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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-02584 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CDR0000698438 | |||
| OSU 10156 | |||
| 2011C0005 | |||
| 8834 | Other Identifier | Ohio State University Comprehensive Cancer Center | |
| 8834 | Other Identifier | CTEP | |
| N01CM00070 | U.S. NIH Grant/Contract | View source | |
| N01CM62207 | U.S. NIH Grant/Contract | View source | |
| P01CA095426 | U.S. NIH Grant/Contract | View source | |
| P30CA016058 | U.S. NIH Grant/Contract | View source | |
| P50CA140158 | U.S. NIH Grant/Contract | View source |
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This phase II trial studies the effect of lenalidomide and vaccine in treating patients with early-stage asymptomatic chronic lymphocytic leukemia or small lymphocytic lymphoma. Lenalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. It may also stimulate the immune system in different ways and stop cancer cells from growing. Vaccines may help the body build an effective immune response to kill cancer cells. Giving lenalidomide together with vaccine therapy may make a stronger immune response and kill more cancer cells.
PRIMARY OBJECTIVE:
I. To determine the proportion of early-stage, high-risk chronic lymphocytic leukemia (CLL) patients achieving a response (>= 4-fold increase from baseline and/or antibody concentrations >= 0.35 ug/mL in 6 of 7 type-specific anti-pneumococcal antibody levels) after 2 doses of pneumococcal 13-valent conjugated vaccine (Prevnar 13, PCV13 [pneumococcal polyvalent vaccine]) administered concurrent with versus sequential to low-dose lenalidomide.
SECONDARY OBJECTIVES:
I. To determine the complete response (CR) rate after 2 years of lenalidomide therapy.
II. To determine the time to first treatment (TFT), defined as the time from diagnosis to first non-lenalidomide therapy for progressive CLL as described by International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria.
III. To determine the incidence of infection and invasive pneumococcal infections following treatment with the PCV13 vaccine and either concurrent or sequential lenalidomide.
IV. To determine the frequency of humoral and cellular immune response to CLL tumor antigens following treatment with the PCV13 vaccine and either concurrent or sequential lenalidomide.
V. To determine the safety and toxicity associated with long-term lenalidomide exposure.
VI. To perform correlative pharmacodynamic and pharmacokinetic studies and correlate these with vaccine/tumor immunologic and disease response.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM A (concurrent PCV13 and lenalidomide): Patients receive low-dose lenalidomide orally (PO) once daily on days 1-28. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive 13-valent protein-conjugated pneumococcal vaccine (PCV13) intramuscularly (IM) on day 1 of courses 3 and 5.
ARM B (sequential PCV13 and lenalidomide): Patients receive PCV13 IM on days 1 and 78 (cycles 1 and 3). Patients also receive low-dose lenalidomide as in arm 1 beginning on day 1 of cycle 4. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity.
