Numerous clinical trials spanning Phase 1 through Phase 4 evaluate the efficacy and safety of CAL-101 (idelalisib) as monotherapy and combination regimens for B-cell malignancies, including chronic lymphocytic leukemia, follicular lymphoma, small lymphocytic lymphoma, and marginal zone lymphoma. Sponsored by pharmaceutical developers such as Gilead Sciences and Dizal Pharmaceuticals alongside academic institutions like the Dana-Farber Cancer Institute and the Sidney Kimmel Comprehensive Cancer Center, these studies encompass completed, active, recruiting, terminated, and withdrawn trial statuses.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05725200 | RECRUITING | Metastatic Colorectal Cancer |
Oslo University Hospital |
2022-09-27 | PHASE2 |
| NCT06205290 | WITHDRAWN | Leukemia, Lymphocytic, Chronic, B-Cell |
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company |
2024-01-16 | PHASE3 |
| NCT07218341 | RECRUITING | Chronic Lymphocytic Leukemia; Lymphoma, Small Lymphocytic |
Eli Lilly and Company |
2026-03-09 | PHASE4 |
| NCT07139873 | RECRUITING | Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma |
Dizal Pharmaceuticals |
2025-09-08 | PHASE3 |
| NCT06846671 | RECRUITING | CLL; Chronic Lymphocytic Leukemia |
BeOne Medicines |
2025-04-10 | PHASE3 |
| NCT06736990 | ACTIVE_NOT_RECRUITING | Idiopathic Pulmonary Fibrosis |
Calluna Pharma AS |
2025-06-20 | PHASE2 |
| NCT02787369 | ACTIVE_NOT_RECRUITING | Recurrent Chronic Lymphoid Leukemia |
Dana-Farber Cancer Institute |
2016-05 | PHASE1 |
| NCT02457598 | TERMINATED | B-cell Malignancies |
Gilead Sciences |
2015-06-16 | PHASE1 |
| NCT04666038 | ACTIVE_NOT_RECRUITING | Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma |
Loxo Oncology, Inc. |
2021-03-09 | PHASE3 |
| NCT04699461 | TERMINATED | Relapsed Follicular Lymphoma; Refractory Follicular Lymphoma |
ADC Therapeutics S.A. |
2021-11-04 | PHASE2 |
| NCT02536300 | TERMINATED | Follicular Lymphoma |
Gilead Sciences |
2016-01-14 | PHASE3 |
| NCT03151057 | TERMINATED | B Cells-Tumors; B Cell Chronic Lymphocytic Leukemia; Follicular Lymphoma; Mantle Cell Lymphoma; Large B-Cell Diffuse Lymphoma of Bone (Diagnosis) |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
2018-07-31 | PHASE1 |
| NCT02445131 | COMPLETED | Chronic Lymphocytic Leucemia |
German CLL Study Group |
2015-05-28 | PHASE2 |
| NCT02662296 | WITHDRAWN | Prolymphocytic Leukemia; Recurrent Chronic Lymphocytic Leukemia; Recurrent Non-Hodgkin Lymphoma; Recurrent Small Lymphocytic Lymphoma |
Fred Hutchinson Cancer Center |
2016-03 | PHASE2 |
| NCT03639324 | WITHDRAWN | Chronic Lymphocytic Leukemia; CLL; Relapsed CLL; Refractory Chronic Lymphocytic Leukemia; Relapsed Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; SLL; Relapsed Small Lymphocytic Lymphoma; Refractory Small Lymphocytic Lymphoma |
Virginia Commonwealth University |
2020-10-02 | PHASE1 |
| NCT03576443 | COMPLETED | Diffuse Large B Cell Lymphoma |
Nordic Lymphoma Group |
2017-07-07 | PHASE2 |
| NCT02970318 | ACTIVE_NOT_RECRUITING | Chronic Lymphocytic Leukemia |
Acerta Pharma BV |
2017-02-02 | PHASE3 |
