113 Participants Needed

Acalabrutinib + Combination Therapy for B-Cell Lymphoma

Recruiting at 40 trial locations
AC
Overseen ByAcerta Call center
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Acerta Pharma BV
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

Part 1: To characterize the safety profile of acalabrutinib alone or in combination with rituximab in subjects with R/R FL.Part 2: To characterize the activity of acalabrutinib alone or in combination with rituximab in subjects with R/R MZL, as measured by ORR.Part 3: To characterize the safety of acalabrutinib in combination with rituximab and lenalidomide in subjects with R/R FL

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is Acalabrutinib safe for humans?

Acalabrutinib has been shown to have a generally acceptable safety profile in humans, with common side effects including headache, diarrhea, and infections. Some studies noted an increased risk of neutropenia (low white blood cell count) and leukopenia (reduced white blood cells), but overall, it was considered to have a favorable safety profile compared to other treatments.12345

How is the drug Acalabrutinib unique for treating B-cell lymphoma?

Acalabrutinib is a highly selective Bruton tyrosine kinase inhibitor, which means it specifically targets a protein that helps cancer cells grow, making it potentially more effective and safer than other treatments. It has shown improved safety outcomes compared to similar drugs, with fewer off-target effects, and is used in combination with Rituximab to enhance its effectiveness in treating B-cell lymphoma.12346

What data supports the effectiveness of the drug combination Acalabrutinib, Lenalidomide, and Rituximab for B-Cell Lymphoma?

Rituximab, when used with chemotherapy, has shown significant effectiveness in treating various types of B-cell lymphomas, including non-Hodgkin lymphoma and chronic lymphocytic leukemia, by improving tumor remission and patient survival. This suggests that Rituximab, as part of a combination therapy, could be effective in treating B-cell lymphoma.7891011

Who Is on the Research Team?

AC

Acerta Call center

Principal Investigator

Acerta Pharma, LLC

Are You a Good Fit for This Trial?

Adults over 18 with certain types of B-cell Non-Hodgkin Lymphoma that have relapsed or didn't respond to previous treatments. Participants must not be pregnant, should agree to use contraception if they can have children, and cannot have serious heart issues or gastrointestinal conditions that could affect the study.

Inclusion Criteria

Agreement to use contraception during the study and for 30 days after the last dose of study drugs if sexually active and able to bear or beget children
I have splenic marginal zone lymphoma with an additional measurable lesion.
I have Follicular Lymphoma that needs treatment and has either come back or didn't respond to previous treatments.
See 5 more

Exclusion Criteria

I do not have significant issues with my digestive system.
I do not have a severe illness that could risk my safety in the study.
Breastfeeding or pregnant
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive acalabrutinib alone or in combination with rituximab and lenalidomide for relapsed, refractory B-cell Non-Hodgkin Lymphoma

Varies by regimen

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Acalabrutinib
  • Lenalidomide
  • Rituximab
Trial Overview The trial is testing Acalabrutinib alone or combined with Rituximab for relapsed/refractory Follicular Lymphoma (FL), and its combination with Rituximab and Lenalidomide for the same condition. It aims to assess safety and effectiveness, including overall response rate in Marginal Zone Lymphoma (MZL).
How Is the Trial Designed?
5Treatment groups
Experimental Treatment
Group I: Part 3: acalabrutinib Regimen 1Experimental Treatment3 Interventions
acalabrutinib Regimen + lenalidomide + rituximab for relapsed, refractory Follicular Lymphoma subjects
Group II: Part 2: acalabrutinib Regimen 2Experimental Treatment2 Interventions
acalabrutinib Regimen 2 + rituximab for relapsed, refractory Marginal Zone Lymphoma subjects
Group III: Part 2: acalabrutinib Regimen 1Experimental Treatment1 Intervention
acalabrutinib Regimen 1 for relapsed, refractory Marginal Zone Lymphoma subjects
Group IV: Part 1: acalabrutinib Regimen 2Experimental Treatment2 Interventions
acalabrutinib Regimen 2 + rituximab for relapsed, refractory, or treatment naive Follicular Lymphoma subjects
Group V: Part 1: acalabrutinib Regimen 1Experimental Treatment1 Intervention
acalabrutinib Regimen 1 for relapsed, refractory Follicular Lymphoma subjects

Acalabrutinib is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Calquence for:
  • Mantle cell lymphoma
  • Chronic lymphocytic leukemia
  • Small lymphocytic lymphoma
🇪🇺
Approved in European Union as Calquence for:
  • Chronic lymphocytic leukemia
  • Small lymphocytic lymphoma
  • Mantle cell lymphoma

Find a Clinic Near You

Who Is Running the Clinical Trial?

