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Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion

Primary Purpose

B-cell Chronic Lymphocytic Leukemia (CLL) With 17p Deletion

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Idelalisib
Rituximab
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B-cell Chronic Lymphocytic Leukemia (CLL) With 17p Deletion focused on measuring Chronic Lymphocytic Leukemia, CLL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Documented diagnosis of B-cell CLL, according to International Workshop on Chronic Lymphocytic Leukemia 2008
  • Presence of 17p deletion in CLL cells as demonstrated by fluorescence in-situ hybridization (FISH) testing
  • No prior therapy for CLL other than corticosteroids for disease complications
  • CLL that warrants treatment
  • Presence of measurable lymphadenopathy
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

Key Exclusion Criteria:

  • Known histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation)
  • Known presence of myelodysplastic syndrome

  • History of a non-CLL malignancy except for the following:

    • the malignancy has been in remission without treatment for ≥ 5 years prior to enrollment, or
    • carcinoma in situ of the cervix, or
    • adequately treated basal or squamous cell skin cancer or other localized non-melanoma skin cancer, or
    • asymptomatic prostate cancer without known metastatic disease and with no current requirement for therapy or requiring only hormonal therapy and with normal prostate specific antigen for ≥ 1 year prior to enrollment, or
    • ductal carcinoma in situ (DCIS) of the breast treated with lumpectomy alone, or
    • other adequately treated Stage 1 or 2 cancer currently in complete remission
  • Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of enrollment
  • Ongoing liver injury
  • History of noninfectious pneumonitis
  • Ongoing inflammatory bowel disease
  • History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
  • Ongoing immunosuppressive therapy other than corticosteroids
  • Received last dose of study drug on another therapeutic clinical trial within 30 days prior to enrollment
  • Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, electrocardiogram (ECG) finding, or laboratory abnormality

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

Sites / Locations

  • Arizona Oncology Associates, PC - HOPE
  • Innovative Clinical Research Institute
  • Rocky Mountain Cancer Centers
  • The University of Chicago Medicine
  • Illinois Cancer Specialists
  • Washington University School of Medicine
  • Duke University
  • GHS Cancer Institute
  • Compass Oncology
  • Willamette Valley Cancer Center and Research Institute
  • Hospital of the University of Pennsylvania, Abramson Cancer Center
  • St Vincent's Hospital, Sydney
  • St George Hospital
  • Icon Cancer Foundation
  • St Vincent's Hospital, Melbourne
  • Liverpool Hospital
  • Innsbruck University Hospital, Inner Medicine,
  • Univ. Klinik für Innere Medizin III LKH
  • Medizinische Universität Wien, Univ. Klinik f. Innere Med. I, Abteilung für Hämatologie und Hämostaseologie
  • AZ Sint-Jan AV Brugge-Oostende
  • University Hospital Leuven
  • University Hospital
  • Faculty Hospital Hradec Kralove
  • Hemato-Onkologicka Klinika Fn
  • Faculty hospital Ostrava
  • Faculty Hospital Kralovske Vinohrady
  • Vseobecna Fakultim Nemocnice
  • Aalborg University Hospital
  • Centre Hospitalier Universitaire Hôpital Avicenne
  • CHRU de Lille, Hopital Claude Huriez
  • Centre Hospitalier Universitaire Nancy
  • Hopital Pitie-Salpetriere
  • University of Debrecen HSC Institute of internal Medicine, Department of Hematology
  • Institute of Hematology "L. e A. Seràgnoli"
  • A.O.Spedali Civili Brescia
  • A.O.Niguarda Ca' Granda
  • Azienda Ospedaliero Universitaria Policlinico di Modena
  • SCDU Medicina II ed Ematologia, A.O.U. San Luigi Gonzaga
  • Uniwersyteckie Centrum Kliniczne
  • Szpital Specjalistyczny w Brzozowie
  • Malopolskie Centrum Medyczne s.c.
  • Wojewodzki Szpital Specjalistyczny
  • Centrum Onkologii-Instytut Marii Sklodowskiej -Curie klinika Nowotworow Ukladu Chlonnego
  • Samodzielny Publiczny Szpital Kliniczny
  • Centro Hospitalar De Lisboa Norte, E.P.E. - Hospital Santa Maria
  • IPO Porto Francisco Gentil, E.P.E
  • Emergency County Clinical Hospital Brasov
  • Spitalul Clinic Colentina
  • Institutul Regional de Oncologie Iasi
  • Hospital Universitario Marques de Valdecilla
  • Hospital Clinic
  • Hospital Universitario Puerta De Hierro
  • Hospital Clinico Universitario De Valencia (Chuv)
  • Saint James's University Hospital
  • Royal Liverpool & Broadgreen Univ. Hospitals
  • University Hospital Southampton NHS Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Idelalisib + rituximab

Arm Description

Participants will receive rituximab for 8 weeks and Idelalisib continuously throughout the study (up to 10 years).

