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This research is being done to assess the effectiveness and safety of acalabrutinib combined with lisocabtagene maraleucel (liso-cel) for people with relapsed/refractory aggressive B-cell lymphoma. This research study involves the study drug acalabrutinib in combination with lisocabtagene maraleuce
- Refractory Aggressive B-cell Lymphomas
- Refractory B-Cell Non-Hodgkin Lymphoma
- Aggressive B-cell NHL
- Diffuse Large B-cell Lymphoma (DLBCL)
- De Novo or Transformed Indolent B-cell Lymphoma
- DLBCL, Nos Genetic Subtypes
- T Cell/Histiocyte-rich Large B-cell Lymphoma
- EBV-Positive DLBCL, Nos
- Primary Mediastinal [Thymic] Large B-cell Lymphoma (PMBCL)
- High-Grade B-Cell Lymphoma, Nos
- C-MYC/BCL6 Double-Hit High-Grade B-Cell Lymphoma
- Grade 3b Follicular Lymphoma
- C-MYC/BCL2 Double-Hit High-Grade B-Cell Lymphoma
- ACALABRUTINIB
- LISOCABTAGENE MARALEUCEL
- Lymphodepleting chemotherapy
Phase 2
Interventional
Primary Outcome:
- Complete response rate (CRR)
Secondary Outcome:
- Overall Response Rate
- Overall Response Rate
- Overall Response Rate
- Progression Free Survival
- Overall Survival
- Duration of Response
- Event free survival
- Rates of bridging therapy
- FACT-G QOL
- ICU Rates
- Re-hospitalization rates
- ER visit rates
- Length of Stay
- Rates of acalabrutinib discontinuation due to toxicity
- Number of Participants treatment related Adverse Event NCI CTCAE 5.0
27
October 2022
- Gender: All
- Minimum age: 18 Years
- Maximum age: N/A
- Healthy volunteers: No
Jeremy Abramson, MD
Massachusetts General Hospital
A Phase 2 Study of Acalabrutinib in Combination With Lisocabtagene Maraleucel in Relapsed/Refractory Aggressive B-cell Lymphomas
NCT05583149
Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.