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Anti-tumor antibiotic

Chemotherapy for Acute Lymphoblastic Leukemia

Q: What are the risks associated with Group II Arm B (VHR B-ALL - Exp Arm1) (CLOSED 02/15/2017)?

<p>Group II Arm B (VHR B-<a href="https://www.withpower.com/clinical-trials/all">ALL</a> - Exp Arm1) (CLOSED 02/15/2017) was given a safety score of 3. This is based on the fact that it is a Phase 3 trial, which suggests that there is some evidence to support its efficacy as well as data from multiple rounds supporting its safety.</p>

Q: What illness does Group II Arm B (VHR B-ALL - Exp Arm1) (CLOSED 02/15/2017) address?

<p>Group II Arm B (VHR B-<a href="https://www.withpower.com/clinical-trials/all">ALL</a> - Exp Arm1) (CLOSED 02/15/2017), which is typically used to treat synovitis, can also be applied to alleviate conditions such as scalp structure, <a href="https://www.withpower.com/clinical-trials/prostate-cancer">prostate cancer</a>, and <a href="https://www.withpower.com/clinical-trials/ulcerative-colitis">ulcerative colitis</a>.</p>

Phase 3

Waitlist Available

Led By Michael J Burke

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

White Blood Cell Count (WBC) Criteria: Age 1-9.99 years: WBC >= 50 000/uL, Age 10-30.99 years: Any WBC, Age 1-30.99 years: Any WBC with Testicular leukemia, CNS leukemia (CNS3), Steroid pretreatment, Patients must have newly diagnosed B lymphoblastic leukemia (2008 World Health Organization [WHO] classification) (also termed B-precursor acute lymphoblastic leukemia); patients with Down syndrome are also eligible, Organ function requirements for patients with Ph-like ALL and a predicted TKI-sensitive mutation: patients identified as Ph-like with a TKI-sensitive kinase mutation must have assessment of organ function performed within 3 days of study entry onto the dasatinib arm of AALL1131, Creatinine clearance or radioisotope glomerular filtration rate (GFR) > 70mL/min/1.73 m^2 or a serum creatinine based on age/gender, Direct bilirubin =< 3 x upper limit of normal (ULN) for age, Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 10 x upper limit of normal (ULN) for age, Shortening fraction >= 27% by echocardiogram, or ejection fraction >= 50% by gated radionuclide study, Patients must have an electrocardiogram (EKG) fewer than 6 days prior to enrollment on the dasatinib arm; patients who have had cardiac assessments by echocardiogram or radionuclide scan at the beginning of induction do not need to have these repeated prior to study entry; correct QT interval (QTc) < 450 msec on baseline electrocardiogram as measured by the Friderica or Bazett formula, No major conduction abnormality (unless a cardiac pacemaker is present), No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry > 94% at sea level if there is clinical indication for determination, Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled; however, drugs that induce CYP3A4/5 (carbamazepine, oxcarbazepine, phenytoin, primidone, phenobarbital) should be avoided, Eligibility criteria for the Longitudinal, Computerized Assessment of Neurocognitive Functioning study: Patients must be aged 6 to 13 years at time of B-ALL diagnosis, enrolled on AALL1131, Patients must be English-, French- or Spanish-speaking (languages in which the assessment is available), Patients must have no known history of neurodevelopmental disorder prior to diagnosis of B-ALL (e.g., Down syndrome, Fragile X, William's Syndrome, mental retardation), Patients must have no significant visual impairment that would prevent computer use and recognition of the visual test stimuli, Eligibility criteria for the National Cancer Institute (NCI) standard risk patients from AALL0932 enrolling on this study at the end of Induction: Effective March 19, 2018, patients enrolled on AALL0932, without Down syndrome, meeting the following criteria will NOT be eligible to continue on AALL0932 or the HR B-ALL stratum of this study at the end of Induction, Effective Amendment 6, patients enrolled on AALL0932, without Down syndrome, meeting the following criteria will NOT be eligible to continue on AALL0932 or the VHR stratum of AALL1131, Patients enrolled on AALL0932, with Down syndrome, meeting the following criteria will NOT be eligible to continue on AALL0932 but WILL BE eligible to enroll on the DS HR B-ALL stratum of this study at the end of Induction, All patients and/or their parents or legal guardians must sign a written informed consent, All institutional, Food and Drug Administration (FDA), and NCI requirements for human studies must be met

