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Blinatumomab for Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma

Phase 1 & 2
Waitlist Available
Led By Jonathan Webster, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pre-B ALL patients in CR1 with high-risk features or all Pre-B ALL patients in second and higher CR
ECOG performance status 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is looking at whether a drug called blinatumomab is safe to use in patients who have had a stem cell transplant to treat leukemia or non-Hodgkin's lymphoma.

Who is the study for?
Adults over 18 with B-cell malignancies like ALL or NHL, post-allogeneic HSCT. They must be in remission but at high risk of relapse, within a specific time frame from transplant, and have recovered blood counts without disease progression. Fertility requires contraception use during the study. Exclusions include recent chemo/radiotherapy, uncontrolled illnesses, certain medications for GVHD, poor organ function, pregnancy/lactation, infections like HIV/HBV/HCV, severe GVHD history or active CNS/testes disease.Check my eligibility
What is being tested?
The trial is testing blinatumomab's safety as a maintenance therapy after allogeneic HSCT in patients with CD19+ B-cell cancers (ALL and NHL). It aims to prevent cancer recurrence by using different doses of blinatumomab along with dexamethasone to manage potential side effects.See study design
What are the potential side effects?
Blinatumomab may cause flu-like symptoms such as fever and chills; neurological issues including headaches and confusion; allergic reactions; low blood cell counts leading to increased infection risk; fatigue; nausea; and liver enzyme changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have high-risk Pre-B ALL in my first complete remission or am in my second or later complete remission.
Select...
I can take care of myself and perform daily activities.
Select...
I have NHL and had a transplant that didn't fully replace my bone marrow.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival at two years post first treatment cycle
Secondary outcome measures
Disease-free Survival
Minimal Residual Disease
Non-Relapse Mortality
+2 more

Side effects data

From 2022 Phase 3 trial • 111 Patients • NCT02393859
52%
Stomatitis
46%
Anaemia
25%
Neutropenia
21%
Thrombocytopenia
21%
Abdominal pain
21%
Vomiting
19%
Pyrexia
17%
Nausea
17%
Febrile neutropenia
17%
Diarrhoea
15%
Platelet count decreased
15%
Headache
13%
Constipation
13%
Epistaxis
13%
Alanine aminotransferase increased
10%
Rash
10%
Back pain
10%
Rhinitis
10%
Hypokalaemia
10%
Pain in extremity
10%
Pruritus
10%
Aspartate aminotransferase increased
8%
Abdominal pain upper
8%
Mucosal inflammation
8%
Hypertension
8%
Hypotension
8%
Arthralgia
8%
Aplasia
8%
Hypertransaminasaemia
6%
Leukopenia
6%
Oral pain
6%
Oropharyngeal pain
6%
Haematoma
6%
Pain
6%
Hepatotoxicity
6%
Fluid balance positive
6%
Antithrombin III decreased
4%
Erythema
4%
Hypogammaglobulinaemia
4%
Anal inflammation
4%
Fatigue
4%
Neutrophil count decreased
2%
Bronchitis
2%
Clostridium difficile colitis
2%
Lipase increased
2%
Pancreatitis acute
2%
Device related infection
2%
Vulvitis
2%
Decreased appetite
2%
Pneumothorax traumatic
2%
Capillary leak syndrome
2%
Petechiae
2%
Staphylococcal infection
2%
Viral infection
2%
B precursor type acute leukaemia
2%
Septic shock
2%
Nasopharyngitis
2%
Cough
2%
Acute lymphocytic leukaemia recurrent
2%
Escherichia bacteraemia
2%
White blood cell count decreased
2%
Agitation
100%
80%
60%
40%
20%
0%
Study treatment Arm
HC3 Chemotherapy
Blinatumomab

Trial Design

1Treatment groups
Experimental Treatment
Group I: Post-alloHSCT MaintenanceExperimental Treatment4 Interventions
Blinatumomab will be administered as a continuous intravenous (IV) infusion over four weeks followed by a two-week treatment free interval. It is recommended that patients are hospitalized at least during the first three days of the first cycle and the first two days of the second cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blinatumomab
2014
Completed Phase 3
~1140
Dexamethasone
2007
Completed Phase 4
~2590

Find a Location

Who is running the clinical trial?

AmgenIndustry Sponsor
1,355 Previous Clinical Trials
1,384,027 Total Patients Enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
554 Previous Clinical Trials
32,867 Total Patients Enrolled
Ivana Gojo, MDStudy ChairJohns Hopkins University
2 Previous Clinical Trials
99 Total Patients Enrolled

Media Library

Blinatumomab Clinical Trial Eligibility Overview. Trial Name: NCT03114865 — Phase 1 & 2
Acute Lymphoblastic Leukemia Research Study Groups: Post-alloHSCT Maintenance
Acute Lymphoblastic Leukemia Clinical Trial 2023: Blinatumomab Highlights & Side Effects. Trial Name: NCT03114865 — Phase 1 & 2
Blinatumomab 2023 Treatment Timeline for Medical Study. Trial Name: NCT03114865 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you provide a comprehensive overview of the research done with Blinatumomab?

"Presently, 586 trials for the Blinatumomab drug are in progress. Of those studies, 146 have reached Phase 3. The primary study location is Joliet, Illinois; however, these investigations have been conducted at 19 424 sites around the world."

Answered by AI

Are there any slots still available for potential participants in this trial?

"Affirmative, the details on clinicaltrials.gov confirm that this trial is actively accruing participants. This research project was initially posted online in September of 2017 and has been refreshed most recently on May 19th 2022."

Answered by AI

What is the cap on participants in this clinical research?

"Affirmative, clinicaltrials.gov has outlined that this trial is actively seeking participants. It was first uploaded to the website on September 5th 2017 and most recently modified on May 19th 2022. The two locations involved in recruiting require a combined total of 64 patients for completion."

Answered by AI

What are the predominant applications of Blinatumomab?

"Blinatumomab is an effective treatment for ophthalmia, sympathetic and a few other conditions such as branch retinal vein occlusion, eye inflammation, and macular edema."

Answered by AI
~7 spots leftby Jun 2025