| NCT02332980 | COMPLETED | Recurrent B-Cell Non-Hodgkin Lymphoma; Recurrent Chronic Lymphocytic Leukemia; Recurrent Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Lymphoplasmacytic Lymphoma; Recurrent Marginal Zone Lymphoma; Recurrent Nodal Marginal Zone Lymphoma; Recurrent Small Lymphocytic Lymphoma; Recurrent Splenic Marginal Zone Lymphoma; Recurrent Waldenstrom Macroglobulinemia; Refractory B-Cell Non-Hodgkin Lymphoma; Refractory Chronic Lymphocytic Leukemia; Refractory Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue; Refractory Follicular Lymphoma; Refractory Lymphoplasmacytic Lymphoma; Refractory Nodal Marginal Zone Lymphoma; Refractory Small Lymphocytic Lymphoma; Refractory Splenic Marginal Zone Lymphoma; Refractory Waldenstrom Macroglobulinemia; Richter Syndrome; Waldenstrom Macroglobulinemia |
Mayo Clinic |
2015-02-19 | PHASE2 |
| NCT03890289 | TERMINATED | Follicular Lymphoma |
Fondazione Italiana Linfomi - ETS |
2019-10-18 | PHASE2 |
| NCT03349346 | WITHDRAWN | Diffuse Large B-Cell Lymphoma; Mediastinal B-cell Lymphoma |
Gilead Sciences |
2019-06 | PHASE1 |
| NCT03878524 | TERMINATED | Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Anatomic Stage IV Breast Cancer AJCC v8; Anemia; Ann Arbor Stage III Hodgkin Lymphoma; Ann Arbor Stage III Non-Hodgkin Lymphoma; Ann Arbor Stage IV Hodgkin Lymphoma; Ann Arbor Stage IV Non-Hodgkin Lymphoma; Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative; Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Castration-Resistant Prostate Carcinoma; Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Hematopoietic and Lymphoid System Neoplasm; Locally Advanced Pancreatic Adenocarcinoma; Metastatic Breast Carcinoma; Metastatic Malignant Solid Neoplasm; Metastatic Pancreatic Adenocarcinoma; Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis; Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable; Primary Myelofibrosis; Recurrent Acute Lymphoblastic Leukemia; Recurrent Acute Myeloid Leukemia; Recurrent Chronic Lymphocytic Leukemia; Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Recurrent Hematologic Malignancy; Recurrent Hodgkin Lymphoma; Recurrent Myelodysplastic Syndrome; Recurrent Myelodysplastic/Myeloproliferative Neoplasm; Recurrent Myeloproliferative Neoplasm; Recurrent Non-Hodgkin Lymphoma; Recurrent Plasma Cell Myeloma; Recurrent Small Lymphocytic Lymphoma; Refractory Acute Lymphoblastic Leukemia; Refractory Acute Myeloid Leukemia; Refractory Chronic Lymphocytic Leukemia; Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Refractory Chronic Myelomonocytic Leukemia; Refractory Hematologic Malignancy; Refractory Hodgkin Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Myelodysplastic Syndrome; Refractory Myelodysplastic/Myeloproliferative Neoplasm; Refractory Non-Hodgkin Lymphoma; Refractory Plasma Cell Myeloma; Refractory Primary Myelofibrosis; Refractory Small Lymphocytic Lymphoma; Stage II Pancreatic Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Stage IV Prostate Cancer AJCC v8; Unresectable Pancreatic Adenocarcinoma |
OHSU Knight Cancer Institute |
2020-04-01 | PHASE1 |
| NCT02135133 | COMPLETED | Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma |
Dana-Farber Cancer Institute |
2014-06 | PHASE2 |
| NCT02962401 | COMPLETED | Waldenstrom Macroglobulinemia |
French Innovative Leukemia Organisation |