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

Study Summary

This trial will study combination chemotherapy in young patients with newly diagnosed B acute lymphoblastic leukemia that is likely to come back or spread, and in patients with Philadelphia chromosome (Ph)-like tyrosine kinase inhibitor (TKI) sensitive mutations.

Who is the study for?

This trial is for young patients with high-risk B acute lymphoblastic leukemia and specific mutations that make them sensitive to certain drugs. They must meet organ function requirements, have no major heart conduction issues, not be pregnant or breastfeeding, agree to use contraception if of childbearing potential, and cannot have received prior cytotoxic chemotherapy.Check my eligibility

What is being tested?

The study tests how well a combination of chemotherapy drugs works against aggressive B acute lymphoblastic leukemia in children and young adults. It includes various medications like Dasatinib and Dexamethasone among others, given in different doses and combinations to see which is most effective at killing cancer cells.See study design

What are the potential side effects?

Potential side effects from the treatments may include damage to organs due to drug toxicity, increased risk of infections, allergic reactions, nausea or vomiting from chemotherapy agents. Specific side effects will vary based on the particular combination of drugs administered.

Eligibility Criteria

Inclusion Criteria

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

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

DFS of Non-DS HR Post-induction Patients Receiving Intrathecal (IT) Methotrexate (MTX) Compared With Patients Receiving Intrathecal Triple Therapy (ITT) on a Modified Berlin-Frankfurt-Munster (MBFM) Interim Maintenance High-dose Methotrexate Backbone

DFS of Non-DS VHR Post-Induction Patients Who Receive a Modified MBFM-IMHDM Regimen That Contains a Second IM (Control Arm) Compared to Patients Receive the Cyclophosphamide + Etoposide Containing Regimen (Experimental Arm 1)

Secondary outcome measures

5-year DFS in Patients With Down Syndrome (DS) and HR B-ALL Treated With Modified Induction and Post-Induction Therapy Regimen With MBFM-IMIDM

DFS for Children and Young Adults With Ph-like B-ALL and a Predicted Tyrosine Kinase Inhibitor (TKI)-Sensitive Mutation Treated With Dasatinib Plus MBFM-IMHDM

Incidence of Osteonecrosis (ON) Defined by Magnetic Resonance (MR) Imaging in Children, Adolescents, and Young Adults 10 Years of Age and Greater

+11 more

Other outcome measures

The Reduction in MRD From End-Induction (EOI) to End-Consolidation (EOC) for Children, Adolescents, and Young Adults With VHR B-ALL Receiving Experimental Arms 1 Compared to the Control Arm

Trial Design

8Treatment groups

Experimental Treatment

Active Control

Group I: Group III PH-like predicted TKI-sensitive kinase mutationExperimental Treatment13 Interventions

Patients receive induction, consolidation, interim maintenance, delayed intensification, interim maintenance and maintenance therapies. See outline for details.

Group II: Group II Arm C (VHR B-ALL - Exp Arm 2) (CLOSED 09/12/2014)Experimental Treatment15 Interventions

Patients receive induction, consolidation, interim maintenance, delayed intensification and maintenance therapies. See outline for details.

Group III: Group II Arm B (VHR B-ALL - Exp Arm1) (CLOSED 02/15/2017)Experimental Treatment13 Interventions

Patients receive consolidation, interim maintenance, delayed intensification and maintenance therapies. See outline for details.

