Your session is about to expire
← Back to Search
Monoclonal Antibodies
Blinatumomab for Acute Lymphoblastic Leukemia
Phase 2
Waitlist Available
Led By Elias Jabbour
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
Patients with B-lineage acute lymphocytic leukemia (ALL) in hematologic complete remission (CR) with molecular failure or molecular relapse starting at any time point after 3 months of frontline therapy; molecular disease or minimal residual disease is defined by a value of at least of 1 x 10^-4 (0.01%) by multicolor flow cytometry and/or by next generation sequencing (NGS)
Performance status of 0, 1, or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18 months
Awards & highlights
Study Summary
This trial looks at how well blinatumomab works in treating patients with leukemia whose disease is in remission but is still present in a small number of cells in the body.
Who is the study for?
This trial is for adults with B-cell acute lymphoblastic leukemia in remission but still have minimal residual disease. Eligible participants must be relatively healthy (performance status 0-2), may have Philadelphia chromosome positive ALL, and should not have other active cancers or life expectancy under 12 months. Pregnant women, HIV+ individuals, those with uncontrolled diseases/infections, or CNS involvement are excluded.Check my eligibility
What is being tested?
The study tests blinatumomab's effectiveness on patients whose leukemia is in remission but detectable at low levels. It's a phase II trial to see if this monoclonal antibody can prevent the growth and spread of remaining cancer cells by activating the immune system.See study design
What are the potential side effects?
Blinatumomab might cause side effects like allergic reactions, fever, headache, fatigue, nausea and increased risk of infections due to its impact on the immune system. The exact side effects will vary from person to person.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My leukemia is in remission but still shows signs of disease on a molecular level.
Select...
I can take care of myself and perform daily activities.
Select...
I do not have another cancer that could shorten my life within a year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Relapse-free survival (RFS)
Secondary outcome measures
Event-free survival
Incidence of toxicity
MRD negativity rate
+2 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%
Decreased appetite
6%
Fatigue
6%
Rash maculo-papular
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%
Engraftment syndrome
2%
Klebsiella infection
2%
Accidental overdose
2%
Nervous system disorder
2%
Perineal cellulitis
2%
Catheter placement
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
1Treatment groups
Experimental Treatment
Group I: Treatment (blinatumomab)Experimental Treatment2 Interventions
Patients receive blinatumomab IV continuously on days 1-28. Treatment repeats every 6 weeks for up to 5 courses in the absence of disease progression or unacceptable toxicity. Patients who do not proceed with stem cell transplantation may receive blinatumomab IV maintenance therapy with one cycle every 3 months for up to 4 cycles. Patients who remain in MRD remission for 3 months and then become MRD positive again can be retreated following the same treatment plan previously received.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blinatumomab
2014
Completed Phase 3
~1210
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,285 Total Patients Enrolled
6 Trials studying Minimal Residual Disease
93 Patients Enrolled for Minimal Residual Disease
National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,926,037 Total Patients Enrolled
10 Trials studying Minimal Residual Disease
263 Patients Enrolled for Minimal Residual Disease
Elias JabbourPrincipal InvestigatorM.D. Anderson Cancer Center
16 Previous Clinical Trials
992 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My leukemia is in remission but still shows signs of disease on a molecular level.I haven't had major cancer treatments or experimental drugs in the last 2 weeks.I can take care of myself and perform daily activities.I haven't had monoclonal antibody therapy in the last 2 weeks.I have ALL with Philadelphia chromosome positive in first or second complete remission.My doctor believes I have an active and uncontrolled disease or infection.I do not have another cancer that could shorten my life within a year.I cannot or do not want to sign the consent form.My cancer has spread to my brain or is affecting areas outside my bone marrow.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (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.
Recent research and studies
Share this study with friends
Copy Link
Messenger