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Induction Therapy With Cytarabine, High-Dose Mitoxantrone and Dasatinib for Patients With Philadelphia-Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Induction Therapy With Cytarabine, High-Dose Mitoxantrone and Dasatinib for Patients With Philadelphia-Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia

Phase I Study of Induction Therapy With Cytarabine, High-Dose Mitoxantrone and Dasatinib for Patients With Philadelphia-Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia (ALL): ALL-6 Protocol

NCT00940524•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

This research study is for people with a specific type of leukemia called Philadelphia chromosome positive acute lymphoblastic leukemia (the type the patients have). The investigators plan to give you combination of 3 drugs (dasatinib, mitoxantrone, cytarabine) for the first part of the chemotherapy (called Induction). The investigators have previously shown that the combination of mitoxantrone and cytarabine is very effective in your kind of leukemia. The purpose of this study is to establish a safe dose range of dasatinib in combination with this standard induction chemotherapy based on side effects. If possible, the trial will also give us an idea of how well this combination might work in treating your leukemia. Previous studies have shown that dasatinib can produce responses when given alone for your kind of leukemia. By using the dasatinib together with the chemotherapy, the investigators believe that we can kill even more leukemia cells than with either treatment alone. The investigators will initially treat patients with a low dose of dasatinib and monitor for side-effects. If the initial group of patients is able to tolerate this low-dose of dasatinib, then future patients will receive higher doses of dasatinib. Mitoxantrone and cytarabine chemotherapy is the standard therapy at the investigators' institution for the patient's leukemia and it is the combination of dasatinib with this chemotherapy that is new and investigational in this study.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Previously untreated and treated adult patients (\> or = 18 years old) with a diagnosis of:
•* Philadelphia-chromosome positive acute lymphoblastic leukemia
•* Lymphoid blast crisis of known chronic myelogenous leukemia NOTE: Patients must have evidence of a t(9;22) in leukemic cells based on chromosomal or molecular analysis.
•NOTE: The diagnosis must be confirmed by the pathology department at MSKCC. NOTE: It is recognized that newly diagnosed patients may be started on therapy with cytarabine and high-dose mitoxantrone (which is the standard of care at our institution for treating adult ALL) prior to the identification of t(9;22) in leukemic cells. These patients will remain eligible for participation on study and will be evaluable for response if it is possible to start treatment with dasatinib within 30 days of receiving induction chemotherapy.
•Patients with adequate hepatic function (AST and ALT \< or = 2.5 the institutional ULN, bilirubin \< or = 2.0 mg/dl).
•Patients with adequate renal function (creatinine \< or = 2.0 mg/dl or creatinine clearance \> 50 ml/min).
•Patients with an LVEF \> or = 50%.
•Karnofsky performance status \> or = 20%.
•Ability to take oral medication (dasatinib must be swallowed whole).
•Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (sensitivity \> or = 25IU HCG/L) within 72 hours prior to the start of study drug administration. Persons of reproductive potential must agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study drug is stopped. Prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.
+2 more criteria

Exclusion Criteria

•Female patients who are pregnant or lactating. Women and men of childbearing age should use effective contraception.
•Patients with uncontrolled active infections.
•Patients who are receiving other systemic chemotherapy. Patients must have been off prior antileukemic therapy for at least 2 weeks (hydroxyurea is considered acceptable).
•NOTE: Patients who had previously received combination therapy with cytarabine, high-dose mitoxantrone and dasatinib will be excluded from the trial. All other prior therapies will be allowed, including prior tyrosine kinase inhibitors usage. Prior dasatinib use will be allowed (as a single agent or in combination therapy, other than the combination therapy with cytarabine and high-dose mitoxantrone).
•Concomitant active secondary malignancy requiring treatment (other than squamous cell and basal cell carcinoma of skin).
•Concurrent medical condition which may increase the risk of toxicity, including: grade ≥ 2 pleural or pericardial effusion.
•Cardiac Symptoms; any of the following should be considered for exclusion:
•* Uncontrolled angina, congestive heart failure or MI within (6 months).
•* Diagnosed congenital long QT syndrome.
•* Any history of clinically significant ventricular arrhythmias (such as ventricular - tachycardia, ventricular fibrillation, or Torsades de pointes).
+9 more criteria

Locations (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Key Dates

Start Date

July 1, 2009

Primary Completion Date

April 1, 2014

Completion Date

April 1, 2014

Last Updated

April 10, 2014

Enrollment

ACTUAL participants

Conditions

LeukemiaAcute Lymphoblastic Leukemia

Interventions

Dasatinib, Mitoxantrone, Cytarabine

DRUG

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Lymphoma, T Cell, PeripheralT-cell Lymphoma+4 more

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RECRUITINGPHASE1

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 10, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Induction Therapy With Cytarabine, High-Dose Mitoxantrone and Dasatinib for Patients With Philadelphia-Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia

Inclusion Criteria

Exclusion Criteria

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

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