2017-03-07 | PHASE2 |
| NCT03257722 | TERMINATED | Non Small Cell Lung Cancer; Metastasis; Recurrence |
Asha Nayak |
2017-09-26 | PHASE1; PHASE2 |
| NCT03742323 | TERMINATED | Acute Lymphoblastic Leukemia |
PETHEMA Foundation |
2018-07-01 | PHASE1; PHASE2 |
| NCT01644253 | TERMINATED | Chronic Lymphocytic Leukemia; Peripheral T-cell Lymphoma |
Aptevo Therapeutics |
2012-09 | PHASE1 |
| NCT02968563 | COMPLETED | Chronic Lymphocytic Leukemia |
Gilead Sciences |
2016-12-13 | PHASE2 |
| NCT01569295 | COMPLETED | Chronic Lymphocytic Leukemia |
Gilead Sciences |
2012-06-15 | PHASE3 |
| NCT02639910 | COMPLETED | Leukemia, Lymphocytic, Chronic, B-Cell; Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma |
MorphoSys AG |
2016-11 | PHASE2 |
| NCT03582098 | Completed | Chronic Lymphocytic Leukaemia |
Gilead Sciences |
2018-09-12 | -- |
| NCT01659021 | TERMINATED | Chronic Lymphocytic Leukemia |
Gilead Sciences |
2012-12-04 | PHASE3 |
| NCT02603445 | COMPLETED | Follicular Lymphoma, Mantle Cell Lymphoma |
Novartis Pharmaceuticals |
2015-11-16 | PHASE1 |
| NCT03151057 | Terminated | B Cells-Tumors|B Cell Chronic Lymphocytic Leukemia|Follicular Lymphoma|Mantle Cell Lymphoma|Large B-Cell Diffuse Lymphoma of Bone (Diagnosis) |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|Gilead Sciences |
2018-07-31 | Phase 1 |
| NCT01090414 | TERMINATED | Chronic Lymphocytic Leukemia; Lymphoma, Non-Hodgkin |
Gilead Sciences |
2010-03-22 | PHASE1; PHASE2 |
| NCT01539291 | TERMINATED | Chronic Lymphocytic Leukemia |
Gilead Sciences |
2012-10-03 | PHASE3 |
| NCT01282424 | COMPLETED | Follicular Lymphoma; Small Lymphocytic Lymphoma; Lymphoplasmacytic Lymphoma; Marginal Zone Lymphoma |
Gilead Sciences |
2011-03-18 | PHASE2 |
| NCT03568929 | Completed | Follicular Non-Hodgkin''s Lymphoma Refractory |
Gilead Sciences |
2018-05-25 | -- |
| NCT02779283 | COMPLETED | Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia |
OHSU Knight Cancer Institute |
2016-01-13 | PHASE1 |
| NCT02739360 | TERMINATED | Lymphoid Malignancies |
Gilead Sciences |
2016-05-04 | PHASE4 |
| NCT02436135 | TERMINATED | Myelofibrosis |
Gilead Sciences |
2015-06-05 | PHASE1 |
| NCT02538614 | TERMINATED | Chronic Lymphocytic Leukemia (CLL) |
Gilead Sciences |
2015-12-29 | PHASE1 |
| NCT01620216 | TERMINATED | Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome; Chronic Myelomonocytic Leukemia; Recurrent Acute Lymphoblastic Leukemia; Recurrent Acute Myeloid Leukemia; Refractory Acute Lymphoblastic Leukemia; Refractory Acute Myeloid Leukemia |
OHSU Knight Cancer Institute |
2012-05-11 | PHASE2 |
| NCT02590588 | TERMINATED | Amyloidosis |
John Mark Sloan |
2016-01 | PHASE2 |
| NCT01980888 | TERMINATED | Chronic Lymphocytic Leukemia |
Gilead Sciences |
2014-02-05 | PHASE3 |
| NCT01732913 | TERMINATED | Indolent Non-Hodgkin's Lymphomas |
Gilead Sciences |
2013-01-16 | PHASE3 |
| NCT01732926 | TERMINATED | Indolent Non-Hodgkin's Lymphomas |
Gilead Sciences |
2013-01-02 | PHASE3 |
| NCT01980875 | TERMINATED | Chronic Lymphocytic Leukemia |
Gilead Sciences |
2015-04-21 | PHASE3 |
| NCT02044822 | TERMINATED | B-cell Chronic Lymphocytic Leukemia (CLL) With 17p Deletion |
Gilead Sciences |
2014-08-06 | PHASE2 |
