Chronic Lymphocytic LeukemiaPhase 3NCT02970318
A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL
A Phase 3 study testing Acalabrutinib (ACP-196), Rituximab and Idelalisib in people with Chronic Lymphocytic Leukemia, run by Acerta Pharma BV at 157 sites in 25 countries.
Trial summary
This study is designed to evaluate the efficacy of acalabrutinib compared with rituximab in combination with idelalisib or bendamustine in previously treated subjects with chronic lymphocytic leukemia (CLL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- What is being tested?
- Acalabrutinib (ACP-196), Rituximab and Idelalisib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 157 sitesin 25 countries
- Study dates
- 2 Feb 2017to 1 Oct 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ≥ 18 years of age.
- ECOG performance status of 0 to 2.
- Diagnosis of CLL that meets published diagnostic criteria (Hallek 2008):
- Monoclonal B-cells (either kappa or lambda light chain restricted) that are clonally co-expressing ≥ 1 B-cell marker (CD19, CD20, or CD23) and CD5.
- Prolymphocytes may comprise ≤ 55% of blood lymphocytes.
- Presence of ≥ 5 x 10^9 B lymphocytes/L (5000/μL) in the peripheral blood (at any point since initial diagnosis).
Show all 30Show fewer
- Must have documented CD20-positive CLL.
- Active disease meeting ≥ 1 of the following IWCLL 2008 criteria for requiring treatment:
- Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia (hemoglobin < 10 g/dL) and/or thrombocytopenia (platelets < 100,000/μL).
- Massive (i.e., ≥ 6 cm below the left costal margin), progressive, or symptomatic splenomegaly.
- Massive nodes (i.e., ≥ 10 cm in the longest diameter), progressive, or symptomatic lymphadenopathy.
- Progressive lymphocytosis with an increase of > 50% over a 2-month period or a LDT of < 6 months. LDT may be obtained by linear regression extrapolation of ALC obtained at intervals of 2 weeks over an observation period of 2 to 3 months. In subjects with initial blood lymphocyte counts of < 30 x 10^9/L (30,000/μL), LDT should not be used as a single parameter to define indication for treatment. In addition, factors contributing to lymphocytosis or lymphadenopathy other than CLL (e.g., infections) should be excluded.
- Autoimmune anemia and/or thrombocytopenia that is poorly responsive to standard therapy.
- Constitutional symptoms documented in the subject's chart with supportive objective measures, as appropriate, defined as ≥ 1 of the following disease-related symptoms or signs:
- Unintentional weight loss ≥ 10% within the previous 6 months before screening.
- Significant fatigue (ECOG performance score 2; inability to work or perform usual activities).
- Fevers higher than 100.5°F or 38.0°C for ≥ 2 weeks before screening without evidence of infection.
- Night sweats for > 1 month before screening without evidence of infection.
- Meet the following laboratory parameters:
- ANC ≥ 750 cells/μL (0.75 x 10^9/L), or ≥ 500 cells/μL (0.50 x 10^9/L) in subjects with documented bone marrow involvement, and independent of growth factor support 7 days before assessment.
- Platelet count ≥ 50,000 cells/μL (50 x 10^9/L), or ≥ 30,000 cells/μL (30 x 10^9/L) in subjects with documented bone marrow involvement, and without transfusion support 7 days before assessment. Subjects with transfusion-dependent thrombocytopenia are excluded. If an Investigator has chosen bendamustine/rituximab as the Arm B treatment, platelets must be ≥ 75,000 cells/μL (75 x 10^9/L).
- Serum AST and ALT ≤ 2.0 x ULN.
- Total bilirubin ≤ 1.5 x ULN.
- Estimated creatinine clearance of ≥ 30 mL/min, calculated using the formula of Cockcroft and Gault [(140-Age) • Mass (kg)/(72 • creatinine mg/dL); multiply by 0.85 if female].
- Must have received ≥ 1 prior systemic therapies for CLL. Note: Single-agent steroids or localized radiation are not considered a prior line of therapy. If a single-agent anti-CD20 antibody was previously administered, subjects must have received ≥ 2 doses.
- Women who are sexually active and can bear children must agree to use highly effective forms of contraception while on the study and for 2 days after the last dose of acalabrutinib, 90 days after the last dose of idelalisib, 6 months after the last dose of bendamustine, or 12 months after the last dose of rituximab, whichever is longer. Highly effective forms of contraception are defined in Section 9.2.5.
