Chronic Lymphocytic Leukemia (CLL)NCT02136511
Expanded Access for Idelalisib in Combination With Rituximab in Chronic Lymphocytic Leukemia
A study testing Idelalisib and Rituximab in people with Chronic Lymphocytic Leukemia (CLL), run by Gilead Sciences at 8 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia (CLL)
- What is being tested?
- Idelalisib and Rituximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- Not given
- Where
- 8 sitesin 4 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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
- CLL that warrants treatment (consistent with accepted IWCLL criteria for initiation of therapy)
- Prior treatment for CLL comprising any of the following:
- Prior treatment with ≥ 1 regimen containing a therapeutic anti-CD20 antibody or
- Prior treatment with ≥ 2 regimens containing ≥ 1 cytotoxic agent
- CLL progression < 24 months since the completion of the last prior therapy for CLL
Show all 14Show fewer
- Appropriate for noncytotoxic-containing therapy based on the presence of any of the following factors:
- 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
- Estimated creatinine clearance < 60 mL/min (as determined by the Cockcroft-Gault method), or
- A Cumulative Illness Rating Scale (CIRS) score of > 6
- A negative serum pregnancy test for female subjects of childbearing potential
- Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
- Lactating females must agree to discontinue nursing before the study drug is administered.
- Evidence of a personally signed informed consent
Who cannot join
- Known hypersensitivity to the idelalisib, its metabolites, or formulation excipient(s)
- Known histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation)
- Known myelodysplastic syndrome
- Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of randomization
- 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
- Ongoing drug-induced pneumonitis
- Ongoing inflammatory bowel disease
- History of anaphylaxis in association with previous administration of monoclonal antibodies
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
United States4 sites
Hackensack University Medical Center
Hackensack, New Jersey, 07601
University of California, San Diego - Moores Cancer Center
La Jolla, California, 92093-0820
Weill Cornell Medical College
New York, New York, 10021
Georgetown University
Washington D.C., District of Columbia, 20007
Italy2 sites
Ospedale San Raffaele
Milan, 20132
A.S.O. Molinette S. Giovanni Battista
Turin, 10126
About this study
Official title: 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.
- Conditions
- Chronic Lymphocytic Leukemia (CLL)
- Being tested
- Idelalisib, Rituximab
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IdelalisibDrug
Also called GS-1101, CAL-101, Zydelig®
Idelalisib 150 mg tablet administered orally twice daily
RituximabDrug
Also called Rituxan®
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic Leukemia (CLL)Studies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Jahn, MD, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136511
- Sponsor's protocol ID
- GS-US-312-1325
- Other IDs
- 2013-005343-82
- Status last verified
- Oct 2014
- First submitted
- 9 May 2014
- Last updated
- 28 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Expanded Access Protocol for Idelalisib in Combination With Rituximab for Relapsed, Previously Treated Subjects With Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT02136511
- Acronym / sponsor ID
- GS-US-312-1325
- Conditions
- Chronic Lymphocytic Leukemia (CLL)
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- First posted
- 13 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
- CLL that warrants treatment (consistent with accepted IWCLL criteria for initiation of therapy)
- Prior treatment for CLL comprising any of the following:
- CLL progression < 24 months since the completion of the last prior therapy for CLL
- Appropriate for noncytotoxic-containing therapy based on the presence of any of the following factors:
Key exclusion criteria (8 listed)
- Known hypersensitivity to the idelalisib, its metabolites, or formulation excipient(s)
- Known histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation)
- Known myelodysplastic syndrome
- Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of randomization
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IdelalisibAlso: GS-1101, CAL-101, Zydelig®Idelalisib 150 mg tablet administered orally twice daily | Drug | – |
| RituximabAlso: Rituxan®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. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Jahn, MD study director
Gilead Sciences
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Idelalisib and Rituximab in people with Chronic Lymphocytic Leukemia (CLL), run by Gilead Sciences at 8 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Italy, Ireland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2014.