Acalabrutinib for Non-Hodgkin's Lymphoma (NHL)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
National Institutes of Health Clinical Center, Bethesda, MD
Non-Hodgkin's Lymphoma (NHL)+4 More
Acalabrutinib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Acalabrutinib With DA-EPOCH-R or R-CHOP for People With Untreated Diffuse Large B-cell Lymphoma

See full description

Eligible Conditions

  • Non-Hodgkin's Lymphoma (NHL)
  • Diffuse Large B-Cell Lymphoma (DLBCL)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Acalabrutinib will improve 1 primary outcome and 5 secondary outcomes in patients with Non-Hodgkin's Lymphoma (NHL). Measurement will happen over the course of every 2 cycles.

6 cycles
Complete response rate
every 2 cycles
Response rate
Year 5
Event-free survival
Overall survival
Progression-free survival
Day 30
Safety and tolerability

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

1 Treatment Group

1
1 of 1
Experimental Treatment

This trial requires 132 total participants across 1 different treatment group

This trial involves a single treatment. Acalabrutinib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

1Acalabrutinib 100 mg orally twice a day for 14 days; Following window: patients with > or = to 25% tumor reduction, treat with DA-EPOCH-R or R-CHOP + acalabrutinib 100mg orally twice a day for the first 10 days, for 6 cycles; whereas, patients with <25% tumor reduction, treat with DA-EPOCH-R or R-CHOP alone for 6 cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
FDA approved
Acalabrutinib
FDA approved
CHOP
2012
Completed Phase 3
~1040

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: initiation of study drug until 30 days after last dose
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly initiation of study drug until 30 days after last dose for reporting.

Closest Location

National Institutes of Health Clinical Center - Bethesda, MD

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Non-Hodgkin's Lymphoma (NHL) or one of the other 4 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
T-cell/histiocyte-rich large B-cell lymphoma
DLBCL associated with chronic inflammation
High-grade B-cell lymphoma, NOS
High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements
You have diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS). show original
You have diffuse large B-cell lymphoma, not otherwise specified, of the germinal center type. show original
You have primary cutaneous diffuse large B-cell lymphoma, leg-type. show original
EBV+ DLBCL, NOS is a form of diffuse large B-cell lymphoma. show original
You have ALK+ large B-cell lymphoma. show original
You have been diagnosed with chronic lymphocytic leukemia/small lymphocytic lymphoma. show original

Patient Q&A Section

What are the signs of lymphoma?

"Signs of lymphoma include malaise, swollen lymph nodes, swollen and tender spleen, pain or tenderness on one side of the body or sudden change in the pattern of lymph-node pain, a change of skin color or a lump in the neck. However, the full range of symptoms and signs may not occur in all patients with lymphoma." - Anonymous Online Contributor

Unverified Answer

How many people get lymphoma a year in the United States?

"Findings from a recent study shows that lymphoma is responsible for the greatest number of cancer deaths in the United States. While it is an uncommon cause of death among whites, it is much more common in Hispanics, and Blacks. Prevention is paramount. It is estimated that the United States has 20 million people with lymphoma each year. We need to educate our children, who are the next generation of doctors and nurses. They need to be aware of the importance of early onset screening for lymphoma. Our country has the highest number of foreign born individuals in the United States, which makes lymphoma especially dangerous. Our nation also has the highest number of African Americans in both the United States and Europe." - Anonymous Online Contributor

Unverified Answer

What is lymphoma?

"There are about 15 types of lymphoma. The prevalence of these diseases ranges widely. They are highly variable in their clinical presentations. Most lymphomas are curable. More knowledge of immunohistochemistry and improved classification of lymphoblastic and other lymphoid neoplasms are increasing the ability to define these diseases and to assess the best treatment to offer them." - Anonymous Online Contributor

Unverified Answer

Can lymphoma be cured?

"Recent findings are not hopeful and chemotherapy should continue to be the primary treatment option for non-Hodgkin's lymphoma, even where it has been found to be curable by surgery or radiotherapy." - Anonymous Online Contributor

Unverified Answer

What is acalabrutinib?

"Acalabrutinib is a novel multi-targeted Bcr-Abl tyrosine kinase inhibitor, approved on the basis of its efficacy in relapsed or refractory relapsed acute lymphoblastic leukemia, with or without Bcr-Abl kinase gene mutations, in adults and children ≥12 years of age. In a phase II study, the efficacy in treating B-cell chronic lymphocytic leukemia was demonstrated in patients with a Bcr-Abl (V560L) mutation (95% of patients) and patients with no Bcr-Abl kinase gene mutation (88% of patients) and in phase III trial of refractory systemic B-cell CLL." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of lymphoma?

"Our survey found that most of the lymphoma is caused by infections, with (perhaps) greater contribution of viral than bacterial infection. Immunosuppression appears to increase the risk of infection-induced lymphomatous transformation. In a recent study, findings may help to guide therapeutic and preventive strategies for lymphoma, but the data of the literature on the associations between viral load and the risk of developing lymphoma is inconclusive. We still have to explore in depth the nature and dynamics of viral interactions with the immune system and with the cellular signalling pathways that are defective in lymphoma." - Anonymous Online Contributor

Unverified Answer

Is acalabrutinib typically used in combination with any other treatments?

"Acalabrutinib is a clinically active agent for the treatment of mantle cell lymphoma in adults. Based on these data, acalabrutinib has a recommended dose of 800 mg once daily." - Anonymous Online Contributor

Unverified Answer

How serious can lymphoma be?

"The American Cancer Society estimates that there will be over 40,000 people dying of lymphoma in 2015, making it the ninth-most common cancer, in the US." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in acalabrutinib for therapeutic use?

"Acalabrutinib is a promising, broad-spectrum Bruton’s tyrosine kinase inhibitor with a novel mechanism of action of preferential inhibition of the Btk catalytic activity. This novel mechanism of action allows acalabrutinib to selectively suppress tyrosine kinase activity while suppressing Btk catalytic activity. As such, it is a potential antitumor agent with broad therapeutic potential as a single-agent and combined with other agents to treat a wide variety of cancers." - Anonymous Online Contributor

Unverified Answer

Is acalabrutinib safe for people?

"ACM is well tolerated with a high rate of completion of courses of treatment. There were few serious adverse events in this study. There have been no deaths resulting from ACM, to date." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Non-Hodgkin's Lymphoma (NHL) by sharing your contact details with the study coordinator.