Outcomes

Primary Outcome Measures

Overall Response Rate
Overall response rate (ORR) was defined as the proportion of participants who achieve a confirmed complete or partial response. ORR was to be assessed by an independent review committee (IRC).

Secondary Outcome Measures

Duration of Response
Duration of response (DOR) was defined as the interval from the first documentation of confirmed complete response or partial response (by IRC) to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is chronic lymphocytic leukemia (CLL) progression based on standard criteria, excluding lymphocytosis alone.
Nodal Response Rate
Nodal response rate was defined as the proportion of participants who achieve a 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Nodal response rate was to be assessed by an IRC.
Complete Response Rate
Complete response rate was defined as the proportion of participants who achieve a confirmed complete response. Complete response rate was to be assessed by an IRC.
Progression-Free Survival
Progression-free survival (PFS) was defined as the interval from first dose of study drug to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is CLL progression based on standard criteria, excluding lymphocytosis alone. PFS was to be assessed by an IRC.
Overall Survival
Overall survival was defined as the interval from the start of study treatment to death from any cause.
Minimal Residual Disease Negativity Rate at Week 36
Minimal residual disease (MRD) negativity rate was defined as the proportion of participants with MRD < 10^-4 assessed by flow cytometry in bone marrow at Week 36 after therapy initiation. For participants receiving the final dose of rituximab after the original scheduled date, the MRD assessment will be performed no fewer than 12 weeks after the last dose of rituximab.

