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Bruton's Tyrosine Kinase (BTK) Inhibitor

Acalabrutinib + R-CHOP for Diffuse Large B-Cell Lymphoma (ESCALADE Trial)

Phase 3
Waitlist Available
Research Sponsored by Acerta Pharma BV
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Disease Stage II to IV by the Ann Arbor Classification
Pathologically confirmed DLBCL, sufficient diagnostic material should be available to forward to a central laboratory for gene expression profiling and pathology review
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at every single visit up to 60 months
Awards & highlights

ESCALADE Trial Summary

This trial is testing a new cancer treatment vs the current standard of care to see if the new treatment is more effective and has fewer side effects.

Who is the study for?
This trial is for men and women aged 18-70 with previously untreated non-GCB DLBCL, a type of lymphoma. Participants must have an ECOG performance status ≤2, IPI score of 1 to 5, and Stage II to IV disease. They need adequate organ function and agree to use contraception during the study plus one year after.Check my eligibility
What is being tested?
The trial tests acalabrutinib combined with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) against a placebo plus R-CHOP in patients under 75 years old. It's randomized and double-blind to compare effectiveness and safety.See study design
What are the potential side effects?
Possible side effects include reactions related to infusion such as fever or chills; low blood counts leading to increased infection risk; nausea; hair loss from chemotherapy drugs like doxorubicin; nerve damage from vincristine causing numbness or tingling.

ESCALADE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer is classified as Stage II to IV.
Select...
My diagnosis of DLBCL is confirmed and samples can be sent for further testing.
Select...
I am between 18 and 70 years old.
Select...
I have not received any treatment for DLBCL.
Select...
I can take care of myself but might not be able to do heavy physical work.

ESCALADE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at every single visit up to 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at every single visit up to 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival (PFS) per the Lugano Classification for NHL in Arm A compared to Arm B
Secondary outcome measures
Investigator-assessed event-free survival (EFS) for NHL in Arm A compared to Arm B
Overall survival in Arm A compared to Arm B
Percentage of Participants Who Achieved a Complete Response (CR) per 2014 Lugano Classification for NHL

Side effects data

From 2016 Phase 2 trial • 31 Patients • NCT02387762
13%
Anaemia
6%
Nausea
6%
Leukopenia
6%
Intervertebral disc degeneration
6%
Dizziness
6%
Oedema peripheral
6%
Diarrhea
6%
Vomiting
6%
Full Blood Count decreased
6%
Contusion
6%
Thrombocytosis
6%
Hyponatraemia
6%
Hypochloraemia
6%
Musculoskeletal chest pain
6%
Haematuria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + Methotrexate
ACP-196 + Methotrexate

ESCALADE Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: acalabrutinib + R-CHOPExperimental Treatment6 Interventions
Acalabrutinib plus Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP)
Group II: placebo + R-CHOPPlacebo Group6 Interventions
Placebo plus Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxorubicin
2012
Completed Phase 3
~7940
Vincristine
2003
Completed Phase 4
~2910
acalabrutinib
2018
Completed Phase 2
~80
Prednisone
2014
Completed Phase 4
~2370
Rituximab
1999
Completed Phase 4
~1880
Cyclophosphamide
1995
Completed Phase 3
~3780

Find a Location

Who is running the clinical trial?

Acerta Pharma BVLead Sponsor
45 Previous Clinical Trials
5,314 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,257 Previous Clinical Trials
288,593,175 Total Patients Enrolled

Media Library

Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04529772 — Phase 3
Non-Hodgkin's Lymphoma Research Study Groups: placebo + R-CHOP, acalabrutinib + R-CHOP
Non-Hodgkin's Lymphoma Clinical Trial 2023: Acalabrutinib Highlights & Side Effects. Trial Name: NCT04529772 — Phase 3
Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04529772 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please outline the risks associated with taking acalabrutinib?

"Acalabrutinib's safety is estimated to be a 3. This medication has gone through Phase 3 trials, which provides some data supporting both efficacy and multiple rounds of safety testing."

Answered by AI

What indications does acalabrutinib usually help with?

"Acalabrutinib is an effective treatment for various types of lung cancer, thyroiditis, and small cell lung cancer."

Answered by AI

Are seniors welcome to apply for participation in this experiment?

"This particular clinical trial is only seeking patients who are between 18-70 years old. Out of the 700+ medical studies available for minors, and the 2907 trials designed for senior citizens, this is one of the few that meets in the middle."

Answered by AI

Is this study actively searching for participants?

"That is correct. According to the latest information found on clinicaltrials.gov, this study is still looking for 600 individuals willing to participate at 38 different sites. The trial was initially posted on October 8th 2020 and has since been updated on November 17th 2020."

Answered by AI

Are there any restrictions on who is eligible to participate in this research project?

"Eligibility criteria for this study includes being between 18-70 years old and having a diffuse large b-cell lymphoma (DLBCL). The aim is to recruit 600 individuals in total."

Answered by AI

Are there different hospitals or research facilities participating in this experiment within the city?

"At the moment, there are 38 hospitals or clinics participating in this trial. If you choose to enroll, try and go to the one that is closest to your home to limit travel time and expenses."

Answered by AI

Could you please tell me what other research studies have been done that included acalabrutinib?

"In 1993, the National Institutes of Health Clinical Center was the first to study acalabrutinib. 5116 studies have completed since then. Presently, there are 1535 clinical trials being conducted worldwide; many taking place in Nyack, New york."

Answered by AI

How many people are enrolled in this clinical trial at most?

"Yes, this is an ongoing clinical trial that was first established on October 8th, 2020. The 38 different recruiting sites across the United States are looking for a total of 600 patients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312)
2020. "A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04529772.
~269 spots leftby Feb 2027
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