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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
ABL-class fusion patients must have definitive evidence of ABL-class fusions involving specific genes
Ph+ patients must have previously started Induction therapy with specific medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

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
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My cancer has a confirmed ABL-class gene fusion.
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I started treatment with specific drugs for my Ph+ condition.
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My cancer has a specific genetic change known as BCR-ABL1.
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I have Ph+ condition and received less than 14 days of initial multiagent therapy.
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I can take care of myself but may not be able to do heavy physical work.
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My kidney function is normal or near normal.
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I was diagnosed with ALL between the ages of 1 and 21.

Timeline

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
Methylprednisolone
2015
Completed Phase 4
~2270
Thioguanine
2012
Completed Phase 4
~10830
Daunorubicin Hydrochloride
2011
Completed Phase 3
~5070
Therapeutic Hydrocortisone
2012
Completed Phase 3
~340
Imatinib Mesylate
2003
Completed Phase 4
~770
Vincristine Sulfate
2005
Completed Phase 3
~10120
Cyclophosphamide
1995
Completed Phase 3
~3780
Cytarabine
2016
Completed Phase 3
~3440
Leucovorin Calcium
2011
Completed Phase 3
~12290
Methotrexate
2013
Completed Phase 4
~3800
Etoposide
2010
Completed Phase 3
~2440
Dexrazoxane Hydrochloride
2013
Completed Phase 1
~50
Pegaspargase
2005
Completed Phase 3
~9010
Dexamethasone
2007
Completed Phase 4
~2590
Mercaptopurine
2012
Completed Phase 4
~12330
Prednisolone
2005
Completed Phase 4
~2720
Doxorubicin
2012
Completed Phase 3
~7940
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1200
Filgrastim
2000
Completed Phase 3
~3670
Ifosfamide
2010
Completed Phase 4
~2980

Find a Location

Who is running the clinical trial?

EsPhALL network I-BFM Study GroupUNKNOWN
EsPhALL Network/ BFM Study GroupUNKNOWN
Children's Oncology GroupLead Sponsor
453 Previous Clinical Trials
236,700 Total Patients Enrolled

Media Library

Calaspargase Pegol (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03007147 — Phase 3
Acute Lymphoblastic Leukemia Research Study Groups: Arm A (imatinib mesylate, EsPhALL chemotherapy), Arm B (imatinib mesylate, COG/BFM chemotherapy), Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)
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

Would elderly citizens be allowed to participate in this research?

"This particular clinical trial is only open to individuals that are below the age of 21 and have already passed their first year."

Answered by AI
~169 spots leftby Sep 2027