Interventional Validation of an MDS-Specific Measure of Quality of Life: Assessing the Responsiveness of the Quality of Life in Myelodysplasia Scale (QUALMS-1) to Different Hypomethylating Agent Regimens for Low and Intermediate Risk Disease

Completed

Conditions studied: Leukemia

In brief

The goal of this research study is to test a quality-of-life questionnaire called QUALMS-1 in patients with MDS. This is an investigational study. Up to 240 participants will be enrolled in this multicenter study. Up to 175 will take part at MD Anderson.

Key facts

Study ID

NCT02378701

Run by

M.D. Anderson Cancer Center

People needed

102

Starts

2015-02-01

Expected to finish

2022-07-18

Last updated by the study team

2022-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Sign an Institutional Review Board (IRB)-approved informed consent document.
• Age greater than or equal to 18 years
• de novo or secondary International Prognostic Scoring Status (IPSS) low- or intermediate-1-risk MDS, including Chronic Myelomonocytic Leukemia (CMML)-1
• Eastern Cooperative Oncology Group (ECOG) performance status of greater than or equal to 3 at study entry
• Organ function as defined below: Serum creatine greater than or equal to mg/dL x upper limit of normal (ULN); Total bilirubin greater than or equal to 2 x ULN; Alanine transaminase (ALT; Serum glutamic pyruvic transaminase=SGPT) greater than or equal to 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.

You may not qualify if…

• Breast feeding females
• Prior therapy with decitabine or azacitidine
• Prior participation in the development of the QUALMS-1 (Dana-Farber Cancer Institute=DFCI)
• Non-English speaking patients

Where it is running

• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
• The Johns Hopkins University — Baltimore, Maryland, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Weill Medical College of Cornell University — New York, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.