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Bi-specific T-Cell Engager
Blinatumomab + Chemotherapy for Leukemia
Phase 3
Recruiting
Led By Yishai Ofran
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
Patients who presented with acute organ dysfunction must have AST (SGOT)/ALT (SGPT) =< 2 X institutional upper limit of normal (ULN)
Patients with a history of hepatitis C virus (HCV) infection must have an undetectable HCV viral load and if indicated, on treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from randomization to failure to achieve induction molecular remission by week 15, confirmed molecular relapse after molecular remission or to death in remission, assessed up to 10 years from the date of registration
Awards & highlights
Study Summary
This trial is testing if adding the drug blinatumomab to the usual chemotherapy and steroids treatment for acute lymphoblastic leukemia (ALL) is more effective than the standard of care.
Who is the study for?
Adults aged 18-75 with newly diagnosed BCR-ABL-positive acute lymphoblastic leukemia (ALL) can join this trial. They should be in decent physical shape, not pregnant or breastfeeding, and willing to use contraception. People with active brain involvement by leukemia, unstable epilepsy, other cancers, or those who have already started certain treatments for ALL are excluded.Check my eligibility
What is being tested?
The study is testing if adding blinatumomab—a cancer cell growth inhibitor—to the usual treatment of chemotherapy, steroids, and a tyrosine kinase inhibitor is more effective for treating ALL. It's a phase III trial where patients receive either standard care or standard care plus blinatumomab.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system such as inflammation in various organs; blood disorders; fatigue; digestive issues like nausea and vomiting; increased risk of infections due to lowered immunity; and potential heart problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver enzymes are within twice the normal limit.
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I had hepatitis C but now have an undetectable viral load, and I'm on treatment if needed.
Select...
I can care for myself but may not be able to do heavy physical work.
Select...
My condition is BCR-ABL1 positive.
Select...
My leukemia is Philadelphia chromosome positive, confirmed by a central lab.
Select...
My hepatitis B is under control or being treated effectively.
Select...
My bilirubin levels are within twice the normal limit, despite recent acute organ issues.
Select...
My bilirubin levels are within twice the normal limit, and I had recent acute organ dysfunction.
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I am between 18 and 75 years old.
Select...
My kidneys work well enough (creatinine clearance > 45 mL/min).
Select...
I have been recently diagnosed with B-ALL or it is suspected.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from randomization to failure to achieve induction molecular remission by week 15, confirmed molecular relapse after molecular remission or to death in remission, assessed up to 10 years from the date of registration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from randomization to failure to achieve induction molecular remission by week 15, confirmed molecular relapse after molecular remission or to death in remission, assessed up to 10 years from the date of registration
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival (OS)
Secondary outcome measures
Event free survival (EFS)
Incidence of adverse events
Rate of MRD negativity
+1 moreSide effects data
From 2022 Phase 3 trial • 111 Patients • NCT0239385980%
Pyrexia
43%
Nausea
37%
Headache
31%
Vomiting
24%
Anaemia
22%
Diarrhoea
20%
Stomatitis
17%
Mucosal inflammation
13%
Rash
13%
Abdominal pain
13%
Platelet count decreased
13%
Hypertension
11%
Pruritus
11%
Erythema
11%
Hypokalaemia
11%
Hypogammaglobulinaemia
11%
Hypotension
9%
Neutropenia
9%
Tremor
9%
Epistaxis
9%
Constipation
9%
Neutrophil count decreased
7%
Agitation
7%
White blood cell count decreased
7%
Immunodeficiency
7%
Hypervolaemia
7%
Alanine aminotransferase increased
7%
Anal inflammation
7%
Cough
7%
Thrombocytopenia
7%
Abdominal pain upper
7%
Petechiae
7%
Fluid overload
6%
Rash maculo-papular
6%
Decreased appetite
6%
Fatigue
6%
Paronychia
6%
Back pain
6%
Nasopharyngitis
6%
Febrile neutropenia
6%
Urticaria
4%
Fluid balance positive
4%
Seizure
4%
Oropharyngeal pain
4%
Aplasia
4%
Pain in extremity
4%
Neurological symptom
4%
Aspartate aminotransferase increased
2%
Haematoma
2%
Herpes virus infection
2%
Klebsiella infection
2%
Accidental overdose
2%
Nervous system disorder
2%
Perineal cellulitis
2%
Catheter placement
2%
Engraftment syndrome
2%
Complication associated with device
2%
Oral pain
2%
Neurological examination abnormal
2%
Blood immunoglobulin G decreased
2%
Antithrombin III decreased
2%
Laryngotracheitis obstructive
2%
Pain
2%
Hypertransaminasaemia
2%
Rhinitis
2%
Body temperature increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Blinatumomab
HC3 Chemotherapy
Trial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: Arm E (steroid, TKI, chemotherapy)Experimental Treatment14 Interventions
Patients treated on Arm C who remain MRD positive at the end of induction therapy receive chemotherapy based re-induction which is identical to regimen described for Arm B according to patient's age and the pre-specified chemotherapy arm.
