Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
azacitadine · 1 trial · 5 indications
Collect all adverse events at each visit
The proportion of participants with response (e.g., partial, complete response) using IWCLL (International Workshop on Chronic Lymphocytic Leukemia) criteria for CLL participants will be computed for all participants with active disease at baseline (in the opinion of the investigator).
| Arm | Type | Description |
|---|---|---|
| Arm A (Phase 1) | EXPERIMENTAL | Step-up doses of venetoclax to the designated cohort dose administered in participants with relapsed or refractory (R/R) Non-Hodgkin lymphoma (NHL) or multiple myeloma (MM) |
| Arm B (Phase 1) | EXPERIMENTAL | Step-up doses of venetoclax to the designated dose administered in participants with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) |
| Arm C (Phase 1) | EXPERIMENTAL | Step-up doses of venetoclax to the designated dose with the addition of azacitidine administered in participants with acute myeloid leukemia (AML) |
| Arm D (Phase 2) | EXPERIMENTAL | Step-up doses of venetoclax to the designated dose with the addition of rituximab in participants with R/R CLL |
| Name | Type | Description |
|---|---|---|
| azacitadine | DRUG | 75 mg/m2 by IV infusion or subcutaneous dosing |
| venetoclax | DRUG | Step-up doses of venetoclax to the designated cohort dose |
| rituximab / IDEC-C2B8 | DRUG | 375 mg/m2 on Week 6 |
Inclusion Criteria: * Participants must have histologically documented diagnosis of NHL (and exhausted options considered standard of care) as defined in the World Health Organization classification scheme and relapsed following or be refractory to standard treatments such as R-CHOP, R-CVP, or flud...
Azacitadine is an investigational small molecule being studied for the treatment of Non-Hodgkin Lymphoma (NHL). It is in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities. The drug is being evaluated for safety and efficacy in patients with this condition.
Azacitadine is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The company is conducting clinical research to evaluate the drug's potential in treating Non-Hodgkin Lymphoma.
Azacitadine is currently in Phase 1 clinical development for Non-Hodgkin Lymphoma. It is an investigational drug, meaning it has not received regulatory approval and is still undergoing clinical trials to assess its safety and efficacy in patients.
Azacitadine was studied in clinical trial NCT02265731, titled "Study Evaluating Venetoclax in Subjects With Hematological Malignancies." This Phase 1 trial, which has been completed, enrolled 38 participants with conditions including Non-Hodgkin Lymphoma, Multiple Myeloma, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, and Acute Myeloid Leukemia.
Azacitadine is not the same as venetoclax. The clinical trial NCT02265731 evaluated venetoclax in subjects with hematological malignancies, including Non-Hodgkin Lymphoma. Azacitadine is a separate investigational drug being developed by AbbVie for the treatment of Non-Hodgkin Lymphoma.