Group IV: Group I Arm B (HR B-ALL) (CLOSED 03/19/2018)Experimental Treatment15 Interventions

Patients receive induction, consolidation, interim maintenance, delayed intensification and maintenance therapies. See outline for details.

Group V: Group I Arm A (HR B-ALL)Experimental Treatment14 Interventions

Patients receive induction, consolidation, interim maintenance, delayed intensification and maintenance therapies. See outline for details.

Group VI: DS HR B-ALL (SER)Experimental Treatment14 Interventions

Patients receive induction, consolidation, interim maintenance, delayed intensification, interim maintenance and maintenance therapies. See outline for details.

Group VII: DS HR B-ALL (RER)Experimental Treatment13 Interventions

Patients receive induction, consolidation, interim maintenance, delayed intensification, interim maintenance and maintenance therapies. See outline for details.

Group VIII: Group II Arm A (VHR B-ALL - Control Arm)Active Control14 Interventions

Patients receive induction, consolidation, interim maintenance, delayed intensification and maintenance therapies. See outline for details.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cytarabine

2016

Completed Phase 3

~3310

Daunorubicin Hydrochloride

2011

Completed Phase 3

~5070

Dexamethasone

2007

Completed Phase 4

~2590

Mercaptopurine

2012

Completed Phase 4

~12330

Hydrocortisone Sodium Succinate

2008

Completed Phase 3

~70

Prednisone

2014

Completed Phase 4

~2370

Thioguanine

2012

Completed Phase 4

~10830

Etoposide

2010

Completed Phase 3

~2440

Leucovorin Calcium

2011

Completed Phase 3

~12290

Dasatinib

2012

Completed Phase 3

~2320

Clofarabine

2007

Completed Phase 3

~1130

Cyclophosphamide

1995

Completed Phase 3

~3780

Doxorubicin Hydrochloride

2019

Completed Phase 3

~17850

Methotrexate

2013

Completed Phase 4

~3800

Pegaspargase

2005

Completed Phase 3

~9010

Radiation Therapy

2017

Completed Phase 3

~7250

Vincristine Sulfate

2005

Completed Phase 3

~10110

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,927,204 Total Patients Enrolled

1 Trials studying Central Nervous System Leukemia

4,997 Patients Enrolled for Central Nervous System Leukemia

Michael J BurkePrincipal InvestigatorChildren's Oncology Group

Media Library

Daunorubicin Hydrochloride (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT02883049 — Phase 3

Central Nervous System Leukemia Research Study Groups: Group II Arm C (VHR B-ALL - Exp Arm 2) (CLOSED 09/12/2014), Group III PH-like predicted TKI-sensitive kinase mutation, DS HR B-ALL (RER), DS HR B-ALL (SER), Group I Arm A (HR B-ALL), Group I Arm B (HR B-ALL) (CLOSED 03/19/2018), Group II Arm A (VHR B-ALL - Control Arm), Group II Arm B (VHR B-ALL - Exp Arm1) (CLOSED 02/15/2017)

Central Nervous System Leukemia Clinical Trial 2023: Daunorubicin Hydrochloride Highlights & Side Effects. Trial Name: NCT02883049 — Phase 3

Daunorubicin Hydrochloride (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02883049 — Phase 3

Frequently Asked Questions

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

How many hospitals have been approved to administer this trial?

"There are many enrolling sites for this trial, including Michigan State University Clinical Center in East Lansing, Nevada, Summerlin Hospital Medical Center in Las Vegas, Indiana, and Saint Vincent Hospital and Health Care Center in Indianapolis. In total, there are over 100 locations recruiting patients for this study."

Answered by AI

How do I sign up for the clinical trial?

