Clinical trial · Interventional
Palliative Care Oncology in Patients With Relapsed, Refractory, and High-Risk Leukemias or MDS
Palliative Care Oncology in Patients With Relapsed, Refractory, and High-Risk Leukemias or High-Risk Myelodysplastic Syndrome: Randomized Phase II Study
NCT04482894CI-TRIAL-00110301active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to estimate the potential benefit of early and continued palliative care (PC) consultation on end of life issues.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ALL, Adult | Adult Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| AML, Adult | Adult Acute Myeloid Leukemia | ALIAS | 0.90 |
| Leukemia, Acute | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Palliative Care Visits | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Palliative Care Intervention
- description
- Participants on this arm will see a palliative care specialist twice a week while they are in the hospital and about every other week when they are out of the hospital. If participants see their oncologist less often than every other week while they're out of the hospital, then visits with the palliative care specialist would be timed to occur on the same day as the oncologist visit. Participants will complete a questionnaire about once a month.
- interventionNames
- Other: Palliative Care Visits
- type
- NO_INTERVENTION
- label
- Standard Clinical Care
- description
- Participants will see a palliative care specialist only if they have a referral from their oncologist according to standard clinical care. Participants on this arm will not be discouraged from requesting a consult.
Primary outcomes (1)
- measure
- Place of death
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
1. Ability to provide informed consent
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Any of the following:
1. Patients with a new diagnosis of AML, ALL, high risk myelodysplastic syndrome (MDS), or high risk chronic myelomonocytic leukemia (CMML) who are age 65 and older.
OR
2. Patients with relapsed AML, ALL, high risk MDS or high risk CMML, ages 18 and older.
OR
3. Patients with refractory AML, ALL, high risk MDS or high risk CMML, ages 18 and older.
Refractory AML/ALL will be defined as persistent leukemia despite two or more cycles of induction chemotherapy.
Refractory MDS will be defined according to the 2006 IWG response criteria Refractory CMML will be based on the assessment of the treating investigator.
Exclusion Criteria:
1\. Participants must not have a diagnosis of Acute Promyelocytic Leukemia (APL)References
Publications (0)
Data not yet available
No reference posted for this study.