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Anti-metabolites

Azacitidine + Chemotherapy for Acute Lymphoblastic Leukemia

Phase 2

Waitlist Available

Led By Erin M Guest

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

Infants must be > 36 weeks gestational age at the time of enrollment

Central nervous system (CNS) status must be determined based on a sample obtained prior to the administration of any systemic or intrathecal chemotherapy, with the exception of steroid pretreatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up five years

Awards & highlights

Study Summary

This trial is testing azacitidine in combination with chemotherapy to see if it is more effective in treating infants with acute lymphoblastic leukemia who have KMT2A gene rearrangement.

Who is the study for?

This trial is for infants over 36 weeks gestational age with newly diagnosed B lymphoblastic leukemia or acute leukemia of ambiguous lineage, without Down syndrome or prior malignancies treated with cytotoxic chemotherapy. They must not have received previous cancer treatments, except certain steroids and intrathecal drugs.Check my eligibility

What is being tested?

The trial tests the side effects of azacitidine combined with other chemotherapy drugs in treating infant leukemia with KMT2A gene rearrangement. It aims to see if using multiple drugs can more effectively kill cancer cells by working together in different ways.See study design

What are the potential side effects?

Potential side effects include damage to healthy cells leading to low blood counts, increased risk of infections, nausea, vomiting, hair loss, mouth sores, and potential harm to organs from drug toxicity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My baby was born after 36 weeks of pregnancy.

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My CNS status was checked before any major cancer treatment, except steroids.

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My leukemia is newly diagnosed and falls under B lymphoblastic or mixed phenotype.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ five years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~five years

This trial's timeline: 3 weeks for screening, Varies for treatment, and five 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

Tolerability of Azacitidine in Combination With Interfant-06 Standard Chemotherapy in Evaluable Infant Patients With Newly Diagnosed ALL With KMT2A Gene Rearrangement (KMT2A-R). KMT2A Gene Rearrangement (KMT2A-R)

Secondary outcome measures

Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 1 Prior to First Course of Azacitidine

Azacitidine

+1 more

Other outcome measures

Event-free Survival (EFS)

Expansion of Infant T Lymphocytes by Stimulation With Artificial Antigen Presenting Cells

Minimal Residual Disease (MRD)

+2 more

Side effects data

From 2021 Phase 1 & 2 trial • 24 Patients • NCT03010358

65%

Infusion related reaction

59%

Neutrophil count decreased

41%

Upper respiratory infection

29%

Aspartate aminotransferase increased

29%

Platelet count decreased

24%

Alanine aminotransferase increased

18%

Sinusitis

18%

Urinary tract infection

12%

Tooth infection

Bronchial infection

Acute Coronary Syndrome

Febrile neutropenia

Sepsis

Infections and infestations - Other, specify

Nail infection

Rhinitis infective

Tumor lysis syndrome

Infusion Related Reaction

Wound infection

100%

80%

60%

40%

20%

Study treatment Arm

Phase 2 and MTD (800 mg Entospletinib Daily)

Phase 1, Dose 1 (400 mg Entospletinib Daily)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (azacitidine, combination chemotherapy)Experimental Treatment18 Interventions

See Detailed Description

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cytarabine

2016

Completed Phase 3

~3310

Thioguanine

2012

Completed Phase 4

~10830

Vincristine

2003

Completed Phase 4

~2910

Azacitidine

2012

Completed Phase 3

~1440

Leucovorin

2005

Completed Phase 4

~5730

Methotrexate

2013

Completed Phase 4

~3800

Leucovorin Calcium

2011

Completed Phase 3

~12290

Cyclophosphamide

1995

Completed Phase 3

~3780

Daunorubicin

2013

Completed Phase 4

~4940

Dexamethasone

2007

Completed Phase 4

~2590

Pegaspargase

2005

Completed Phase 3

~9010

Prednisolone

2005

Completed Phase 4

~2720

Vincristine Sulfate

2005

Completed Phase 3

~10110

Daunorubicin Hydrochloride

2011

Completed Phase 3

~5070

Hydrocortisone Sodium Succinate

2008

Completed Phase 3

~70

Mercaptopurine

2012

Completed Phase 4

~12330

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,075 Total Patients Enrolled

Erin M GuestPrincipal InvestigatorChildren's Oncology Group

Media Library

Azacitidine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT02828358 — Phase 2

Acute Leukemia Research Study Groups: Treatment (azacitidine, combination chemotherapy)

Acute Leukemia Clinical Trial 2023: Azacitidine Highlights & Side Effects. Trial Name: NCT02828358 — Phase 2

Azacitidine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02828358 — Phase 2

Frequently Asked Questions

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

What do people typically use Pharmacological Study for?

"Multiple myeloma is commonly treated with pharmacological agents. These drugs can also be effective at treating other conditions such as eye disease, subarachnoid blockage, and solid organ rejection."

Answered by AI

How many individuals are being welcomed into this clinical research program?

"Unfortunately, this particular trial is not currently recruiting patients. The listing was posted on March 27th, 2017 and updated as recently as October 7th, 2022. However, there are 1565 other clinical trials actively looking for leukemia patients and 2361 trials testing new drugs that are still enrolling participants."

Answered by AI

Can people join this clinical trial at present?

"No, this study is no longer recruiting patients. The trial was originally posted on March 27th, 2017 and the most recent update was on October 7th, 2022. If you are interested in other studies, there are 1565 trials for leukemia, lymphocytic, acute, l1 and 2361 Pharmacological Studies currently looking for participants."

Answered by AI

Could you please tell us more about the potential risks of this medication?

"There is some data supporting the safety of the drugs under study, but none indicating whether or not they are effective. As such, we have given it a score of 2."

Answered by AI

What goals does this research project aim to achieve?

"The primary aim of this study, which will follow patients for approximately 6 months, is to measure the tolerability of azacitidine in combination with Interfant-06 standard chemotherapy in 30 evaluable infant patients with newly diagnosed ALL with KMT2A gene rearrangement (KMT2A-R). Other objectives include assessing Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 5 of Second Course of Azacitidine which is defined as Will calculate the percentage of CpG site"

Answered by AI

Are there other drugs that have been studied in a similar way to the one being proposed?

"This Pharmacological Study was first conducted in 1995 at the National Institutes of Health Clinical Center. So far, 4787 clinical trials have completed with 2361 more currently recruiting patients. A large number of these studies are based out of Syracuse, New york."

Answered by AI

In how many different medical facilities is this research project being conducted today?

"State University of New york Upstate Medical University in Syracuse, New York, Cardinal Glennon Children's Medical Center in Saint Louis, Missouri, and Southern Illinois University School of Medicine in Springfield, Illinois are just some of the locations where this study is taking place. In total, there are 100 research sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Azacitidine and Combination Chemotherapy in Treating Infants With Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement

2017. "Azacitidine and Combination Chemotherapy in Treating Infants With Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02828358.

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