Clinical Trials Logo

Clinical Trial Details — Status: Approved for marketing

Administrative data

NCT number NCT02136511
Other study ID # GS-US-312-1325
Secondary ID 2013-005343-82
Status Approved for marketing
Phase N/A
First received May 9, 2014
Last updated October 27, 2014

Study information

Verified date October 2014
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Expanded Access

Clinical 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.


Recruitment information / eligibility

Status Approved for marketing
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

N/A


Related Conditions & MeSH terms


Intervention

Drug:
Idelalisib
Idelalisib 150 mg tablet administered orally twice daily
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.

Locations

Country Name City State
Ireland St. James University Hospital Dublin
Italy Ospedale San Raffaele Milano
Italy A.S.O. Molinette S. Giovanni Battista Turin
United Kingdom Hammersmith Hospital London
United States Hackensack University Medical Center Hackensack New Jersey
United States University of California, San Diego - Moores Cancer Center La Jolla California
United States Weill Cornell Medical College New York New York
United States Georgetown University Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Ireland,  Italy,  United Kingdom, 

See also
  Status Clinical Trial Phase
Recruiting NCT03588598 - Safety, Tolerability, and Pharmacokinetics of SHC014748M in Patients With Indolent B-Cell Hematologic Malignancies Phase 1
Recruiting NCT06043011 - Registry Platform Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms
Completed NCT02265731 - Study Evaluating Venetoclax in Subjects With Hematological Malignancies Phase 1/Phase 2
Completed NCT02582879 - informCLL™: A Disease Registry for Patients With Chronic Lymphocytic Leukemia
Completed NCT02553304 - Molecular Features Underlying Racial Differences in Survival of Taiwanese Chronic Lymphocytic Leukemia Patients
Completed NCT01419691 - Phase I and II Study of Auranofin in Chronic Lymphocytic Leukemia (CLL) Phase 2
Completed NCT01188681 - Safety and Efficacy Study of TRU-016 Plus Bendamustine vs. Bendamustine in Relapsed Chronic Lymphocytic Leukemia Phase 1/Phase 2
Recruiting NCT04758975 - Venetoclax, Rituximab and Ibrutinib in TN Patients With CLL Undetectable Minimal Residual Disease (uMRD) in Treatment-naïve Patients With Chronic Lymphocytic Leukemia (CLL) Phase 2
Terminated NCT02914938 - A Study of ME-401 in Subjects With CLL/SLL, FL, and B-cell Non Hodgkin's Lymphoma Phase 1
Active, not recruiting NCT01976520 - Vaccine Therapy for Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Phase 1
Terminated NCT01463852 - A Study of the Effect of Vinca Alkaloids on c-Jun N-terminal Kinase (JNK) Phosphorylation in Patients With Chronic Lymphocytic Leukemia (CLL) Phase 0
Terminated NCT01203930 - A Study of Idelalisib and Rituximab in Elderly Patients With Untreated CLL or SLL Phase 2
Recruiting NCT02966756 - A Study of Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Phase 2
Active, not recruiting NCT05105841 - Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax in Combination With Intravenous (IV) Obinutuzumab or Oral Ibrutinib in Adult Participants With Untreated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Phase 2
Recruiting NCT04072458 - A Clinical Trial of BP1002 in Patients With Advanced Lymphoid Malignancies Phase 1
Withdrawn NCT01754870 - Phase II Study of Bendamustine and Rituximab Induction Chemoimmunotherapy Followed by Maintenance Rituximab (Rituxan®) and Lenalidomide (Revlimid®) in Relapsed and Refractory Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL) Phase 2
Recruiting NCT01758042 - Bone Marrow and Kidney Transplant for Patients With Chronic Kidney Disease and Blood Disorders N/A
Completed NCT01885897 - IL-15 Super Agonist ALT-803 to Treat Relapse Of Hematologic Malignancy After Allogeneic SCT Phase 1/Phase 2
Active, not recruiting NCT04830137 - A Study of NX-2127 in Adults With Relapsed/Refractory B-cell Malignancies Phase 1
Recruiting NCT03547115 - A Study of Voruciclib Alone or in Combination With Venetoclax in Subjects With B-Cell Malignancies or AML Phase 1