Immune Response to SARS-CoV-2 (COVID-19) Vaccines in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

• Sponsor: University of Washington (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04852822
• Collaborator: CLL Global Research Foundation (Other)
• Enrollment: 500
• Locations: 12
• Anticipated Duration (Months): 40.7
• Patients Per Site: 41.7
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

This study evaluates the immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). CLL and SLL are types of blood cancer that begin in cells of the immune system. CLL/SLL and the medications used to treat these conditions may change the way vaccines work in a patient's body. The purpose of this study is to find out if patients with CLL/SLL make antibodies, or have an immune response, to the SARS-CoV-2 vaccines. Information gained from this study may help researchers better understand how effective the vaccines work in preventing COVID-19 (coronavirus disease 2019) in patients with CLL and SLL.

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma	Procedure: Biospecimen Collection; Other: Electronic Health Record Review

Detailed Description

OUTLINE:

For patients who have not been vaccinated at the time of enrollment, they will undergo collection of blood samples prior to the first vaccine dose, just before the second vaccine dose, and then at 1, 6, and 12 months after the second vaccine dose. Patients' medical records are also reviewed.

For patients enrolled after vaccination, they will undergo collection of blood samples at 1-4, 6, and 12 months after completing the vaccination series. Patients who receive booster dose also undergo collection of blood samples at 1, 6, and 12 months post final booster dose.

After completion of study, patients are followed up every 6 months for 2 years.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Multicenter Evaluation of SARS-CoV-2 Vaccines in Patients With CLL/SLL
• Actual Study Start Date: Mar 18, 2021
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Aug 8, 2024

Arms and Interventions

Arm

Intervention/Treatment

Observational (biospecimen collection, medical record review) For patients who have not been vaccinated at the time of enrollment, they will undergo collection of blood samples prior to the first vaccine dose, just before the second vaccine dose, and then at 1, 6, and 12 months after the second vaccine dose. Patients' medical records are also reviewed. For patients enrolled after vaccination, they will undergo collection of blood samples at 1-4, 6, and 12 months after completing the vaccination series. Patients who receive booster dose also undergo collection of blood samples at 1, 6, and 12 months post final booster dose.

Procedure: Biospecimen Collection; Undergo collection of blood samples; Other: Electronic Health Record Review; Medical records are reviewed

Outcome Measures

Primary Outcome Measures

1. Response rate to the SARS-CoV-2 vaccine among patients with chronic lymphocytic leukemia/small lymphocytic lymphoma [Up to 2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age >= 18 years

• A diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

• Willing and able to participate in all required evaluations and procedures in this study

Exclusion Criteria:

• Any evidence of prior SARS-CoV-2/COVID19 infection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	City of Hope	Duarte	California	United States	91010
2	UC Irvine Health/Chao Family Comprehensive Cancer Center	Orange	California	United States	92868
3	UC San Diego Medical Center - Hillcrest	San Diego	California	United States	92103
4	MedStar Georgetown University Hospital	Washington	District of Columbia	United States	20007
5	University of Miami Miller School of Medicine-Sylvester Cancer Center	Miami	Florida	United States	33136
6	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02215
7	Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center	Cleveland	Ohio	United States	44195
8	Ohio State University Comprehensive Cancer Center	Columbus	Ohio	United States	43210
9	Oregon Health & Sciences University	Portland	Oregon	United States	97239
10	M D Anderson Cancer Center	Houston	Texas	United States	77030
11	Huntsman Cancer Institute/University of Utah	Salt Lake City	Utah	United States	84112
12	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington	United States	98109

Sponsors and Collaborators

• University of Washington
• CLL Global Research Foundation

Investigators

• Principal Investigator: Chaitra S. Ujjani, MD, Fred Hutch/University of Washington Cancer Consortium

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Washington
• ClinicalTrials.gov Identifier: NCT04852822
• Other Study ID Numbers: RG1121418; NCI-2021-02178; 10646
• First Posted: Apr 21, 2021
• Last Update Posted: Aug 18, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lymphoma; Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell

Study Results

No Results Posted as of Aug 18, 2022