Chronic Lymphocytic Leukemia (CLL) Clinical Trial
Official title:
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
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.
n/a
| 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 |
NCT02553304 -
Molecular Features Underlying Racial Differences in Survival of Taiwanese Chronic Lymphocytic Leukemia Patients
|
||
| Completed |
NCT02582879 -
informCLL™: A Disease Registry for Patients With Chronic Lymphocytic Leukemia
|
||
| 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 | |
| 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 | |
| Active, not recruiting |
NCT04285567 -
A Study to Compare the Efficacy and Safety of a Combined Regimen of Venetoclax and Obinutuzumab Versus Fludarabine, Cyclophosphamide, and Rituximab (FCR)/ Bendamustine And Rituximab (BR) in FIT Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without DEL (17P) or TP53 Mutation
|
Phase 3 |