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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I can care for myself but may need occasional help.
Select...
I agree to use two effective birth control methods during and 90 days after treatment.
Select...
My leukemia/lymphoma has returned or is not responding to treatment, and it can be measured by scans.
Select...
My kidney function, measured by creatinine clearance, is within the normal range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of CR
Secondary outcome measures
Incidence of adverse events graded according to the National Cancer Institute CTCAE v4.03
MRD response
ORR defined as CR plus CRi assessed by disease-specific response criteria
+2 moreTrial 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 3
~1880
Blinatumomab
2014
Completed Phase 3
~1210
Find a Location
Who is running the clinical trial?
Pharmacyclics LLC.Industry Sponsor
113 Previous Clinical Trials
13,800 Total Patients Enrolled
Brian JonasLead Sponsor
4 Previous Clinical Trials
70 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,663 Previous Clinical Trials
40,925,885 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can care for myself but may need occasional help.I agree to use two effective birth control methods during and 90 days after treatment.My current medications won't interfere with the trial drugs.You have had allergic reactions to medications that are similar to ibrutinib, blinatumomab, or other drugs being used in this study.I have not received any live vaccines in the last 4 weeks.I have graft-versus-host disease that is moderate to severe.I finished IV antibiotics for an infection less than a week ago or have an ongoing infection.I have a bleeding disorder like von Willebrand's disease or hemophilia.I have been diagnosed with T-ALL or Burkitt's leukemia/lymphoma.I haven't had cancer treatments or investigational therapy within the last two weeks or five half-lives, whichever is shorter.I don't have ongoing major side effects from previous cancer treatments, except for hair loss.I have not had major surgery in the last 4 weeks.I had cancer before, but it was treated successfully and has been inactive for over 3 years.I am currently taking warfarin or similar blood thinners.I haven't taken strong CYP3A inhibitors in the last 7 days.I have significant liver problems (Child-Pugh class B or C).I am willing and able to follow the study's requirements and understand its risks.My kidney function, measured by creatinine clearance, is within the normal range.My leukemia/lymphoma has returned or is not responding to treatment, and it can be measured by scans.I do not have any severe illnesses or heart problems that could make the study unsafe for me.I do not have active HIV, HCV, or HBV, or if positive, my tests meet the trial's specific conditions.I have been treated with ibrutinib or blinatumomab.I need regular blood transfusions but my platelet count is above 10,000.I had a bone marrow transplant less than 3 months ago.I am a woman who cannot become pregnant or I have tested negative for pregnancy recently.I currently have active leukemia in my brain or spinal cord.I have not had a stroke or brain bleed in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ibrutinib, blinatumomab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What sort of dangers is Blinatumomab reported to have for those who use it?
"From 1 to 3, the safety of Blinatumomab has been determined as a 2 due to Phase 2 trial data which confirm that there is some evidence backing its security but no proof of efficacy."
Answered by AI
What other investigations have been done concerning Blinatumomab?
"At present, 202 clinical trials are running with Blinatumomab and 32 of them have reached Phase 3. Detroit is the hub for these studies but there's a dispersed network of 9599 locations actively studying this medication."
Answered by AI
How many people have enrolled in this research trial?
"Affirmative. Clinicaltrials.gov indicates that this medical trial, initially advertised on June 27th 2017, is actively searching for 20 patients at 1 location."
Answered by AI
What indications are commonly treated using Blinatumomab?
"Blinatumomab is primarily prescribed for mantle cell lymphoma, but has also proven to be effective with refractory b-cell precursor acute lymphoblastic leukemia as well as kidney and heart transplantation."
Answered by AI
Are there available openings for individuals to take part in this trial?
"Information displayed on clinicaltrials.gov verifies that this medical trial is still recruiting individuals - with the initial posting dating back to June 27th, 2017 and its most recent update occurring in early June of 2022."
Answered by AI
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