← Back to Search

Monoclonal Antibodies

Lenalidomide + Blinatumomab for Lymphoma

Phase 1

Waitlist Available

Led By Joseph M Tuscano

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Body surface area (BSA)-normalized creatinine clearance >= 60 mL/min/1.73 m^2

Patients must have had at least two prior chemotherapeutic or biologic regimens

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

Study Summary

This trial is testing the side effects and best dose of lenalidomide and blinatumomab when given together to patients with non-Hodgkin lymphoma that has returned after a period of improvement.

Who is the study for?

This trial is for adults with various types of relapsed Non-Hodgkin Lymphoma who have tried at least two prior treatments and are not eligible for standard cures. They must have measurable disease, normal organ function tests, no brain metastases or uncontrolled illnesses, and not be pregnant or breastfeeding. HIV-positive patients can join if they meet certain conditions.Check my eligibility

What is being tested?

The trial is testing the combination of Lenalidomide and Blinatumomab to find the safest doses and observe side effects in treating relapsed Non-Hodgkin Lymphoma. Lenalidomide boosts the immune system while Blinatumomab targets cancer cells directly.See study design

What are the potential side effects?

Possible side effects include allergic reactions similar to other compounds like lenalidomide and blinatumomab, infections due to a weakened immune system, heart issues such as congestive heart failure or angina, liver problems from hepatitis B or C, psychiatric illness affecting study compliance.

Eligibility Criteria

Inclusion Criteria

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

Select...

My kidneys work well enough to clear waste from my body.

Select...

I have undergone at least two different cancer treatments.

Select...

My lymphoma has returned and tests positive for CD19.

Select...

I can care for myself but may need occasional help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 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

Incidence of toxicity

Secondary outcome measures

Changes in the frequency of CD4+ T cells

Changes in the production of interferon (INF)-gamma from CD4+ T cells

Clinical anti-tumor response (complete response and partial response as per International workshop lymphoma response criteria)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (blinatumomab, lenalidomide)Experimental Treatment2 Interventions

INDUCTION: Patients receive blinatumomab IV continuously on days 1-56 and lenalidomide PO on days 29-49 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients achieving response including stable disease receive blinatumomab IV continuously on days 1-7 and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receiving response including stable disease after completion of Consolidation receive lenalidomide PO on days 1-21. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Blinatumomab

2014

Completed Phase 3

~1210

Lenalidomide

2005

Completed Phase 3

~1480

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,109 Total Patients Enrolled

Joseph M TuscanoPrincipal InvestigatorCity of Hope Comprehensive Cancer Center LAO

6 Previous Clinical Trials

225 Total Patients Enrolled

Media Library

Blinatumomab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02568553 — Phase 1

Blinatumomab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02568553 — Phase 1

Non-Hodgkin's Lymphoma Research Study Groups: Treatment (blinatumomab, lenalidomide)

Non-Hodgkin's Lymphoma Clinical Trial 2023: Blinatumomab Highlights & Side Effects. Trial Name: NCT02568553 — Phase 1

Frequently Asked Questions

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

What medical conditions is Blinatumomab commonly employed to treat?

"Blinatumomab is typically prescribed as a tertiary treatment step after two other systemic chemotherapy treatments. This medication can also be used for treating amyloidosis, refractory b-cell precursor acute lymphoblastic leukemia, and kidney afflictions."

Answered by AI

Has Blinatumomab gained approval from the Food and Drug Administration?

"The safety profile of Blinatumomab was rated a 1, as it is in Phase 1 and there is only limited evidence regarding its efficacy and safety."

Answered by AI

What is the current scale of participants in this research project?

"This clinical trial has already reached its recruitment limit, with the most recent edits being made on June 28th 2022. Should you be in search of other studies to participate in, there are currently 2833 trials searching for patients suffering from leukemia and lymphocytic chronic b-cell related illnesses as well as 315 Blinatumomab trials recruiting participants."

Answered by AI

Is recruitment still active for this experiment?

"As per the data on clinicaltrials.gov, this particular medical trial is not currently recruiting participants. It was originally posted in June 2016 and last updated two years ago; nonetheless, there are 3148 other trials which are actively seeking patient enrollment presently."

Answered by AI

How many venues are hosting this empirical research?

"University of Kansas Cancer Center situated in Kansas City, University of Wisconsin Carbone Cancer Centre located in Duarte, and City of Hope Comprehensive Cancer Centre placed in Birmingham are a few amongst the 10 other medical sites that are running this trial."

Answered by AI

What have other scholarly investigations revealed about Blinatumomab?

"Presently, 315 studies utilizing Blinatumomab are in progress. 65 of those trials fall into Phase 3 and the majority of them are based out of Chicago, Illinois. Nevertheless, there are 15607 medical centres running research on this treatment globally."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Lenalidomide and Blinatumomab for the Treatment of Relapsed Non-Hodgkin Lymphoma

2016. "Lenalidomide and Blinatumomab for the Treatment of Relapsed Non-Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02568553.

All > Tennessee > Paid Studies Wisconsin