The all Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the all Hub cannot guarantee the accuracy of translated content. The all and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.
The ALL Hub is an independent medical education platform, sponsored by Jazz Pharmaceuticals, Amgen, and Pfizer and supported through an educational grant from the Hippocrate Conference Institute, an association of the Servier Group. The funders are allowed no direct influence on our content. The levels of sponsorship listed are reflective of the amount of funding given. View funders.
Now you can support HCPs in making informed decisions for their patients
Your contribution helps us continuously deliver expertly curated content to HCPs worldwide. You will also have the opportunity to make a content suggestion for consideration and receive updates on the impact contributions are making to our content.
Find out more
Create an account and access these new features:
Bookmark content to read later
Select your specific areas of interest
View all content recommended for you
Venetoclax plus chemotherapy in pediatric and AYA patients with R/R ALL: Phase I trial results
Despite treatment advances, the prognosis for patients with R/R ALL remains poor, with an unmet need for novel therapies. A phase I trial (NCT03236857) evaluating the efficacy and safety of venetoclax (Ven) + chemotherapy in pediatric and AYA patients with R/R ALL was published in Pediatric Blood & Cancer by Place et al.1 Patients were treated with Ven monotherapy (n = 1), Ven + VXL (n = 20), or Ven + cytarabine-based chemotherapy (n = 10).1 Primary outcomes included safety, determination of DLTs, RP2D, and PK of Ven monotherapy, with secondary outcomes of Ven monotherapy preliminary efficacy and Ven + chemotherapy preliminary efficacy and safety.1
|
Key learnings |
The most frequent Grade 3–4 TEAEs included febrile neutropenia (55%), thrombocytopenia (45%), hypokalemia (39%), and anemia (35%). |
Serious TEAEs included febrile neutropenia (42%) and sepsis (16%). Six patients experienced fatal TEAEs, with one of these considered possibly related to Ven. DLTs included Grade 3 ALT and AST increases. The RP2D was determined to be 800 mg AED (reduced to 400 mg if needed). |
The ORR was 42% overall; 55% in the Ven + VXL group and 20% in the Ven + cytarabine-based group; with all responding patients achieving CR/CRi. The overall median OS and PFS were 3.9 months and 0.9 months, respectively. |
Ven-based chemotherapy was well tolerated with promising efficacy in pediatric and AYA patients with R/R ALL. Future large-scale studies will help to identify biomarkers influencing treatment responses. |
Abbreviations: AED, age-adjusted adult equivalent dose; ALL, acute lymphoblastic leukemia; ALT, alanine transaminase; AST; aspartate aminotransferase; AYA, adolescent and young adult; CR, complete remission; CRi, complete remission with incomplete hematologic recovery; DLT, dose limiting toxicity; ORR, overall response rate; PK, pharmacokinetics; R/R, relapsed/refractory; RP2D, recommended phase II dose; TEAE, treatment-emergent adverse event; Ven, venetoclax; VXL, vincristine-dexamethasone-pegasparaginase.
References
Please indicate your level of agreement with the following statements:
The content was clear and easy to understand
The content addressed the learning objectives
The content was relevant to my practice
I will change my clinical practice as a result of this content
