (1.5 x 109/L) or ≥ 1000 cells/mm3 (1.5 x 109/L) with bone marrow involvement. Growth factor use is allowed in order to achieve this
* Platelet count ≥ 50,000 cells/mm3 (50 x 109/L) independent of transfusion within 7 days of screening
* Hemoglobin ≥8 g/dL (without transfusion support.)

* Phase I and Phase II:
* Patients eligible for Hematopoietic stem cell transplantation (HSCT)
* Cutaneous T-cell lymphoma (CTCL) and T-cell-prolymphocytic leukemia (TPLL)
* Suspected and confirmed central nervous system involvement
* Previous treatment with venetoclax or a PI3K inhibitor.
* Active malignancy other than NHL requiring ongoing therapy, with the exception of hormonal therapy (i.e. castration-sensitive prostate cancer stable on testosterone blockade)
* Patients receiving cancer therapy (i.e., chemotherapy, radiation therapy, immunotherapy, biologic therapy, surgery) within 2 weeks of Cycle 1/Day 1 with the following exceptions:
* For patients on targeted therapies, a washout of least five half-lives is required
* Patients who experience clinical deterioration may start therapy after a shorter washout period with prior approval by the PI
* Corticosteroid therapy (prednisone or equivalent \<20 mg daily) is allowed
* Patients with multiple basal cell carcinomas that undergo sequential Moh's excisions with interim observation
* Allogeneic hematologic stem cell transplant within 6 months of starting study treatment or active graft vs. host disease (GVHD) requiring treatment or prophylaxis
* Any active systemic infection requiring systemic antibiotics or other uncontrolled, active infections
* Positive Human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) antibody test
* Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
* Uncontrolled and/or active systemic infection (viral, bacterial or fungal)
* Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative-, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate
* Uncontrolled, not disease-related autoimmune hemolytic anemia or ITP
* History of stroke or intracranial hemorrhage
* History of severe bleeding disorder (hemophilia A or B, von Willebrand disease (VWD)), history of spontaneous bleeding requiring blood transfusions or other medical intervention, history of life-threatening hemorrhage within 3 months of first dose.
* Currently active gastrointestinal disease, including colitis, inflammatory bowel disease and diarrhea requiring therapy
* Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to enrollment
* Cardiac history of CHF requiring treatment or Ejection Fraction ≤ 50% or chronic stable angina
* Use of Coumadin for anticoagulation (other anticoagulants permitted)
* Lactating or pregnant
* Unable to swallow capsules or malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction resulting in malabsorption or chronic diarrhea
* Concurrent administration of medications or foods that are strong inhibitors or inducers of CYP3A (see Appendix D)
* Treatment with any of the following within 7 days prior to the first dose of study drug:
* Steroid therapy for anti-neoplastic intent (defined as prednisone or equivalent \>20 mg daily)
* Moderate or strong cytochrome P450 3A (CYP3A) inhibitors (see Appendix D for examples)
* Moderate or strong CYP3A inducers (see Appendix D for examples)
* Administration or consumption of any of the following within 7 days prior to the first dose of study drug:
* Grapefruit or grapefruit products
* Seville oranges (including marmalade containing Seville oranges)
* Star fruit

Contacts and Locations

Study Contact

Vladimir Bonhomme

CONTACT

310-794-6500

VBonhomme@mednet.ucla.edu

Vanessa Crowell

CONTACT

vcrowell@mednet.ucla.edu

Study Locations (Sites)

David Geffen School of Medicine at the University of California at Los Angeles

Los Angeles, California, 90095-1406

United States

Collaborators and Investigators

Sponsor: Jonsson Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-02

Study Completion Date2031-06-01

Study Record Updates

Study Start Date2025-05-02

Study Completion Date2031-06-01

Terms related to this study

Keywords Provided by Researchers

leukemia
refractory
relapsed

Additional Relevant MeSH Terms

T-cell-prolymphocytic Leukemia
Cutaneous T-Cell Lymphoma Refractory