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Adding Ruxolitinib to a Combination of Dasatinib Plus Dexamethasone in Remission Induction Therapy in Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Patients Aged 40 Years or Older

Information source: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Lymphoblastic Leukemia

Intervention: Ruxolitinib (Drug); Dasatinib (Drug); Dexamethasone (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Memorial Sloan Kettering Cancer Center

Official(s) and/or principal investigator(s):
Dan Douer, MD, Principal Investigator, Affiliation: Memorial Sloan Kettering Cancer Center

Overall contact:
Dan Douer, MD, Phone: 212-639-2471

Summary

The purpose of this study is to test the safety of a new combination of three oral drugs in Ph+ ALL. These drugs are dexamethasone, dasatinib, and ruxolitinib. All three drugs have been studied before in humans. This is a phase I study in which ruxolitinib dose will start low for the first patient together with dexamethasone plus dasatinib. If this dose does not cause a bad side effect, the ruxolitinib dose will slowly be made higher as new patients take part in the study. This will help the investigators find the right dose of ruxolitinib to give together with dexamethasone and dasatinib that will be used in future studies

Clinical Details

Official title: Phase I Trial Adding Ruxolitinib to a Combination of Dasatinib Plus Dexamethasone in Remission Induction Therapy in Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Patients Aged 40 Years or Older.

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Clinical response

Secondary outcome: Complete Molecular Remission (CMR) rate

Eligibility

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patient able to give informed consent.

- Precursor B-cell acute lymphoblastic leukemia Philadelphia chromosome-positive (Ph+)

patients.

- Precursor B-cell lineage determined by standard flow cytometry.

- Ph+ by cytogenetics (karyotype/FISH) and/or molecular (BCR-ABL1 transcripts)

- Determined in CLIA-certified laboratory

- Previously untreated, except for below allowances in a recent diagnosis:

- Previously received HyperCVAD cycle 1A +/- cycle 1B.

- Previously received Induction Phase I +/- Induction Phase II of BFM-modeled

(Pediatric or Pediatric-Inspired) ALL regimen

- Previously received other representative (modified from HyperCVAD, BFM, or AML-

like) ALL induction course

- Including bcr-abl TKI plus corticosteroid

- Acceptable end-organ function, except for documented exclusions for organ function

compromise due to ALL itself

- Aged 40 years and older

- ECOG performance status ≤ 2

- Men and women of childbearing potential must be willing to practice an effective

method of birth control during treatment and for at least 4 months following treatment on study Exclusion Criteria:

- Ph-negative ALL

- Relapsed Ph+ ALL or patients with dominant leukemic clone bearing documented bcr-abl

mutations enabling bcr-abl TKI resistance at diagnosis

- Lymphoid blast crisis of chronic myelogenous leukemia (CML)

- Mature B-cell (Burkitt's) ALL

- Clinical signs of CNS disease

- Active ALL in CNS or testes

- Serum creatinine > 1. 5x ULN and calculated creatinine clearance, based on a 24-hour

urine collection, < 30 mL/min--unless related to ALL/tumor lysis syndrome and able to be corrected

- Direct Bilirubin > 2x ULN; AST/ALT > 10x ULN, unless related to ALL liver

infiltration.

- Pregnant women or women who are breast-feeding

- Patients with HIV, Hepatitis B, or Hepatitis C

- Pre-treatment QTcF > 480 msecs

- Active malignancy requiring treatment other than ALL within two years prior to start

of treatment, with the exception of basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or DCIS or LCIS of the breast

- Active, uncontrolled infection, any other concurrent disease, or medical condition

that is deemed to interfere with the conduct of the study as judged by the investigator

- Unable to tolerate anti-viral and anti- Pneumocystis jirovecii prophylaxis while on

pre-phase and remission induction therapy

- Unable to tolerate gastrointestinal prophylaxis therapy with sucralfate while on

pre-phase and remission induction therapy. Or severe pre-existing GI disorder that requires PPI or H2 receptor antagonist therapy be uninterrupted

Locations and Contacts

Dan Douer, MD, Phone: 212-639-2471

Memorial Sloan Kettering Cancer Center, New York, New York 10065, United States; Recruiting
Dan Douer, MD, Phone: 212-639-2471
Ross Levine, MD, Phone: 646-888-2767
Dan Douer, MD, Principal Investigator
Additional Information

Memorial Sloan Kettering Cancer Center

Starting date: June 2015
Last updated: July 9, 2015

Page last updated: August 23, 2015

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