Return to List

Study Summary
No. 2011-1123:.......Leukemia......Zeev Estrov......Leukemia
.
Study Summary Title
Study Summary
Number:		2011-1123
Study Title:Phase II Study of Azacytidine Followed by GM-CSF in Patients with Low- or Intermediate-1- Risk Myelodysplastic Syndrome (MDS)
.
Physician New Patient Referral
Name:Zeev EstrovPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:LeukemiaReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-704-1675
Contact us about clinical trials
.
General Information
Disease Group:LeukemiaSupported By:N/A
Phase of Study:Phase IIReturn
Visit:
Treatment
Agents:		Azacitidine
GM-CSF		Home Care:
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
Description/
Intervention:		The goal of this clinical research study is to learn if the combination of
azacitidine and GM-CSF can help to control MDS. The safety of these drugs will
also be studied.

Azacitidine is designed to block certain proteins that stop the function of
tumor-fighting genes. By blocking the "bad" proteins, the tumor-fighting genes
may be able to work better.

Granulocyte-macrophage colony-stimulating factor (GM-CSF) is designed to help
produce white blood cells. This may help to fight infections.
.
Study Objectives / Outcomes
1. To determine the safety and activity of azacytidine followed by GM-CSF in patients with low- or intermediate-1-risk myelodysplastic syndrome (MDS)
2. To evaluate the effect of this treatment on hematopoietic cell gene expression.
.
Study Status Information
Study Activation / Registration Date:
IRB Review and Approval Date:03/15/2012
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Terminated
Projected Accrual:N/A
.
Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Patients with low- or intermediate-1-risk MDS according to the IPSS classification

2) Signed informed consent indicating that patients are aware of the investigational nature of this study in keeping with the policies of UTMDACC.

3) Age >/= 18 years old.

4) Prior therapy with growth factor support, lenalidomide, or other investigational agents is allowed.

5) Previously untreated patients are eligible for this study.
Exclusion Criteria:1) Any previous adverse reaction (>/= CTCAE grade 2) to GM-CSF.

2) Prior treatment with azacytidine or decitabine.

3) Unresolved diarrhea >/= CTCAE grade 2.
.
Links
Registration Number: NCT01542684
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
.
Results

Return to Clinical Trials at M.D. Anderson Cancer Center