Loading clinical trials...

A Study of Idelalisib and Rituximab in Elderly Patients With Untreated CLL or SLL | Clinical Trials | Clareo Health

TERMINATEDPHASE2

A Study of Idelalisib and Rituximab in Elderly Patients With Untreated CLL or SLL

A Phase 2 Single Arm Study to Investigate the Safety and Clinical Activity of Idelalisib Alone and in Combination With Rituximab in Elderly Subjects With Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

NCT01203930•Gilead Sciences

View on ClinicalTrials.gov

Summary

This study is to evaluate the safety and clinical activity of idelalisib alone and in combination with rituximab in patients with CLL or SLL. This Phase 2 study will be the first time that idelalisib is administered to previously untreated patients with hematologic malignancies. Idelalisib has demonstrated clinical activity as a single agent in relapsed or refractory CLL and SLL with acceptable toxicity, which supports its evaluation in previously untreated patients. The study population is limited to patients over 65 years of age because younger patients are generally appropriate for standard immunochemotherapy regimens that are highly active. Since the mechanism of action of idelalisib is distinct from rituximab, it is hypothesized that the combination will be more active than either agent alone. This study will establish initial safety and clinical activity of idelalisib in combination with rituximab in patients with CLL or SLL. Cohort 2 of this study will establish safety and clinical activity of idelalisib alone in subjects with untreated CLL or SLL.

Eligibility

Age

65 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically or cytologically confirmed CLL or SLL.
•Age ≥ 65
•Presence of measurable lymphadenopathy (defined as the presence of ≥1 nodal lesion that measures ≥ 1.5 cm in the longest diameter (LD) and ≥ 1.0 cm in the longest perpendicular diameter (LPD) as assessed by physical exam, computed tomography (CT) or magnetic resonance imaging (MRI)).
•CLL - Binet Stage C or Rai Stage III or IV or has active disease defined by meeting at least one of the following criteria:
•* Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia
•* Massive (ie, \> 6 cm below the left costal margin) or progressive or symptomatic splenomegaly
•* Massive nodes (ie, \> 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy
•* Progressive lymphocytosis with an increase of more than 50% over a 2-month period or lymphocyte doubling time of less than 6 months
•* Autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroids or other standard therapy
•* At least one of the following disease-related symptoms:
+8 more criteria

Exclusion Criteria

•Prior therapy for CLL or SLL, except corticosteroids for symptom relief
•Treatment with a short course of corticosteroids for symptom relief within 1-week prior to Visit 1
•Known active central nervous system involvement of the malignancy
•Ongoing active, serious infection requiring systemic therapy. Patients may be receiving prophylactic antibiotics and antiviral therapy at the discretion of the treating physician.
•Serum creatinine ≥ 2.0 mg/dL
•Serum bilirubin ≥ 2 mg/dL (unless due to Gilbert's syndrome) or serum transaminases (ie, aspartate aminotransferase (AST), alanine aminotransferase (ALT)) ≥ 2 x upper limit of normal
•Positive test for human immunodeficiency virus (HIV) antibodies
•Active hepatitis B or C (confirmed by ribonucleic acid (RNA) test). Patients with serologic evidence of prior exposure are eligible.
•History of a non-CLL malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate-specific antigen for ≥ 1 year prior to study entry, other adequately treated Stage 1 or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for ≥ 5 years.

Locations (6)

University of California, San Diego, Moores Cancer Center

La Jolla, California, United States

Stanford University School of Medicine

Stanford, California, United States

Columbia University - Herbert Irving Pavilion

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

The Universtity of Texas MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

October 1, 2010

Primary Completion Date

August 1, 2015

Completion Date

June 1, 2016

Last Updated

November 16, 2018

Enrollment

105

ACTUAL participants

Conditions

Chronic Lymphocytic Leukemia (CLL)Small Lymphocytic Lymphoma (SLL)

Interventions

Idelalisib

DRUG

Rituximab

DRUG

Registry Platform Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms

NCT06043011

Chronic Lymphocytic Leukemia (CLL)Diffuse Large B-cell Lymphoma (DLBCL)+4 more

View study

RECRUITINGPHASE1

A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies

NCT06528301

Lymphoma, B-CellLymphoma, Non-Hodgkin (NHL)+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 16, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of Idelalisib and Rituximab in Elderly Patients With Untreated CLL or SLL

Inclusion Criteria

Exclusion Criteria

Registry Platform Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms

A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies

Zanubrutinib and Venetoclax in CLL (ZANU-VEN)

Venetoclax, Rituximab and Ibrutinib in TN Patients With CLL Undetectable Minimal Residual Disease (uMRD) in Treatment-naïve Patients With Chronic Lymphocytic Leukemia (CLL)

Long-term Follow-up Study for Patients Treated With CLBR001 CAR-T

First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma