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NCT04002947 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Diffuse Large B Cell Lymphoma and Non-Hodgkin's Lymphoma, sponsored by National Cancer Institute (NCI).

Recruiting
Registry status
Phase 2
Development phase
132
Enrollment target
1
Study location

NCT04002947 is a Phase 2 study of Diffuse Large B Cell Lymphoma and Non-Hodgkin's Lymphoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 132 participants, below the 218-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (39% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04002947, a Phase 2 study of Diffuse Large B Cell Lymphoma and Non-Hodgkin's Lymphoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).

RECRUITING
Registry status
Phase 2
Development phase
132 participants
Enrollment target
1
Study location

Study Summary

Background: Diffuse large B-cell lymphoma is the most common type of non-Hodgkin lymphoma. Most people with this cancer can be cured. But those who are not cured have a poor prognosis. Researchers want to add another drug to standard treatment see if it can improve the cure rate. Objective: To see if the drug acalabrutinib given with rituximab and standard combination chemotherapy can improve the cure rate of aggressive B-cell lymphomas such as diffuse large B-cell lymphoma. Eligibility: People ages 18 and older with an aggressive B-cell lymphomas that have not been treated Design: Participants will be screened with: Blood and urine tests Physical exam Medical history Tumor biopsy Bone marrow biopsy: A needle will remove marrow from the participant s hipbone. Lumbar puncture: If necessary, a needle will remove fluid from the participant s spinal canal. Imaging scans Participants will take the study drug for up to 14 days. It is a pill taken 2 times a day. Then they will have more scans. They will get rituximab and chemotherapy. They may get these drugs through a needle in an arm vein. Or they may them through a tube placed in a vein in their chest or in their neck. They might also keep taking the study drug. Each treatment cycle lasts 21 days. They will have up to 6 cycles. Participants may have 4 doses of another drug injected into their spinal fluid. Participants will have repeats of the screening tests throughout the study. Participants will have a follow-up visit 30 days after their last treatment, then every 3 months for 2 years, then every 6 months for 3 years, and then yearly.

Interventions

  • BIOLOGICAL Rituximab
  • DRUG Acalabrutinib
  • DRUG DA-EPOCH
  • DRUG CHOP

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 132 participants
Start Date 2019-08-05
Est. Completion 2030-03-31
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT04002947

The ClinicalTrials.gov registry entry for NCT04002947 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 218-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (39% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Diffuse Large B Cell Lymphoma appearing as the primary indexed condition, and to 4 interventions - of which Rituximab is the first listed.

NCT04002947 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT04002947 about?

NCT04002947 is a clinical study titled "Acalabrutinib With DA-EPOCH-R or R-CHOP for People With Untreated Diffuse Large B-cell Lymphoma". Background: Diffuse large B-cell lymphoma is the most common type of non-Hodgkin lymphoma. Most people with this cancer can be cured. But those who are not cured have a poor prognosis. Researchers want to add another drug to standard treatment see if it can improve the cure rate. Objective: To se...

What is the current status of trial NCT04002947?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 132 participants. The study started on 2019-08-05. Estimated completion is 2030-03-31.

What conditions does trial NCT04002947 study?

This clinical trial studies the following conditions: Diffuse Large B Cell Lymphoma, Non-Hodgkin's Lymphoma, DLBCL, NHL.

What interventions are being tested in trial NCT04002947?

The interventions under investigation include: Rituximab (BIOLOGICAL), Acalabrutinib (DRUG), DA-EPOCH (DRUG), CHOP (DRUG).

Who is sponsoring clinical trial NCT04002947?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04002947 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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