Personalized Kinase Inhibitor Therapy Combined With Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia

Summary

This phase IB trial studies the feasibility of using a functional laboratory based study to determine how well the test can be used to select personalized kinase inhibitor therapy in combination with standard chemotherapy in treating patients with newly diagnosed acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). It also evaluates safety and potential efficacy. Kinase inhibitor is a type of substance that blocks an enzyme called a kinase. Human cells have many different kinase enzymes, and they help control important cell functions. Certain kinases are more active in some types of cancer cells and blocking them may help keep the cancer cells from growing. Testing samples of blood from patients with AML and ALL in the laboratory with kinase inhibitors may help determine which kinase inhibitor has more activity against cancer cells and which one should be combined with standard of care chemotherapy. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving a personalized kinase inhibitor therapy combined with standard chemotherapy may be a better treatment for AML and ALL.

Conditions

• Acute Lymphoblastic Leukemia
• Acute Myeloid Leukemia

Interventions

DRUG

Cyclophosphamide

Given IV

DRUG

Cytarabine

Given IV

DRUG

Dasatinib

Given PO

DRUG

Dexamethasone

Given PO

DRUG

Doxorubicin Hydrochloride

Given IV

DRUG

Idarubicin

Given IV

DRUG

Idelalisib

Given PO

DEVICE

In Vitro Kinase Inhibitor Assay

Correlative studies

DRUG

Leucovorin Calcium

Given IV

DRUG

Methotrexate

Given IV

DRUG

Methylprednisolone Sodium Succinate

Given IV

DRUG

Ponatinib Hydrochloride

Given PO

BIOLOGICAL

Rituximab

Given IV

DRUG

Ruxolitinib Phosphate

Given PO

DRUG

Sorafenib Tosylate

Given PO

DRUG

Sunitinib Malate

Given PO

DRUG

Vincristine Sulfate

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• OHSU Knight Cancer Institute

  lead OTHER

Principal Investigators

• Stephen Spurgeon · OHSU Knight Cancer Institute

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-01-13

Primary Completion

2018-04-19

Completion

2018-09-20

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations