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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
Must not have
Patients with secondary B acute lymphoblastic leukemia (B-ALL) that developed after treatment of a prior malignancy with cytotoxic chemotherapy
Patients with known absence of KMT2A-rearrangement leukemia prior to enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up five years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My B-ALL developed after chemotherapy for another cancer.
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My leukemia does not have the KMT2A rearrangement.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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
Azacitidine
+1 more
Other study objectives
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
33%
Infusion Related Reaction
33%
Alanine aminotransferase increased
33%
Aspartate aminotransferase increased
33%
Neutrophil count decreased
17%
Sinusitis
17%
Tumor Lysis Syndrome
17%
Interoperative Hemorrhage
17%
Platelet count decreased
17%
Febrile neutropenia
17%
Infusion related reaction
17%
Upper respiratory infection
17%
Otitis externa
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1, Dose 1 (400 mg Entospletinib Daily)
Phase 2 and MTD (800 mg Entospletinib Daily)

Awards & Highlights

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

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
Azacitidine
2012
Completed Phase 3
~1440
Cyclophosphamide
2010
Completed Phase 4
~2310
Cytarabine
2016
Completed Phase 3
~3330
Daunorubicin
2013
Completed Phase 4
~5040
Daunorubicin Hydrochloride
2011
Completed Phase 3
~5330
Dexamethasone
2007
Completed Phase 4
~2650
Hydrocortisone Sodium Succinate
2008
Completed Phase 3
~70
Leucovorin
2005
Completed Phase 4
~6010
Leucovorin Calcium
2011
Completed Phase 3
~12500
Methotrexate
2019
Completed Phase 4
~4400
Pegaspargase
2005
Completed Phase 3
~9260
Prednisolone
2005
Completed Phase 4
~3570
Thioguanine
2012
Completed Phase 4
~10830
Vincristine
2003
Completed Phase 4
~2970
Vincristine Sulfate
2005
Completed Phase 3
~10270
Mercaptopurine
2012
Completed Phase 4
~12550

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,906 Previous Clinical Trials
41,011,971 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
~9 spots leftby Nov 2025
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