← Back to Search

Small Molecule Kinase Inhibitor

Combination Chemotherapy for Lymphoma

Phase 2

Recruiting

Led By Jason Westin

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to take aspirin (81 mg) daily or alternative therapy as prophylactic anticoagulation

All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program

Must not have

Contraindication to any of the required concomitant drugs or supportive treatments or intolerance to hydration due to preexisting pulmonary or cardiac impairment including pleural effusion requiring thoracentesis or ascites requiring paracentesis not due to lymphoma

Participants with severe bradycardia (heart rate <40 bpm, hypotension, light-headedness, syncope)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time between study entry and death from any cause, assessed up to 2 years post-treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing rituximab, lenalidomide, acalabrutinib, tafasitamab to see if they can help control non-germinal center diffuse large B-cell lymphoma.

Who is the study for?

Adults diagnosed with non-germinal center diffuse large B-cell lymphoma who haven't had treatment, except possibly a short course of steroids or one dose of cyclophosphamide for urgent issues. They must have measurable disease, acceptable liver and kidney function, no significant neuropathy or serious medical conditions, not be pregnant or breastfeeding, able to sign consent form, willing to follow birth control requirements and join the REMS program.

What is being tested?

The trial is testing rituximab, lenalidomide, acalabrutinib, tafasitamab alone and in combination with chemotherapy drugs (prednisone, doxorubicin hydrochloride, cyclophosphamide, vincristine) for treating newly diagnosed non-germinal center diffuse large B-cell lymphoma. The goal is to see how well these treatments work together in controlling this type of lymphoma.

What are the potential side effects?

Possible side effects include reactions related to monoclonal antibodies like rituximab and tafasitamab; organ inflammation; blood disorders from chemotherapy agents; increased risk of infections due to immune system suppression; fatigue; digestive issues from anti-inflammatory drugs like prednisone.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can take daily aspirin or a similar medication for blood thinning.

Select...

I am registered and can follow the Revlimid REMS program requirements.

Select...

My cancer can be measured and is larger than 1.5cm.

Select...

I am 18 years or older and can give my consent.

Select...

My kidneys work well enough, with a creatinine clearance of 30ml/min or more.

Select...

I am willing to receive blood transfusions.

Select...

My diagnosis is diffuse large B-cell lymphoma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot take certain medications or treatments due to other health issues.

Select...

I have severe slow heart rate, low blood pressure, or fainting spells.

Select...

I am allergic to specific cancer drugs like lenalidomide or thalidomide.

Select...

I need ongoing treatment with strong medications that affect liver enzymes.

Select...

My lymphoma has spread to my brain or spinal cord.

Select...

I have not had major surgery in the last 4 weeks and all my wounds from past surgeries or injuries are healed.

Select...

I do not have a bleeding disorder like hemophilia.

Select...

I have uncontrolled AIHA or ITP.

Select...

I need warfarin or a similar drug for blood thinning.

Select...

I do not have any serious health conditions that are uncontrolled or would interfere with the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time between study entry and death from any cause, assessed up to 2 years post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time between study entry and death from any cause, assessed up to 2 years post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and time between study entry and death from any cause, assessed up to 2 years post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complete response rate

Overall response rate

Secondary study objectives

Incidence of adverse events (AEs)

Overall survival

Progression free survival

Side effects data

From 2016 Phase 2 & 3 trial • 86 Patients • NCT03002038

Gastrointestinal intolerance

Impaired liver function test

100%

80%

60%

40%

20%

Study treatment Arm

Azathioprine

Rituximab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (uLTRA, CHOP)Experimental Treatment8 Interventions

COHORT I (SMART STOP): Patients receive rituximab IV over 4-6 hours on day 1, acalabrutinib PO BID on days 1-21, lenalidomide QD on days 1-10, and tafasitamab IV over 2 hours on days 1, 8, and 15. Treatments repeat every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. COHORT II (uLTRA-CHOP): Patients who achieve a complete response to the Smart Stop in Cohort I, receive rituximab IV over 4-6 hours on day 1, acalabrutinib PO BID on days 1-21, lenalidomide QD on days 1-10, and tafasitamab IV over 2 hours on days 1, 8, and 15. Treatments repeat every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive cyclophosphamide IV over 1 hour, doxorubicin hydrochloride IV over 15 minutes, vincristine IV over 15 minutes on day 1, and prednisone PO QD on days 1-5. Treatments repeat every 21 days for up to 6 cycles in the absence of disease progr

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Doxorubicin Hydrochloride

2019

Completed Phase 3

~17860

Prednisone

2014

Completed Phase 4

~2500