← Back to Search

Alkylating agents

Chemotherapy + Immunotherapy for Acute Lymphoblastic Leukemia

Q: 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.

Q: 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.

Q: What medical conditions does Blinatumomab typically treat?

Merkel cell <a href="https://www.withpower.com/clinical-trials/cancer">cancer</a> is most frequently treated with Blinatumomab. However, this medication can also be used to effectively target <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a>, synovitis, and scalp structure.

Q: 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 <a href="https://www.withpower.com/clinical-trials/acute-lymphoblastic-leukemia">acute lymphoblastic leukemia</a>. 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 <a href="https://www.withpower.com/clinical-trials/oncology">Oncology</a> Group (ECOG)-American College of Radiation Imaging Network (ACRIN) Leukemia Translational Research Laboratory (LTRL) and reported to the institution, INDUCTION ELIGIBILITY CR

Q: 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.

Q: 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, <a href="https://www.withpower.com/clinical-trials/montana">Montana</a>.

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

Select...

My blood tests show I am in remission from cancer.

Select...

My bilirubin levels are less than 1.5 times the upper limit.

Select...

My kidney function, measured by creatinine, is within the normal range.

Select...

My bone marrow sample will be tested for minimal residual disease.

Select...

I can care for myself but may not be able to do heavy physical work.

Select...

I am between 30 and 70 years old.

Select...

My leukemia diagnosis was confirmed through specific blood tests.

Select...

My tests show I do not have the Philadelphia chromosome in my cancer cells.

Select...

I can care for myself after initial cancer treatment.

Select...

My cancer responded completely to the initial treatment.

Select...

I can care for myself but may not be able to do heavy physical work.

Select...

I can care for myself and am up and about more than 50% of my waking hours.

Select...

My blood tests show I am currently in remission.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

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

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

Neutropenia

Tremor

Epistaxis

Constipation

Neutrophil count decreased

Agitation

White blood cell count decreased

Immunodeficiency

Hypervolaemia

Alanine aminotransferase increased

Anal inflammation

Cough

Thrombocytopenia

Abdominal pain upper

Petechiae

Fluid overload

Decreased appetite

Fatigue

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

Engraftment syndrome

Nervous system disorder

Oral pain

Klebsiella infection

Herpes virus infection

Haematoma

Complication associated with device

Perineal cellulitis

Catheter placement

Accidental overdose

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

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

Lumbar Puncture

2016

Completed Phase 3

~510

Methotrexate

2013

Completed Phase 4

~3800

Pegaspargase

2005

Completed Phase 3

~9010

Cytarabine

2016

Completed Phase 3

~3310

Allogeneic Hematopoietic Stem Cell Transplantation

2012

Completed Phase 2

~1200

Biospecimen Collection

2004

Completed Phase 2

~1700

Bone Marrow Aspiration

2011

Completed Phase 2

~1740

Bone Marrow Biopsy

2021

Completed Phase 2

~10

Cyclophosphamide

1995

Completed Phase 3

~3770

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

Mercaptopurine

2012

Completed Phase 4

~12330

Prednisone

2014

Completed Phase 4

~2370

Rituximab

1999

Completed Phase 4

~1880

Vincristine

2003

Completed Phase 4

~2910

Vincristine Sulfate

2005

Completed Phase 3

~10150

Blinatumomab

2014

Completed Phase 3

~1210

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,687 Previous Clinical Trials

40,929,883 Total Patients Enrolled

Canadian Cancer Trials GroupNETWORK

126 Previous Clinical Trials

67,554 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