Patients may undergo bone marrow biopsy and aspirate and computed tomography (CT) during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024)
After completion of study treatment, patients are followed up for 30 days, every 3 months for 1 year, and then every 6 months thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (Concurrent PCV13 and lenalidomide) | Experimental | Patients receive low-dose lenalidomide PO once daily on days 1-28. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive PCV13 IM on day 1 of courses 3 and 5. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) |
|
| Arm B (Sequential PCV13 and lenalidomide) | Experimental | Patients receive PCV13 IM on days 1 and 78 (cycles 1 and 3). Patients also receive low-dose lenalidomide as in arm 1 beginning on day 1 of course 4. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo blood sample collection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Who Achieve an Antibody Response | Defined as achieving at least a four-fold increase in post-vaccination serotype-specific immunoglobulin G (IgG) titers or serotype-specific IgG concentrations of >= 0.35 ug/mL for 6 of 7 serotypes measured by a standard enzyme linked immunosorbent assay. | Up to 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion Rates | Summarized using descriptive statistics by treatment arm. | Up to 4 years |
| Complete Response Rate | 95% confidence intervals will be estimated. A designation of complete response (CR) requires all of the following for a period of at least two months from completion of therapy:
|
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Inclusion Criteria:
Patients must have histologically identified chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) as defined by the World Health Organization (WHO) classification of hematopoietic neoplasms
CLL/SLL cells must demonstrate one or more of the following high-risk genomic features:
Patients cannot meet any of the following consensus criteria for initiating treatment:
No prior therapy for CLL/SLL, including chemotherapy, radiotherapy, and/or immunotherapy will be allowed
Age ≥ 18 years and < 80 years (or with justification if older than 80 years due to the higher risk of toxicity in patients older than 80 years). CLL is rare in children and likely represents a different disease process. As a result, children are excluded from this study but may be eligible for future pediatric phase 2 combination trials
Estimated life expectancy of greater than 24 months
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
Total bilirubin =< 1.5 times upper limit of normal (ULN) (unless secondary to Gilbert disease)
Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate-pyruvate transaminase [SGPT]) =< 2.5 times ULN
Creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal according to the Cockcroft-Gault formula
Absolute neutrophil count (ANC) >= 1,500/uL
Platelet count >= 100,000/uL
Able to swallow capsules without difficulty and no history of malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction
Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting lenalidomide. Further, they must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before starting lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy; a FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kerry Rogers | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A (Concurrent PCV13 and Lenalidomide) | Patients receive low-dose lenalidomide PO once daily on days 1-28. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive PCV13 IM on day 1 of courses 3 and 5. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 15, 2024 |
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| Bone Marrow Aspiration | Procedure | Undergo bone marrow aspiration |
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| Bone Marrow Biopsy | Procedure | Undergo bone marrow biopsy |
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| Computed Tomography | Procedure | Undergo CT |
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| Lenalidomide | Drug | Given PO |
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| Pneumococcal Polyvalent Vaccine | Biological | Given IM (concurrently or sequentially) |
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| At 2 years |
| Time to First Treatment | Defined by International Workshop on chronic lymphocytic leukemia (CLL) (IWCLL) 2008 criteria. Summarized and explored between treatment arms using Kaplan-Meier methods. Reported as the probability of not starting the next treatment and its 95% CI for each year. | From study entry to first therapy for progressive CLL, assessed up to 4 years |
| Overall Survival | Summarized and explored between treatment arms using Kaplan-Meier methods. | Up to 4 years |
| Progression-free Survival | Defined by International Workshop on chronic lymphocytic leukemia (CLL) (IWCLL) 2008 criteria. Summarized and explored between treatment arms using Kaplan-Meier methods. | Time from start of treatment to time of disease progression or death secondary to any cause, assessed up to 2 years |
| Number of Adverse Events | Summarized by and across treatment arms, along with the type, severity, and perceived attribution to study according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5. The rates of severe (grade 3+) toxicity (at least possibly related to treatment) and non-hematologic toxicity will be summarized; assuming the incidence of severe toxicity is binomially distributed, 95% confidence intervals will be calculated. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine the toxicity patterns. Adverse events occurring in greater than 5% of the participants in each arm will be reported in this outcome measure. | Up to 4 years |
