Current Clinical Trials

A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
  1. Davood Vafai, MD
    Davood Vafai, MD
  2. for people 18 Years and up (full criteria)
  3. Rancho Mirage, CA
  4. study started October 2022
  5. Davood Vafai, MD
  6. Accepting new patients

Description

Summary

The purpose of this study is to compare the efficacy and safety of pirtobruitinib (LOXO-305) to ibrutinib in participants with CLL/SLL. Participants may or may not have already had treatment for their cancer. Participation could last up to six years.

Official Title

A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN-CLL-314)

Keywords

Chronic Lymphocytic Leukemia

Eligibility

for people 18 Years and up
Inclusion Criteria: Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 Adequate organ function Platelets greater than or equal to (≥)50 x 10?/liter (L) or ≥30 x 10?/L in participants with documented bone marrow involvement considered to impair hematopoiesis, Hemoglobin ≥8 grams/deciliter (g/dL) or ≥6 g/dL in participants with documented bone marrow involvement considered to impair hemat... more
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Inclusion Criteria:

Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria

Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2

Adequate organ function

Platelets greater than or equal to (≥)50 x 10?/liter (L) or ≥30 x 10?/L in participants with documented bone marrow involvement considered to impair hematopoiesis, Hemoglobin ≥8 grams/deciliter (g/dL) or ≥6 g/dL in participants with documented bone marrow involvement considered to impair hematopoiesis Absolute neutrophil count ≥0.75 x 10?/L or ≥0.50 × 10?/L in participants with documented bone marrow involvement considered to impair hematopoiesis

Kidney function: Estimated creatinine clearance ≥30 milliliters per minute (mL/min)

Exclusion Criteria:

Known or suspected Richter's transformation to diffuse large B-cell lymphoma (DLBCL), prolymphocytic leukemia, or Hodgkin's lymphoma at any time preceding enrollment Known or suspected central nervous system (CNS) involvement

A significant history of renal, neurologic, psychiatric, endocrine, metabolic or immunologic disease

Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia [AIHA], idiopathic thrombocytopenic purpura [ITP])

Significant cardiovascular disease including ejection fraction < 40% and any grade ongoing atrial fibrillation or atrial flutter Hepatitis B or hepatitis C testing indicating active/ongoing infection, based on Screening laboratory tests

Active cytomegalovirus (CMV) infection Active uncontrolled systemic bacterial, viral, or fungal infection Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count Clinically significant active malabsorption syndrome or other condition likely to affect GI absorption of the oral-administered study treatments Ongoing inflammatory bowel disease Prior exposure to BTK inhibitor (covalent or noncovalent) Concurrent use of investigational agent or anticancer therapy except hormonal therapy Participants requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist Use of ≥ 20 mg prednisone daily or equivalent dose of steroid at the time of first dose of study drug Vaccination with a live vaccine within 28 days prior to randomization Participants receiving chronic therapy with a strong cytochrome P450 (CYP)3A inhibitor (except posaconazole and voriconazole) which cannot be stopped within 3-5 half lives of the CYP3A inhibitor therapy prior to start of study drug treatment Participants with known hypersensitivity, including anaphylaxis, to any component or excipient of pirtobrutinib or ibrutinib

Lead Scientists at Eisenhower Health

Davood Vafai, MD
Board Certified in Internal Medicine and Medical Oncology, Dr. Vafai is a graduate of the Tehran Medical School in Iran. After medical school, Dr. Vafai completed his internship at Englewood Hospital in New Jersey, and a residency and oncology fellowship at the University of Southern California. He completed another fellowship in hematology and bone marrow transplantation at the University of California, San Diego.“My father had cancer, as did other family mem... more
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Board Certified in Internal Medicine and Medical Oncology, Dr. Vafai is a graduate of the Tehran Medical School in Iran. After medical school, Dr. Vafai completed his internship at Englewood Hospital in New Jersey, and a residency and oncology fellowship at the University of Southern California. He completed another fellowship in hematology and bone marrow transplantation at the University of California, San Diego.

“My father had cancer, as did other family members,” says Davood Vafai, MD, a Board Certified Medical Oncologist with Eisenhower Hematology/Oncologist Specialists. “I saw what this disease does and how it progresses, so I decided to pursue oncology as a career. It became a personal and professional challenge.”

In his current practice, Dr. Vafai sees a broad range of hematology and oncology patients; his professional interests focus on lung cancer and blood cancers such as lymphoma, leukemia and multiple myeloma. “One of the reasons for my fellowship in bone marrow transplantation is that these types of patients need a great deal of care, and I wanted to be involved,” explains Dr. Vafai.

He is the author of several publications and book chapters in addition to being Sub-investigator or pincipal Investigator for 120 oncologic treatment protocols and new drug investigations. He is an active participant on the Eisenhower Medical Center Tumor Board, and runs the Hematology/Oncology Journal Club on campus. He loves teaching and is passionate about the advances in oncology that have extended quality months of life in patients living with malignancies.

As the engineer of the lung cancer chemotherapy regimen Carboplatin and Taxol, Dr. Vafai presented this treatment at the American Society of Clinical Oncology in 1995. Since then, the Carboplatin and Taxol treatment has been a standard in lung cancer treatment in United States and across the globe. It is now being used in the treatment of many other cancers.

Additionally, Dr. Vafai is the principal investigator of the International Early Lung Cancer Action Project (I-ELCAP) at Eisenhower Medical Center which he has led for more than a decade. This modality of detection and treatment was just recently approved by United States Task Force, and is now considered a standard of treatment in the United States.

Dr. Vafai marvels at the tremendous advances in cancer treatment that have developed in years since he’s been in practice. “Oncology is probably the most complex and fastest-growing field in medicine,” he comments. “It gives patients and doctors a lot of hope.”

Clinical Study Details

  1. Accepting new patients
  2. study started October 2022
  3. Interventional
  4. Expecting 650 study participants
  5. February 20, 2024