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Protocol # 21-422

Status

Not yet recruiting

Description

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

Condition

  • 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

Interventions

  • ACALABRUTINIB
  • LISOCABTAGENE MARALEUCEL
  • Lymphodepleting chemotherapy

Phase

Phase 2

Study Type

Interventional

Further Study Details

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

Enrollment

27

Study Start Date

October 2022

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Jeremy Abramson, MD

Source

Massachusetts General Hospital

Official title

A Phase 2 Study of Acalabrutinib in Combination With Lisocabtagene Maraleucel in Relapsed/Refractory Aggressive B-cell Lymphomas

Clinicaltrials.gov Identifier

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.