| Pharmacokinetic (PK) Parameters of Lenalidomide | PK will be graphically evaluated within and across arms to assess potential patterns and relationships. | Baseline, days 1 and 2 of course 2 (Arm A) and days 1 and 2 of course 5 (Arm B) |
| Change in Serum Immunoglobulin | Pharmacodynamic markers will be graphically evaluated within and across arms to assess potential patterns and relationships. | Baseline up to 4 years |
| Change in Anti-tumor Antibody Levels | Pharmacodynamic markers will be graphically evaluated within and across arms to assess potential patterns and relationships. | Baseline up to 4 years |
| Antibody Titre Levels for Serotype 1 | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Up to cycle 10 day 1 (each cycle is 28 days) |
| Antibody Titre Levels for Serotype 2 | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Up to cycle 10 day 1 (each cycle is 28 days) |
| Antibody Titre Levels for Serotype 3 | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Up to cycle 10 day 1 (each cycle is 28 days) |
| Antibody Titre Levels for Serotype 4 | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Up to cycle 10 day 1 (each cycle is 28 days) |
| Antibody Titre Levels for Serotype 5 | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Up to cycle 10 day 1 (each cycle is 28 days) |
| Antibody Titre Levels for Serotype 8 | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Up to cycle 10 day 1 (each cycle is 28 days) |
| Antibody Titre Levels for Serotype 9N | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Up to cycle 10 day 1 (each cycle is 28 days) |
| Antibody Titre Levels for Serotype 12F | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Up to cycle 10 day 1 (each cycle is 28 days) |
| Antibody Titre Levels for Serotype 14 | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Up to cycle 10 day 1 (each cycle is 28 days) |
| Antibody Titre Levels for Serotype 17F | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Up to cycle 10 day 1 (each cycle is 28 days) |
| Antibody Titre Levels for Serotype 19F | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Up to cycle 10 day 1 (each cycle is 28 days) |
| Antibody Titre Levels for Serotype 20 | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Up to cycle 10 day 1 (each cycle is 28 days) |
| Antibody Titre Levels for Serotype 22F | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Up to cycle 10 day 1 (each cycle is 28 days) |
| Antibody Titre Levels for Serotype 23F | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Up to cycle 10 day 1 (each cycle is 28 days) |
| Antibody Titre Levels for Serotype 6B | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Up to cycle 10 day 1 (each cycle is 28 days) |
| Antibody Titre Levels for Serotype 10A | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Up to cycle 10 day 1 (each cycle is 28 days) |
| Antibody Titre Levels for Serotype 11A | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Up to cycle 10 day 1 (each cycle is 28 days) |
| Antibody Titre Levels for Serotype 7F | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Up to cycle 10 day 1 (each cycle is 28 days) |
| Antibody Titre Levels for Serotype 15B | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Up to cycle 10 day 1 (each cycle is 28 days) |
| Antibody Titre Levels for Serotype 18C | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Up to cycle 10 day 1 (each cycle is 28 days) |
| Antibody Titre Levels for Serotype 19A | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Up to cycle 10 day 1 (each cycle is 28 days) |
| Antibody Titre Levels for Serotype 9V | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Up to cycle 10 day 1 (each cycle is 28 days) |
| Antibody Titre Levels for Serotype 33F | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Up to cycle 10 day 1 (each cycle is 28 days) |
| FG001 | Arm B (Sequential PCV13 and Lenalidomide) | Patients receive PCV13 IM on days 1 and 78 (cycles 1 and 3). Patients also receive low-dose lenalidomide as in arm 1 beginning on day 1 of course 4. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially) |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A (Concurrent PCV13 and Lenalidomide) | Patients receive low-dose lenalidomide PO once daily on days 1-28. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive PCV13 IM on day 1 of courses 3 and 5. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially) |
| BG001 | Arm B (Sequential PCV13 and Lenalidomide) | Patients receive PCV13 IM on days 1 and 78 (cycles 1 and 3). Patients also receive low-dose lenalidomide as in arm 1 beginning on day 1 of course 4. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Patients Who Achieve an Antibody Response | Defined as achieving at least a four-fold increase in post-vaccination serotype-specific immunoglobulin G (IgG) titers or serotype-specific IgG concentrations of >= 0.35 ug/mL for 6 of 7 serotypes measured by a standard enzyme linked immunosorbent assay. | Posted | Number | percentage of participants | Up to 1 month |
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| Secondary | Seroconversion Rates | Summarized using descriptive statistics by treatment arm. | Not Posted | Up to 4 years | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Complete Response Rate | 95% confidence intervals will be estimated. A designation of complete response (CR) requires all of the following for a period of at least two months from completion of therapy:
