Phase 2 N=113 Randomized Treatment

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

Leukemia

Bottom Line

View on ClinicalTrials.gov: NCT01720225 ↗

Enrolled (actual)

113

Serious AEs

40.7%

Results posted

Dec 2020

Primary outcome: Primary: Participants With a Response — 49; 19 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Decitabine (Drug); Azacitidine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: M.D. Anderson Cancer Center
Primary completion: Jan 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Participants With a Response	49; 19	—
SECONDARY Number of Participants Who Became Transfusion Independent	12; 3	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

Sign an Institutional Review Board (IRB)-approved informed consent document.
Age >/= than18 years
de novo or secondary International Prostate Symptom Score (IPSS) low- or intermediate-1 - risk MDS, including CMML
Eastern Cooperative Oncology Group (ECOG) performance status of </= 3 at study entry.
Organ function as defined: Serum creatinine </= 3 x Upper Limit of Normal (ULN), Total bilirubin </= 2 x ULN, Alanine transaminase (ALT) (SGPT) </= 2 x ULN
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

Breast feeding females
Prior therapy with decitabine or azacitidine

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01720225). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.