Clinical trial · Observational
Effectiveness of Protected Environment Rooms for AML and MDS
Effectiveness of HEPA-filtered Rooms ("Protected Environment") to Prevent Morbidity and Mortality in Patients Age >/ = 60 Receiving Lower Intensity ("Targeted") Therapy for Untreated AML and High-risk Myelodysplasia (MDS)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated due to low accrual.
Summary
Brief summary (as posted)
The goal of this clinical research study is to learn if the "protected environment" (PE) can help to prevent infections in patients aged 60 and above who are receiving what is considered low-intensity treatment for newly-diagnosed AML or high-risk MDS.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myelogenous Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Protective environment
- description
- Participants in a Protective environment
- label
- Not a protective environment
- description
- Participants not in a protective environment
Primary outcomes (1)
- measure
- Success Rate
- timeFrame
- Baseline to 6 weeks post randomization to PE or Non PE
- description
- Success is defined as number of participants with no death, pneumonia, or sepsis within 6 weeks of randomization compared to total number of participants to evaluate effect of the protected environment (PE) by (adaptively) randomly assigning patients age \>/= 60 given targeted therapies between treatment inside or outside the PE.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * AML or high-risk MDS (\> 10% blasts in the marrow or blood) * Patient is to be given "targeted therapy". Examples of targeted therapies are tipifarnib + low-dose ara-C, decitabine, and 5 azacitidine + valproic acid. * Age \>/= 60 years and Zubrod performance status of 0,1, or 2 * Informed consent obtained Exclusion Criteria: * Cannot receive ara-C at a dose \>/= 100 mg/m2 daily, anthracyclines, or cloretazine.
References
Publications (0)
Data not yet available