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

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

Category:

Leukemia / Lymphoma

Diseases Treated:

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.

Description

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 Criteria, among others, include:

  • 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

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).

Contact

Sima Jeha, MD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.