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Cell Therapy

Blinatumomab + HCT for Acute Lymphoblastic Leukemia

Phase 2
Recruiting
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Karnofsky Performance Status ≥ 60% for patients 16 years and older and Lansky Play Score ≥ 60 for patients under 16 years of age
First remission with persistent disease identified as end of consolidation (EOC) MRD > 0.01%.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days +19, +91, +135 and +180 post-hct
Awards & highlights

Study Summary

This trial is testing whether a new treatment for leukemia, which uses cells from another person, followed by a different drug, can help reduce relapse rates and improve survival.

Who is the study for?
This trial is for young people (≤25 years) with high-risk B-cell acute lymphoblastic leukemia. They must be in remission or have very-high risk biology ALL and an available donor for a stem cell transplant. Participants need good organ function, controlled seizures if present, no active infections or GVHD, and agree to use contraception.Check my eligibility
What is being tested?
The study tests alpha/beta T-cell and B-cell depleted hematopoietic cell transplantation followed by blinatumomab therapy to see if it can lower relapse rates and improve survival in patients with high-risk B-ALL while reducing treatment side effects.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system's response to the treatments, which could affect various organs. Specific side effects are not listed but would relate to the interventions used: HCT procedure and blinatumomab therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can care for myself but may not be able to do active work or play.
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My cancer is in its first remission but still shows minimal signs of disease.
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My B-ALL is in remission with no detectable disease in my bone marrow.
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I have not had brain or spinal radiation during this study, and it's been over 90 days since my last radiation if I ever had any.
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I am 25 years old or younger.
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I am in remission after my first or later relapse.
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My ALL is high-risk and I'm going for a stem cell transplant in my first remission.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days +19, +91, +135 and +180 post-hct
This trial's timeline: 3 weeks for screening, Varies for treatment, and days +19, +91, +135 and +180 post-hct for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of patients who are able to receive the blinatumomab infusion [Feasibility]
Secondary outcome measures
Acute & Chronic GVHD
Cumulative incidence of treatment-related adverse events [Tolerability]
Disease Free Survival
+9 more
Other outcome measures
Analysis of immune cell phenotyping
Functional assessment of lymphocyte subsets
Serum cytokine analysis

Side effects data

From 2022 Phase 3 trial • 111 Patients • NCT02393859
80%
Pyrexia
43%
Nausea
37%
Headache
31%
Vomiting
24%
Anaemia
22%
Diarrhoea
20%
Stomatitis
17%
Mucosal inflammation
13%
Abdominal pain
13%
Rash
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%
Herpes virus infection
2%
Haematoma
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

2Treatment groups
Experimental Treatment
Group I: Alpha/beta T-cell and B-cell Depleted, Reduced Intensity HCTExperimental Treatment2 Interventions
Patients who are MRD Negative by Flow cytometry and are MRD Negative by High Throughput Sequencing, will receive a reduced intensity conditioning regimen followed by an alpha/beta T-cell and B-cell depleted transplant. They will also receive a 28 day continuous infusion of blinatumomab starting on Day 100 post-transplant in the absence of significant ongoing GVHD.
Group II: Alpha/beta T-cell and B-cell Depleted, Myeloablative HCTExperimental Treatment2 Interventions
Patients who are MRD Negative by Flow cytometry but are MRD Positive by High Throughput Sequencing, will receive a myeloablative conditioning regimen which includes total body irradiation (TBI) followed by an alpha/beta T-cell and B-cell depleted transplant. They will also receive a 28 day continuous infusion of blinatumomab starting on Day 100 post-transplant in the absence of significant ongoing GVHD.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blinatumomab
FDA approved

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonOTHER
1,189 Previous Clinical Trials
3,169,521 Total Patients Enrolled
Medical College of WisconsinLead Sponsor
610 Previous Clinical Trials
1,162,688 Total Patients Enrolled
AmgenIndustry Sponsor
1,371 Previous Clinical Trials
1,378,193 Total Patients Enrolled

Media Library

Alpha/Beta T-cell and B-cell depleted HCT (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04746209 — Phase 2
Acute Lymphoblastic Leukemia Clinical Trial 2023: Alpha/Beta T-cell and B-cell depleted HCT Highlights & Side Effects. Trial Name: NCT04746209 — Phase 2
Alpha/Beta T-cell and B-cell depleted HCT (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04746209 — Phase 2
Acute Lymphoblastic Leukemia Research Study Groups: Alpha/beta T-cell and B-cell Depleted, Myeloablative HCT, Alpha/beta T-cell and B-cell Depleted, Reduced Intensity HCT

Frequently Asked Questions

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

What is the patient population for this experiment?

"That is correct, the listing on clinicaltrials.gov makes it clear that this study is actively looking for participants. The trial was originally posted on February 1st, 2021 and has since been edited September 12th, 2021. Currently, the plan is to have 25 patients at a single site."

Answered by AI

Are researchers looking for participants in this clinical trial right now?

"Yes, this trial is still open and accepting patients. It was first posted on February 1st, 2021 with the most recent update being September 12th, 2021."

Answered by AI

When did the FDA give Blinatumomab the okay for public consumption?

"While there is some data supporting Blinatumomab's safety, none of it indicates that the medication is effective. As such, it received a score of 2."

Answered by AI

Are there any precedent studies involving Blinatumomab?

"As of right now, 47 clinical trials are being conducted to study Blinatumomab. 10 of those trials are currently in Phase 3. Although the majority of research studies for Blinatumomab are located in Baltimore, Maryland, there are 2492 total locations running these investigations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Blinatumomab After TCR Alpha Beta/CD19 Depleted HCT
Rachel Phelan 2021. "Blinatumomab After TCR Alpha Beta/CD19 Depleted HCT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04746209.
~6 spots leftby Apr 2025
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