| The number of participants analyzed for complete response at 2 years is the number of participants for whom response data was available at the 2 year mark. | Posted | Number | 95% Confidence Interval | percentage of participants | At 2 years |
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| Secondary | Time to First Treatment | Defined by International Workshop on chronic lymphocytic leukemia (CLL) (IWCLL) 2008 criteria. Summarized and explored between treatment arms using Kaplan-Meier methods. Reported as the probability of not starting the next treatment and its 95% CI for each year. | Posted | Number | 95% Confidence Interval | probabibility rate | From study entry to first therapy for progressive CLL, assessed up to 4 years |
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| Secondary | Overall Survival | Summarized and explored between treatment arms using Kaplan-Meier methods. | Not Posted | Up to 4 years | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival | Defined by International Workshop on chronic lymphocytic leukemia (CLL) (IWCLL) 2008 criteria. Summarized and explored between treatment arms using Kaplan-Meier methods. | Not Posted | Time from start of treatment to time of disease progression or death secondary to any cause, assessed up to 2 years | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Number of Adverse Events | Summarized by and across treatment arms, along with the type, severity, and perceived attribution to study according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5. The rates of severe (grade 3+) toxicity (at least possibly related to treatment) and non-hematologic toxicity will be summarized; assuming the incidence of severe toxicity is binomially distributed, 95% confidence intervals will be calculated. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine the toxicity patterns. Adverse events occurring in greater than 5% of the participants in each arm will be reported in this outcome measure. | Posted | Number | Number of Events | Up to 4 years |
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| Secondary | Pharmacokinetic (PK) Parameters of Lenalidomide | PK will be graphically evaluated within and across arms to assess potential patterns and relationships. | Not Posted | Baseline, days 1 and 2 of course 2 (Arm A) and days 1 and 2 of course 5 (Arm B) | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Change in Serum Immunoglobulin | Pharmacodynamic markers will be graphically evaluated within and across arms to assess potential patterns and relationships. | Not Posted | Baseline up to 4 years | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Change in Anti-tumor Antibody Levels | Pharmacodynamic markers will be graphically evaluated within and across arms to assess potential patterns and relationships. | Not Posted | Baseline up to 4 years | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Antibody Titre Levels for Serotype 1 | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1. | Posted | Mean | Standard Deviation | micrograms per milliliter | Up to cycle 10 day 1 (each cycle is 28 days) |
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| Secondary | Antibody Titre Levels for Serotype 2 | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1. | Posted | Mean | Standard Deviation | micrograms per milliliter | Up to cycle 10 day 1 (each cycle is 28 days) |
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| Secondary | Antibody Titre Levels for Serotype 3 | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1. | Posted | Mean | Standard Deviation | micrograms per milliliter | Up to cycle 10 day 1 (each cycle is 28 days) |
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| Secondary | Antibody Titre Levels for Serotype 4 | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1. | Posted | Mean | Standard Deviation | micrograms per milliliter | Up to cycle 10 day 1 (each cycle is 28 days) |
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| Secondary | Antibody Titre Levels for Serotype 5 | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1. | Posted | Mean | Standard Deviation | micrograms per milliliter | Up to cycle 10 day 1 (each cycle is 28 days) |
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| Secondary | Antibody Titre Levels for Serotype 8 | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1. | Posted | Mean | Standard Deviation | micrograms per milliliter | Up to cycle 10 day 1 (each cycle is 28 days) |
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| Secondary | Antibody Titre Levels for Serotype 9N | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1. | Posted | Mean | Standard Deviation | micrograms per milliliter | Up to cycle 10 day 1 (each cycle is 28 days) |
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| Secondary | Antibody Titre Levels for Serotype 12F | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1. | Posted | Mean | Standard Deviation | micrograms per milliliter | Up to cycle 10 day 1 (each cycle is 28 days) |
| ||||||||||||||||||||||||||||||
| Secondary | Antibody Titre Levels for Serotype 14 | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1. | Posted | Mean | Standard Deviation | micrograms per milliliter | Up to cycle 10 day 1 (each cycle is 28 days) |
| ||||||||||||||||||||||||||||||
