Expanded Access for Idelalisib in Combination With Rituximab in Chronic Lymphocytic Leukemia

October 27, 2014 updated by: Gilead Sciences

An Expanded Access Protocol for Idelalisib in Combination With Rituximab for Relapsed, Previously Treated Subjects With Chronic Lymphocytic Leukemia

This study is to provide idelalisib (IDELA) to individuals with relapsed, previously treated chronic lymphocytic leukemia (CLL) who have limited treatment options and are not eligible for other Gilead-sponsored studies.

Study Overview

Status

Approved for marketing

Conditions

Intervention / Treatment

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland, 8
        • St. James University Hospital
  • Italy
      • Milano, Italy, 20132
        • Ospedale San Raffaele
      • Turin, Italy, 10126
        • A.S.O. Molinette S. Giovanni Battista
  • United Kingdom
      • London, United Kingdom, W12 0HS
        • Hammersmith Hospital
  • United States
    • California
      • La Jolla, California, United States, 92093-0820
        • University of California, San Diego - Moores Cancer Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • New York
      • New York, New York, United States, 10021
        • Weill Cornell Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female ≥ 18 years of age with a diagnosis of B-cell CLL established according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria and documented within medical records
  2. CLL that warrants treatment (consistent with accepted IWCLL criteria for initiation of therapy)

  3. Prior treatment for CLL comprising any of the following:

    1. Prior treatment with ≥ 1 regimen containing a therapeutic anti-CD20 antibody or
    2. Prior treatment with ≥ 2 regimens containing ≥ 1 cytotoxic agent
  4. CLL progression < 24 months since the completion of the last prior therapy for CLL

  5. Appropriate for noncytotoxic-containing therapy based on the presence of any of the following factors:

    1. Grade ≥ 3 neutropenia or thrombocytopenia attributable to cumulative myelotoxicity from prior administration of cytotoxic agents (as documented by bone marrow biopsy obtained since last prior therapy), or
    2. Estimated creatinine clearance < 60 mL/min (as determined by the Cockcroft-Gault method), or
    3. A Cumulative Illness Rating Scale (CIRS) score of > 6
  6. A negative serum pregnancy test for female subjects of childbearing potential
  7. Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
  8. Lactating females must agree to discontinue nursing before the study drug is administered.
  9. Evidence of a personally signed informed consent

Exclusion Criteria:

  1. Known hypersensitivity to the idelalisib, its metabolites, or formulation excipient(s)
  2. Known histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation)
  3. Known myelodysplastic syndrome
  4. Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of randomization
  5. Ongoing drug-induced liver injury, chronic active hepatitis C (HCV), chronic active hepatitis B (HBV), alcoholic liver disease, nonalcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension
  6. Ongoing drug-induced pneumonitis
  7. Ongoing inflammatory bowel disease
  8. History of anaphylaxis in association with previous administration of monoclonal antibodies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Investigators

  • Study Director: Thomas Jahn, MD, Gilead Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

May 9, 2014

First Submitted That Met QC Criteria

May 9, 2014

First Posted (Estimate)

May 13, 2014

Study Record Updates

Last Update Posted (Estimate)

October 28, 2014

Last Update Submitted That Met QC Criteria

October 27, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-312-1325
  • 2013-005343-82 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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