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Alkylating agents

Chemotherapy + Dasatinib for Acute Lymphoblastic Leukemia

Q: Has Dasatinib been cleared by the FDA?

<p><a href="https://www.withpower.com/clinical-trials/dasatinib">Dasatinib</a>'s safety is based on preliminary data from Phase 2 trials, meaning that while there is some evidence of safety, there is no efficacy data at this time.</p>

Phase 2

Waitlist Available

Led By Farhad Ravandi-Kashani, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2

Adequate liver function (bilirubin less than or equal to 3.0 mg/dl, unless considered due to tumor), and renal function (creatinine less than or equal to 3.0 mg/dl, unless considered due to tumor)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the time from treatment until any failure (resistant disease, relapse, or death), assessed up to 2 years

Awards & highlights

Study Summary

This trial is testing how well combination chemotherapy and dasatinib works in treating people with Philadelphia-positive or B-cell receptor-ABL positive acute lymphoblastic leukemia.

Who is the study for?

This trial is for people with newly diagnosed or relapsed Philadelphia-positive acute lymphoblastic leukemia. Participants must have good heart, liver, and kidney function, be able to consent, and have an ECOG performance status of 2 or less (meaning they can do some activities but not work). Pregnant women and those with serious infections, recent heart attacks, certain heart conditions or bleeding disorders are excluded.Check my eligibility

What is being tested?

The study tests a combination of chemotherapy drugs (cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, cytarabine) with dasatinib. This mix aims to stop cancer cells from growing by killing them or stopping their division. The goal is to see if this combo works better for treating the specific type of leukemia in the participants.See study design

What are the potential side effects?

Possible side effects include nausea and vomiting from chemotherapy; low blood cell counts leading to increased infection risk; hair loss; mouth sores; fatigue; and liver damage. Dasatinib may cause fluid retention leading to swelling around the eyes or in the lungs (pleural effusion), diarrhea, headache and skin rash.

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 ~ the time from treatment until any failure (resistant disease, relapse, or death), assessed up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the time from treatment until any failure (resistant disease, relapse, or death), assessed up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and the time from treatment until any failure (resistant disease, relapse, or death), assessed up to 2 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

Event-free survival rate

Secondary outcome measures

Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Overall response rate

Overall survival

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (chemotherapy, dasatinib)Experimental Treatment8 Interventions

See detailed description in outline.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Methotrexate

2013

Completed Phase 4

~3800

Prednisone

2014

Completed Phase 4

~2370

Cytarabine

2016

Completed Phase 3

~3310

Cyclophosphamide

1995

Completed Phase 3

~3770

Dasatinib

2012

Completed Phase 3

~2320

Vincristine

2003

Completed Phase 4

~2910

Doxorubicin

2012

Completed Phase 3

~7940

Dexamethasone

2007

Completed Phase 4

~2590

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,560 Total Patients Enrolled

M.D. Anderson Cancer CenterLead Sponsor

2,967 Previous Clinical Trials

1,804,695 Total Patients Enrolled

Farhad Ravandi-Kashani, MDPrincipal InvestigatorM.D. Anderson Cancer Center

15 Previous Clinical Trials

701 Total Patients Enrolled

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT00390793 — Phase 2

Acute Lymphoblastic Leukemia Research Study Groups: Treatment (chemotherapy, dasatinib)

Acute Lymphoblastic Leukemia Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT00390793 — Phase 2

Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00390793 — Phase 2

Frequently Asked Questions

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

Are individuals needed for this test currently?

"Unfortunately, this clinical trial is not presently looking for new participants. Although, it is worth noting that this study was first posted on September 28th, 2006 and was most recently updated on October 11th, 2022. Additionally, if you are interested in other trials, there are 1592 trials for leukemia, lymphocytic, acute, l1 and 2017 for Dasatinib that are actively recruiting patients."

Answered by AI

Has Dasatinib been cleared by the FDA?

"Dasatinib's safety is based on preliminary data from Phase 2 trials, meaning that while there is some evidence of safety, there is no efficacy data at this time."

Answered by AI

How many people total are eligible to enroll in this clinical trial?

"Unfortunately, this particular study has completed recruitment. Although, if you're interested in other trials, there are currently 1592 active leukemia trials and 2017 active Dasatinib trials that are looking for patients."

Answered by AI

For what purpose is Dasatinib most often prescribed?

"Dasatinib is often used to alleviate macular edema. This medication can also target other disorders, such as pheochromocytomas, eye, and ulcerative colitis."

Answered by AI

What have been the findings of previous research studies on Dasatinib?

"Dasatinib is currently being trialled in 439 Phase 3 clinical trials taking place at 64895 locations worldwide."

Answered by AI

Is there anything else like this that has been done before?

"As of now, there are 2017 ongoing studies for Dasatinib in 87 countries and 3402 cities. The first trial, which was sponsored by Alfacell, concluded its Phase 3 in 1997. 3742 studies have been conducted in the years since."

Answered by AI

Recent research and studies

BloodJournal

First Report of Phase 2 Study of Dasatinib with Hyper-cvad for the Frontline Treatment of Patients with Philadelphia Chromosome–positive (ph+) Acute Lymphoblastic Leukemia

Ravandi, Farhad, Susan O'Brien, Deborah Thomas, Stefan Faderl, Dan Jones, Rebecca Garris, Samuel Dara, et al.. 2010. “First Report of Phase 2 Study of Dasatinib with Hyper-cvad for the Frontline Treatment of Patients with Philadelphia Chromosome–positive (ph+) Acute Lymphoblastic Leukemia”. Blood. American Society of Hematology. doi:10.1182/blood-2009-12-261586.

BloodJournal

First Report of Phase 2 Study of Dasatinib with Hyper-cvad for the Frontline Treatment of Patients with Philadelphia Chromosome–positive (ph+) Acute Lymphoblastic Leukemia

clinicaltrials.govStudy

Combination Chemotherapy and Dasatinib in Treating Participants With Philadelphia Positive or BCR-ABL Positive Acute Lymphoblastic Leukemia.

2006. "Combination Chemotherapy and Dasatinib in Treating Participants With Philadelphia Positive or BCR-ABL Positive Acute Lymphoblastic Leukemia.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00390793.