| Secondary | Antibody Titre Levels for Serotype 17F | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1. | Posted | Mean | Standard Deviation | micrograms per milliliter | Up to cycle 10 day 1 (each cycle is 28 days) |
| ||||||||||||||||||||||||||||||
| Secondary | Antibody Titre Levels for Serotype 19F | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1. | Posted | Mean | Standard Deviation | micrograms per milliliter | Up to cycle 10 day 1 (each cycle is 28 days) |
| ||||||||||||||||||||||||||||||
| Secondary | Antibody Titre Levels for Serotype 20 | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1. | Posted | Mean | Standard Deviation | micrograms per milliliter | Up to cycle 10 day 1 (each cycle is 28 days) |
| ||||||||||||||||||||||||||||||
| Secondary | Antibody Titre Levels for Serotype 22F | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1. | Posted | Mean | Standard Deviation | micrograms per milliliter | Up to cycle 10 day 1 (each cycle is 28 days) |
| ||||||||||||||||||||||||||||||
| Secondary | Antibody Titre Levels for Serotype 23F | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1. | Posted | Mean | Standard Deviation | micrograms per milliliter | Up to cycle 10 day 1 (each cycle is 28 days) |
| ||||||||||||||||||||||||||||||
| Secondary | Antibody Titre Levels for Serotype 6B | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1. | Posted | Mean | Standard Deviation | micrograms per milliliter | Up to cycle 10 day 1 (each cycle is 28 days) |
| ||||||||||||||||||||||||||||||
| Secondary | Antibody Titre Levels for Serotype 10A | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1. | Posted | Mean | Standard Deviation | micrograms per milliliter | Up to cycle 10 day 1 (each cycle is 28 days) |
| ||||||||||||||||||||||||||||||
| Secondary | Antibody Titre Levels for Serotype 11A | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1. | Posted | Mean | Standard Deviation | micrograms per milliliter | Up to cycle 10 day 1 (each cycle is 28 days) |
| ||||||||||||||||||||||||||||||
| Secondary | Antibody Titre Levels for Serotype 7F | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1. | Posted | Mean | Standard Deviation | micrograms per milliliter | Up to cycle 10 day 1 (each cycle is 28 days) |
| ||||||||||||||||||||||||||||||
| Secondary | Antibody Titre Levels for Serotype 15B | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1. | Posted | Mean | Standard Deviation | micrograms per milliliter | Up to cycle 10 day 1 (each cycle is 28 days) |
| ||||||||||||||||||||||||||||||
| Secondary | Antibody Titre Levels for Serotype 18C | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1. | Posted | Mean | Standard Deviation | micrograms per milliliter | Up to cycle 10 day 1 (each cycle is 28 days) |
| ||||||||||||||||||||||||||||||
| Secondary | Antibody Titre Levels for Serotype 19A | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1. | Posted | Mean | Standard Deviation | micrograms per milliliter | Up to cycle 10 day 1 (each cycle is 28 days) |
| ||||||||||||||||||||||||||||||
| Secondary | Antibody Titre Levels for Serotype 9V | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1. | Posted | Mean | Standard Deviation | micrograms per milliliter | Up to cycle 10 day 1 (each cycle is 28 days) |
| ||||||||||||||||||||||||||||||
| Secondary | Antibody Titre Levels for Serotype 33F | Summarized using descriptive statistics by treatment arm. Changes in serotype-specific markers will be graphically evaluated between the two arms and the nonparametric Mann-Whitney rank sum test will be used to compare the geometric mean concentrations. | Participants in arm A were analyzed on cycle 1 day 1 (c1d1), c3d1, c5d1, and c6d1. Participants in arm B were analyzed on c1d1, c3d1, c4d1, and c10d1. | Posted | Mean | Standard Deviation | micrograms per milliliter | Up to cycle 10 day 1 (each cycle is 28 days) |
|
Up to 4 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A (Concurrent PCV13 and Lenalidomide) | Patients receive low-dose lenalidomide PO once daily on days 1-28. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive PCV13 IM on day 1 of courses 3 and 5. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially) | 0 | 24 | 12 | 24 | 24 | 24 |
| EG001 | Arm B (Sequential PCV13 and Lenalidomide) | Patients receive PCV13 IM on days 1 and 78 (cycles 1 and 3). Patients also receive low-dose lenalidomide as in arm 1 beginning on day 1 of course 4. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially) | 1 | 25 | 13 | 25 | 25 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Chest pain- cardiac | Cardiac disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Fever | General disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Gallbladder pain | Hepatobiliary disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Meningitis | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE v.5.0 | Systematic Assessment |
| |
| Alanine Aminotransferase increased | Investigations | CTCAE v.5.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE v.5.0 | Systematic Assessment |
| |
| Creatinine Increased | Investigations | CTCAE v.5.0 | Systematic Assessment |
| |
| Lipase Increased | Investigations | CTCAE v.5.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE v.5.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Neoplasms benign, malignant and unspecified, other | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v.5.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Prostatic obstruction | Reproductive system and breast disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Rash Maculo-papular | Skin and subcutaneous tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE v.5.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Lymph node pain | Blood and lymphatic system disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Cardiac disorders- other | Cardiac disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Sinus Tachycardia | Cardiac disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Ear and labyrinth disorders, other | Ear and labyrinth disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Ear Pain | Ear and labyrinth disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Eye disorders, other | Eye disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Floaters | Eye disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Bloating | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Gastrointestinal disorders, other | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Chills | General disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Fever | General disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Flu like symptoms | General disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Localized edema | General disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Pain | General disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Gallbladder pain | Hepatobiliary disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Bronchial infection | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Infections and infestations, other | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Nail infection | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Papulopustular rash | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Prostate infection | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | CTCAE v.5.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE v.5.0 | Systematic Assessment |
| |
| Injury, poisoning and procedural complications, other | Injury, poisoning and procedural complications | CTCAE v.5.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE v.5.0 | Systematic Assessment |
| |
| Alkaline Phosphatase Increased | Investigations | CTCAE v.5.0 | Systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | CTCAE v.5.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE v.5.0 | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE v.5.0 | Systematic Assessment |
| |
| Hemoglobin increased | Investigations | CTCAE v.5.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE v.5.0 | Systematic Assessment |
| |
| Lymphocyte count increased | Investigations | CTCAE v.5.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE v.5.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE v.5.0 | Systematic Assessment |
| |
| Weight gain | Investigations | CTCAE v.5.0 | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE v.5.0 | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE v.5.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hyperuricemia | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Metabolism and nutrition disorders, other | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Musculoskeletal and connective tissue disorder, other | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Neoplasms benign, malignant and unspecified, other | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v.5.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Dysesthesia | Nervous system disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Sinus pain | Nervous system disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Renal calculi | Renal and urinary disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Laryngeal inflammation | Respiratory, thoracic and mediastinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders, other | Respiratory, thoracic and mediastinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders, other | Skin and subcutaneous tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE v.5.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kerry Rogers | The Ohio State University Comprehensive Cancer Center | 614-293-3873 | Kerry.Rogers@osumc.edu |
| Jul 29, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 15, 2024 | Jul 29, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D001706 | Biopsy |
| D000077269 | Lenalidomide |
| D022242 | Pneumococcal Vaccines |
| C414006 | 23-valent pneumococcal capsular polysaccharide vaccine |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | Arm B (Sequential PCV13 and Lenalidomide) | Patients receive PCV13 IM on days 1 and 78 (cycles 1 and 3). Patients also receive low-dose lenalidomide as in arm 1 beginning on day 1 of course 4. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially) |
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| Arm B (Sequential PCV13 and Lenalidomide) |
Patients receive PCV13 IM on days 1 and 78 (cycles 1 and 3). Patients also receive low-dose lenalidomide as in arm 1 beginning on day 1 of course 4. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo bone marrow biopsy and aspirate and CT during screening and blood sample collection throughout the study. (Blood sample collection discontinued with approval of protocol version 24 dated 3/15/2024) Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspiration: Undergo bone marrow aspiration Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT Lenalidomide: Given PO Pneumococcal Polyvalent Vaccine: Given IM (concurrently or sequentially) |
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