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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01569295
First received: March 27, 2012
Last updated: June 9, 2017
Last verified: June 2017
  Purpose
This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect of idelalisib on the onset, magnitude, and duration of tumor control. Eligible patients will be randomized with a 1:1 ratio into 1 of the 2 treatment arms to receive either idelalisib or placebo. All subjects will be administered bendamustine and rituximab.

Condition Intervention Phase
Chronic Lymphocytic Leukemia Drug: Idelalisib Drug: Rituximab Drug: Bendamustine Drug: Placebo to match idelalisib Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Progression-Free Survival [ Time Frame: Up to 30 months ]
    Progression-free survival (PFS) is defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause.


Secondary Outcome Measures:
  • Overall Response Rate [ Time Frame: Up to 30 months ]
    Overall response rate (ORR) is defined as the proportion of participants who achieve a complete response or partial response.

  • Lymph Node Response Rate [ Time Frame: Up to 30 months ]
    Lymph node response rate is defined as the proportion of participants who achieve a ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters (SPD) of index lesions.

  • Overall Survival [ Time Frame: Up to 30 months ]
    Overall survival (OS) is defined as the interval from randomization to death from any cause.

  • Complete Response Rate [ Time Frame: Up to 30 months ]
    Complete response (CR) rate is defined as the proportion of participants who achieve a CR.


Enrollment: 416
Actual Study Start Date: June 26, 2012
Estimated Study Completion Date: December 2017
Primary Completion Date: June 15, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Idelalisib+bendamustine+rituximab
Participants will receive idelalisib plus bendamustine and rituximab for up to 30 months.
Drug: Idelalisib
Idelalisib 150 mg administered orally twice daily
Other Names:
  • GS-1101
  • CAL 101
  • CAL-101
  • Zydelig®
Drug: Rituximab
Rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a maximum of 6 infusions
Other Names:
  • Rituxan®
  • MabThera
Drug: Bendamustine
Bendamustine 70 mg/mg^2/day on 2 consecutive days every 28 days administered intravenously for a maximum of 12 infusions
Other Names:
  • Ribomustin
  • Treanda®
  • SDX-105
Placebo Comparator: Placebo to match idelalisib+bendamustine+rituximab
Participants will receive placebo to match idelalisib plus bendamustine and rituximab for up to 30 months.
Drug: Rituximab
Rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a maximum of 6 infusions
Other Names:
  • Rituxan®
  • MabThera
Drug: Bendamustine
Bendamustine 70 mg/mg^2/day on 2 consecutive days every 28 days administered intravenously for a maximum of 12 infusions
Other Names:
  • Ribomustin
  • Treanda®
  • SDX-105
Drug: Placebo to match idelalisib
Placebo to match idelalisib administered orally twice daily

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Previously treated recurrent CLL
  • Measurable lymphadenopathy
  • Requires therapy for CLL
  • Has experienced CLL progression <36 months since the completion of the last prior therapy

Key Exclusion Criteria:

  • Recent history of a major non-CLL malignancy
  • Evidence of an ongoing infection
  • CLL refractory to bendamustine
  • Concurrent participation in another therapeutic clinical trial

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01569295

  Show 106 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences
  More Information

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01569295     History of Changes
Other Study ID Numbers: GS-US-312-0115
2011-006292-20 ( EudraCT Number )
Study First Received: March 27, 2012
Last Updated: June 9, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gilead Sciences:
Zydelig
CLL
CAL 101
CAL-101
GS 1101
GS-1101
PI3K
Rituxan
Rituximab
Bendamustine
Leukemia
idelalisib

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Idelalisib
Rituximab
Bendamustine Hydrochloride
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 17, 2017