NCT00382590

Brief Summary

Primary Objective: 1\. To evaluate whether 5 azacytidine (5-aza)/valproic acid (VPA) or low dose ara-C produces longer event free survival time in patients age \> or = 60 years with untreated Acute Myeloid Leukemia (AML) or high risk Myelodysplastic Syndrome (MDS) who are typically ineligible for, or not placed on, studies of new agents. Secondary Objective: 1\. To evaluate whether pre-treatment methylation/acetylation status in AML/MDS blasts predicts response to either therapy or whether the ability of the 5 azacytidine + valproic acid combination to induce demethylation or acetylation parallels response.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2005

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

August 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 29, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

April 14, 2011

Completed
Last Updated

August 7, 2012

Status Verified

August 1, 2012

Enrollment Period

2.5 years

First QC Date

September 27, 2006

Results QC Date

August 13, 2009

Last Update Submit

August 1, 2012

Conditions

Acute Myelogenous LeukemiaMyelodysplastic SyndromeLeukemia

Keywords

Acute Myelogenous LeukemiaAMLMyelodysplastic SyndromeLeukemiaMDSAzacytidine5-Azacytidine5-azaVidaza5-AZCAZA-CRLadakamycinAra-CCytarabineCytosarDepoCytCytosine arabinosine hydrochlorideValproic AcidVPADepakene

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Response

    Patient response defined by: Death, Resistant to Therapy \[no major hematologic improvement using International Myelodysplastic Syndromes (MDS) Working Group (Cheson B, Bennett J, Kantarjian H et al, Blood 2006) criteria after a maximum of 4 courses\], or Relapse.

    Evaluated every 3 weeks, following 4 courses (16/24 weeks ) and till study end

Study Arms (2)

5-Aza + VPA

ACTIVE COMPARATOR

5-Azacytidine (5-Aza) 75 mg/m\^2 subcutaneously daily + Valproic Acid (VPA) 50 mg/m\^2 orally daily, each for 7 days

Drug: 5-AzacytidineDrug: Valproic Acid (VPA)

Ara-C

ACTIVE COMPARATOR

Low-Dose Ara-C 20 mg twice daily subcutaneously for 10 days.

Drug: Ara-C

Interventions

5-AzacytidineDRUG

75 mg/m\^2 daily for 7 days (days 1-7) via subcutaneous injection.

Also known as: Azacytidine, 5-aza, Vidaza, 5-AZC, AZA-CR, Ladakamycin
5-Aza + VPA
Ara-CDRUG

20 mg twice daily via subcutaneous injection for 10 days.

Also known as: Cytarabine, Cytosar, DepoCyt, Cytosine arabinosine hydrochloride
Ara-C
Valproic Acid (VPA)DRUG

50 mg/m\^2 orally daily days 1-7.

Also known as: VPA, Depakene
5-Aza + VPA

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have untreated AML, or untreated MDS with \> 10% blasts in marrow or blood.
  • They must be at least age 60.
  • They must either have a serum creatinine \> 1.9 mg/ml, a serum bilirubin \> 1.9 mg/ml, or a Zubrod performance status of 3 or 4.
  • Alternatively, they must not be candidates for protocols of higher priority.
  • They must provide written consent.

You may not qualify if:

  • \) Must not have the cytogenetic abnormalities inv (16), t (16;16) t (8;21), or t (15;17). The relatively good prognoses of patients with these findings do not warrant use of 5 azacytidine, + valproic acid or low-dose ara-C (LDAC).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteMyelodysplastic SyndromesLeukemia

Interventions

AzacitidineCytarabineValproic Acid

Condition Hierarchy (Ancestors)

Leukemia, MyeloidNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow Diseases

Intervention Hierarchy (Ancestors)

Aza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesArabinonucleosidesPentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsFatty Acids, VolatileFatty AcidsLipids

Results Point of Contact

Title
Guillermo Garcia-Manero, MD / Associate Professor
Organization
UT MD Anderson Cancer Center
eharriso@mdanderson.org
713-745-3428

Study Officials

  • Guillermo Garcia-Manero, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2006

First Posted

September 29, 2006

Study Start

August 1, 2005

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

August 7, 2012

Results First Posted

April 14, 2011

Record last verified: 2012-08

Locations

US(1)