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

This treatment has been approved for sale to the public.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT02136511
First received: May 9, 2014
Last updated: October 27, 2014
Last verified: October 2014
  Purpose
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 Intervention
Chronic Lymphocytic Leukemia (CLL) Drug: Idelalisib Drug: Rituximab

Study Type: Expanded Access     What is Expanded Access?
Official Title: An Expanded Access Protocol for Idelalisib in Combination With Rituximab for Relapsed, Previously Treated Subjects With Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

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®
  Eligibility

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

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
  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: NCT02136511

Locations
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
Ireland
St. James University Hospital
Dublin, Ireland, 8
Italy
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
Investigators
Study Director: Thomas Jahn, MD Gilead Sciences
  More Information

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02136511     History of Changes
Other Study ID Numbers: GS-US-312-1325
2013-005343-82 ( EudraCT Number )
Study First Received: May 9, 2014
Last Updated: October 27, 2014

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
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 28, 2017