Decitabine Versus Azacitidine in Myelodysplastic Syndrome Patients With Low and Intermediate-1 Risk

This study is currently recruiting participants.
Verified October 2013 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01720225
First received: October 31, 2012
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

The goal of this clinical research study is to compare how two different drugs, decitabine and azacitidine, when given on a shorter than standard dosing schedule can help to control MDS. The safety of the drugs will also be studied.

Decitabine is designed to damage the DNA (the genetic material) of cells, which may cause cancer cells to die.

Azacitidine is designed to block certain proteins in cancer cells whose job is to stop the function of the tumor-fighting proteins. By blocking the "bad" proteins, the tumor-fighting genes may be able to work better. This could cause the cancer cells to die.


Condition Intervention Phase
Leukemia
Drug: Decitabine
Drug: Azacitidine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Randomized Study of Lower Doses of Decitabine (DAC; 20 mg/m2 IV Daily for 3 Days Every Month) Versus Azacitidine (AZA; 75 mg/m2 SC/IV Daily for 3 Days Every Month) in Myelodysplastic Syndrome (MDS) Patients With Low and Intermediate-1 Risk Disease

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Overall Improvement Rate (OIR) [ Time Frame: 56 days ] [ Designated as safety issue: Yes ]
    Overall improvement rate (OIR), defined as complete remission (CR), partial remission (PR), marrow CR (mCR), or hematologic improvement (HI), measured at the end of each cycle using each patient's best response with the 2 different agents. Response assessed using the modified International Working Group 2006 criteria. The best response within the first two cycles will be the OIR for each treatment arm that will be used in the adaptive randomization algorithm.


Secondary Outcome Measures:
  • Transfusion Independence [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Transfusion independence defined as being transfusion-free for ≥8 consecutive weeks between the first dose and study treatment discontinuation.


Estimated Enrollment: 120
Study Start Date: November 2012
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Decitabine
Patients randomized to receive Decitabine 20 mg/m2 by vein daily for 3 days (days 1-3) every 28 days.
Drug: Decitabine
20 mg/m2 by vein daily for 3 days (days 1-3) every 28 days.
Other Names:
  • DAC
  • Dacogen
Experimental: Azacitidine
Patients randomized to receive Azacitidine 75 mg/m2 subcutaneously or by vein daily for 3 days (days 1-3) every 28 days.
Drug: Azacitidine
75 mg/m2 subcutaneously or by vein daily for 3 days (days 1-3) every 28 days.
Other Names:
  • AZA
  • 5-azacytidine
  • 5-aza
  • Vidaza
  • 5-AZC
  • AZA-CR
  • Ladakamycin
  • NSC-102816

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Sign an IRB-approved informed consent document.
  2. Age >/= than18 years
  3. de novo or secondary IPSS low- or intermediate-1 - risk MDS, including CMML
  4. ECOG performance status of </= 3 at study entry.
  5. Organ function as defined: Serum creatinine </= 3 x ULN, Total bilirubin </= 2 x ULN, ALT (SGPT) </= 2 x ULN
  6. Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days and will also need to use contraceptives. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential.

Exclusion Criteria:

  1. Breast feeding females
  2. Prior therapy with decitabine or azacitidine
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01720225

Contacts
Contact: Elias Jabbour, MD 713-792-7305

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Elias Jabbour, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01720225     History of Changes
Other Study ID Numbers: 2012-0507
Study First Received: October 31, 2012
Last Updated: October 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Leukemia
Myelodysplastic syndromes
MDS
Low and Intermediate-1 Risk Disease
Decitabine
DAC
Dacogen
Azacitidine
AZA
5-azacytidine
5-aza
Vidaza
5-AZC
AZA-CR
Ladakamycin
NSC-102816

Additional relevant MeSH terms:
Leukemia
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Azacitidine
Decitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014