COBRA-KAI study: COVID-19 vaccination in patients with a hematological disease

Phase 1

Active, not recruiting

Conditions: hematological diseases
MedDRA version: 20.0Level: LLTClassification code 10019426Term: Hematologic disorderSystem Organ Class: 100000004851
MedDRA version: 21.1Level: LLTClassification code 10066481Term: Hematological malignancySystem Organ Class: 100000004864
MedDRA version: 20.1Level: LLTClassification code 10069761Term: Hematological infectionSystem Organ Class: 100000004862
MedDRA version: 20.0Level: LLTClassification code 10072113Term: Congenital hematological disorderSystem Organ Class: 100000004850
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Registration Number: EUCTR2021-001072-41-NL

Lead Sponsor: Amsterdam UMC location VUmc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 850

Inclusion Criteria

- Age =18 years
- The following patient cohorts will be included: B-cell non Hodgkin lymphoma, multiple myeloma, chronic lymphocytic leukemia (CLL), acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), myeloproliferative diseases (MPN), patients with hemoglobinopathies (sickle cell disease and thalassemia), patients who received cell therapy (autologous HCT, allogeneic HCT or CAR T-cell therapy) AND
- Patients must either currently receive immuno-chemotherapy or have received such therapy in the past 6 months, or currently receive targeted agents, or have received autologous or allogeneic stem cell transplantation no longer than 6 months prior, or have received CAR-T therapy.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 250

Exclusion Criteria

- Unwilling or unable to give informed consent
- Known allergy to one of the components of the vaccine
- Patients with a life expectancy of < 12 months
- Of note: although we will investigate serologic evidence of prior infection with SARS-CoV-2 in all participants, seropositivity is not an exclusion criterion. The main reasons for this are first that we expect seroprevalence to be well below 5%, because of the stringent isolation measures that are already in place in this patient population; second, a test-first-strategy for seroprevalence would seriously hamper the speed of vaccination rollout, whereas vaccination of seropositive patients is indicated nonetheless, according to the national vaccination guidelines