- Men who are sexually active and can beget children must agree to use highly effective forms of contraception during the study and for 90 days after the last dose of idelalisib, 6 months after the last dose of bendamustine, or 12 months after the last dose of rituximab, whichever is longer. Highly effective forms of contraception are defined in Section 9.2.5.
- Men must agree to refrain from sperm donation during the study and for 90 days after the last dose of idelalisib, 6 months after the last dose of bendamustine, or 12 months after the last dose of rituximab, whichever is longer.
- Willing and able to participate in all required evaluations and procedures in this study protocol, including swallowing capsules without difficulty.
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations).
Who cannot join
- Known CNS lymphoma or leukemia.
- Known prolymphocytic leukemia or history of, or currently suspected, Richter's syndrome.
- Uncontrolled AIHA or ITP defined as declining hemoglobin or platelet count secondary to autoimmune destruction within the screening period or requirement for high doses of steroids (> 20 mg daily of prednisone or equivalent).
- Prior exposure to a BCL-2 inhibitor (e.g., venetoclax/ABT-199) or a BCR inhibitor (e.g., BTK inhibitors or PI3K inhibitors). Prior bendamustine is allowed if Investigator's choice for treatment in Arm B is idelalisib with rituximab. Bendamustine retreatment is allowed if the prior response to bendamustine lasted > 24 months.
- Received any chemotherapy, external beam radiation therapy, anticancer antibodies, or investigational drug within 30 days before first dose of study drug.
- Corticosteroid use > 20 mg daily prednisone equivalent within 1 week before first dose of study drug, except as indicated for other medical conditions such as inhaled steroid for asthma, topical steroid use, or as premedication for administration of study drug or contrast. For example, subjects requiring steroids at daily doses > 20 mg prednisone equivalent systemic exposure daily, or those who are administered steroids for leukemia control or white blood cell count lowering are excluded.
Show all 34Show fewer
- Prior radio- or toxin-conjugated antibody therapy.
- Prior allogeneic stem cell transplant or prior autologous transplant within 6 months of first dose of study drug(s) or presence of graft-vs-host disease or receiving treatment for graft-vs-host disease.
- Major surgical procedure within 30 days of first dose of study drug. Note: If a subject had major surgery, they must have recovered adequately from any toxicity and/or complications from the intervention before the first dose of study drug.
- History of prior malignancy except for the following:
- Malignancy treated with curative intent and with no evidence of active disease present for more than 2 years before screening and felt to be at low risk for recurrence by treating physician.
- Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled nonmelanomatous skin cancer.
- Adequately treated carcinoma in situ without current evidence of disease.
- Significant cardiovascular disease such as uncontrolled or untreated symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or QTc > 480 msec (calculated using Fridericia's formula: QT/RR^0.33) at screening. Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study.
- Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach, or extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
- Received a live virus vaccination within 28 days of first dose of study drug.
- Known history of infection with HIV or any uncontrolled active systemic infection (e.g., bacterial, viral, or fungal). For study sites in Germany: active infection with human immunodeficiency virus (seropositivity for HIV-1 or HIV-2 antibodies, and if positive, reactivity against the HIV-specific p24 antigen).
- Active CMV infection (active viremia as evidenced by positive polymerase chain reaction [PCR] result for CMV DNA).
- Serologic status reflecting active hepatitis B or C infection.
- Subjects who are anti-HBc positive and who are surface antigen negative will need to have a negative PCR result before randomization. Those who are HbsAg-positive or hepatitis B PCR positive will be excluded.
- Subjects who are hepatitis C antibody positive will need to have a negative PCR result before randomization. Those who are hepatitis C PCR positive will be excluded.
- Ongoing, drug-induced liver injury, alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, ongoing extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension.
- History of or ongoing drug-induced pneumonitis.
- History of serious allergic reactions including anaphylaxis and toxic epidermal necrolysis.
- History of stroke or intracranial hemorrhage within 6 months before first dose of study drug.
- History of bleeding diathesis (e.g., hemophilia, von Willebrand disease).
- Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon) within 7 days of first dose of study drug.
- Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening.
- Requires treatment with a strong CYP3A inhibitor/inducer.
- Requires treatment with proton-pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving proton-pump inhibitors who switch to H2-receptor antagonists or antacids are eligible for enrollment to this study.
- Breast feeding or pregnant.
- Concurrent participation in another therapeutic clinical trial.
- Prothrombin time/INR or aPTT (in the absence of a Lupus anticoagulant) > 2.0 x ULN. Exception: Subjects receiving warfarin are excluded, however, those receiving other anticoagulant therapy who have a higher INR/aPTT may be permitted to enroll to this study after discussion with the medical monitor.
