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Stopped was stopped prematurely due to drug manufacturer withdrawing supply/funding. Patients already enrolled on study were allowed to continue treatment.
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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This research study is studying several new investigational drug combinations as a possible treatment for follicular lymphoma.
The drugs involved are:
This research study is a Phase 1 clinical trial. Phase 1 clinical trials test the safety of an investigational intervention and also try to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the intervention is being studied.
Utomilumab and avelumab are drugs which may stimulate the immune system against tumor cells. Because they activate the immune system, they are sometimes called immunotherapy drugs. The FDA (the U.S. Food and Drug Administration) has not approved utomilumab or avelumab for treatment of this cancer.
Rituximab is approved by the FDA (the U.S. Food and Drug Administration) as a treatment option for this disease.
The purpose of this research is to learn about the effects of combining the immunotherapy drugs utomilumab and avelumab with rituximab in follicular lymphoma. The investigators hope to learn how safe the combinations of treatments are for participants with follicular lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituximab+Utomilumab+Avelumab-3mg | Experimental |
|
|
| Rituximab+Utomilumab+Avelumab-10mg | Experimental |
|
|
| PF04518600-0.3mg | Experimental | -PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg |
|
| Rituximab+PF04518600-0.3mg | Experimental |
|
|
| Rituximab+Utomilumab+PF04518600-0.3mg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Recommended Phase 2 Dosing | Patients assessed for DLT after each 28-day cycle of treatment. Up to two cohorts of 3 patients per dose level plus expansion cohort. Rituximab/Utomilumab/Avelumab arm assessed 2 dose levels. Rituximab/Utomilumab/PF04518600 assessed 3 dose levels. Rituximab/PF04518600/Avelumab assessed 2 dose levels. | 6 months total, assessed after each 28-day cycle |
| Number of Participants With Complete Response Per Lugano Criteria | Per 2014 Lugano criteria, a complete response is defined as PET-CT, score 1, 2, or 3* with or without a residual mass on 5PS Or on CT, target nodes/nodal masses must regress to ≤ 1.5 cm in LDi, and no extralymphatic sites of disease | Response assessed after completing treatment (6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Partial Response Per Lugano Criteria | Per 2014 Lugano criteria, partial response is defined as PET-CT Score 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size Or On CT ≥ 50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; no increase in non-measured lesions; spleen if enlarged must have regressed by >50% in length beyond normal |
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Inclusion Criteria:
Patients must have histologically determined follicular lymphoma, grade 1-3A, with pathologic review at the participating institutions, that has either:
Patients with active histologic transformation are excluded. Relapsed/refractory patients with prior transformation may be included as long as there is no evidence of transformation at the time of study entry by pathology, imaging, or clinical status
Patients in part B, without prior anti-lymphoma therapy, must be in need of treatment as defined by any of the following criteria:
Symptomatic adenopathy
Organ function impairment due to disease involvement, including cytopenias due to marrow involvement (WBC <1.5x109/L; absolute neutrophil count [ANC] <1.0x109/L, Hgb <10g/dL; platelets <100x109/L)
Constitutional symptoms
Maximum diameter of disease > 7cm
-->3 nodal sites of involvement
Risk of local compressive symptoms
Splenomegaly (craniocaudal diameter > 16cm on CT imaging)
Clinically significant pleural or peritoneal effusion
Leukemic phase (>5x109/L circulating malignant cells)
Rapid generalized disease progression
Renal infiltration
Bone lesions
Patients may have had a prior autologous stem cell transplant and may have been treated with autologous chimeric antigen receptor T-cells (CAR T-cells).
Not in need of urgent cytoreductive therapy in the opinion of the investigator
Measurable disease that has not been previously irradiated on CT scans of at least 1.5 cm, OR if the patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation. Imaging must be completed no greater than 6 weeks prior to study enrollment.
Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (see Appendix A)
Adequate hematologic and organ function:
AST/ALT < 2.5 X ULN, unless documented liver involvement by lymphoma, in which case AST/ALT must be <5 x ULN
Age >18 years
Ability to understand and the willingness to sign a written informed consent document.
Willingness to provide pre-treatment (or recent archival w/o intervening therapy), and on-treatment tumor samples by core needle or excisional surgical biopsy
Exclusion Criteria:
Patients currently receiving anticancer therapies or who have received anticancer therapies within 28 days of the start of study drug (including chemotherapy, radiation therapy, antibody based therapy, etc.), or 56 days for radioimmunotherapy. Steroids for symptom palliation are allowed, but must be either discontinued or on stable doses of < 10mg daily of prednisone (or the equivalent) at the time of initiation of protocol therapy.
Patients may not be receiving any other investigational agents, or have received investigational agents within 4 weeks (or 3 half-lives, whichever is longer) of beginning treatment.
History of severe allergic or anaphylactic reactions to monoclonal antibody therapy unless in consultation with an allergy specialist they are deemed eligible for retreatment with desensitization.
Patients who have previously received therapy with any drug that works by a similar mechanism of action as any drug being tested in a given cohort will be excluded from that cohort but will be allowed to enroll in other open cohorts.
