ACTIVE_NOT_RECRUITING

Tafasitamab and Zanubrutinib for the Treatment of Patients With Newly Diagnosed Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, TaZA CLL Study

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Conditions

Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

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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 phase II trial tests how well tafasitamab and zanubrutinib works in treating patients with newly diagnosed chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Tafasitamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Zanubrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of a protein that signals cancer cells to multiply. This may stop the growth and spread of cancer cells. Giving tafasitamab and zanubrutinib in combination may kill more cancer cells in patients with CLL/SLL than giving either treatment alone.

Official Title

A Phase 2 Study With a Safety Lead-In of the Anti-CD19 Antibody Tafasitamab With the BTK Inhibitor Zanubrutinib in Newly Diagnosed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) - TaZa CLL Study

Quick Facts

Study Start:2023-05-18
Study Completion:2026-04-19
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05718869

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 CriteriaExclusion Criteria
  1. * Documented informed consent of the participant and/or legally authorized representative
  2. * Assent, when appropriate, will be obtained per institutional guidelines
  3. * Age: \>= 18 years
  4. * Eastern Cooperative Oncology Group (ECOG) =\< 2
  5. * Histologically or flow cytometry confirmed diagnosis of B-CLL/SLL as documented by medical records and with histology based on criteria established by the World Health Organization (WHO)
  6. * No prior treatment for CLL, except steroids and/or rituximab to treat autoimmune complications
  7. * Active disease meeting criteria for requiring treatment per the iwCLL 2018 guidelines
  8. * A minimum of any one of the following constitutional symptoms:
  9. * Unintentional weight loss \> 10% within the previous 6 months prior to screening
  10. * Extreme fatigue (unable to work or perform usual activities)
  11. * Fevers of greater than 100.5 degrees Fahrenheit (F) for \>= 2 weeks without evidence of infection
  12. * Night sweats without evidence of infection
  13. * Evidence of progressive marrow failure as manifested by the development of, or worsening of anemia or thrombocytopenia
  14. * Massive (i.e., \> 6 cm below the left costal margin), progressive or symptomatic splenomegaly
  15. * Massive nodes or clusters (i.e., \> 10 cm in longest diameter) or progressive lymphadenopathy
  16. * Progressive lymphocytosis with an increase of \> 50% over a 2-month period, or an anticipated doubling time of less than 6 months
  17. * Autoimmune anemia or thrombocytopenia that is poorly responsive to corticosteroids
  18. * Symptomatic or functional extranodal involvement (eg, skin, kidney, lung, spine)
  19. * Participant must be able to swallow tablets or capsules. A participant with any gastrointestinal disease that would impair ability to swallow, retain, or absorb drug is not eligible
  20. * Absolute neutrophil count (ANC) \>= 1,000/mm\^3 unless due to bone marrow involvement
  21. * NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement
  22. * Platelets \>= 75,000/mm\^3 unless due to bone marrow involvement, and independent of transfusion support, with no active bleeding
  23. * Direct bilirubin =\< 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease or compensated hemolysis directly attributable to CLL)
  24. * Aspartate aminotransferase (AST) =\< 2.5 X ULN
  25. * Alanine aminotransferase (ALT) =\< 2.5 X ULN
  26. * Estimated creatinine clearance of \>= 30 mL/min using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
  27. * IF NOT RECEIVING ANTICOAGULANTS: International normalized ratio (INR) OR prothrombin (PT) =\< 1.5 x ULN; IF ON ANTICOAGULANT THERAPY: PT must be within therapeutic range of intended use of anticoagulants
  28. * IF NOT RECEIVING ANTICOAGULANTS: Activated partial thromboplastin time (aPTT) =\< 1.5 x ULN; IF ON ANTICOAGULANT THERAPY: aPTT must be within therapeutic range of intended use of anticoagulants
  29. * Women of childbearing potential (WOCBP): negative serum pregnancy test
  30. * Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of protocol therapy
  31. * A woman is considered of childbearing potential, ie, fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. Contraception methods include the following:
  32. * Combined (estrogen- and progestogen- containing) hormonal contraception associated with the inhibition of ovulation or oral, intravaginal, or transdermal
  33. * Progestogen-only hormonal contraception associated with the inhibition of ovulation or oral, injectable, implantable
  34. * An intrauterine device
  35. * Intrauterine hormone-releasing system
  36. * Bilateral tubal occlusion vasectomized partner (provided that the vasectomized partner is the sole sexual partner of the woman of childbearing potential study participant and that the vasectomized partner has received medical assessment of surgical success)
