The Capability of Haemato-oncology Patients to Generate Antibodies Against COVID-19

NCT04746092 | Unknown

• 1 other identifier: 1068-20
• Study Type: observational
• Target: 630
• Locations: 1 country
• Sites: 1

Brief Summary

The corona pandemic is a continuing global challenge due to Corona Virus 2019 (COVID-19). The purpose of the study is to evaluate the capability of Haemato-oncology patients to generate antibodies against COVID-19 after infection and vaccination.

Conditions

CLL; Multiple Myeloma; Lymphoma

Outcome Measures

Primary Outcomes (1)

• Capability of Haemato-oncology patients to generate antibodies against COVID-19 after infection and vaccination.

  Evaluate the capability of Haemato-oncology patients to generate antibodies against COVID-19 after infection and vaccination by using serology tests.

  14 to 21 days counting since second vaccination is initiated.

Secondary Outcomes (3)

• Assess COVID19 morbidity rates

  12-month follow-up as part of routine clinic visits.

• Documentation of the vaccine side effects

  14 to 21 days counting since second vaccination is initiated.

• Comparison of antibody formation to COVID19 between haemato-oncology patients and healthy participants

  During the results processing phase about a year and a half from the beginning of the study

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

CLL, Lymphoma or Multiple Myeloma patients and and their caregivers - healthy participants.

You may qualify if:

• Age ≥ 18 years old
• Patient sex - male and female
• CLL, Lymphoma or Multiple Myeloma patients, in follow up or during an active treatment period, who have recovered from COVID19 (COVID19 recovery defined as the presence of two negative PCR tests), who have been vaccinated against the virus or patients who plan to be vaccinated against COVID19
• Healthy participants who have been vaccinated against the virus as a control group.

You may not qualify if:

• Irrelevant

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel-Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

Location

Related Publications (2)

• Perry C, Luttwak E, Balaban R, Shefer G, Morales MM, Aharon A, Tabib Y, Cohen YC, Benyamini N, Beyar-Katz O, Neaman M, Vitkon R, Keren-Khadmy N, Levin M, Herishanu Y, Avivi I. Efficacy of the BNT162b2 mRNA COVID-19 vaccine in patients with B-cell non-Hodgkin lymphoma. Blood Adv. 2021 Aug 24;5(16):3053-3061. doi: 10.1182/bloodadvances.2021005094.

  PMID: 34387648 DERIVED

• Herishanu Y, Avivi I, Aharon A, Shefer G, Levi S, Bronstein Y, Morales M, Ziv T, Shorer Arbel Y, Scarfo L, Joffe E, Perry C, Ghia P. Efficacy of the BNT162b2 mRNA COVID-19 vaccine in patients with chronic lymphocytic leukemia. Blood. 2021 Jun 10;137(23):3165-3173. doi: 10.1182/blood.2021011568.

  PMID: 33861303 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample

MeSH Terms

Conditions

Multiple Myeloma; Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Lymphatic Diseases

Study Officials

• Yair Herishanu, Prof.

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 9, 2021
• Study Start: January 6, 2021
• Primary Completion: May 24, 2022
• Study Completion: May 24, 2022
• Last Updated: August 16, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)