Your session is about to expire
← Back to Search
Bi-specific T-cell Engager (BiTE)
Blinatumomab for Acute Lymphoblastic Leukemia
Phase 1 & 2
Recruiting
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged 18 years or older
- In untreated first, second, third or greater relapse or refractory relapse
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1) up to approximately 28 weeks
Awards & highlights
Study Summary
This trial will test the safety and effectiveness of a new cancer drug for people with a certain type of leukemia.
Who is the study for?
This trial is for adults with B-precursor Acute Lymphoblastic Leukemia (ALL) who may have relapsed after stem cell transplant, have a certain percentage of cancer cells in their bone marrow, or are not responding to other treatments. It's open to those with an ECOG Performance Status of 2 or less and includes patients intolerant to tyrosine kinase inhibitors.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of Blinatumomab given under the skin for treating ALL. It aims to find the highest dose patients can tolerate without severe side effects and establish recommended doses for future phases. The trial also examines how the body processes this drug.See study design
What are the potential side effects?
Blinatumomab can cause side effects like allergic reactions at the injection site, fever, headache, nausea, fatigue, and infections. Some people might experience neurological issues such as seizures or confusion.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My condition is in its first or later relapse and has not been treated yet.
Select...
My disease did not fully respond to the initial treatment.
Select...
My B Cell ALL Ph+ disease has not responded to previous TKI treatments.
Select...
My cancer did not fully respond to the last treatment I received.
Select...
My condition did not improve after receiving secondary treatment.
Select...
My condition relapsed after a stem cell transplant.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My condition worsened or didn't improve after my first follow-up treatment.
Select...
My cancer did not respond to initial treatment or to at least one follow-up treatment.
Select...
My cancer has returned after my second complete remission.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (day 1) up to approximately 28 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1) up to approximately 28 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose Escalation Phase: Number of participants who experience dose limiting toxicities (DLTs)
Dose Escalation Phase: Number of participants who experience one or more adverse events (AEs)
Dose Escalation Phase: Number of participants who experience one or more serious TEAEs
+8 moreSecondary outcome measures
Dose Escalation Phase and Phase 2 (Ph-IIC cohort): Number of participants who achieve CR/CRh
Dose Escalation Phase: AUC of blinatumomab
Dose Escalation Phase: Cmax of blinatumomab
+16 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%
Hypokalaemia
11%
Erythema
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%
Complication associated with device
2%
Engraftment syndrome
2%
Perineal cellulitis
2%
Klebsiella infection
2%
Nervous system disorder
2%
Catheter placement
2%
Oral pain
2%
Accidental overdose
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
3Treatment groups
Experimental Treatment
Group I: Ph-IIC: Clinical PK Evaluation of SC Blinatumomab FormulationsExperimental Treatment1 Intervention
1 cohort of participants will be enrolled into the Ph-IIC arm. The clinical PK evaluation cohort (Ph-IIC) will be conducted to compare the PK of SC1 and SC2 formulations at the RP2D determined from the dose expansion phase, in participants with R/R B-ALL.
Group II: Dose Expansion Phase: Blinatumomab SC1Experimental Treatment1 Intervention
Up to 4 cohorts of participants with R/R B-ALL will be enrolled to the preliminary recommended phase 2 dose (RP2D) and schedule determined from dose escalation phase. Each cohort will aim to further assess safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy.
Group III: Dose Escalation Phase: Blinatumomab Subcutaneous Formulation 1 (SC1)Experimental Treatment1 Intervention
Cohorts of at least 3 participants each will be treated with escalating doses of bilinatumomab to determine the maximum tolerated dose (MTD). The MTD will be defined as the dose for which the estimate of the toxicity rate from an isotonic regression (Yan et al, 2017) is closest to the target toxicity rate. Safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy will be assessed.
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?
AmgenLead Sponsor
1,371 Previous Clinical Trials
1,377,981 Total Patients Enrolled
MDStudy DirectorAmgen
914 Previous Clinical Trials
924,454 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have B-precursor acute lymphoblastic leukemia.I have leukemia in my brain or spinal cord.I had a stem cell transplant from a donor within the last 12 weeks.My condition is in its first or later relapse and has not been treated yet.My disease did not fully respond to the initial treatment.My B Cell ALL Ph+ disease has not responded to previous TKI treatments.My cancer did not fully respond to the last treatment I received.My condition did not improve after receiving secondary treatment.I have no history of major brain-related health issues like epilepsy, stroke, or dementia.I haven't had immunotherapy in the last 4 weeks, but past CD19 therapy is okay if it ended over 4 weeks ago.My cancer returned after initially responding to treatment.I haven't had cancer chemotherapy in the last 2 weeks, with some exceptions.I do not have any uncontrolled infections or conditions that could worsen with treatment.I have not had cancer other than ALL in the last 3 years.I plan to breastfeed during and shortly after treatment.My condition relapsed after a stem cell transplant.I can take care of myself and am up and about more than half of my waking hours.My condition worsened or didn't improve after my first follow-up treatment.My cancer did not respond to initial treatment or to at least one follow-up treatment.My cancer has returned after my second complete remission.
Research Study Groups:
This trial has the following groups:- Group 1: Ph-IIC: Clinical PK Evaluation of SC Blinatumomab Formulations
- Group 2: Dose Expansion Phase: Blinatumomab SC1
- Group 3: Dose Escalation Phase: Blinatumomab Subcutaneous Formulation 1 (SC1)
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.
Has Blinatumomab been tested in previous medical investigations?
"At the present moment, 46 clinical studies concerning blinatumomab are in progress with 9 trials being within Phase 3. Although most of these investigations take place in Santa Barbara, California, there is a total of 2395 trial sites across the world researching this medication."
Answered by AI
What is the highest capacity of participants for this research project?
"Affirmative. According to the information provided on clinicaltrials.gov, this examination is presently attempting to recruit patients. It was originally advertised on April 1st 2021 and has been adjusted most recently in September 28th 2022. The researchers are searching for 105 individuals from 3 different sites."
Answered by AI
Is this research study currently enrolling volunteers?
"Affirmative. Clinicaltrials.gov declares that this examination is now accepting participants since it was first published on April 1st 2021 and last updated September 28th 2022, with the aim of recruiting 105 patients from 3 distinct locations."
Answered by AI
Can you elucidate the potential risks associated with using Blinatumomab?
"Due to the preliminary nature of this Phase 1 trial, only limited data exists that supports Blinatumomab's efficacy and safety; as a result, we assigned it a rating of 1."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger