Assesment of the Immune Response to RSV Vaccine in Patients With Myeloma, Lymphoma and Hematological Leukemia

NCT06944119 | Active Not Recruiting

• 1 other identifier: 0646-24-TLV
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective study in which hematological oncology patients who were vaccinated against RSV will undergo a blood test to assess their immune response to the vaccine. As part of the study, hematological oncology patients with CLL, lymphoma, acute leukemia, myelodysplastic syndrome, and multiple myeloma, who are being monitored at the Hematology Institute at Ichilov, will be offered a blood test to evaluate their immune response to the RSV vaccine (serology, neutralizing antibodies, and cellular response). In the study, a blood sample of up to 10 ml will be taken in a chemistry tube and blood bank on the day of vaccination and about one month after that. The serological test will be conducted in the hospital's virology laboratory. The test result and its significance will be communicated to the patient by the treating hematologist in TASMC clinic. In this group of patients, a follow-up will be conducted over a 12-month period (during routine clinic visits) to document the incidence of RSV infection and complications related to the vaccine.

Conditions

Myeloma; Lymphoma; CLL; Myelodysplastic Syndrome; Leukemia Acute Myeloid - AML

Outcome Measures

Primary Outcomes (1)

• To assess the immune response to the RSV vaccine in patients with CLL, multiple myeloma, lymphoma, myelodysplastic syndrome, and acute leukemia, by measuring antibody levels in the blood up to 6 weeks after receiving the vaccine

  The response rate Is expected to be 60-70%

  Up to 45 days post-vaccination

Secondary Outcomes (3)

• To evaluate the safety of the vaccine by measuring the incidence of Treatment-Emergent Adverse Events

  Up to 45 days post-vaccination

• To identify factors predicting success/failure in achieving an antibody response to the vaccine.

  Up to 1 year

• To assess the incidence rate of RSV infection in individuals vaccinated against RSV over a 12-month period following vaccination.

  Up to 1 year

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 60 years and older diagnosed with multiple myeloma, lymphoma, CLL, myelodysplastic syndrome, and acute leukemia who are scheduled to receive the RSV vaccine.

You may qualify if:

• Patients aged 60 years and older
• Patients diagnosed with multiple myeloma(MM) or lymphoma or CLL or myelodysplastic syndrome (MDS) or acute leukemia

You may not qualify if:

• Patients who have been previously vaccinated against RSV
• Patients who have experienced a severe reaction to any vaccine in the past

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Neoplasms, Plasma Cell; Lymphoma; Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Bone Marrow Diseases; Hematologic Diseases

Study Officials

• Irit Avivi, MD

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: April 25, 2025
• Study Start: January 20, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 28, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)