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Efficacy and Safety of Idelalisib (GS-1101; CAL-101) in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01659021
First received: August 3, 2012
Last updated: February 14, 2017
Last verified: February 2017
  Purpose
This study will evaluate the effect of the addition of idelalisib (GS-1101) to ofatumumab on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL).

Condition Intervention Phase
Chronic Lymphocytic Leukemia Drug: Idelalisib Drug: Ofatumumab Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Ofatumumab 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 37 months ]
    Progression-free survival was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression was CLL progression based on standard criteria (other than lymphocytosis alone) as defined by the 2008 update of the International Workshop on CLL guidelines, ie, appearance of any new lesion; increase by ≥ 50% in the sum of the products of the perpendicular diameters of measured lymph nodes (SPD); new or ≥ 50% enlargement of liver or spleen; transformation to a more aggressive histology (eg, Richter's or prolymphocytic transformation); reduction in the number of blood cells (cytopenia) attributable to CLL.


Secondary Outcome Measures:
  • Overall Response Rate [ Time Frame: Up to 37 months ]

    Overall response rate was defined as the percentage of participants who achieved a best overall response of complete response or partial response.

    • Complete response was defined as no lymphadenopathy, hepatomegaly, splenomegaly; normal complete blood count; confirmed by bone marrow aspirate & biopsy.
    • Partial response was defined as >1 of the following criteria: a 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver size, spleen size; plus ≥ 1 of the following: ≥ 1500/μL absolute neutrophil count, > 100000/μL platelets, > 11.0 g/dL hemoglobin or 50% improvement for either of these parameters without transfusions or growth factors.

  • Lymph Node Response Rate [ Time Frame: Up to 37 months ]
    Lymph node response rate was defined as the proportion of participants who achieved a ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters (SPD) of index lymph nodes.

  • Overall Survival [ Time Frame: Up to 5 years ]
    Overall survival was defined as the interval from randomization to death from any cause.

  • Progression-Free Survival in Subgroup of Participants With Chromosome 17p Deletion and/or TP53 Mutation [ Time Frame: Up to 37 months ]
  • Complete Response Rate [ Time Frame: Up to 37 months ]
    Complete response rate was defined as the percentage of participants who achieve a complete response and maintain their response for at least 8 weeks (with a 1-week window).


Enrollment: 261
Actual Study Start Date: December 4, 2012
Estimated Study Completion Date: March 2023
Primary Completion Date: January 15, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Idelalisib+ofatumumab

Randomized Initial Therapy (24 weeks): Idelalisib + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)

Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation.

Drug: Idelalisib
Idelalisib 150 mg tablets administered orally twice daily
Other Names:
  • Zydelig®
  • GS-1101
  • CAL-101
Drug: Ofatumumab
Ofatumumab administered intravenously
Other Name: Arzerra®
Active Comparator: Ofatumumab

Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)

Continuing Therapy/Observation: Observation until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation.

Drug: Ofatumumab
Ofatumumab administered intravenously
Other Name: Arzerra®

  Eligibility

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

Key Inclusion Criteria:

  • Adults with previously treated recurrent CLL who have measurable lymphadenopathy
  • Require therapy for CLL
  • Have experienced CLL progression < 24 months since the completion of the last prior therapy
  • Have disease that is not refractory to ofatumumab

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: NCT01659021

  Show 80 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences
  More Information

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01659021     History of Changes
Other Study ID Numbers: GS-US-312-0119
2012-001236-65 ( EudraCT Number )
Study First Received: August 3, 2012
Results First Received: February 14, 2017
Last Updated: February 14, 2017

Keywords provided by Gilead Sciences:
CLL
Chronic Lymphocytic Leukemia
GS-1101
CAL-101
Ofatumumab

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
Antibodies, Monoclonal
Idelalisib
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 23, 2017