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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02136511
Expanded Access Status : Approved for marketing
First Posted : May 13, 2014
Last Update Posted : October 28, 2014
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment
Chronic Lymphocytic Leukemia (CLL) Drug: Idelalisib Drug: Rituximab

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Study Type : Expanded Access
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: An Expanded Access Protocol for Idelalisib in Combination With Rituximab for Relapsed, Previously Treated Subjects With Chronic Lymphocytic Leukemia

Intervention Details:
  • Drug: Idelalisib
    Idelalisib 150 mg tablet administered orally twice daily
    Other Names:
    • GS-1101
    • CAL-101
    • Zydelig®
  • Drug: Rituximab
    Rituximab administered intravenously starting at 375 mg/m^2 at Week 0 and continuing with a dose of 500 mg/m^2 at Weeks 2, 4, 6, 8, 12, 16, and 20.
    Other Name: Rituxan®

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02136511

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United States, California
University of California, San Diego - Moores Cancer Center
La Jolla, California, United States, 92093-0820
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20007
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10021
St. James University Hospital
Dublin, Ireland, 8
Ospedale San Raffaele
Milano, Italy, 20132
A.S.O. Molinette S. Giovanni Battista
Turin, Italy, 10126
United Kingdom
Hammersmith Hospital
London, United Kingdom, W12 0HS
Sponsors and Collaborators
Gilead Sciences
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Study Director: Thomas Jahn, MD Gilead Sciences
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Responsible Party: Gilead Sciences Identifier: NCT02136511    
Other Study ID Numbers: GS-US-312-1325
2013-005343-82 ( EudraCT Number )
First Posted: May 13, 2014    Key Record Dates
Last Update Posted: October 28, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action