Patients whose molecular test remains MRD positive after re-induction proceed to follow-up at the discretion of the investigator or receive anti CD-19 CAR- T cell therapy, inotuzumab ozogamicin, intensive chemotherapy, or palliative care.
Group II: Arm D (steroid, TKI, chemotherapy, immunotherapy)Experimental Treatment12 Interventions
Patients treated on Arm B who remain MRD positive at the end of induction therapy receive blinatumomab based re-induction identical to the regimen described for Arm C.
Patients whose molecular test remains MRD positive after re-induction proceed to follow-up at the discretion of the investigator or receive anti CD-19 CAR- T cell therapy, inotuzumab ozogamicin, intensive chemotherapy, or palliative care.
Group III: Arm C (steroid, TKI, chemotherapy, immunotherapy)Experimental Treatment12 Interventions
CYCLE 1: Patients receive ponatinib PO QD or dasatinib PO QD on days 1-28. Patients also receive dexamethasone PO or IV on day 1 and blinatumomab IV continuously on days 1-28, followed by methotrexate IT on day 28 or 29.
CYCLE 2: Patients receive ponatinib PO QD or dasatinib PO QD on days 1-28. Patients also receive dexamethasone PO or IV on day 1 and blinatumomab IV continuously on days 1-28.
Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
Group IV: Arm B (steroid, TKI, chemotherapy)Experimental Treatment15 Interventions
See Detailed Description.
Group V: Arm A (steroid, TKI), Single Arm Pre-InductionActive Control9 Interventions
Patients receive prednisone PO QD on days 1-21 and ponatinib PO QD or dasatinib PO QD on days 1-21 based on investigator's choice.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Electrocardiography
2014
N/A
~150
Lumbar Puncture
2016
Completed Phase 3
~510
Biospecimen Collection
2004
Completed Phase 2
~1730
Blinatumomab
2014
Completed Phase 3
~1210
Cyclophosphamide
1995
Completed Phase 3
~3770
Cytarabine
2016
Completed Phase 3
~3310
Dexamethasone
2007
Completed Phase 4
~2590
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Vincristine Sulfate
2005
Completed Phase 3
~10110
Dasatinib
2012
Completed Phase 3
~2320
Echocardiography
2013
Completed Phase 4
~11670
Ponatinib Hydrochloride
2014
Completed Phase 2
~20
Mesna
2003
Completed Phase 2
~1380
Methotrexate
2013
Completed Phase 4
~3800
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,660 Previous Clinical Trials
40,924,334 Total Patients Enrolled
Yishai OfranPrincipal InvestigatorECOG-ACRIN Cancer Research Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver enzymes are within twice the normal limit.Any major side effects from my previous treatments have gone away.I had hepatitis C but now have an undetectable viral load, and I'm on treatment if needed.I have taken a TKI for no more than 14 days before joining this study.My leukemia is BCR-ABL1 positive.I can care for myself but may not be able to do heavy physical work.My condition is BCR-ABL1 positive.Your total bilirubin level should not be higher than 3 mg/dL, unless you have Gilbert's syndrome, in which case it should not be higher than 5 mg/dL. This test should have been done within the last 28 days.My leukemia is Philadelphia chromosome positive, confirmed by a central lab.My epilepsy is stable and does not need treatment.My hepatitis B is under control or being treated effectively.My acute organ dysfunction is due to leukemia.My liver enzymes increased due to medication, but I had no prior organ issues.My bilirubin levels are within twice the normal limit, despite recent acute organ issues.I do not have any uncontrolled infections or other conditions that could worsen with treatment.I have a history of heart issues or have been treated with heart-toxic drugs.My bilirubin levels are within twice the normal limit, and I had recent acute organ dysfunction.Requirements for being considered for the first step of the study.I do not have lymphoid blast crisis CML.I do not have BCR/ABL T-ALL.I have not received chemotherapy for B-ALL.I am under 70 and my chemotherapy plan is already decided.I am between 18 and 75 years old.My doctor has decided on the specific targeted therapy I will receive.I am HIV positive, on treatment, and my viral load has been undetectable for the last 6 months.My kidney function, measured by creatinine clearance, is good.Requirements for joining the first phase of the study.I had cancer before, but it won't affect this trial's treatment.I do not have any other active cancer.My leukemia has not spread to my brain or spinal cord.My kidneys work well enough (creatinine clearance > 45 mL/min).I have recovered from any serious infections caused by treatments.I have been on the initial treatment for 7 to 21 days before the next study phase.I have been recently diagnosed with B-ALL or it is suspected.To check if you are eligible for the study, you need to provide a sample of your bone marrow or blood for testing. The test will check if you have a specific type of leukemia and if you have a certain genetic mutation. The results will be sent back to your doctor within 2 days. If you have already been diagnosed with a certain type of leukemia, you may skip this step.
