← Back to Search

Chemotherapy

Imatinib + Chemotherapy for Acute Lymphoblastic Leukemia

Phase 3

Recruiting

Led By Prof. Andrea Biondi

Research Sponsored by Children's Oncology Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ph+ patients must have previously started Induction therapy with specific medications

ABL-class fusion patients must have definitive evidence of ABL-class fusions involving specific genes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial is studying the combination of imatinib mesylate with two different chemotherapy regimens to treat patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia.

Who is the study for?

This trial is for patients up to 21 years old with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (ALL) or similar ABL-class fusion positive ALL. They must have started standard induction therapy but not received more than 14 days of it, and their organ functions should meet specific criteria. Excluded are those with chronic myelogenous leukemia, previous cancer treated with cytotoxic chemotherapy, uncontrolled infections or illnesses requiring intensive support, Down syndrome, pregnancy or breastfeeding women, and those unwilling to use contraception.Check my eligibility

What is being tested?

The study tests imatinib mesylate combined with two different chemotherapy regimens in treating new cases of Philadelphia chromosome positive ALL. It aims to determine if a less intense chemo regimen can be as effective as a stronger one when paired with imatinib but cause fewer side effects. The effectiveness of this combination is also being tested on another group with ABL-class fusion positive ALL.See study design

What are the potential side effects?

Potential side effects include reactions from the drug combination such as nausea, vomiting, hair loss, increased risk of infection due to lowered blood cell counts, heart problems like changes in rhythm or function; liver issues indicated by elevated bilirubin levels; kidney dysfunction; and general symptoms like fatigue.

Eligibility Criteria

Inclusion Criteria

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

Select...

I started treatment with specific drugs for my Ph+ condition.

Select...

My cancer has a confirmed ABL-class gene fusion.

Select...

I was diagnosed with ALL between the ages of 1 and 21.

Select...

My cancer has a specific genetic change known as BCR-ABL1.

Select...

My kidney function is normal or near normal.

Select...

I have Ph+ condition and received less than 14 days of initial multiagent therapy.

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

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

Disease free survival (DFS) of Randomized Arms (standard risk [SR] Philadelphia chromosome [Ph+] acute lymphoblastic leukemia [ALL] patients)

Secondary outcome measures

DFS on Randomized Arms (SR Ph+ ALL and ABL-class fusion positive patients)

EFS of all Ph+ patients

EFS of all eligibility ABL-class fusion positive ALL patients

+8 more

Other outcome measures

Adherence to imatinib mesylate after allogeneic HSCT in high risk Ph+ ALL patients

Adherence to oral chemotherapeutic agents in standard risk Ph+ ALL patients

Frequency of p190 and p210 BCR-ABL1 fusion variants

+6 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)Experimental Treatment23 Interventions

See Detailed Description

Group II: Arm B (imatinib mesylate, COG/BFM chemotherapy)Experimental Treatment17 Interventions

See Detailed Description.

Group III: Arm A (imatinib mesylate, EsPhALL chemotherapy)Experimental Treatment22 Interventions

See Detailed Description

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Allogeneic Hematopoietic Stem Cell Transplantation

2012

Completed Phase 2

~1200

Cyclophosphamide

1995

Completed Phase 3

~3770

Cytarabine

2016

Completed Phase 3

~3310

Dexamethasone

2007

Completed Phase 4

~2590

Methotrexate

2013

Completed Phase 4

~3800

Dexrazoxane Hydrochloride

2013

Completed Phase 1

~50

Vincristine Sulfate

2005

Completed Phase 3

~10110

Imatinib Mesylate

2003

Completed Phase 4

~800

Pegaspargase

2005

Completed Phase 3

~9010

Therapeutic Hydrocortisone

2012

Completed Phase 3

~340

Etoposide

2010

Completed Phase 3

~2440

Prednisolone

2005

Completed Phase 4

~2720

Leucovorin Calcium

2011

Completed Phase 3

~12310

Methylprednisolone

2015

Completed Phase 4

~2280

Doxorubicin

2012

Completed Phase 3

~7940

Daunorubicin Hydrochloride

2011

Completed Phase 3

~5070

Mercaptopurine

2012

Completed Phase 4

~12330

Thioguanine

2012

Completed Phase 4

~10830

Filgrastim

2000

Completed Phase 3

~3670

Ifosfamide

2010

Completed Phase 4

~2980

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

EsPhALL Network/ BFM Study GroupUNKNOWN

EsPhALL network I-BFM Study GroupUNKNOWN

Children's Oncology GroupLead Sponsor

454 Previous Clinical Trials

237,465 Total Patients Enrolled

Media Library

Calaspargase Pegol (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03007147 — Phase 3

Acute Lymphoblastic Leukemia Research Study Groups: Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT), Arm A (imatinib mesylate, EsPhALL chemotherapy), Arm B (imatinib mesylate, COG/BFM chemotherapy)

Acute Lymphoblastic Leukemia Clinical Trial 2023: Calaspargase Pegol Highlights & Side Effects. Trial Name: NCT03007147 — Phase 3

Calaspargase Pegol (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03007147 — Phase 3

Frequently Asked Questions

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

What is the standard treatment for Arm A (imatinib mesylate, EsPhALL chemotherapy)?

"synovitis is often treated with Arm A (imatinib mesylate, EsPhALL chemotherapy). However, Arm A (imatinib mesylate, EsPhALL chemotherapy) is also effective in other areas such as proctitis, scalp structure, and prostate cancer."

Answered by AI

Has the FDA cleared Arm A (imatinib mesylate, EsPhALL chemotherapy) for patient use?

"Arm A of this study, which is a combination of imatinib mesylate and EsPhALL chemotherapy, has received a score of 3 for safety. This means that there is both some evidence supporting efficacy and multiple rounds data affirming its safety."

Answered by AI

What does this study aim to learn or prove?

"The key metric that will be used to assess the success of this study is Disease free survival (DFS), which will be evaluated over a period of up to 3 years. Secondary outcomes include OS of standard risk patients, Feasibility of post hematopoietic stem cell transplantation (HSCT) imatinib mesylate administration after allogenic HSCT in high risk Ph+ ALL patients, and OS of SR Ph+ patients by randomization group."

Answered by AI

How many medical facilities are hosting this research project?

"100 different hospitals and medical centres are participating in this trial, with notable locations being Bronson Methodist Hospital in Kalamazoo, Carolinas Medical Center/Levine Cancer Institute in Charlotte, Massachusetts General Hospital Cancer Center in Boston."

Answered by AI

How can I sign up to help researchers with this project?

"This study is looking for 475 participants between the ages of 1 and 21 who have acute lymphoblastic leukemia. In order to be eligible, participants must meet the following criteria: -They must be willing to have diagnostic samples collected and analyzed according to procedures set by the National front-line protocol. -Patients should be enrolled on National ALL protocol prior to enrollment on EsPhALL2017/COGAALL1631. Regardless of initial front-line protocol baseline diagnostic samples must be available to develop an MRD probe. -BCR-ABL1 fusion (Ph+): newly diagnosed ALL"

Answered by AI

Are there any other trials that have looked at Arm A specifically (imatinib mesylate, EsPhALL chemotherapy)?

"As of now, 2536 different clinical trials are underway studying Arm A (imatinib mesylate, EsPhALL chemotherapy). Of these active studies, 594 have progressed to Phase 3. Most of the research for Arm A (imatinib mesylate, EsPhALL chemotherapy) is conducted in Duarte, California; however, 85968 total locations across the globe are running trials for this treatment."

Answered by AI