Phase
Condition
Leukemia
Lymphoma, B-cell
Chronic Lymphocytic Leukemia
Treatment
Prednisone
Doxorubicin
Acalabrutinib
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Master Inclusion Criteria applicable to all substudies:
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Contraception during treatment and at least 6 months after final dose.
Confirmed CD19 expression if prior anti-CD19 therapy.
Substudy 1 Specific Inclusion Criteria:
Participants with CLL must require treatment according to the international workshopon Chronic Lymphocytic Leukemia (iwCLL) criteria.
SLL: at least 1 measurable site per Lugano.
Absolute lymphocytes <10,000.
Cohort 1A: at least 2 prior lines of therapy, including a Bruton tyrosine kinaseinhibitor (BTKi) and B-cell lymphoma 2 inhibitor (BCL2i).
Cohort 1B: at least 1 prior line of therapy and is BTKi-sensitive.
Substudy 2 Specific Inclusion Criteria:
MCL diagnosis per WHO.
Clinical Stage II, III, or IV by Ann Arbor Classification.
At least 1 measurable site per Lugano
ALC < 10,000.
Cohort 2A: Relapse or progressed after 2 or more lines of therapy including BTKi.
Cohort 2B: Relapse or progressed after 1 or more line of therapy, not including aBTKi.
Substudy 3 Specific Inclusion Criteria:
Large B-cell lymphoma per WHO 2022.
R/R B-NHL after at least 1 prior line of therapy.
International Prognostic Index (IPI) 2-5.
At least 1 measurable site as per Lugano.
Left ventricular ejection fraction (LVEF) >50%.
Contraception at least 12 months after last dose of R-CHOP or 6 months after lastdose of AZD0486.
Exclusion
Exclusion Criteria:
Master Exclusion Criteria applicable to all substudies:
central nervous system (CNS) lymphoma.
Surgery within 14 days of study drug.
Clinically significant cardiovascular (CV) disease.
Unresolved Grade >2 AEs from prior anticancer therapy (except alopecia or fatigue).
Any anticancer therapy within 5 half-lives or 21 days (whichever is shorter) priorto treatment.
Radiation therapy within 28 days.
Prior CAR-T or auto-haematopoietic stem cell transplant (HSCT) within 12 weeks orprior T-cell engager (TCE) within 8 weeks.
Prior Grade > 3 cytokine release syndrome (CRS) or immune effector cell-associatedneurotoxicity syndrome (ICANS) event.
Substudy 1 Specific Exclusion Criteria:
CLL transformation to more aggressive lymphoma
Cohort 1B: bleeding diathesis, CYP3A inhibitor or inducer, history of ICH or strokewithin 6 months, GI malabsorption, receiving vitamin K antagonist
Substudy 2 Specific Exclusion Criteria:
- Cohort 2B: bleeding diathesis, CYP3A inhibitor or inducer, history of ICH or strokewithin 6 months, GI malabsorption, receiving vitamin K antagonist
Substudy 3 Specific Exclusion Criteria:
Mediastinal grey-zone lymphoma, Burkitt, Richter's transformation, primary effusionlarge B-cell lymphoma (LBCL)
Cumulative dose of anthracycline >150 mg/m2
Study Design
Study Description
Connect with a study center
Research Site
Heidelberg, 3084
AustraliaSite Not Available
Research Site
Melbourne, 3004
AustraliaActive - Recruiting
Research Site
Nedlands, 6009
AustraliaSite Not Available
Research Site
Beijing, 100044
ChinaSite Not Available
Research Site
Guangzhou, 510060
ChinaSite Not Available
Research Site
Jinan, 250013
ChinaSite Not Available
Research Site
Tianjin, 300060
ChinaSite Not Available
Research Site
Zhengzhou, 450008
ChinaSite Not Available
Research Site
Ostrava - Poruba, 708 52
CzechiaSite Not Available
Research Site
Praha 2, 12808
CzechiaSite Not Available
Research Site
Praha 2 - Nové Město, 12820
CzechiaSite Not Available
Research Site
Aalborg, 9000
DenmarkSite Not Available
Research Site
Aarhus N, 8200
DenmarkSite Not Available
Research Site
Copenhagen, 2100
DenmarkSite Not Available
Research Site
Montpellier, 34295
FranceSite Not Available
Research Site
Paris, 75010
FranceSite Not Available
Research Site
Saint Cloud, 92210
FranceSite Not Available
Research Site
Villejuif Cedex, 94805
FranceSite Not Available
Research Site
Kiel, 24105
GermanySite Not Available
Research Site
München, 81377
GermanySite Not Available
Research Site
Wuerzburg, 97080
GermanySite Not Available
Research Site
Koto-ku, 135-8550
JapanSite Not Available
Research Site
Matsuyama-shi, 791-0280
JapanActive - Recruiting
Research Site
Nagoya-shi, 464-8681
JapanSite Not Available
Research Site
Busan, 48108
Korea, Republic ofActive - Recruiting
Research Site
Seoul, 03080
Korea, Republic ofSite Not Available
Research Site
Barcelona, 8036
SpainSite Not Available
Research Site
Madrid, 28034
SpainSite Not Available
Research Site
Palma de Mallorca, 7120
SpainSite Not Available
Research Site
Santiago de Compostela, 15706
SpainSite Not Available
Research Site
Valencia, 46026
SpainSite Not Available
Research Site
Changhua, 500
TaiwanSite Not Available
Research Site
Kaohsiung City, 83301
TaiwanSite Not Available
Research Site
Tainan, 710
TaiwanSite Not Available
Research Site
Taipei, 100
TaiwanSite Not Available
Research Site
Derriford, PL6 5FP
United KingdomActive - Recruiting
Research Site
London, SE5 9RS
United KingdomSite Not Available
Research Site
Oxford, 0X3 7LJ
United KingdomSite Not Available
Research Site
Boston, Massachusetts 02215
United StatesActive - Recruiting
Research Site
New Brunswick, New Jersey 08901
United StatesActive - Recruiting
Research Site
New York, New York 10029
United StatesSite Not Available
Research Site
Charlotte, North Carolina 28204
United StatesSite Not Available
Research Site
Portland, Oregon 97239
United StatesSite Not Available
Research Site
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Research Site
Providence, Rhode Island 02903
United StatesActive - Recruiting
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