- History of confirmed progressive multifocal leukoencephalopathy (PML)
Trial locations and contacts
157 sites in 25 countries.
157 sites in 25 countries
United States13 sites
Research Site
Athens, Georgia, 30607
Research Site
Brick, New Jersey, 08724
Research Site
Canton, Ohio, 44719
Research Site
Cedar Rapids, Iowa, 52403
Research Site
Chandler, Arizona, 85224
Research Site
Fort Sam Houston, Texas, 78234
Research Site
Joliet, Illinois, 60435
Research Site
Lincoln, Nebraska, 68506
Research Site
Mount Sterling, Kentucky, 40353
Research Site
Nyack, New York, 10960
Research Site
Oxnard, California, 93030
Research Site
Round Rock, Texas, 78665
Research Site
Saint Cloud, Minnesota, 56303
Australia11 sites
Research Site
Adelaide, 5000
Research Site
Box Hill, 3128
Research Site
Frankston, 3199
Research Site
Geelong, 3220
Research Site
Gosford, 2250
Research Site
Hobart, 7000
Research Site
Kogarah, 2217
Research Site
Murdoch, 6150
Research Site
Nedlands, 6009
Research Site
South Brisbane, 4101
Research Site
Woodville, 5011
Russia11 sites
Research Site
Novosibirsk, 630087
Research Site
Obninsk, 249031
Research Site
Penza, 440008
Research Site
Ryazan, 390000
Research Site
Saint Petersburg, 194044
Research Site
Saint Petersburg, 197341
Research Site
Sochi, Unk
Research Site
Tula, 300053
Research Site
Volgograd, Unk
Research Site
Yaroslavl, 150023
Research Site
Yekaterinburg, 620072
France10 sites
Research Site
Bordeaux, 33076, FR
Research Site
Brest, 29609
Research Site
Montpellier, 34295
Research Site
Nantes, 44093
Research Site
Paris, 75010
Research Site
Paris, 75651
Research Site
Perpignan, 66000
Research Site
Provence Alpes Cote D'Azur, 13273
Research Site
Rennes, 35000
Research Site
Rouen, 76038
Italy10 sites
Research Site
Aviano, 33081
Research Site
Bergamo, 24127
Research Site
Brescia, 25123
Research Site
Florence, 50134
Research Site
Genova, 16126
Research Site
Genova, 16132
Research Site
Meldola, 47014
Research Site
Milan, 20132
Research Site
Milan, 20162
Research Site
Modena, 41100
Spain10 sites
Research Site
Badalona, 8916
Research Site
Madrid, 28006
Research Site
Madrid, 28009
Research Site
Madrid, 28031
Research Site
Madrid, 28033
Research Site
Madrid, 28041
Research Site
Majadahonda, 28222
Research Site
Salamanca, 37007
Research Site
Santander, 39008
Research Site
Valencia, 46026
United Kingdom9 sites
Research Site
Birmingham, B9 5SS
Research Site
Cambridge, CB2 0QQ
Research Site
Canterbury, CT1 3NG
Research Site
Leicester, LE1 7RH
Research Site
London, SE5 9RS
Research Site
Maidstone, ME16 9QQ
Research Site
Manchester, M20 4BX
Research Site
Southampton, SO16 6YD
Research Site
Wolverhampton, WV10 0QP
Canada8 sites
Research Site
Barrie, Ontario, L4M 6M2
Research Site
Calgary, T2N 2T9
Research Site
Montreal, H3T 1E2
Research Site
Ottawa, K1H 8L6
Research Site
Regina, S4T 7T1
Research Site
Saint John, E2L 4L2
Research Site
Toronto, M4N 3M5
Research Site
Toronto, M5G 2M9
South Korea8 sites
Research Site
Busan, 49241
Research Site
Daegu, 41944
Research Site
Donggu, 44033
Research Site
Gyeonggi-do, 13620
Research Site
Incheon, UNK
Research Site
Jeonju, 54907
Research Site
Seoul, 3080
Research Site
Seoul, 3722
Poland7 sites
Research Site
Bialystok, 15-276
Research Site
Bydgoszcz, 85-168
Research Site
Gdansk, 80-129
Research Site
Krakow, 30-727
Research Site
Lodz, 93-510
Research Site
Lublin, 20-081
Research Site
Woj. Podkarpackie, 36-200
Ukraine7 sites
Research Site
Cherkasy, 18009
Research Site
Dnipropetrovsk, 49102
Research Site
Ivano-Frankivsk
Research Site
Khmelnytsky, 29000
Research Site
Kyiv, 03022
Research Site
Kyiv
Research Site
Zhytomyr, 10002
Czechia6 sites
Research Site
Brno, 625 00
Research Site
Nový Hradec Králové, 500 05
Research Site
Olomouc, 779 00
Research Site
Ostrava Poruba, 708 52
Research Site
Plzen - Lochotin, 304 60
Research Site
Prague, 100 34
Israel6 sites
Research Site
Ashkelon, 7830604
Research Site
Haifa, 34362
Research Site
Jerusalem, 9112001
Research Site
Kfar Saba, 4428164
Research Site
Nahariya, 22100
Research Site
Petah Tikvah, 49102
Austria5 sites
Research Site
Linz, 4010
Research Site
Salzburg, 5020
Research Site
Vienna, 1130
Research Site
Vienna, 1160
Research Site
Wels, 4600
Germany5 sites
Research Site
Aschaffenburg, 63739
Research Site
Dresden, 1307
Research Site
München, 81377
Research Site
Mutlangen, 73557
Research Site
Ulm, 89081
Belgium4 sites
Research Site
Antwerp, 2060
Research Site
Ghent, 9000
Research Site
Roeselare, 8900
Research Site
Yvoir, 5530
Bulgaria4 sites
Research Site
Pleven, 5800
Research Site
Plovdiv, 4002
Research Site
Stara Zagora, 6000
Research Site
Vratsa, 3000
Hungary4 sites
Research Site
Budapest, 1122
Research Site
Debrecen, 4032
Research Site
Gyula, 5700
Research Site
Kaposvár, 7400
New Zealand4 sites
Research Site
Addington, 8011
Research Site
Dunedin, 9016
Research Site
Palmerston North, 4442
Research Site
Tauranga, 3112
Singapore3 sites
Research Site
SGP, 169608
Research Site
SGP, 188770
Research Site
SGP, 217562
Sweden3 sites
Research Site
Gothenburg, 413 46
Research Site
Luleå, 97180
Research Site
Stockholm, 171 76
Taiwan3 sites
Research Site
Hualien City, 970
Research Site
Tainan, 70403
Research Site
Taipei, 100
About this study
Official title: A Randomized, Multicenter, Open-Label, Phase 3 Study of Acalabrutinib (ACP-196) Versus Investigator's Choice of Either Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Subjects With R/R Chronic Lymphocytic Leukemia
This study is designed to evaluate the efficacy of acalabrutinib compared with rituximab in combination with idelalisib or bendamustine in previously treated subjects with chronic lymphocytic leukemia (CLL).
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- Acalabrutinib (ACP-196), Rituximab, Idelalisib, Bendamustine
- Keywords
- CLL, BTK, Bruton Tyrosine Kinase, acalabrutinib, ACP-196
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acalabrutinib (ACP-196)Drug
Acalabrutinib monotherapy
RituximabDrug
Rituximab in combination with idelalisib or bendamustine
IdelalisibDrug
Idelalisib in combination with rituximab
BendamustineDrug
Bendamustine in combination with rituximab
| Study group | Role | What they receive |
|---|---|---|
| Acalabrutinib (ACP-196) | Experimental | Acalabrutinib (ACP-196) Monotherapy Receives: Drug: Acalabrutinib (ACP-196) |
| Rituximab Plus Idelalisib or Bendamustine | Active comparator | Investigator's Choice of Rituximab Plus Idelalisib or Bendamustine Receives: Drug: Rituximab; Drug: Idelalisib; Drug: Bendamustine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS) Per Independent Review Committee (IRC) Assessment
To evaluate the efficacy of acalabrutinib monotherapy (Arm A) compared with idelalisib/rituximab or bendamustine/rituximab (Arm B) based on Independent Review Committee (IRC) assessment of progression-free survival (PFS) per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria (Hallek 2008) with incorporation of the clarification for treatment-related lymphocytosis (Cheson 2012) hereafter referred to as IWCLL 2008 criteria in subjects with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL). As planned and reported in the interim clinical study report (dated 17 July 2019), because the study did cross the boundary at interim analysis.
IRC assessments were discontinued after the interim analysis. All IRC-related efficacy analyses in this clinical study report were based on the interim analysis data cutoff date of 15 January 2019. All other efficacy analyses were based on the final analysis data cutoff date of 03 September 2021.
