Efficacy and Safety of Idelalisib in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

A Phase 3, Randomized, Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01659021
• Other study ID #: GS-US-312-0119
• Secondary ID: 2012-001236-65
• Status: Terminated
• Phase: Phase 3
• Start date: December 4, 2012
• Est. completion date: August 15, 2018

Study information

• Verified date: August 2019
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the effect of the addition of idelalisib to ofatumumab on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 261
• Est. completion date: August 15, 2018
• Est. primary completion date: August 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Adults with previously treated recurrent CLL who have measurable lymphadenopathy

• Require therapy for CLL

• Have experienced CLL progression < 24 months since the completion of the last prior therapy

• Have disease that is not refractory to ofatumumab

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• Idelalisib
150 mg tablets administered orally twice daily
• Ofatumumab
Administered intravenously

Locations

Country	Name	City	State
Australia	Ashford Cancer Centre Research	Ashford	South Australia
Australia	Box Hill Hospital	Box Hill	Victoria
Australia	Royal Brisbane and Women's Hospital	Herston	Queensland
Australia	Saint George and Sutherland Hospitals	Kogarah	New South Wales
Australia	Frankston Hospital	Melbourne	Victoria
Australia	Haematology and Oncology Clinics of Australia at Mater	Milton	Queensland
Australia	Prince of Wales Hospital	Randwick	New South Wales
Australia	Westmead Hospital	Westmead	New South Wales
Australia	Queen Elizabeth Hospital	Woodville
Belgium	Ziekenhuis Netwerk Antwerpen	Antwerpen
Belgium	Cliniques Universitaires Saint Luc	Brussels
Belgium	Universitair Ziekenhuis Gent	Ghent
Belgium	Universitaire Ziekenhuis Gasthuisberg	Leuven
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Centre Hospitalier Universitaire de Montréal	Montréal	Quebec
Canada	Saskatchewan Cancer Agency	Regina	Saskatchewan
Canada	Centre Hospitalier Regional de Rimouski	Rimouski	Quebec
Canada	Hopital Regional De Sudbury Regional Hospital (HRSRH) - Regional Cancer Program (RCP)	Sudbury	Ontario
Canada	Cancer Care Manitoba	Winnipeg	Manitoba
Canada	Cancer Care Manitoba	Winnipeg
Denmark	Aalborg Hospital	Aalborg
Denmark	Aarhus University Hospital	Århus
France	CHRU Clermont- Ferrand CHU Estaing	Auvergne
France	Centre Hospitalier Universitaire Hôpital Avicenne	Ile-de-france
France	Hôpital Saint Louis	Paris Cedex 10	Ile-de-france
France	Centre Hospitalier de Perpignan	Perpignan	Languedoc-Roussillon
France	Center Hospitalier Universitaire de Bordeaux	Pessac Cedex	Aquitaine
France	Centre Hospitalier Universitaire Purpan	Toulouse Cedex	Midi-pyrenees
France	Centre Hospitalier Universitaire Nancy	Vandoeuvre	Limousin, Lorraine
Ireland	University College Cork	Cork
Ireland	Saint James's Hospital	Dublin
Poland	Szpital Specjalistyczny w Brzozowie	Brzozow
Poland	Collegium Medicum Uniwersytetu Jagiellonskiego w K	Kraków	Malopolskie
Poland	Wojewódzki Szpital Specjalistyczny im. Mikolaja Kopernika w Lodzi	Lódz
Poland	Wojewódzki Szpital Specjalistyczny im. Janusza Kor	Slupsk	Pomorskie
Poland	Centralny Szpital Kliniczny MSW	Warszawa
Poland	Samodzielny Publiczny Szpital Kliniczny N1 Klinika	Wroclaw
Spain	Hospital Clínic i Provincial	Barcelona
Spain	Hospital Vall d´Hebrón	Barcelona
Spain	Hospital Puerta de Hierro Majadahonda	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario La Princesa	Madrid
Spain	Hospital Morales Meseguer	Murcia
Sweden	Sunderby Sjukhus	Luleå
Sweden	Karolinska University Hospital Huddinge	Stockholm
Sweden	Karolinska University Hospital Solna	Stockholm
United Kingdom	Birmingham Heartlands Hospital	Birmingham	England
United Kingdom	Darent Valley Hospital	Dartford	England
United Kingdom	Royal Surrey County Hospital NHS Trust	Guildford	England
United Kingdom	Saint James's University Hospital	Leeds
United Kingdom	University College London	London
United Kingdom	University College London	London
United Kingdom	Haematology and Transplant Unit	Manchester	England
United Kingdom	Norfolk and Norwich University Hospital	Norwich	Norfolk
United Kingdom	Department of Haematology, Cancer and Haematology Centre, Churchill Hospital (Oxford University Hospitals)	Oxford
United States	Georgia Regents University	Augusta	Georgia
United States	Center for Cancer and Blood Disorders, PC	Bethesda	Maryland
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Tennessee Oncology, PLLC	Chattanooga	Tennessee
United States	Oncology Hematology Care, Inc.	Cincinnati	Ohio
United States	The Ohio State University Medical Center	Columbus	Ohio
United States	Kaiser Permanente of Colorado	Denver	Colorado
United States	City of Hope	Duarte	California
United States	California Cancer Associates for Research and Excellence (CCARE)	Fresno	California
United States	Saint Mary's Regional Cancer Center	Grand Junction	Colorado
United States	Upstate Oncology Associates	Greenville	South Carolina
United States	Cancer Specialists of North Florida	Jacksonville	Florida
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Montgomery Cancer Center	Mount Sterling	Kentucky
United States	Tenessee Oncology, PLLC	Nashville	Tennessee
United States	Weill Cornell Medical Center	New York	New York
United States	Oregon Health and Science University	Portland	Oregon
United States	Washington University Medical Center	Saint Louis	Missouri
United States	Utah Cancer Specialists	Salt Lake City	Utah
United States	Kaiser Permanente	San Diego	California
United States	Coastal Integrative Cancer Care	San Luis Obispo	California
United States	Stanford University Medical Center	Stanford	California
United States	Northwest Medical Specialties	Tacoma	Washington
United States	Kaiser Permanente Vallejo Medical Center	Vallejo	California

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Denmark,  France,  Ireland,  Poland,  Spain,  Sweden,  United Kingdom, 

References & Publications (6)

Flinn I, Kimby E, Cotter FE, Giles FJ, Janssens A, Pulczynski EJ, et al. A Phase 3, Randomized, Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination with Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia

Jones J, Robak T, Wach M, Brown JR, Menter AR, Vandenberghe E, et al. Updated results of a phase 3 randomized, controlled study of idelalisib in combination with ofatumumab for previously treated chronic lymphocytic leukemia (CLL) [Poster 7515]. American

Jones JA, Robak T, Brown JR, Awan FT, Badoux X, Coutre S, Loscertales J, Taylor K, Vandenberghe E, Wach M, Wagner-Johnston N, Ysebaert L, Dreiling L, Dubowy R, Xing G, Flinn IW, Owen C. Efficacy and safety of idelalisib in combination with ofatumumab for — View Citation

Jones JA, Wach M, Robak T, Brown JR, Menter AR, Vanderberghe E, et al. Results of a Phase 3 Randomized, Controlled Study Evaluating the Efficacy and Safety of Idelalisib (IDELA) in Combination with Ofatumumab (OFA) for Previously Treated Chronic Lymphocyt

Robak T, Jones J, Wach M, Brown JR, Menter AR, Vandenberghe E, et al. Updated results of a phase 3 randomized, controlled study of idelalisib in combination with ofatumumab for previously treated chronic lymphocytic leukemia (CLL) [Poster 213]. 21st Congr

Robak T, Wach M, Jones J, Owen C, Brown J, Menter A, et al. Results Of A Phase 3 Randomized Controlled Study Evaluating The Efficacy And Safety Of Idelalisib (Idela) In Combination With Ofatumumab (Ofa) For Previously Treated Chronic Lymphocytic Leukemia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival	Progression-free survival (PFS) was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression was CLL progression based on standard criteria (other than lymphocytosis alone) as defined by the 2008 update of the International Workshop on CLL guidelines, ie, appearance of any new lesion; increase by = 50% in the sum of the products of the perpendicular diameters of measured lymph nodes (SPD); new or = 50% enlargement of liver or spleen; transformation to a more aggressive histology (eg, Richter's or prolymphocytic transformation); reduction in the number of blood cells (cytopenia) attributable to CLL. PFS was analyzed using Kaplan-Meier (KM) estimates.	Randomization to End of Study (up to 60 months)
Secondary	Overall Response Rate	Overall response rate was defined as the percentage of participants who achieved a best overall response of complete response or partial response.; Complete response was defined as no lymphadenopathy, hepatomegaly, splenomegaly; normal complete blood count; confirmed by bone marrow aspirate & biopsy.; Partial response was defined as >1 of the following criteria: a 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver size, spleen size; plus = 1 of the following: = 1500/µL absolute neutrophil count, > 100000/µL platelets, > 11.0 g/dL hemoglobin or 50% improvement for either of these parameters without transfusions or growth factors. Overall response rate was analyzed using KM estimates.	Randomization to End of Study (up to 60 months)
Secondary	Lymph Node Response Rate	Lymph node response rate was defined as the proportion of participants who achieved a = 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters (SPD) of index lymph nodes.	Randomization to End of Study (up to 60 months)
Secondary	Overall Survival	Overall survival was defined as the interval from randomization to death from any cause. Overall survival was analyzed using KM estimates.	Randomization to Last Long-Term Follow-Up Visit (up to maximum of 5 years)
Secondary	Progression-Free Survival in Subgroup of Participants With Chromosome 17p Deletion and/or TP53 Mutation	Progression-free survival in subgroup of participants with chromosome 17p deletion and/or TP53 mutation was analyzed using KM estimates.	Randomization to End of Study (up to 60 months)
Secondary	Complete Response Rate	Complete response rate was defined as the percentage of participants who achieve a complete response and maintain their response for at least 8 weeks (with a 1-week window).	Randomization to End of Study (up to 60 months)