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Alkylating agents

Chemotherapy + Immunotherapy for Acute Lymphoblastic Leukemia

Phase 3
Waitlist Available
Led By Mark R Litzow
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 have maintained peripheral blood evidence of a remission and must have a CR or CRi for randomization or assignment to blinatumomab or no blinatumomab
Direct or total bilirubin < 1.5 x ULN for randomization or assignment to blinatumomab or no blinatumomab
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights

Study Summary

This trial is testing a new chemotherapy treatment for leukemia that includes an immunotherapy drug.

Who is the study for?
Adults aged 30-70 with a new diagnosis of BCR-ABL-negative B lineage acute lymphoblastic leukemia (ALL) are eligible. They must have normal kidney and liver function, not be pregnant or breastfeeding, use contraception if necessary, and have no recent severe heart issues. HIV-positive patients can join under certain conditions.Check my eligibility
What is being tested?
The trial is testing whether adding the immunotherapy drug Blinatumomab to standard combination chemotherapy improves outcomes in treating newly diagnosed ALL compared to chemotherapy alone.See study design
What are the potential side effects?
Chemotherapy may cause nausea, hair loss, fatigue, increased infection risk, and organ damage. Blinatumomab might lead to immune system reactions like fever or difficulty breathing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood tests show I am in remission from cancer.
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My bilirubin levels are less than 1.5 times the upper limit.
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My kidney function, measured by creatinine, is within the normal range.
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My bone marrow sample will be tested for minimal residual disease.
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I can care for myself but may not be able to do heavy physical work.
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I am between 30 and 70 years old.
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My leukemia diagnosis was confirmed through specific blood tests.
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My tests show I do not have the Philadelphia chromosome in my cancer cells.
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I can care for myself after initial cancer treatment.
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My cancer responded completely to the initial treatment.
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I can care for myself but may not be able to do heavy physical work.
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I can care for myself and am up and about more than 50% of my waking hours.
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My blood tests show I am currently in remission.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 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
Secondary outcome measures
Incidence of adverse events
Minimal residual disease (MRD) status
Relapse-free survival
Other outcome measures
Identification and characterization of the BCR/ABL1-like phenotype

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

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (blinatumomab, chemotherapy)Experimental Treatment20 Interventions
See Detailed Description
Group II: Arm II (chemotherapy)Active Control19 Interventions
See Detailed Description
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
2016
Completed Phase 3
~3310
Pegaspargase
2005
Completed Phase 3
~9010
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1200
Biospecimen Collection
2004
Completed Phase 2
~1920
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Cyclophosphamide
1995
Completed Phase 3
~3780
Daunorubicin
2013
Completed Phase 4
~4940
Daunorubicin Hydrochloride
2011
Completed Phase 3
~5070
Dexamethasone
2007
Completed Phase 4
~2590
Etoposide
2010
Completed Phase 3
~2440
Lumbar Puncture
2016
Completed Phase 3
~510
Mercaptopurine
2012
Completed Phase 4
~12330
Methotrexate
2013
Completed Phase 4
~3800
Prednisone
2014
Completed Phase 4
~2370
Rituximab
1999
Completed Phase 4
~1880
Vincristine
2003
Completed Phase 4
~2920
Vincristine Sulfate
2005
Completed Phase 3
~10120
Blinatumomab
2014
Completed Phase 3
~1140

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,609 Previous Clinical Trials
40,915,158 Total Patients Enrolled
Canadian Cancer Trials GroupNETWORK
122 Previous Clinical Trials
66,664 Total Patients Enrolled
Mark R LitzowPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02003222 — Phase 3
Acute Lymphoblastic Leukemia Research Study Groups: Arm II (chemotherapy), Arm I (blinatumomab, chemotherapy)
Acute Lymphoblastic Leukemia Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT02003222 — Phase 3
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02003222 — Phase 3

Frequently Asked Questions

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

Has the FDA given Blinatumomab the green light?

"There is some evidence, from both this Phase 3 trial and others, that Blinatumomab is effective and safe."

Answered by AI

Is this research project only looking for participants who are under 40 years old?

"The ideal participants for this study will be between the ages of 30 and 70."

Answered by AI

What medical conditions does Blinatumomab typically treat?

"Merkel cell cancer is most frequently treated with Blinatumomab. However, this medication can also be used to effectively target leukemia, synovitis, and scalp structure."

Answered by AI

Could I inquire about the requirements to take part in this research project?

"This trial is looking for 488 patients aged between 30 and 70 that have been diagnosed with acute lymphoblastic leukemia. Most notably, applicants are required to meet the following criteria: PRE-REGISTRATION, Diagnostic bone marrow and peripheral blood specimens must be submitted for immunophenotyping and selected molecular testing, and the establishment of BCR/ABL status; testing will be performed by the Eastern Cooperative Oncology Group (ECOG)-American College of Radiation Imaging Network (ACRIN) Leukemia Translational Research Laboratory (LTRL) and reported to the institution, INDUCTION ELIGIBILITY CR"

Answered by AI

Are people with this condition still able to join the research project?

"According to the most recent update on clinicaltrials.gov, this particular trial is not currently looking for participants. It was initially posted on December 23rd, 2013 but was last updated on September 15th, 2022. Although this study is not presently recruiting, there are 3,816 other trials that are."

Answered by AI

Is Blinatumomab a new drug on the market?

"Blinatumomab has a long clinical history, with the first study being conducted in 1993 at the National Institutes of Health Clinical Center. There have been a total of 4524 completed studies on this medication. Additionally, there are 2273 clinical trials actively recruiting patients which are located in many places, including Anaconda, Montana."

Answered by AI
~45 spots leftby Mar 2025