| NCT02468557 | TERMINATED | Previously Untreated Pancreatic Ductal Adenocarcinoma; Relapsed/Refractory Pancreatic Ductal Adenocarcinoma |
Gilead Sciences |
2015-07-30 | PHASE1 |
| NCT02258529 | TERMINATED | Follicular Lymphoma; Small Lymphocytic Lymphoma |
Gilead Sciences |
2015-09-14 | PHASE2 |
| NCT02439138 | TERMINATED | Waldenstrom's Macroglobulinemia |
Dana-Farber Cancer Institute |
2015-10 | PHASE2 |
| NCT01306643 | COMPLETED | Indolent Non-Hodgkin's Lymphoma; Follicular Lymphoma; Small Lymphocytic Lymphoma; Marginal Zone Lymphoma |
Gilead Sciences |
2011-02 | PHASE1; PHASE2 |
| NCT01203930 | TERMINATED | Chronic Lymphocytic Leukemia (CLL); Small Lymphocytic Lymphoma (SLL) |
Gilead Sciences |
2010-10 | PHASE2 |
| NCT01088048 | COMPLETED | Indolent Non-Hodgkin's Lymphoma; Chronic Lymphocytic Leukemia; Mantle Cell Lymphoma |
Gilead Sciences |
2010-03-25 | PHASE1 |
| NCT01796470 | TERMINATED | Chronic Lymphocytic Leukemia; Mantle Cell Lymphoma; Diffuse Large B-cell Lymphoma; Indolent Non-Hodgkin's Lymphoma |
Gilead Sciences |
2013-06-20 | PHASE2 |
| NCT02242045 | COMPLETED | Chronic Lymphocytic Leukemia; Indolent Non-Hodgkin Lymphoma; Follicular Lymphoma; Small Lymphocytic Lymphoma; Lymphoplasmacytic Lymphoma (With or Without Waldenstrom Macroglobulinemia); Marginal Zone Lymphoma |
Gilead Sciences |
2014-10-01 | PHASE1 |
| NCT01659047 | WITHDRAWN | Chronic Lymphocytic Leukemia |
Gilead Sciences |
2012-08 | PHASE2 |
| NCT01838434 | COMPLETED | Relapsed/Refractory Mantle Cell Lymphoma |
Alliance for Clinical Trials in Oncology |
2013-10-17 | PHASE1 |
| NCT01393106 | COMPLETED | Hodgkin Lymphoma |
Gilead Sciences |
2011-09 | PHASE2 |
| NCT01644799 | COMPLETED | Recurrent Follicular Lymphoma |
Alliance for Clinical Trials in Oncology |
2013-08-02 | PHASE1 |
| NCT01539512 | COMPLETED | Chronic Lymphocytic Leukemia |
Gilead Sciences |
2012-04 | PHASE3 |
| NCT00710528 | COMPLETED | Chronic Lymphocytic Leukemia (CLL); Lymphoma, Non-Hodgkin (NHL); Acute Myeloid Leukemia (AML); Multiple Myeloma (MM) |
Gilead Sciences |
2008-06 | PHASE1 |
| NCT00836914 | COMPLETED | Allergic Rhinitis |
Gilead Sciences |
2009-02 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2023-02-21)
Check the
CAL-101 (Idelalisib)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
- CAL-101 (Idelalisib) Mechanism of Action: PI3Kδ Inhibition in B Cell Research
- CAL-101 (Idelalisib) Working Concentration | Cell Culture | Treatment
- CAL-101 (Idelalisib) Solubility in DMSO
- CAL-101 (Idelalisib) Stock Solution
- CAL-101 (Idelalisib) Storage
- CAL-101 (Idelalisib) Stability
- CAL-101 (Idelalisib) Combination Database
- CAL-101 (Idelalisib) Molecular Weight
- CAL-101 (Idelalisib) SMILES
- CAL-101 (Idelalisib) CAS Number
- CAL-101 (Idelalisib) Chemical Structure (2D and 3D)
- CAL-101 (Idelalisib) IC50 for Cell-based and Cell-free Assays
- CAL-101 (Idelalisib) MedChemExpress (HY-13026)? Try a better option.
- CAL-101 (Idelalisib) Cayman (15279)? Try a better option.
- CAL-101 (Idelalisib) Tocris (7631)? Try a better option.
- CAL-101 (Idelalisib) APExBIO (A3005)? Try a better option.
- CAL-101 (Idelalisib) Sigma (SML4246)? Try a better option.
- CAL-101 (Idelalisib) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.