Phase
Condition
Lymphocytic Leukemia, Chronic
Lymphoma
Chronic Lymphocytic Leukemia
Treatment
NX-5948
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age: ≥ 18 years
Confirmed relapsed/refractory CLL/SLL that meets iwCLL criteria for diagnosis andsystemic treatment
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Must have received a covalent BTK inhibitor (BTKi), a non-covalent BTKi, and a BCL-2inhibitor either in separate lines of treatment or in combination
Measurable disease by radiographic assessment
Adequate organ and bone marrow function
Must sign an informed consent form indicating that he or she understands the purposeof the procedures required for the study and is willing to participate
Exclusion
Exclusion Criteria:
Known or suspected prolymphocytic leukemia or Richter's transformation beforeentering study
Investigational agent or anticancer therapy within 5 half-lives or 14 days (whichever is shorter) before planned start of study drug
Antibody therapy must stop at least 4 weeks before the first dose of study drug
No other systemic anticancer therapy is allowed at the same time as this study;exception: continuation of hormonal therapy for breast and prostate cancer isallowed, if they are not on the list of prohibited concomitant medications inthis study
Radiotherapy within 2 weeks of the first dose of study drug except for focalpalliative radiation
Use of systemic corticosteroids >20 mg/day prednisone or equivalent within the 7days before start of study drug except for those used as premedication for radiodiagnostic contrast
Use of systemic immunosuppressive drugs other than systemic corticosteroids within 60 days before the first dose of study drug
Previously treated with a BTK degrader
Previous chimeric antigen receptor (CAR) T-cell therapy or autologous hematopoieticcell transplant <1 year prior to enrollment
Thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, or symptomaticcerebrovascular events), stroke, or intracranial hemorrhage within 6 months ofplanned start of study drug
Note: Other Inclusion/Exclusion criteria may apply as defined in the protocol.
Study Design
Study Description
Connect with a study center
CHU de Nantes
Nantes, 44000
FranceActive - Recruiting
CHU de Nantes
Nantes 2990969, 44000
FranceSite Not Available
AUSL della Romagna UO Ematologia
Ravenna, 48121
ItalyActive - Recruiting
Pratia Hematologia Sp. z o.o.
Katowice, 40-519
PolandActive - Recruiting
Pratia Hematologia Sp. z o.o.
Katowice 3096472, 40-519
PolandSite Not Available
Pratia S.A.
Krakow, 30-225
PolandActive - Recruiting
Pratia S.A.
Krakow 3094802, 30-225
PolandSite Not Available
Aidport Sp. z o.o.
Skorzewo, 60-185
PolandActive - Recruiting
Aidport Sp. z o.o.
Skorzewo 3085749, 60-185
PolandSite Not Available
Pratia Warszawa / Pratia MTZ
Warsaw, 02-172
PolandActive - Recruiting
Pratia Warszawa / Pratia MTZ
Warsaw 756135, 02-172
PolandSite Not Available
Oxford University Hospitals NHS Foundation Trust
Headington, Oxford OX3 9D
United KingdomActive - Recruiting
Oxford University Hospitals NHS Foundation Trust
Headington 2647239, Oxford OX3 9D
United KingdomSite Not Available
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ
United KingdomActive - Recruiting
The Royal Marsden NHS Foundation Trust
London 2643743, SW3 6JJ
United KingdomSite Not Available
The Christie NHS Foundation Trust
Manchester, M20 4BX
United KingdomActive - Recruiting
The Christie NHS Foundation Trust
Manchester 2643123, M20 4BX
United KingdomSite Not Available
Colorado Blood Institute
Denver, Colorado 80218
United StatesActive - Recruiting
Colorado Blood Institute
Denver 5419384, Colorado 5417618 80218
United StatesSite Not Available
Florida Cancer Specialists
Sarasota, Florida 34232
United StatesActive - Recruiting
Florida Cancer Specialists
Sarasota 4172131, Florida 4155751 34232
United StatesSite Not Available
Maryland Oncology Hematology
Silver Spring, Maryland 20904
United StatesActive - Recruiting
Maryland Oncology Hematology
Silver Spring 4369596, Maryland 4361885 20904
United StatesSite Not Available
Novant Health Cancer Institute
Winston-Salem, North Carolina 27103
United StatesActive - Recruiting
University of Cincinnati
Cincinnati, Ohio 45221
United StatesActive - Recruiting
Oncology Hematology Care
Fairfield, Ohio 45014
United StatesActive - Recruiting
Oncology Hematology Care
Fairfield 4511283, Ohio 5165418 45014
United StatesSite Not Available
SCRI Oncology Partners
Nashville, Tennessee 37203
United StatesActive - Recruiting
SCRI Oncology Partners
Nashville 4644585, Tennessee 4662168 37203
United StatesSite Not Available
Texas Oncology - Center South
Austin, Texas 78705
United StatesActive - Recruiting
Texas Oncology - Center South
Austin 4671654, Texas 4736286 78705
United StatesSite Not Available
Virginia Cancer Specialists, PC
Fairfax, Virginia 22031
United StatesActive - Recruiting

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