  37. * Sexual abstinence (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatment, starting the day prior to first dose of study drug, for the duration of the study, and for \>= 90 days after the last dose of zanubrutinib or ibrutinib. Total sexual abstinence should only be used as a contraceptive method if it is in line with the patients' usual and preferred lifestyle. Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods), declaration of abstinence for the duration of exposure to investigational medicinal product, and withdrawal are not acceptable methods of contraception. Of note, barrier contraception (including male and female condoms with or without spermicide) is not considered a highly effective method of contraception, and, if used, this method must be used in combination with another acceptable method listed above. If patient is using hormonal contraceptives such as birth control pills or devices, a barrier method of contraception (eg, condoms) must also be used. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle-stimulating hormone level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single follicle-stimulating hormone measurement is insufficient
  1. * Chronic use of corticosteroids in excess of 20 mg/day prednisone or its equivalent
  2. * Major surgery (under general anesthesia) within 30 days prior to therapy
  3. * Uncontrolled coagulopathy or bleeding disorder. Direct oral anticoagulants are allowed
  4. * Use of moderate or strong cytochrome P450 3A4 (CYP3A4) inducer within 2 weeks of the first day of study therapy. CYP3A inhibitors are allowed.
  5. * For patients intended to enroll on dose level (DL) -1 use of strong CYP3A inhibitors will be prohibited on-therapy and their use must be stopped at minimum 2 weeks prior to the first day of study therapy
  6. * Exposure to vaccination with live vaccine within 30 days prior to cycle 1 day 1 (C1D1), or anticipated need for such vaccination during treatment
  7. * History of prior malignancy except:
  8. * Malignancy treated with curative intent and no known active disease present for \>= 2 years prior to initiation of therapy on current study
  9. * Adequately treated non-melanoma skin cancer or lentigo maligna (melanoma in situ) without evidence of disease
  10. * Adequately treated in situ carcinomas (e.g., cervical, esophageal, etc.) without evidence of disease
  11. * Asymptomatic prostate cancer managed with "watch and wait" strategy
  12. * Uncontrolled immune hemolysis or thrombocytopenia (positive direct antiglobulin test in absence of hemolysis or history of immune-mediated cytopenias are not exclusions)
  13. * Known positive test result for SARS-CoV-2 unless follow-up test was negative or investigator deems the infection is fully resolved
  14. * Known positive test result for hepatitis C (hepatitis C virus \[HCV\] antibody serology testing) and a positive test result for HCV ribonucleic acid (RNA). Participants with positive serology are eligible in case of negative HCV RNA test results
  15. * Known positive test result for chronic hepatitis B virus (HBV) infection (defined by hepatitis B virus surface antigen \[HBsAg\] positivity)
  16. * Participants with occult or prior HBV infection (defined as negative HBsAg and positive total hepatitis B core antibody) may be included if HBV deoxyribonucleic acid (DNA) was undetectable, provided that they are willing to undergo ongoing DNA testing.
  17. * Antiviral prophylaxis may be administered as per institutional guidelines.
  18. * Participants who have protective titers of HBsAb after vaccination or prior but cured hepatitis B are eligible
  19. * Known seropositive for or history of active viral infection with human immunodeficiency virus (HIV)
  20. * Clinically significant cardiovascular disease including the following:
  21. * Myocardial infarction within 6 months before screening
  22. * Unstable angina within 3 months before screening
  23. * New York Heart Association class III or IV congestive heart failure
  24. * History of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, Torsades de Pointes)
  25. * QTcF \> 480 milliseconds based on Fridericia's formula
  26. * History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place
  27. * Known severe chronic obstructive pulmonary disease (COPD)
  28. * Known hepatic cirrhosis or severe pre-existing hepatic impairment
  29. * Major surgery (requiring general anesthesia) within 14 days before the first dose of study drug or a scheduled surgery during study period
  30. * Patients with clinically significant medical condition of malabsorption, inflammatory bowel disease, chronic conditions which manifest with diarrhea, refractory nausea, vomiting or any other condition that will interfere significantly with drug absorption
  31. * Females only: Pregnant or breastfeeding
  32. * Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
  33. * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Contacts and Locations

Principal Investigator

Matthew Mei
PRINCIPAL_INVESTIGATOR
City of Hope Medical Center

Study Locations (Sites)

City of Hope Medical Center
Duarte, California, 91010
United States
City of Hope at Irvine Lennar
Irvine, California, 92618
United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, 33146
United States

Collaborators and Investigators

Sponsor: City of Hope Medical Center

  • Matthew Mei, PRINCIPAL_INVESTIGATOR, City of Hope Medical 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 Date2023-05-18
Study Completion Date2026-04-19

Study Record Updates

Study Start Date2023-05-18
Study Completion Date2026-04-19

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma