Decitabine Maintenance for Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndrome (MDS) Post Transplant

Phase 1

Completed

• Conditions: Myelodysplastic Syndromes; Leukemia, Myeloid, Acute
• Interventions: Drug: Decitabine

• Registration Number: NCT00986804
• Lead Sponsor: Washington University School of Medicine

Brief Summary

Primary:

To determine the maximum tolerated dose and schedule of decitabine when administered as maintenance therapy after allogeneic hematopoietic stem cell transplantation (alloHSCT) performed for AML or high-risk MDS.

Detailed Description

Secondary:

* To determine the safety and tolerability of decitabine as maintenance therapy after alloHSCT.

* To determine the rates disease relapse, 1-year disease-free survival, and overall survival.

* To assess lymphoid and myeloid chimerism while on decitabine maintenance.

* To determine the incidence of acute and chronic GVHD.

* To assess immunologic reconstitution after alloHSCT.

* To assess changes in gene expression and methylation patterns following decitabine treatment

* To assess the effects of decitabine on immune reconstitution post transplant.

* To access the frequency of FoxP3+ CD3+/CD4+ and CD3+/CD8+ lymphocytes before and after decitabine treatment.

Study Timeline

• Study First Submitted: 2009-09-29
• Study First Submitted QC: 2009-09-29
• Study First Posted: 2009-09-30
• Study Start: 2009-12
• Primary Completion: 2014-05
• Status Verified: 2016-02
• Study Completion: 2016-02
• Last Update Submitted: 2016-02-11
• Last Update Posted: 2016-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Level 1	Decitabine	Decitabine 5.0 mg/m2/day on Days 1 thru 5 every 6 weeks for as many as 8 cycles.
Level 4	Decitabine	Decitabine 15.0 mg/m2/day on Days 1 thru 5 every 6 weeks for as many as 8 cycles.
Level 2	Decitabine	Decitabine 7.5 mg/m2/day on Days 1 thru 5 every 6 weeks for as many as 8 cycles.
Level 3	Decitabine	Decitabine 10.0 mg/m2/day on Days 1 thru 5 every 6 weeks for as many as 8 cycles.

Primary Outcome Measures

Name	Time	Method
To determine the maximum tolerated dose and schedule of decitabine when administered as maintenance therapy after alloHSCT performed for AML or high-risk MDS.	Up to 6 weeks (completion of first cycle)

Secondary Outcome Measures

Name	Time	Method
To assess immunologic reconstitution after alloHSCT.	End of study (42 weeks)
To determine overall survival.	Every 3 months for 2 years then every 6 months for 3 years
To assess lymphoid and myeloid chimerism while on decitabine maintenance.	End of cycle 3 (18 weeks)
To determine the incidence of acute GVHD.	End of study (42 weeks)
To determine the rates disease relapse	Every 3 months for 2 years then every 6 months for 3 years
To access the frequency of FoxP3+ CD3+/CD4+ and CD3+/CD8+ lymphocytes before and after decitabine treatment.	End of cycle 3 (18 weeks)
To determine the 1-year disease-free survival	1 year
To determine the safety and tolerability of decitabine as maintenance therapy after alloHSCT.	Up to 30 days after end of study (approximately 46 weeks)
To assess changes in gene expression and methylation patterns following decitabine treatment	End of study (42 weeks)
To assess the effects of decitabine on immune reconstitution post transplant.	End of study (42 weeks)
To determine the incidence of chronic GVHD.	End of study (42 weeks)

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States