Patients who have undergone prior allogeneic stem cell transplantation
Patients with a history of or active autoimmune disease (except controlled asthma, Hashimoto thyroiditis, atopic dermatitis, and/or vitiligo), or requiring systemic corticosteroids at a dose of 10mg prednisone equivalent daily. Patients with a history of autoimmune disease who never required corticosteroids and with no evidence of disease activity, and in whom the risk of reactivation is felt not to be serious, may be enrolled after discussion with the overall study chair. Exceptions to this are patients with a history of inflammatory bowel disease (ulcerative colitis and Crohn's disease). These patients are excluded regardless of whether their disease is active or inactive.
Patients with active pneumonitis or colitis, or patients with chronic liver disease and/or cirrhosis
Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or patients that may require major surgery during the course of the study.
Patients with known leptomeningeal or brain metastases. Imaging or spinal fluid analysis to exclude CNS involvement is not required, unless there is clinical suspicion by the treating investigator.
Patients with known HIV infection or hepatitis B or C infection. Testing for HIV is optional. Testing for hepatitis B and C is mandatory. Patients with hepatitis B core Ab positivity but negative surface antigen and negative viral load may be enrolled if they can be treated with a prophylactic agent (eg, entecavir); patients with hepatitis C seropositivity who have undergone successful treatment with negative viral load can also be enrolled.
Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
Prior history of another malignancy (except for non-melanoma skin cancer or in situ cervical or breast cancer) unless disease free for at least three years. Patients with prostate cancer are allowed if PSA is less than 1.
Patients should not have received immunization with attenuated live vaccine within one week of study entry or during study period.
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. Women of child bearing potential (WOCBP) or male study participants of reproductive potential must agree to use double barrier birth control method of contraception during the course of the study treatment period and for 3 months after completing study treatment. WOCBP are defined as sexually mature women who have not undergone a hysterectomy or who are not postmenopausal (no menses) for at least 12 consecutive months. WOCBP must have a negative urine or serum pregnancy test within 14 days prior to administration of treatment.
History of noncompliance to medical regimens.
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
Patients with any one of the following currently on or in the previous 6 months will be excluded from cohorts A2, A3, and B2 (any cohort that includes treatment with PF04518600) myocardial infarction, congenital long QT syndrome, torsade's de points, left anterior hemiblock (bifascicular block), unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism or other clinically significant episode of thrombo-embolic disease*. Ongoing cardiac dysrhythmias of NCI CTCAE grade > 2, atrial fibrillation of any grade, or QTcF interval >470msec at screening (except in case of right bundle branch block, these cases must be discussed with the principal investigator). *Cases must be discussed in detail with the principal investigator to judge eligibility. Anticoagulation (heparin only, no vitamin K antagonists or factor Xa inhibitors will be allowed if indicated.
Other uncontrolled intercurrent illness that would limit adherence to study requirements
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| Name | Affiliation | Role |
|---|---|---|
| Caron A. Jacobson, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| Yale New-Haven Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37851072 | Derived | Merryman RW, Redd RA, Freedman AS, Ahn IE, Brown JR, Crombie JL, Davids MS, Fisher DC, Jacobsen ED, Kim AI, LaCasce AS, Ng S, Odejide OO, Parry EM, Isufi I, Kline J, Cohen JB, Mehta-Shah N, Bartlett NL, Mei M, Kuntz TM, Wolff J, Rodig SJ, Armand P, Jacobson CA. A multi-cohort phase 1b trial of rituximab in combination with immunotherapy doublets in relapsed/refractory follicular lymphoma. Ann Hematol. 2024 Jan;103(1):185-198. doi: 10.1007/s00277-023-05475-0. Epub 2023 Oct 18. |
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The study was terminated early due to the drug manufacturer stopping drug supply.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rituximab+Utomilumab+Avelumab-3mg |
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug |
| FG001 | Rituximab+Utomilumab+Avelumab-10mg |
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug |
| FG002 | PF04518600-0.3mg | -PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40 |
| FG003 | Rituximab+PF04518600-0.3mg |
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40 |
| FG004 | Rituximab+Utomilumab+PF04518600-0.3mg |
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40 |
| FG005 | Rituximab+PF04518600-0.3mg+Avelumab-3mg |
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40 Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug |
| FG006 | Rituximab+PF04518600-0.3mg+Avelumab-10mg |
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40 Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The number of unique patients analyzed is 24; however, one patient was treated on two arms (Rituximab+Utomilumab+Avelumab-10mg and Rituximab+PF04518600-0.3mg)
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| ID | Title | Description |
|---|---|---|
| BG000 | Rituximab+Utomilumab+Avelumab-3mg |
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Recommended Phase 2 Dosing | Patients assessed for DLT after each 28-day cycle of treatment. Up to two cohorts of 3 patients per dose level plus expansion cohort. Rituximab/Utomilumab/Avelumab arm assessed 2 dose levels. Rituximab/Utomilumab/PF04518600 assessed 3 dose levels. Rituximab/PF04518600/Avelumab assessed 2 dose levels. | All patients treated with any amount of study treatment. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg) | Posted | Number | mg | 6 months total, assessed after each 28-day cycle |
|
Adverse events collected starting at baseline over each of 6 cycles of treatment (for 28-day cycles) and up to 30 days after last dose of treatment or until resolution of toxicity to grade 1 or baseline. All-Cause Mortality was monitored up to 4 years (6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months).