Research Study Groups:
This trial has the following groups:- Group 1: Arm E (steroid, TKI, chemotherapy)
- Group 2: Arm A (steroid, TKI), Single Arm Pre-Induction
- Group 3: Arm B (steroid, TKI, chemotherapy)
- Group 4: Arm C (steroid, TKI, chemotherapy, immunotherapy)
- Group 5: Arm D (steroid, TKI, chemotherapy, immunotherapy)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
How many people are receiving the experimental therapy?
"Yes, this is an active clinical trial that was first posted on October 14th, 2020 and is looking for 348 patients at 69 different sites."
Answered by AI
Might I be a good candidate for this particular clinical trial?
"This study is looking for 348 patients between the ages of 18 and 75 who have leukemia. To be eligible, patients must also meet the following criteria: ELIGIBILITY CRITERIA FOR PREREGISTRATION (TO STEP 0) - INCLUSION, Patient must be >= 18 and =< 75 years of age, Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status between 0-3, Patient must be newly diagnosed with B-ALL or is suspected to have ALL, NOTE: Bone marrow aspirate and/or peripheral blood specimen must be submitted to the American College of Rad"
Answered by AI
Are there any more room for patients who want to enroll in this trial?
"This clinical trial, which is currently seeking participants, was first posted on October 14th 2020 and most recently edited on November 9th 2022."
Answered by AI
For what illnesses is Blinatumomab regularly prescribed?
"Blinatumomab is frequently used to ameliorate macular edema. This medication can also be helpful in the management of other conditions such as pheochromocytomas, eye inflammation, and ulcerative colitis."
Answered by AI
At how many different sites is this experiment being conducted?
"There are 69 clinical trial sites that patients can choose from, such as Freeman Health System in Joplin, Marshfield Medical Center-Marshfield in Marshfield, and Virginia Commonwealth University/Massey Cancer Center in Richmond."
Answered by AI
What are some of the dangers associated with Blinatumomab?
"There is some clinical evidence to support the efficacy of blinatumomab, and it has received multiple rounds of safety testing, so we have given it a score of 3."
Answered by AI
What are some similar studies to the one being conducted with Blinatumomab?
"2085 studies involving Blinatumomab are currently active, with 444 in Phase 3. Most of these clinical trials are based in Mishawaka, Indiana, but there are 67104 locations running similar research programs."
Answered by AI
Is this a novel clinical trial?
"Blinatumomab has been the subject of medical research since 1997 when Alfacell Corporation first sponsored a clinical trial. Since then, it has undergone Phase 3 drug approval and there are currently 2085 live studies being conducted in 87 different countries."
Answered by AI
Will elderly patients be excluded from this research project?
"Patients that meet the age requirements of 18-75 years old are eligible for this particular study. However, there are 958 other clinical trials available for individuals under 18 and 2933 trials for patients over 65."
Answered by AI
Who else is applying?
What state do they live in?
Virginia
Michigan
How old are they?
18 - 65
What site did they apply to?
Northwestern University
What portion of applicants met pre-screening criteria?
Met criteria
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