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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Chronic Lymphocytic Leukemia

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

18 mon

Safety Issue:

No

Principal Investigator

Langdon Miller, MD

Investigator Role:

Study Director

Investigator Affiliation:

Gilead Sciences

Authority:

United States: Food and Drug Administration

Study ID:

GS-US-312-0120

NCT ID:

NCT01659047

Start Date:

August 2012

Completion Date:

December 2015

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Chronic Lymphocytic Leukemia
  • CLL
  • CAL-101
  • Ofatumumab
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

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