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New treatment option for T-cell-prolymphocytic Leukemia
Official title Duvelisib and Venetoclax in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
ClinicalTrials.gov ID: NCT06810778
What this study is testing
What is Duvelisib?
Duvelisib is an investigational medicine, given as an once-weekly, being studied as a potential treatment for t-cell-prolymphocytic leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Phase I: Histologically confirmed relapsed/refractory PTCL, except the following lymphoma subtypes: cutaneous T-cell lymphoma (CTCL) and...
- 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: o Serum aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x upper limit of normal (ULN)...
You likely can't join if
- 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...
See the full eligibility criteria
Who can join
- 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: o Serum aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x upper limit of normal (ULN), bilirubin ≤ 1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or...
- Adequate renal function as defined by: o Creatinine clearance ≥ 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24 hours urine collection
- 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.)
What rules you out
- 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 o Patients with a history of an allogeneic stem cell...
- 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 o For HCV and HBV, patients with evidence of prior infection also excluded
- 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: people with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative-, anti-HBs antibody positive...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.