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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Institute (NCI)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

DLBCL, NOS, Activated B-cell type (ABC)

DLBCL, NOS, Germinal center B-cell type (GCB)

T-cell/histiocyte-rich large B-cell lymphoma

Primary cutaneous DLBCL, leg-type

Disqualifiers

Primary DLBCL of the central nervous system (PCNSL)

Primary mediastinal B-cell lymphoma (PMBL)

Plasmablastic lymphoma

Intravascular large B-cell lymphoma

Trial design

Design model

Single group

Treatments tested in this trial

  • DA-EPOCH

    Drug

    Vincristine 1.4 mg/m2 (2 mg cap) IV on Day 1, Doxorubicin 10 mg/m2/day CIVI on Days 1-4, Etoposide 50 mg/m2/day CIVI on Days 1-4, Cyclophosphamide 750 mg/m2 IV on Day 5. Prednisone 60 mg/m2 PO BID is administered daily on Days 1-5 of each cycle. Each cycle is 21 days and drugs will be given for 6 cycles.

  • Rituximab

    Biological/Vaccine

    Rituximab 375 mg/m2 IV on Day 1 of each 21-day cycle for 6 cycles.

  • CHOP

    Drug

    Cyclophosphamide 750 mg/m2 IV, Doxorubicin 50 mg/m2 IV, Vincristine 1.4 mg/m2 (2 mg cap) IV are administered on Day 1 of each 21-day cycle for 6 cycles. Prednisone 40 mg/m2 PO is administered daily on Days 1-5 of each cycle.

  • Acalabrutinib

    Drug

    Acalabrutinib is administered orally at 100 mg twice a day for 14 days during the window period. During combination therapy, acalabrutinib is administered 100 mg twice daily for the first 10 days for 6 cycles.

Treatment groups

132 Participants
are divided into 1 treatment group
Group A: 1Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Response rate

Number of patients who achieve a CR, PR or SD

Time frame
every 2 cycles

Secondary outcomes

1

Safety and tolerability

Incidence of adverse events (i.e., grade and frequency)

Time frame
initiation of study drug until 30 days after last dose
2

Progression-free survival

The response rate will be determined and reported along with a 95% confidence interval.

Time frame
every 3-6 months for 5 years then yearly
3

Overall survival

The response rate will be determined and reported along with a 95% confidence interval.

Time frame
every 3-6 months for 5 years then yearly
4

Event-free survival

The response rate will be determined and reported along with a 95% confidence interval.

Time frame
every 3-6 months for 5 years then yearly

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.