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New treatment option for Myeloid Malignancy
Official title Azacitidine and Chimerism in MDS or AML Patients After Allogeneic Stem Cell Transplant
ClinicalTrials.gov ID: NCT03850418
What this study is testing
What is azacitidine?
azacitidine is an investigational medicine, being studied as a potential treatment for myeloid malignancy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Previous studies provide a rationale for administration of AZA after allo SCT for decreasing chimerism. The investigators hypothesize that azacitidine can be well tolerated after SCT and help decrease rate of decreasing donor chimerism and hence decrease relapse without increasing GVHD
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients with AML/MDS/MPN, CMML post Allogeneic SCT who experience any drop in total or myeloid chimerism any time after day 30, or their day 30 or...
- \>=30 -180 days post SCT and patients must have ANC\> 1000, PLT \> 50,000
- Age 18-75 years old
- Performance score of at least 70% by Karnofsky
- Adequate kidney and liver function as demonstrated by:
You likely can't join if
- Positive for HIV, HBsAg, HCV or other viral hepatitis or cirrhosis from any cause
- Active or prior CNS leukemia, unless in complete remission for at least 2 months.
- History of serious chronic mental disorder or drug-abuse accompanied by documented problems of compliance with therapeutic programs.
- Uncontrolled infection
- Grade III, IV graft versus host disease (GVHD
See the full eligibility criteria
- Patients with AML/MDS/MPN, CMML post Allogeneic SCT who experience any drop in total or myeloid chimerism any time after day 30, or their day 30 or day100 myeloid donor chimerism is below 98% without concurrent...
- \>=30 -180 days post SCT and patients must have ANC\> 1000, PLT \> 50,000
- Age 18-75 years old
- Performance score of at least 70% by Karnofsky
- Adequate kidney and liver function as demonstrated by:
- Creatinine clearance should be \>60 ml/min
- Total Bilirubin \<1.5, ALT/AST/Alk Phos \< 2.5 x normal. No evidence of chronic active hepatitis or cirrhosis.
- Negative Beta HCG test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. Women of child bearing potential must be willing to use an effective...
- Patient or patient's legal representative, parent(s) or guardian able to sign informed consent.
- Patients must be off any prior chemotherapy, radiotherapy, or other investigational therapy within 2 weeks prior to start treatment
- Positive for HIV, HBsAg, HCV or other viral hepatitis or cirrhosis from any cause
- Active or prior CNS leukemia, unless in complete remission for at least 2 months.
- History of serious chronic mental disorder or drug-abuse accompanied by documented problems of compliance with therapeutic programs.
- Uncontrolled infection
- Grade III, IV graft versus host disease (GVHD
The study team makes the final eligibility decision.
Where it's taking place
- Detroit, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Detroit, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.