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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

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

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ duration of treatment and follow up until death or date of primary analysis (about 7.5 years)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Dose-limiting Toxicity (Cohort II)

Overall Survival Rate (Cohort I)

Secondary outcome measures

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%

Rash

13%

Abdominal pain

13%

Platelet count decreased

13%

Hypertension

11%

Erythema

11%

Hypokalaemia

11%

Pruritus

11%

Hypogammaglobulinaemia

11%

Hypotension

Neutropenia

Tremor

Epistaxis

Constipation

Neutrophil count decreased

White blood cell count decreased

Immunodeficiency

Agitation

Hypervolaemia

Alanine aminotransferase increased

Anal inflammation

Cough

Thrombocytopenia

Abdominal pain upper

Petechiae

Fluid overload

Fatigue

Decreased appetite

Rash maculo-papular

Paronychia

Back pain

Nasopharyngitis

Febrile neutropenia

Urticaria

Fluid balance positive

Seizure

Oropharyngeal pain

Aplasia

Pain in extremity

Neurological symptom

Aspartate aminotransferase increased

Haematoma

Herpes virus infection

Klebsiella infection

Accidental overdose

Nervous system disorder

Perineal cellulitis

Catheter placement

Engraftment syndrome

Complication associated with device

Oral pain

Neurological examination abnormal

Blood immunoglobulin G decreased

Antithrombin III decreased

Laryngotracheitis obstructive

Pain

Hypertransaminasaemia

Rhinitis

Body temperature increased

100%

80%

60%

40%

20%

Study treatment Arm

Blinatumomab

HC3 Chemotherapy

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

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Echocardiography

2013

Completed Phase 4

~11670

Biospecimen Collection

2004

Completed Phase 2

~1730

Lumbar Puncture

2016

Completed Phase 3

~510

Computed Tomography

2017

Completed Phase 2

~2720

Biopsy

2014

Completed Phase 4

~850

Blinatumomab

2014

Completed Phase 3

~1210

Mercaptopurine

2012

Completed Phase 4

~12330

Methotrexate

2013

Completed Phase 4

~3800

Methotrexate Sodium

2021

Completed Phase 1

~20

Prednisone

2014

Completed Phase 4

~2370

Vincristine

2003

Completed Phase 4

~2910

Vincristine Sulfate

2005

Completed Phase 3

~10110

Dasatinib

2012

Completed Phase 3

~2320

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,100 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

Frequently Asked Questions

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

Under what circumstances is Blinatumomab most frequently prescribed?

"Blinatumomab can be utilized to treat pheochromocytomas, ulcerative colitis, and the varicella-zoster virus related retinal necrosis."

Answered by AI

Are there any open spots to enroll in this trial?

"Currently, this investigation is not taking on new participants. It was initially posted online in December of 2015 and revised most recently in September 2022. If you are searching for other trials involving B acute lymphoblastic leukemia with t(9;22) (q34.1; q11.2); bcr-abl1 there are currently 1497 available studies while 746 medical experiments related to Blinatumomab are actively recruiting patients at the moment."

Answered by AI

Where are the active sites of this trial taking place?

"This medical trial is presently running in a total of 100 different locations, with Effingham, Peoria and Wichita being amongst the most notable. To reduce travelling commitments for those who enrol, it is recommended that they choose the site closest to them."

Answered by AI

What is the maximum allowable enrollment for this clinical trial?

"At this juncture, this clinical trial is not currently recruiting. This research was originally posted on December 1st 2015 and last updated September 3rd 2022. For those looking for other trials, 1497 studies are enrolling individuals diagnosed with b acute lymphoblastic leukemia with t(9;22)(q34.1;q11.2); bcr-abl1 and 746 investigations related to Blinatumomab have open slots available for patient enrolment."

Answered by AI

What is the intended outcome of this clinical experiment?

"This clinical trial, lasting up to 42 days post-remission therapy, aims to evaluate overall survival in Cohort I as its primary outcome. Secondary outcomes include estimated 95% confidence intervals for the incidence of toxicity and minimal residual disease negativity which will be assessed descriptively within each cohort."

Answered by AI

Has Blinatumomab been cleared by the Food and Drug Administration?

"Our team at Power assigned a score of 2 to blinatumomab on the safety scale, as there is clinical evidence pointing to its security but none yet alluding to its efficacy."

Answered by AI

Has Blinatumomab been researched in other investigations?

"Blinatumomab was first tested in 2001 at UCSF Helen Diller Family Comprehensive Cancer Center and this has resulted in 2191 completed studies to date. Currently, 746 trials are underway with a significant number occurring near Effingham, Illinois."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia

2015. "Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02143414.

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