NCT00349596

Brief Summary

The goal of this clinical research study is to find the safety of decitabine in patients with acute lymphocytic leukemia. Upon agreement of the patient, additional blood and bone marrow samples to be used to evaluate the effect of the treatment on leukemic cells. Also, with agreement of the patient, any leftover blood and bone marrow samples that are collected at the start of the study and during the regularly scheduled evaluations to be sent for research studies. The research studies will examine changes in the blood and bone marrow cells that might help explain the causes of leukemia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2006

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 7, 2006

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 15, 2014

Status Verified

October 1, 2014

Enrollment Period

8.3 years

First QC Date

July 6, 2006

Last Update Submit

October 13, 2014

Conditions

Acute Lymphocytic Leukemia

Keywords

Hypomethylating agentChemotherapyRelapsed or refractory ALLAcute Lymphocytic Leukemia (ALL)

Outcome Measures

Primary Outcomes (4)

  • To determine the safety and tolerability of 5-aza-2'-deoxycytidine (decitabine) administered daily for 5 days every other week in patients with relapsed or refractory acute lymphocytic leukemia (ALL).

    4 Years

  • To determine the clinical activity of this schedule of decitabine in this patient population.

    4 Years

  • To determine the safety and tolerability of decitabine in combination with hyperCVAD based chemotherapy in patients with relapsed or refractory ALL.

    4 Years

  • To determine the clinical activity of this schedule of decitabine in combination with hyperCVAD in this patient population.

    4 Years

Secondary Outcomes (1)

  • To determine the effects of decitabine administration on DNA methylation and gene expression in this patient population.

    4 Years

Study Arms (1)

Decitabine

EXPERIMENTAL

Decitabine administered intravenously (IV) over 1 hour at 10 mg/m2 daily x 5 days every other week.

Drug: Decitabine

Interventions

DecitabineDRUG

Administered intravenously (IV) over 1 hour at 10 mg/m2 daily x 5 days every other week.

Also known as: 5-Aza-2'-Deoxycytidine, Dacogen
Decitabine

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with refractory or relapsed acute lymphocytic leukemia (ALL).
  • Signed informed consent indicating that patients are aware of the investigational nature of this study in keeping with the policies of University of Texas MD Anderson Cancer Center (UTMDACC).
  • Patients of any age are eligible.
  • Patients must have been off chemotherapy for 1 week prior to entering this study and recovered from the toxic effects (\< grade 2) of that therapy, unless there is evidence of rapidly progressive disease. Use of high dose steroids with dexamethasone is allowed during the first 2 courses of therapy. Imatinib mesylate (Gleevec) must be stopped 1 week prior to entering this study.
  • Adequate liver function (bilirubin of \< 3 mg/dL, serum glutamate pyruvate transaminase (SGPT) \< 5 x ULN) and renal function (creatinine \< 3mg/dL) unless proven to be related to disease infiltration.
  • Women of childbearing potential must practice contraception. Child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization. Men and women must continue birth control for the duration of the trial.

You may not qualify if:

  • \) Nursing and pregnant females are excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaRecurrence

Interventions

Decitabine

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AzacitidineAza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Guillermo Garcia-Manero, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2006

First Posted

July 7, 2006

Study Start

July 1, 2006

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

October 15, 2014

Record last verified: 2014-10

Locations

US(1)