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Monoclonal Antibodies

Ibrutinib + Blinatumomab for Acute Lymphoblastic Leukemia

Phase 2

Recruiting

Research Sponsored by Brian Jonas

Eligibility Criteria Checklist

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

Must have

Karnofsky performance status (KPS) performance status of 60% or greater

Male and female subjects who agree to use both a highly effective methods of birth control (e.g., condoms, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], complete abstinence, or sterilized partner) and a barrier method (e.g. condoms, vaginal ring, sponge, etc) during the period of therapy and for 90 days after the last dose of study drug

Must not have

Any active acute GVHD or chronic GVHD greater than grade 1

Known bleeding disorders (e.g., von Willebrand's disease) or hemophilia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying if ibrutinib and blinatumomab are effective in treating relapsed or refractory B acute lymphoblastic leukemia.

Who is the study for?

This trial is for adults with B acute lymphoblastic leukemia that's returned or isn't responding to treatment. They must have proper liver and kidney function, no major bleeding disorders, not be pregnant or breastfeeding, and agree to use effective birth control. People can't join if they've had certain recent treatments, active central nervous system leukemia, severe heart conditions, or are positive for HIV/HCV/HBV without a negative PCR result.

What is being tested?

The trial tests the combination of Ibrutinib (which blocks enzymes needed for cancer cell growth) and Blinatumomab (a monoclonal antibody that may stop cancer cells from growing). It aims to see if this combo is more effective in patients with relapsed/refractory B acute lymphoblastic leukemia.

What are the potential side effects?

Possible side effects include allergic reactions similar to other compounds like Ibrutinib and Blinatumomab, risk of infection due to immune system suppression by the drugs, liver problems indicated by elevated enzyme levels in blood tests, fatigue from anemia caused by bone marrow suppression.

Eligibility Criteria

Inclusion Criteria

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

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I can care for myself but may need occasional help.

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I agree to use two effective birth control methods during and 90 days after treatment.

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My leukemia/lymphoma has returned or is not responding to treatment, and it can be measured by scans.

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My kidney function, measured by creatinine clearance, is within the normal range.

Exclusion Criteria

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

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I have graft-versus-host disease that is moderate to severe.

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I have a bleeding disorder like von Willebrand's disease or hemophilia.

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I do not have active HIV, HCV, or HBV, or if positive, my tests meet the trial's specific conditions.

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I have been diagnosed with T-ALL or Burkitt's leukemia/lymphoma.

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I have not had major surgery in the last 4 weeks.

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I am currently taking warfarin or similar blood thinners.

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I haven't taken strong CYP3A inhibitors in the last 7 days.

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I have significant liver problems (Child-Pugh class B or C).

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I am willing and able to follow the study's requirements and understand its risks.

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I have been treated with ibrutinib or blinatumomab.

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I had a bone marrow transplant less than 3 months ago.

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I currently have active leukemia in my brain or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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 (ibrutinib, blinatumomab)Experimental Treatment2 Interventions

INDUCTION THERAPY: Patients receive ibrutinib PO QD on days 1-49 of course 1 and days 1-42 of course 2, and blinatumomab IV on days 8-35 of course 1 and days 1-28 of course 2 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION THERAPY: Patients with CR/CRi after Induction Therapy receive ibrutinib PO QD on days 1-42 and blinatumomab IV on days 1-28. Treatment repeats every 42 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ibrutinib

2014

Completed Phase 4

~2060

Blinatumomab

2014

Completed Phase 3

~1230