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DVALL: Leukemia Lymphoma Clinical Trial: A Pilot Study of Decitabine and Vorinostat With Chemotherapy for Relapsed ALL

About this study

This is a pilot study to characterize side effects and feasibility of adding two new drugs (decitabine and vorinostat) in combination before and during administration of commonly used re-induction chemotherapy drugs for treating children with relapsed acute lymphocytic leukemia. There are also secondary research objectives to study the biological activity and genetic profile of these drugs. Bone marrow and blood will be collected for these studies at specified times in the protocol.

Objectives

  • To learn more about the effects (good and bad) of adding decitabine and vorinostat to chemotherapy drugs that are commonly given to treat relapsed ALL
  • To find out if giving decitabine and vorinostat with chemotherapy will change the DNA of the leukemia cells found in the blood and bone marrow of children/young adults who are taking part in this study
  • To find out if this is an effective treatment for children and young adults with relapsed ALL

Eligibility overview

  • Participant is equal to or greater of 1 year of age and less or equal to 25 years of age at the time of study enrollment
  • Participant has a diagnosis of acute lymphoblastic leukemia (ALL) with > 25% blasts in the bone marrow (M3), with or without extramedullary disease. Participants may have CNS 1, 2 or 3 disease
  • Female participant of childbearing potential has had a negative urine or serum pregnancy test confirmed prior to enrollment

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Overview

Full title:

A Pilot Study of Decitabine and Vorinostat with Chemotherapy for Relapsed ALL (TACL protocol T2009-003)

Study goal:

1) To learn more about the effects (good and bad) of adding decitabine and vorinostat to chemotherapy drugs that are commonly given to treat relapsed ALL. 2) To find out if giving decitabine and vorinostat with chemotherapy will change the DNA of the leukemia cells found in the blood and bone marrow of children/young adults who are taking part in this study. 3) To find out if this is an effective treatment for children and young adults with relapsed ALL.

Diagnosis:

Relapsed ALL

Age:

Participant is equal to or greater of 1 year of age and less or equal to 25 years of age at the time of study enrollment

Clinical trials categories:

Childhood Cancer Leukemia Acute Lymphoblastic Leukemia (ALL)

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