Acerta Pharma BV

Lead Sponsor

Trials
46
Recruited
5,900+

AstraZeneca

Industry Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Published Research Related to This Trial

In a study of 34 patients with relapsed/refractory chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL), maintenance therapy with lenalidomide after bendamustine and rituximab (BR) did not significantly improve progression-free survival (PFS), which was 18.3 months compared to 15.2 months without maintenance.
The study highlighted challenges with lenalidomide maintenance due to hematological and infectious toxicities, as only 6 out of 19 patients completed the intended 12 cycles, suggesting that lenalidomide may be more effective in earlier treatment settings.
Bendamustine + rituximab chemoimmunotherapy and maintenance lenalidomide in relapsed, refractory chronic lymphocytic leukaemia and small lymphocytic lymphoma: A Wisconsin Oncology Network Study.Chang, JE., Havighurst, T., Kim, K., et al.[2018]
In a study involving four patients with primary refractory or early relapsed T cell rich B cell lymphomas (TCRBCL), the combination of rituximab with chemotherapy (vinorelbine and gemcitabine) resulted in three complete responses and one partial response, demonstrating significant efficacy.
The treatment was well-tolerated, with no significant adverse effects reported, suggesting that rituximab combined with chemotherapy could be a promising option for treating TCRBCL and warrants further investigation in larger trials.
Rituximab in combination with vinorelbine/gemcitabine chemotherapy in patients with primary refractory or early relapsed T cell rich B cell lymphoma. A pilot study.Xiros, N., Economopoulos, T., Valsami, S., et al.[2022]
The combination of bendamustine and rituximab showed promising therapeutic efficacy in treating lymphoproliferative diseases, achieving an overall response rate of 65% in chronic lymphocytic leukemia (CLL) and 96% in indolent lymphoma among 71 patients studied.
However, the treatment was associated with significant hematotoxicity, with severe neutropenia and thrombocytopenia occurring in 33% and 18% of patients, respectively, and a notable risk of severe infections in aggressive lymphoma and CLL patients.
Routine use of bendamustine and rituximab combination therapy in consecutive patients with lymphoproliferative diseases: a survey from Tyrolean hospitals.Waldthaler, C., Stauder, R., Schnallinger, M., et al.[2021]

Citations

Bendamustine + rituximab chemoimmunotherapy and maintenance lenalidomide in relapsed, refractory chronic lymphocytic leukaemia and small lymphocytic lymphoma: A Wisconsin Oncology Network Study. [2018]
Rituximab in combination with vinorelbine/gemcitabine chemotherapy in patients with primary refractory or early relapsed T cell rich B cell lymphoma. A pilot study. [2022]
Routine use of bendamustine and rituximab combination therapy in consecutive patients with lymphoproliferative diseases: a survey from Tyrolean hospitals. [2021]
Bendamustine plus Rituximab Versus R-CHOP as First-Line Treatment for Patients with Follicular Lymphoma Grade 3A: Evidence from a Multicenter, Retrospective Study. [2019]
Spotlight on rituximab in non-Hodgkin lymphoma and chronic lymphocytic leukemia. [2018]
Acalabrutinib: Managing Adverse Events and Improving Adherence in Patients With Mantle Cell Lymphoma. [2022]
Matching-adjusted indirect comparisons of safety and efficacy of acalabrutinib versus other targeted therapies in patients with treatment-naïve chronic lymphocytic leukemia. [2021]
EMA Review of Acalabrutinib for the Treatment of Adult Patients with Chronic Lymphocytic Leukemia. [2021]
A phase 2, multicentre, open-label trial (ACE-LY-003) of acalabrutinib in patients with relapsed or refractory marginal zone lymphoma. [2022]
Acalabrutinib: A Selective Bruton Tyrosine Kinase Inhibitor for the Treatment of B-Cell Malignancies. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Acalabrutinib Versus Investigator's Choice in Relapsed/Refractory Chronic Lymphocytic Leukemia: Final ASCEND Trial Results. [2022]
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