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Anti-metabolites

5 Azacytidine for Erythroleukemia

Phase 2

Waitlist Available

Led By Sebastian Mayer, MD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years post-transplant

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Summary

The purpose of this study is to determine whether 5-Azacytidine priming before the conditioning regimen for subjects receiving a hematopoietic stem cell transplant is an effective treatment for high risk myeloid malignancies in complete remission (CR).

Eligible Conditions

Erythroleukemia
Myelodysplastic Syndrome
Acute Erythroblastic Leukemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years post-transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years post-transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years post-transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disease Free Survival at 1 Year Post-transplant

Secondary study objectives

Acute Graft-versus-Host Disease (GVHD)

Disease Free Survival at 2 Years Post-transplant

Disease Free Survival at 6 Months Post-transplant

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 5 AzacytidineExperimental Treatment5 Interventions

Patients will be given a five day course of subcutaneous 5-azacytidine, followed by a reduced intensity conditioning regimen of fludarabine and melphalan with or without total body irradiation prior to an allogeneic hematopoietic stem cell transplantation from a related or unrelated HLA matched donor.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Azacitidine

FDA approved

Total Body Irradiation

2006

Completed Phase 3

~820

Fludarabine

FDA approved