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Monoclonal Antibodies

Blinatumomab + Chemotherapy/Dasatinib for Acute Lymphoblastic Leukemia

Phase 2
Waitlist Available
Led By Anjali S Advani
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 must not have systemic fungal, bacterial, viral, or other uncontrolled infections
Patients must not have CTCAE >= grade 2 neuropathy within 14 days prior to registration
Must not have
Patients with Burkitt's (L3) are excluded
Patients with CNS3 are excluded from the trial
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of treatment and follow up until death or date of primary analysis (about 7.5 years)
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying the side effects and efficacy of blinatumomab and combination chemotherapy or dasatinib and prednisone in treating older patients with acute lymphoblastic leukemia.

Who is the study for?
This trial is for older patients (65+) with acute lymphoblastic leukemia (ALL), including those with Philadelphia chromosome positive ALL or Ph-like DSMKF. It's suitable for newly diagnosed, relapsed, or refractory cases. Participants must have a certain percentage of lymphoblasts in blood/marrow and be able to provide consent for immunogenicity testing. Exclusions include CNS3 status, Burkitt's leukemia, prior significant treatments for ALL within specific time frames before registration, uncontrolled infections, and other serious health conditions.
What is being tested?
The trial tests blinatumomab combined with chemotherapy drugs like prednisone and vincristine versus dasatinib plus prednisone and blinatumomab in treating older adults with ALL. Blinatumomab is an immunotherapy that may help the immune system attack cancer cells while dasatinib targets enzymes needed by cancer cells to grow.
What are the potential side effects?
Potential side effects include reactions related to the immune system's response to treatment which can affect organ function; infusion-related reactions; fatigue; digestive issues such as nausea or diarrhea; blood disorders like low counts of various types of blood cells leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have any ongoing serious infections.
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I have not had severe nerve pain or damage in the last 2 weeks.
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My blood or bone marrow has at least 20% lymphoblasts indicating acute lymphoblastic leukemia.
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I do not have any significant brain or nervous system disorders.
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I haven't had monoclonal antibody therapy in the last 42 days.
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My kidney function is normal, with a creatinine level at or below 1.5 mg/dl.
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My cancer has not spread to my testicles.
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I have been diagnosed with a type of leukemia called precursor B cell ALL.
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My leukemia is either Philadelphia chromosome positive or negative.
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I have not had any treatment for acute lymphoblastic leukemia.
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I can take care of myself and am up and about more than 50% of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have Burkitt's lymphoma.
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I do not have CNS3 condition.
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I have never had a stem cell transplant.
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I do not have fluid buildup around my heart, in my abdomen, or in my lungs.
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I am not taking any proton pump inhibitors.
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My heart pumps well, with an ejection fraction of 45% or higher.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of treatment and follow up until death or date of primary analysis (about 7.5 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of treatment and follow up until death or date of primary analysis (about 7.5 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Dose-limiting Toxicity (Cohort II)
Overall Survival Rate (Cohort I)
Secondary study objectives
Anti-idiotype Antibody Development
Complete Response Rate (Cohort I)
Disease-free Survival (Cohort II)
+4 more

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%
Platelet count decreased
13%
Rash
13%
Hypertension
11%
Erythema
11%
Pruritus
11%
Hypokalaemia
11%
Hypogammaglobulinaemia
11%
Hypotension
9%
Neutropenia
9%
Epistaxis
9%
Tremor
9%
Constipation
9%
Neutrophil count decreased
7%
White blood cell count decreased
7%
Alanine aminotransferase increased
7%
Immunodeficiency
7%
Agitation
7%
Hypervolaemia
7%
Anal inflammation
7%
Cough
7%
Thrombocytopenia
7%
Abdominal pain upper
7%
Petechiae
7%
Fluid overload
6%
Back pain
6%
Rash maculo-papular
6%
Paronychia
6%
Decreased appetite
6%
Fatigue
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%
Oral pain
2%
Engraftment syndrome
2%
Herpes virus infection
2%
Blood immunoglobulin G decreased
2%
Complication associated with device
2%
Nervous system disorder
2%
Klebsiella infection
2%
Perineal cellulitis
2%
Accidental overdose
2%
Haematoma
2%
Neurological examination abnormal
2%
Catheter placement
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort II (dasatinib, prednisone, blinatumomab)Experimental Treatment11 Interventions
See Detailed Description
Group II: Cohort I (blinatumomab, POMP)Experimental Treatment15 Interventions
See Detailed Description
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~2030
Bone Marrow Aspiration and Biopsy
2016
Completed Phase 1
~40
Computed Tomography
2017
Completed Phase 2
~2790
Echocardiography
2013
Completed Phase 4
~11580
Lumbar Puncture
2016
Completed Phase 3
~510
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Biopsy
2014
Completed Phase 4
~1150
Blinatumomab
2014
Completed Phase 3
~1230
Mercaptopurine
2012
Completed Phase 4
~13290
Methotrexate
2019
Completed Phase 4
~4400
Methotrexate Sodium
2021
Completed Phase 1
~20
Prednisone
2014
Completed Phase 4
~2500
Vincristine
2003
Completed Phase 4
~2970
Vincristine Sulfate
2005
Completed Phase 3
~10270
Dasatinib
2012
Completed Phase 3
~2320

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,957 Previous Clinical Trials
41,112,034 Total Patients Enrolled
Anjali S AdvaniPrincipal InvestigatorSWOG Cancer Research Network
1 Previous Clinical Trials
39 Total Patients Enrolled

Media Library

Blinatumomab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02143414 — Phase 2
Acute Lymphoblastic Leukemia Research Study Groups: Cohort I (blinatumomab, POMP), Cohort II (dasatinib, prednisone, blinatumomab)
Acute Lymphoblastic Leukemia Clinical Trial 2023: Blinatumomab Highlights & Side Effects. Trial Name: NCT02143414 — Phase 2
Blinatumomab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02143414 — Phase 2
~5 spots leftby Dec 2025
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