Clinical trial · Interventional
Feasiblity and Safety of Home-based Intensive Chemotherapy
A National Danish Proof of Concept on Feasiblity and Safety of Home-based Intensive Chemotherapy in Patients With Acute Leukemia.
- 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)
a multicenter single-arm feasibility and safety study of home-based intensive chemotherapy in patients with newly diagnosed acute myeloid leukemia and their quality of life and psychological wellbeing. This national study included patients from six sites in Denmark who received intensive chemotherapy on programmed CADD Solis infusion pumps through a central venous catheter and were also managed as outpatients during treatment-induced pancytopenia.
Conditions
Conditions (1)
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 Leukemia | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Home-based chemotherapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Feasiblity and Safety
- description
- All eligible patients will be assigned to this arm
- interventionNames
- Other: Home-based chemotherapy
Primary outcomes (8)
- measure
- Recruitment rate
- timeFrame
- up to 3 years
- description
- Number of participants included from eligible patients
- measure
- Adherence to intervention
- timeFrame
- Up to 24 weeks
- description
- Number of weeks completed out of planned weeks of intervention
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Participants 18 years or older were included within the first 28 days from diagnosis with AML or high-risk MDS if intensive chemotherapy treatment was planned. Exclusion Criteria: Patients were excluded if they did not understand, read and speak Danish, suffered from a severe illness requiring hospitalization if they had an unstable medical disease or any cognitive/psychiatric disorders. During the intervention, participants were withdrawn if hospitalized in an intensive care unit for more than two weeks, if they had a psychological condition (delirium or severe depression), or in case of transition to terminal care or if deceased. Moreover, participants were censored if they relapsed or transitioned to hematopoietic stem cell transplantation (HSCT).
References
Publications (1)
- DERIVEDNorskov KH, Fridthjof K, Kampmann P, Dunweber A, Andersen CL, Renaberg T, Schollkopf C, Ahmad SA, Schou K, Jensen CF, Moller P, Lundholm BW, Marcher C, Jepsen L, Orntoft AK, Ommen HB, Andersen L, Behrentzs A, Hasselgren CF, Severinsen M, Grand MK, Jarden M, Moller T, Kjeldsen L. A national Danish proof of concept on feasibility and safety of home -based intensive chemotherapy in patients with acute myeloid leukemia. Leuk Res. 2022 Jan;112:106756. doi: 10.1016/j.leukres.2021.106756. Epub 2021 Nov 22. PMID 34839055