Measured: IRC assessments from randomization date until disease progression or death or IRC discontinuation on 15Jan2019 (as IA per this data cutoff showed crossing superiority boundary) whichever came first, up to 22 months of follow-up
Secondary outcomes (7)
Progression-free Survival (PFS) Per Investigator Assessment
PFS per investigator assessment based on the final analysis data cutoff date of 03 September 2021.
Measured: From randomization date to date of disease progression or death due to any cause or data cutoff date on 03Sep2021, whichever came first, regardless of use of subsequent anticancer therapy, until 53 months of follow-up.
IRC-assessed Overall Response Rate (ORR) Per IWCLL 2008 Criteria Based on Data Cutoff 15 January 2019 From Interim Analysis
IRC-assessed overall response rate (ORR) including complete response (CR), CR with incomplete blood count recovery (CRi) nodular PR (nPR), and Partial Response (PR)
Measured: IRC assessments from randomization date until disease progression or death or IRC discontinuation on 15Jan2019 (as IA per this data cutoff showed crossing superiority boundary) whichever came first, up to 22 months of follow-up
Investigator Assessed Overall Response Rate (ORR) Per IWCLL 2008 Criteria Based on Data Cutoff 03 September 2021
IRC-assessed overall response rate (ORR) including complete response (CR), CR with incomplete blood count recovery (CRi) nodular PR (nPR), and Partial Response (PR)
Measured: Investigator assessments were done from randomization date until date of death or date of exit from study or data cut off date on 03Sep2021, whichever came first, up to 53 months of follow-up.
Overall Survival (OS)
Overall Survival (OS) was based on data cutoff date of 03Sep2021
Measured: From randomization date to date of death due to any cause, or date of study discontinuation, or date of data cutoff on 03Sep2021, whichever came first until 54 months of follow-up.
Duration of Response (DOR) Per Independent Review Committee (IRC) Assessment Based on 15 January 2019 Data Cutoff From Interim Analysis.
Duration of Response (DOR) is defined as from the first documentation of CR, CRi, PR, or nPR to the earlier of the first documentation of disease progression or death from any cause.
Measured: IRC assessments from randomization date until disease progression or death or IRC discontinuation on 15Jan2019 (as IA per this data cutoff showed crossing superiority boundary) whichever came first, up to 22 months of follow-up
Duration of Response (DOR) Per Investigator Assessment Based on 03 September 2021 Data Cutoff
Duration of Response (DOR) is defined as from the first documentation of CR, CRi, PR, or nPR to the earlier of the first documentation of disease progression or death from any cause.
Measured: Investigator assessments were done from randomization date until date of death or study discontinuation or data cutoff date on 03Sep2021, whichever came first up to 53 months of follow-up.
Time to Next Treatment (TTNT) Based on 03 September 2021 Data Cutoff
Time to Next Treatment (TTNT) is defined as the time from date of randomization to date of institution of non-protocol-specified treatment for CLL (or first dose date of acalabrutinib for Arm B subjects crossing over to receive acalabrutinib) or death due to any cause, whichever comes first.
Measured: From randomization date to start of non-protocol specified subsequent anticancer therapy for CLL or death due to any cause or study discontinuation or data cutoff date on 03Sep2021,, whichever came first up to 53 months of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study start2 Feb 2017
- Primary completion3 Sep 2021
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acerta Pharma BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Acerta Clinical Trials, Study director, 1-888-292-9613; acertamc@dlss.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02970318
- Sponsor's protocol ID
- ACE-CL-309
- Other IDs
- 2015-004454-17, 2015
- Status last verified
- Oct 2026
- First submitted
- 18 Nov 2016
- Last updated
- 23 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Publications
Eek D, Ivanescu C, Corredoira L, Meyers O, Cella D. Content validity and psychometric evaluation of the Functional Assessment of Chronic Illness Therapy-Fatigue scale in patients with chronic lymphocytic leukemia. J Patient Rep Outcomes. 2021 Mar 11;5(1):27. doi: 10.1186/s41687-021-00294-1.
PubMed 33709202Ghia P, Pluta A, Wach M, Lysak D, Kozak T, Simkovic M, Kaplan P, Kraychok I, Illes A, de la Serna J, Dolan S, Campbell P, Musuraca G, Jacob A, Avery E, Lee JH, Liang W, Patel P, Quah C, Jurczak W. ASCEND: Phase III, Randomized Trial of Acalabrutinib Versus Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia. J Clin Oncol. 2020 Sep 1;38(25):2849-2861. doi: 10.1200/JCO.19.03355. Epub 2020 May 27.
PubMed 32459600