Is NCT06810778 recruiting in Los Angeles, CA?

Yes, NCT06810778 is currently recruiting participants at its Los Angeles, CA location. This t-cell-prolymphocytic leukemia clinical trial is actively enrolling qualified participants.

How do I join the t-cell-prolymphocytic leukemia clinical trial in Los Angeles?

To join this clinical trial in Los Angeles, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Los Angeles clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

T-cell-prolymphocytic Leukemia Clinical Trial in Los Angeles, CA

About This T-cell-prolymphocytic Leukemia Study in Los Angeles

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.

Sponsor: Jonsson Comprehensive Cancer Center

Who Can Participate

Inclusion 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: 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 of non-hepatic origin

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.)

Exclusion Criteria

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 transplant \> 6 months prior to starting study treatment should be stable, off of immunosuppression for at least 2 months.

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: 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)

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Los Angeles?

Yes, this clinical trial (NCT06810778) has an active research site in Los Angeles, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

T-cell-prolymphocytic Leukemia Treatment Options in Los Angeles, CA

If you're searching for t-cell-prolymphocytic leukemia treatment options in Los Angeles, CA, this clinical trial (NCT06810778) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Los Angeles research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced t-cell-prolymphocytic leukemia specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all t-cell-prolymphocytic leukemia clinical trials near you to find additional studies recruiting in your area.

T-cell-prolymphocytic Leukemia Clinical Trial in Los Angeles, CA

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