Stopping TKI to Assess Treatment-Free Remission in Pediatric Chronic Myeloid Leukemia

What is the Purpose of this Study?

This study focuses on children, adolescents and young adults who have been diagnosed with chronic myeloid leukemia (CML) and whose level of disease is very low (molecular remission). To stay in molecular remission, treatment for CML requires patients to take a type of medication called a tyrosine kinase inhibitor (TKI) every day. In this study, researchers aim to determine whether children, adolescents, and young adults can stop taking their TKI medication and remain in molecular remission, in addition to assessing whether patients who restart TKI will re-achieve molecular remission. The study will also evaluate how stopping TKI medications affects social, emotional and behavioral functioning (neurocognitive function).


Eligibility

  • * Patient must have been diagnosed with CML-CP at \< 18 years of age.
  • * Patient must have histologic verification of CML-CP at original diagnosis
  • * Patient must be in molecular remission (MR) with a BCR-ABL1 level of =\< 0.01% BCR-ABL1 as measured using the International Scale (IS) by RQ-PCR for \>= 2 consecutive years at the time of enrollment
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Where can I participate?

Cedars-Sinai Cancer at SOCC : Amy Oppenheim

More about this Clinical Trial

What is the full name of this clinical trial?

AAML18P1: Stopping Tyrosine Kinase Inhibitors to Assess Treatment-Free Remission in Pediatric Chronic Myeloid Leukemia - Chronic Phase ^

Study Details
Disease Type/Condition

Myeloid and Monocytic Leukemia

Principal Investigator

Majlessipour, Fataneh

Co-Investigators

Behrooz Hakimian, Leo Mascarenhas, Nicole Baca

Age Group

Both

Phase

II

IRB Number

STUDY00002830

ClinicalTrials.gov ID

NCT03817398

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Name

Amy Oppenheim

Phone
+1 310-423-3713
Email
amy.oppenheim@cshs.org
Study Detail
Disease Type/Condition

Myeloid and Monocytic Leukemia

Principal Investigator

Majlessipour, Fataneh

Age Group

Both

Phase

II

IRB Number

AAML18P1

ClinicalTrials.gov ID

NCT03817398

Key Eligibility
ClinicalTrials.gov

Contact
Name

Amy Oppenheim

Phone
+1 310-423-3713
Email
amy.oppenheim@cshs.org