Full Information

First Posted
January 22, 2014
Last Updated
October 19, 2018
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02044822
Brief Title
Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion
Official Title
A Phase 2, Single Arm Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Study Start Date
August 6, 2014 (Actual)
Primary Completion Date
April 27, 2016 (Actual)
Study Completion Date
May 17, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study is to evaluate overall response rate (ORR) following treatment with idelalisib plus rituximab in participants with previously untreated chronic lymphocytic leukemia (CLL) with 17p deletion. An increased rate of deaths and serious adverse events (SAEs) among participants with front-line CLL and early-line indolent non-Hodgkin lymphoma (iNHL) treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated those studies in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). All front-line studies of idelalisib, including this study, were also terminated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-cell Chronic Lymphocytic Leukemia (CLL) With 17p Deletion
Keywords
Chronic Lymphocytic Leukemia, CLL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Idelalisib + rituximab
Arm Type
Experimental
Arm Description
Participants will receive rituximab for 8 weeks and Idelalisib continuously throughout the study (up to 10 years).
Intervention Type
Drug
Intervention Name(s)
Idelalisib
Other Intervention Name(s)
GS-1101, CAL-101, Zydelig®
Intervention Description
150 mg tablets administered orally twice daily
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan
Intervention Description
375 mg/m^2 administered intravenously once weekly x 8 weeks
Primary Outcome Measure Information:
Title
Overall Response Rate
Description
Overall response rate (ORR) was defined as the proportion of participants who achieve a confirmed complete or partial response. ORR was to be assessed by an independent review committee (IRC).
Secondary Outcome Measure Information:
Title
Duration of Response
Description
Duration of response (DOR) was defined as the interval from the first documentation of confirmed complete response or partial response (by IRC) to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is chronic lymphocytic leukemia (CLL) progression based on standard criteria, excluding lymphocytosis alone.
Title
Nodal Response Rate
Description
Nodal response rate was defined as the proportion of participants who achieve a 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Nodal response rate was to be assessed by an IRC.
Title
Complete Response Rate
Description
Complete response rate was defined as the proportion of participants who achieve a confirmed complete response. Complete response rate was to be assessed by an IRC.
Title
Progression-Free Survival
Description
Progression-free survival (PFS) was defined as the interval from first dose of study drug to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is CLL progression based on standard criteria, excluding lymphocytosis alone. PFS was to be assessed by an IRC.
Title
Overall Survival
Description
Overall survival was defined as the interval from the start of study treatment to death from any cause.
Title
Minimal Residual Disease Negativity Rate at Week 36
Description
Minimal residual disease (MRD) negativity rate was defined as the proportion of participants with MRD < 10^-4 assessed by flow cytometry in bone marrow at Week 36 after therapy initiation. For participants receiving the final dose of rituximab after the original scheduled date, the MRD assessment will be performed no fewer than 12 weeks after the last dose of rituximab.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Documented diagnosis of B-cell CLL, according to International Workshop on Chronic Lymphocytic Leukemia 2008 Presence of 17p deletion in CLL cells as demonstrated by fluorescence in-situ hybridization (FISH) testing No prior therapy for CLL other than corticosteroids for disease complications CLL that warrants treatment Presence of measurable lymphadenopathy Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 Key Exclusion Criteria: Known histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation) Known presence of myelodysplastic syndrome History of a non-CLL malignancy except for the following: the malignancy has been in remission without treatment for ≥ 5 years prior to enrollment, or carcinoma in situ of the cervix, or adequately treated basal or squamous cell skin cancer or other localized non-melanoma skin cancer, or asymptomatic prostate cancer without known metastatic disease and with no current requirement for therapy or requiring only hormonal therapy and with normal prostate specific antigen for ≥ 1 year prior to enrollment, or ductal carcinoma in situ (DCIS) of the breast treated with lumpectomy alone, or other adequately treated Stage 1 or 2 cancer currently in complete remission Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of enrollment Ongoing liver injury History of noninfectious pneumonitis Ongoing inflammatory bowel disease History of prior allogeneic bone marrow progenitor cell or solid organ transplantation Ongoing immunosuppressive therapy other than corticosteroids Received last dose of study drug on another therapeutic clinical trial within 30 days prior to enrollment Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, electrocardiogram (ECG) finding, or laboratory abnormality Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Oncology Associates, PC - HOPE
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Innovative Clinical Research Institute
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80303
Country
United States
Facility Name
The University of Chicago Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Illinois Cancer Specialists
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
GHS Cancer Institute
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Compass Oncology
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Willamette Valley Cancer Center and Research Institute
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Facility Name
Hospital of the University of Pennsylvania, Abramson Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
St Vincent's Hospital, Sydney
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
St George Hospital
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Icon Cancer Foundation
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
St Vincent's Hospital, Melbourne
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Liverpool Hospital
City
Liverpool
ZIP/Postal Code
NSW 2170
Country
Australia
Facility Name
Innsbruck University Hospital, Inner Medicine,
City
Innsbruck
ZIP/Postal Code
A-6020
Country
Austria
Facility Name
Univ. Klinik für Innere Medizin III LKH
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Medizinische Universität Wien, Univ. Klinik f. Innere Med. I, Abteilung für Hämatologie und Hämostaseologie
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
AZ Sint-Jan AV Brugge-Oostende
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
University Hospital Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
University Hospital
City
Brno
Country
Czechia
Facility Name
Faculty Hospital Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Hemato-Onkologicka Klinika Fn
City
Olomuc
Country
Czechia
Facility Name
Faculty hospital Ostrava
City
Ostrava-Poruba
ZIP/Postal Code
70852
Country
Czechia
Facility Name
Faculty Hospital Kralovske Vinohrady
City
Prague 10
ZIP/Postal Code
10034
Country
Czechia
Facility Name
Vseobecna Fakultim Nemocnice
City
Praha
ZIP/Postal Code
12808
Country
Czechia
Facility Name
Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
Centre Hospitalier Universitaire Hôpital Avicenne
City
Bobigny
ZIP/Postal Code
93009
Country
France
Facility Name
CHRU de Lille, Hopital Claude Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Centre Hospitalier Universitaire Nancy
City
Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Hopital Pitie-Salpetriere
City
Paris cedex 13
ZIP/Postal Code
75651
Country
France
Facility Name
University of Debrecen HSC Institute of internal Medicine, Department of Hematology
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Institute of Hematology "L. e A. Seràgnoli"
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
A.O.Spedali Civili Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
A.O.Niguarda Ca' Granda
City
Milan
ZIP/Postal Code
20162
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Policlinico di Modena
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
SCDU Medicina II ed Ematologia, A.O.U. San Luigi Gonzaga
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdańsk
State/Province
Pomorskie
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Szpital Specjalistyczny w Brzozowie
City
Brzozow
ZIP/Postal Code
36-200
Country
Poland
Facility Name
Malopolskie Centrum Medyczne s.c.
City
Krakow
ZIP/Postal Code
30-510
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny
City
Lodz
ZIP/Postal Code
93-510
Country
Poland
Facility Name
Centrum Onkologii-Instytut Marii Sklodowskiej -Curie klinika Nowotworow Ukladu Chlonnego
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny
City
Wroclaw
ZIP/Postal Code
50-367
Country
Poland
Facility Name
Centro Hospitalar De Lisboa Norte, E.P.E. - Hospital Santa Maria
City
Lisbon
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
IPO Porto Francisco Gentil, E.P.E
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Emergency County Clinical Hospital Brasov
City
Brasov
ZIP/Postal Code
500326
Country
Romania
Facility Name
Spitalul Clinic Colentina
City
Bucharest
ZIP/Postal Code
20125
Country
Romania
Facility Name
Institutul Regional de Oncologie Iasi
City
Iasi
ZIP/Postal Code
700348
Country
Romania
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Clinic
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario Puerta De Hierro
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Clinico Universitario De Valencia (Chuv)
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Saint James's University Hospital
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Royal Liverpool & Broadgreen Univ. Hospitals
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
University Hospital Southampton NHS Trust
City
Southampton
ZIP/Postal Code
16
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
IPD Sharing Time Frame
18 months after study completion
IPD Sharing Access Criteria
A secured external environment with username, password, and RSA code.
IPD Sharing URL
http://www.gilead.com/research/disclosure-and-transparency

Learn more about this trial

Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion

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