Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Rare Diseases

Inflammation

Syndrome

Preleukemia

Myelodysplastic Syndromes

Anemia

Hematologic Diseases

Bone Marrow Diseases

Precancerous Conditions

200 mg canakinumab subcutaneously every three weeks

Administration for a duration of 6 months for all patients and in case of response further treatment for up to three years

Canakinumab Injection

Anne Sophie Kubasch, Dr.

Hematologic improvement of erythrocytes after 6 months of canakinumab treatment.

To study the erythroid response rate (HI-E) of canakinumab in patients with IPSS-R very low, low, or intermediate risk MDS or MDS/MPN after 6 months of treatment.

Efficacy and Safety of Canakinumab for the Treatment of Anemia in LR-MDS Patients

A Phase II, Single-Arm, Open-Label Study to Assess the Efficacy and Safety of Canakinumab for the Treatment of Anemia in Patients With IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes or MDS/MPN

Erythroid response rate (HI-E) of canakinumab

Duration of erythroid response rate will be measured up to loss of response or reaching end of study (after max. 3 years of treatment)

The safety profile of canakinumab will be described by collecting AE (adverse event) and SAE (serious adverse event) information up to the start of new treatment or reaching end of study (after max. 3 years of treatment). Special consideration will be laid on events that lead to treatment discontinuation.

Proportion of disease progression (after reaching PD at any time during the trial after primary end-point visit)

QoL assessment using the QUALMS questionnaire up to end of treatment:

38-item assessment tool for patients with Myelodysplastic Syndromes (MDS) QUALMS scores ranged from 24 to 99, with higher scores for better outcome

QoL assessment using the EORTC-C30 questionnaire up to end of treatment:

To assess patient-reported quality of life during canakinumab treatment: 30 questions assessing the quality of life of oncology patients across 10 subscales will be analyzed. All subscales have a score range from 0 to 100 points.

Function subscales: a higher score represents a higher quality of life. Symptoms subscales: higher score represents higher level of symptoms/problems, i.e., represents lower quality of life

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