A Phase 2, Single-Arm, Open-Label Study Evaluating the Efficacy and Safety of Single Agent GS 1101 (CAL 101) as Therapy for Previously Treated Chronic Lymphocytic Leukemia

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01659047

Enrollment

Registered

2012-08-07

Start date

2012-08-31

Completion date

2015-12-31

Last updated

2012-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia

Keywords

Chronic Lymphocytic Leukemia, CLL, CAL-101, Ofatumumab

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 2, multicenter, single-arm, controlled, clinical trial evaluating the efficacy and safety of the phosphatidylinositol 3-kinase delta (PI3K-delta) inhibitor GS-1101 (CAL-101) as therapy for previously treated chronic lymphocytic leukemia. This clinical trial (Study GS-US-312-0120) is a single-arm in which compliant subjects from GS US-312-0119 -Arm B who experience progression of CLL while receiving single-agent ofatumumab therapy are potentially eligible to receive single-agent, open-label GS 1101 therapy.

Interventions

DRUGGS-1101

150 mg taken twice daily by mouth

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Participation in Study GS-US-312-0119 * Occurrence of confirmed progression of CLL while receiving single-agent ofatumumab in Study GS US 312 0119. * Permanent cessation of Study GS-US-312-0119 (single-agent ofatumumab) and no intervening or continuing therapy (including radiotherapy, chemotherapy, immunotherapy, or investigational therapy) for the treatment of CLL. * The time from permanent cessation of single-agent ofatumumab on Study GS-US-312-0119 and the initiation of GS 1101 on Study GS-US-312-0120 is no more than 12 weeks.

Design outcomes

Primary

Measure	Time frame	Description
Progression-free survival	18 mon	—
Patient Well-Being	18 months	Health-related quality-of-life questionnaire
Disease-related Biomarkers	18 months	—
Pharmacokinetics	6 months	Evaluation of plasma concentrations at peak (Cmax) and trough (Cmin)
Incidence of Adverse Events	18 months	—
Health Resource Utilization	18 months	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026