WARD Fase 1 

Study design: 

Non-randomized, non-controlled interventional trial

Sample size: 

100 participants

Study Sites:

Rigshospitalet, Copenhagen

Inclusion criteria:

Adult patients (≥ 18 years) diagnosed with haematologic malignant disease (e.g. malignant lymphoma) scheduled for treatment with immune therapy, including chimeric antigen receptor T-cell treatment (CART) and T-cell engaging bispecific antibodies (BsAbs)

Study Procedures:

Before and after the anti-cancer treatment, the patient have blood tests drawn that can provide detailed information about the patient’s immune system.

After the treatment, the patient is fitted with wireless monitoring equipment (WARD equipment), that measures pulse, blood pressure, temperature, heart rate, and blood oxygen saturation. The equipment continuously sends data on these parameters to a tablet in real time. This tablet is connected to a smartphone possessed by the nursing staff. If there are significant fluctuations in one or more of the vital parameters, an alarm will be triggered on the staff’s smartphone, allowing them to react accordingly.

Outcome:

·         Primary: Cytokine release syndrome (CRS) grade two or above within 30 days after anti-cancer treatment

·         Secondary: Other severe complications assessed by international criteria used in WARD project within 30 days after anti-cancer treatment

Primary Investigators:

Sandra Egedie Lyby Taylor Pitter

NCT:

Not registered yet