History of Changes for Study: NCT01569295

A Randomized, Double-Blind and Placebo-Controlled Study of GS-1101 in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)

Latest version (submitted March 2, 2020) on ClinicalTrials.gov

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Study Record Versions

Version	Submitted Date	Changes
1	March 30, 2012	None (earliest Version on record)
2	May 31, 2012	Recruitment Status, Study Status, Outcome Measures, Contacts/Locations and Oversight
3	June 18, 2012	Study Status
4	July 18, 2012	Study Status and Contacts/Locations
5	August 29, 2012	Study Status and Contacts/Locations
6	September 15, 2012	Study Status and Contacts/Locations
7	November 12, 2012	Contacts/Locations and Study Status
8	November 28, 2012	Contacts/Locations and Study Status
9	January 12, 2013	Arms and Interventions, Contacts/Locations, Study Description, Study Status, Study Identification and Conditions
10	March 11, 2013	Contacts/Locations and Study Status
11	March 18, 2013	Contacts/Locations and Study Status
12	June 24, 2013	Contacts/Locations and Study Status
13	August 20, 2013	Study Status and Contacts/Locations
14	September 20, 2013	Contacts/Locations and Study Status
15	December 23, 2013	Outcome Measures, Study Status, Study Description, Contacts/Locations, Arms and Interventions and Study Identification
16	February 6, 2014	Study Status and Contacts/Locations
17	March 7, 2014	Contacts/Locations and Study Status
18	April 14, 2014	Study Status and Contacts/Locations
19	May 22, 2014	Study Status and Contacts/Locations
20	July 2, 2014	Study Status and Contacts/Locations
21	July 24, 2014	Contacts/Locations and Study Status
22	September 5, 2014	Recruitment Status, Contacts/Locations, Arms and Interventions, Study Status, Outcome Measures and Conditions
23	October 21, 2014	Study Status and Contacts/Locations
24	May 1, 2015	Contacts/Locations and Study Status
25	December 4, 2015	Study Status
26	January 20, 2016	Study Status
27	May 24, 2016	Study Status, Study Design and Eligibility
28	June 9, 2017	Contacts/Locations, Study Status, Oversight, Eligibility and Study Identification
29	October 24, 2017	Study Status
	Results Submission Events
December 18, 2017		Returned after QC review: January 18, 2018
30	January 29, 2018	Study Status, Outcome Measures, More Information, References, Arms and Interventions, Adverse Events, Baseline Characteristics, Participant Flow, Contacts/Locations and Study Description
31	June 25, 2018	Study Status
32	October 9, 2018	Study Status
33	January 7, 2019	Study Status
34	May 6, 2019	Study Status
35	June 26, 2019	Recruitment Status, Study Status and IPDSharing
36	March 2, 2020	Outcome Measures, Adverse Events, Participant Flow, Baseline Characteristics, Study Status, More Information, IPDSharing, Document Section, Eligibility, Arms and Interventions, Conditions, Study Description and Study Identification

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Study NCT01569295
Submitted Date: March 30, 2012 (v1)

Study Identification


Unique Protocol ID:	GS-US-312-0115
Brief Title:	A Randomized, Double-Blind and Placebo-Controlled Study of GS-1101 in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)
Official Title:	A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-1101 (CAL-101) in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia
Secondary IDs:

Study Status


Record Verification:	March 2012
Overall Status:	Not yet recruiting
Study Start:	May 2012
Primary Completion:	October 2015 [Anticipated]
Study Completion:	December 2016 [Anticipated]

First Submitted:	March 27, 2012
First Submitted that Met QC Criteria:	March 30, 2012
First Posted:	April 3, 2012 [Estimate]

Last Update Submitted that Met QC Criteria:	March 30, 2012
Last Update Posted:	April 3, 2012 [Estimate]

Study Description

Brief Summary:

The purpose of this study is to evaluate the effect of GS-1101 on the onset, magnitude, and duration of tumor control.

Detailed Description:

This is a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-1101 (CAL-101) in Combination with Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia.

Eligible patients will be randomized with a 1:1 ratio into 1 of the 2 treatment arms to receive either GS-1101 or placebo. All subjects will be administered bendamustine and rituximab.

Conditions


Conditions:	Chronic Lymphocytic Leukemia
Keywords:	CLL CAL 101 CAL-101 GS 1101 GS-1101 PI3K Rituxan Rituximab Bendamustine Leukemia

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Triple (Participant, Care Provider, Investigator)
Allocation:	Randomized
Enrollment:	390 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Active Comparator: GS-1101 + bendamustine/rituximab	Drug: GS-1101 GS-1101 150 mg taken twice daily by mouth Other Names: CAL 101 CAL-101 Drug: Rituximab Rituximab 375 mg/m2 Wk 0 and then 500 mg/m2 Wk 4,8,12,16,and 20 administered intravenously Other Names: Rituxan, MabThera Drug: Bendamustine Bendamustine 70 mg/mg2/day on 2 consecutive days at Wk 0,4,8,12,16, and 20 administered intravenously Other Names: Ribomustin, Treanda, SDX-105
Placebo Comparator: Placebo + bendamustine/rituximab	Drug: Rituximab Rituximab 375 mg/m2 Wk 0 and then 500 mg/m2 Wk 4,8,12,16,and 20 administered intravenously Other Names: Rituxan, MabThera Drug: Bendamustine Bendamustine 70 mg/mg2/day on 2 consecutive days at Wk 0,4,8,12,16, and 20 administered intravenously Other Names: Ribomustin, Treanda, SDX-105 Drug: Placebo Placebo taken twice daily by mouth

Outcome Measures


Primary Outcome Measures:
1.	Progression-Free Survival [ Time Frame: 18 Months ]
Secondary Outcome Measures:
1.	Overall Response Rate [ Time Frame: 18 months ]
2.	Patient Well-Being (health-related quality-of-life questionnaire) [ Time Frame: 18 months ]
3.	Disease-Related Biomarkers [ Time Frame: 18 months ]
4.	Pharmacokinetics [ Time Frame: 6 months ] Peak Plasma Concentration (Cmax) and Trough Plasma Concentration (Cmin)
5.	Incidence of Adverse Events [ Time Frame: 18 months ]
6.	Health Resource Utilization (utility measure questionnaire) [ Time Frame: 18 months ]

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion: Previously treated recurrent CLL Measurable lymphadenopathy Requires therapy for CLL Has experienced CLL progression <36 months since the completion of the last prior therapy Exclusion: Recent history of a major non-CLL malignancy Evidence of an ongoing infection CLL refractory to bendamustine Concurrent participation in another therapeutic clinical trial

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