"This trial is recruiting 5956 patients, between the ages of 1 Year and 31 who have ph-like acute lymphoblastic leukemia. It is important that participants also meet the following criteria: Patients must have newly diagnosed B lymphoblastic leukemia (2008 World Health Organization [WHO] classification) (also termed B-precursor acute lymphoblastic leukemia); patients with Down syndrome are also eligible, Organ function requirements for patients with Ph-like ALL and a predicted TKI-sensitive mutation: patients identified as Ph-like with a TKI-sensitive kinase mutation must have assessment of organ function performed within 3 days of study"

Answered by AI

How many people are being recruited for this clinical trial?

"Unfortunately, this study is no longer recruiting patients. The trial was initially posted on February 27th 2012 and had its last update September 20th 2022. However, there are plenty of other studies actively looking for participants that might be a better match. There are 1547 trials actively recruiting patients with ph-like acute lymphoblastic leukemia and 2512 studies for Group II Arm B (VHR B-ALL - Exp Arm1) (CLOSED 02/15/2017)."

Answered by AI

Are there any previous cases of Group II Arm B (VHR B-ALL - Exp Arm1) (CLOSED 02/15/2017)?

"As of right now, there are 2512 active clinical trials researching Group II Arm B (VHR B-ALL - Exp Arm1) (CLOSED 02/15/2017), with 575 of those being in Phase 3. Most studies for Group II Arm B (VHR B-ALL - Exp Arm1) (CLOSED 02/15/2017) originate from Duarte, California; however, there are 86664 total locations running these sorts of trials."

Answered by AI

Are people aged 50 years or older being accepted into this research program?

"The age bracket for this study is 1-31 years old."

Answered by AI

What are the risks associated with Group II Arm B (VHR B-ALL - Exp Arm1) (CLOSED 02/15/2017)?

"Group II Arm B (VHR B-ALL - Exp Arm1) (CLOSED 02/15/2017) was given a safety score of 3. This is based on the fact that it is a Phase 3 trial, which suggests that there is some evidence to support its efficacy as well as data from multiple rounds supporting its safety."

Answered by AI

What illness does Group II Arm B (VHR B-ALL - Exp Arm1) (CLOSED 02/15/2017) address?

"Group II Arm B (VHR B-ALL - Exp Arm1) (CLOSED 02/15/2017), which is typically used to treat synovitis, can also be applied to alleviate conditions such as scalp structure, prostate cancer, and ulcerative colitis."

Answered by AI

Are new participants still being sought for this research project?

"Unfortunately, this particular trial is no longer looking for patients. It was first posted on February 27th 2012 and was last updated on September 20th 2022. However, there are presently 1547 studies actively searching for participants with ph-like acute lymphoblastic leukemia and 2512 studies for Group II Arm B (VHR B-ALL - Exp Arm1) (CLOSED 02/15/2017) that are still enrolling patients."

Answered by AI

What are the medical professionals who designed this trial hoping to achieve?

"The purpose of this 5-year clinical trial is to compare the disease-free survival (DFS) rates of children, adolescents, and young adults with very high-risk (VHR) B-cell acute lymphoblastic leukemia (ALL) between two treatment arms. Secondary objectives include comparing the DFS rates for Ph-like ALL patients treated with dasatinib plus MBFM-IMHDM, assessing the toxicity and tolerability of MBFM-interim maintenance intermediate dose methotrexate (IMIDM) in children with Down syndrome, and estimating the overall survival (OS) rate for HR B-"

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

Impact of Intrathecal Triple Therapy Versus Intrathecal Methotrexate on Disease-free Survival for High-risk B-lymphoblastic Leukemia: Children’s Oncology Group Study AALL1131

Salzer, Wanda L., Michael J. Burke, Meenakshi Devidas, Yunfeng Dai, Kristina K. Hardy, John A. Kairalla, Lia Gore, et al.. 2020. “Impact of Intrathecal Triple Therapy Versus Intrathecal Methotrexate on Disease-free Survival for High-risk B-lymphoblastic Leukemia: Children’s Oncology Group Study AALL1131”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.19.02892.

clinicaltrials.govStudy

Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations

2012. "Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02883049.

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