Acute Myeloid Leukemia Clinical Trial

Matched Targeted Therapy For High-Risk Leukemias and MDS

Summary

This research study is seeking to gain new knowledge about Recurrent, Refractory, or High Risk Leukemias in children and young adults.

This study is evaluating the use of specialized testing called leukemia profiling. Once the profiling is performed, the results are evaluated by an expert panel of physicians, scientists and pharmacists. This may result in a recommendation for a specific cancer therapy or a clinical trial called matched targeted therapy (MTT). The results of the leukemia profiling and, if applicable, the MTT recommendation will be communicated to the participant's primary oncologist.

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Full Description

This study will determine whether it is possible to use profiling results and determine a matched targeted therapy for patients with leukemia. It will describe the range of mutations found in patients with leukemia with this type of profiling, and describe the clinical outcomes of patients who receive a matched targeted therapy.

Our tissues and organs are made up of cells. Cancer occurs when the molecules that normally control cell growth are damaged. The damage results in unchecked cell growth which causes a tumor, a collection of cancer cells. The damage is referred to as an alteration. There are different types of cancer-causing alterations. Genes are the part of cells that contain the instructions which tell our cells how to make the right proteins to grow and work. Genes are composed of DNA letters that spell out these instructions.

By participating in this study, the participant's leukemia cells will be tested for cancer causing alterations. This testing is called leukemia profiling. The leukemia profiling will be performed using bone marrow or blood that has already been obtained during a clinical test. Alternately, the profiling may be done on leukemia cells that are planned to be obtained as part of routine clinical care.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Birth to ≤ 30 years at study entry
Diagnosis: Patients will be enrolled in one of the two cohorts based on diagnosis:

Cohort 1: Relapsed/refractory leukemia

Acute lymphoblastic leukemia, first or greater relapse
Acute myeloid leukemia, first or greater relapse
Leukemia refractory to induction chemotherapy
Other recurrent leukemia
Myelodysplastic syndrome (MDS), first or greater relapse, or refractory to initial therapy

Cohort 2: New diagnosis

Acute myeloid leukemia, new diagnosis
New diagnosis infant MLL-rearranged ALL or low hypodiploid (<40 chromosomes) ALL
Rare leukemia- e.g., JMML, leukemia of ambiguous lineage
Secondary leukemia
Myelodysplastic syndrome (MDS) not eligible for stem cell transplant

Pathologic Criteria

Histologic confirmation of leukemia at the time of diagnosis or recurrence

Specimen Samples

Sufficient leukemia specimen available for profiling from diagnosis or recurrence OR bone marrow aspirate/blood draw/pheresis/other fresh sample of patient leukemia cells planned for clinical care anticipated to allow collection of minimum specimen for testing.

Exclusion Criteria:

Insufficient leukemia specimen available for profiling from diagnosis or recurrence; or bone marrow evaluation/blood draw/other leukemia cell sample NOT planned to be obtained for clinical care; or peripheral blast percentage <20% AND clinical blood draw not planned.

Study is for people with:

Acute Myeloid Leukemia

Estimated Enrollment:

338

Study ID:

NCT02670525

Recruitment Status:

Active, not recruiting

Sponsor:

Dana-Farber Cancer Institute

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There are 15 Locations for this study

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UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco California, 94158, United States
Children's Hospital Colorado
Aurora Colorado, 80045, United States
Children's Healthcare of Atlanta
Atlanta Georgia, 30322, United States
The University of Chicago
Chicago Illinois, 60637, United States
Johns Hopkins Hospital
Baltimore Maryland, 21287, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Children's Hospital's and Clinics of Minnesota
Minneapolis Minnesota, 55404, United States
Washington University at St. Louis School of Medicine
Saint Louis Missouri, 63110, United States
The Children's Hospital at Montefiore
Bronx New York, 10467, United States
Roswell Park Comprehensive Cancer Center
Buffalo New York, 14263, United States
Columbia University Medical Center
New York New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Children's Hospital of Philadelphia
Philadelphia Pennsylvania, 19404, United States
Seattle Children's Hospital
Seattle Washington, 98105, United States
Children's Hospital of Wisconsin
Milwaukee Wisconsin, 53226, United States

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Estimated Enrollment:

338

Study ID:

NCT02670525

Recruitment Status:

Active, not recruiting

Sponsor:


Dana-Farber Cancer Institute

How clear is this clinincal trial information?

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