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Also known as Venetoclax
venetoclax and ibrutinib · 1 trial · 3 indications
MRD evaluation performed by 8 colours flow cytometry analysis in the bone marrow
| Arm | Type | Description |
|---|---|---|
| FCR | ACTIVE_COMPARATOR | FCR : * rituximab (R): 375 mg/m² IV D1 cycle 1 and 500 mg/m² IV D1 cycles 2 to 6. * fludarabine (F): 40 mg/m² orally, D2 to D4 - cycles 1 to 6. * cyclophosphamide (C): 250 mg/m² orally, D2 to D4 - cycles 1 to 6. |
| venetoclax and ibrutinib (I+VEN) | EXPERIMENTAL | * ibrutinib: 420 mg/d orally, continuously from Month 1 to the end of treatment, either Month 15 or Month 27 * venetoclax: stepwise weekly dose ramp-up beginning at Month 4 from a starting dose of 20 mg/d to the final dose of 400 mg/d (20, 50, 100, 200 and then 400 mg) over a 5 weeks, and then 400 mg/d continuously from Month 5 to the end of treatment, either Month 15 or Month 27. |
| Name | Type | Description |
|---|---|---|
| venetoclax and ibrutinib (I+VEN) | DRUG | The treatment will start with ibrutinib alone for 3 months (lead-in phase) from Month 1 to Month 3 and then venetoclax will be added from Month 4 with an initial ramp-up period. The total duration of treatment with (I+VEN) will depend on the response achieved at Month 9: * if BM MRD at M9 \< 0.01%, the treatment with (I+VEN) will be continued for 6 additional months until Month 15 and stopped then. MRD will be assessed at Month 15 (PB), Month 21 (PB) and Month 27 (PB and BM) * if BM MRD at M9 ≥ 0.01%, the treatment with (I+VEN) will be continued for 18 additional months until Month 27 and stopped then, whatever the results of MRD assessments that will be performed at the same time points as above. |
| FCR | DRUG | All patients will receive 6 cycles of FCR administered at 4 weeks intervals (D1 = D29) from Month 1 to Month 6. 6 cycles of FCR will be administered at 4 weeks intervals (D1 = D29) from Month 1 to Month 6. |
Inclusion Criteria: * Age 18 years or older. * Immunophenotypically confirmed CLL (according to IWCLL guidelines, RMH score 4-5 or RMH 3 providing CD200high and CD20low), excluding small lymphocytic lymphoma without lymphocytosis. * Indication for treatment according to the 2018 IWCLL criteria and ...
Venetoclax is being studied for use in Acute Myeloid Leukemia (AML), Follicular Lymphoma, Chronic Lymphocytic Leukemia (CLL), Intermediate Risk Chronic Lymphocytic Leukemia, and other malignancies. It is also being evaluated in healthy volunteer studies. The drug is in clinical development for these oncology indications.
Venetoclax is developed by AbbVie Inc., which trades under the ticker ABBV. The company is conducting clinical trials of the drug across multiple oncology indications, including chronic lymphocytic leukemia and follicular lymphoma.
Venetoclax is in Phase 1 clinical development. While some completed trials were Phase 2, the current active trials are Phase 1. The drug is investigational and has not been approved for the indications listed in the clinical trial data.
Venetoclax is being studied in several trials, including NCT02187861 for relapsed and refractory follicular lymphoma, NCT02966756 for relapsed or refractory chronic lymphocytic leukemia, and NCT05016947 for B-cell acute lymphoblastic leukemia. These trials are conducted in multiple countries.
Venetoclax is also known as venetoclax plus azacitidine with or without donor lymphocyte infusion, and as venetoclax plus azacitidine plus donor lymphocyte infusion. These names refer to combination regimens that include venetoclax as a component.