There were no patients treated on arm 3, Rituximab+Avelumab+PF04518600. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rituximab+Utomilumab+Avelumab-3mg |
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Platelet count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
This trial was terminated early due to drug manufacturer discontinuing drug and no longer supplying.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Caron Jacobson, MD | Dana-Farber Cancer Institute | 617-632-6404 | caron_jacobson@dfci.harvard.edu |
Not provided
| 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 | Feb 18, 2021 | Sep 20, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
Not provided
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| C577122 | utomilumab |
| C000609138 | avelumab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Experimental |
|
|
| Rituximab+PF04518600-0.3mg+Avelumab-3mg | Experimental |
|
|
| Rituximab+PF04518600-0.3mg+Avelumab-10mg | Experimental |
|
|
|
|
| Utomilumab | Drug | Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug |
|
|
| Avelumab | Drug | Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug |
|
|
| PF04518600 | Drug | In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40 |
|
|
| Response assessed after completing treatment (6 months) |
| Number of Participants With Objective Response Per Lugano Criteria | Objective response rate is defined as complete + partial response (CR + PR) Per 2014 Lugano criteria, CR is defined as PET-CT, score 1, 2, or 3* with or without a residual mass on 5PS Or on CT, target nodes/nodal masses must regress to ≤ 1.5 cm in LDi, and no extralymphatic sites of disease Per 2014 Lugano criteria, PR is defined as PET-CT Score 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size. Or On CT ≥ 50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; no increase in non-measured lesions; spleen if enlarged must have regressed by >50% in length beyond normal | Response assessed after completing treatment (6 months) |
| Number of Participants With Objective Response Per LYRIC Criteria | Objective response rate is defined as complete + partial response (CR + PR) Per LYRIC criteria, CR is defined as PET-CT, score 1, 2, or 3* with or without a residual mass on 5PS Or on CT, target nodes/nodal masses must regress to ≤ 1.5 cm in LDi, and no extralymphatic sites of disease Per LYRIC criteria, PR is defined as PET-CT Score 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size. Or On CT ≥ 50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; no increase in non-measured lesions; spleen if enlarged must have regressed by >50% in length beyond normal | Response assessed after completing treatment (6 months) |
| Number of Participants With Complete Response Per LYRIC Criteria | Per LYRIC criteria, complete response is defined as PET-CT, score 1, 2, or 3* with or without a residual mass on 5PS Or on CT, target nodes/nodal masses must regress to ≤ 1.5 cm in LDi, and no extralymphatic sites of disease | Response assessed after completing treatment (6 months) |
| Progression-Free Survival Per Lugano Criteria | Time from registration until earlier of progression (Lugano criteria) or death from any cause, censored at date last known alive and progression-free | 6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months |
| Progression-Free Survival Per LYRIC Criteria | Time from registration until earlier of progression (LYRIC criteria) or death from any cause, censored at date last known alive and progression-free | 6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months |
| Overall Survival | Time from registration until death from any cause, censored at date last known alive | 6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months |
| Number of Participants With Grade 3 and Higher Toxicities | Number of patients who experience any adverse event with grade 3 or higher regardless of attribution to one or more study treatments | 6 cycles (approximately 6 months) of treatment |
| Number of Participants With Grade 3 and Higher Related Toxicities | Number of patients who experience any adverse event with grade 3 or higher related to one or more study treatments | 6 cycles (approximately 6 months) of treatment |
| Number of Participants With Grade 2 or Higher Toxicity | Number of patients who experience any adverse event with grade 2 or higher regardless of treatment attribution | 6 cycles (approximately 6 months) of treatment followed |
| New Haven |
| Connecticut |
| 06510 |
| United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Washington University in St. Louis | St Louis | Missouri | 63130 | United States |
| BG001 | Rituximab+Utomilumab+Avelumab-10mg |
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug -PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg |
| BG002 | PF04518600-0.3mg | PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40 |
| BG003 | Rituximab+PF04518600-0.3mg |
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40 |
| BG004 | Rituximab+Utomilumab+PF04518600-0.3mg |
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40 |
| BG005 | Rituximab+PF04518600-0.3mg+Avelumab-3mg |
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40 Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug |
| BG006 | Rituximab+PF04518600-0.3mg+Avelumab-10mg |
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40 Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug |
| BG007 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| ECOG Performance Status | Count of Participants | Participants |
|
| OG001 | Rituximab/Utomilumab/Avelumab - Level 2 | Dose level 2: Rituximab 375mg/mg2 IV q7 days x 4 doses, utomilumab 100mg IV q28d, avelumab 10mg/kg IV q14 days
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug |
| OG002 | Rituximab/Utomilumab/PF04518600 - Level 1 | Dose level 0: PF-04518600 0.3mg/kg IV q14 days
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40 |
| OG003 | Rituximab/Utomilumab/PF04518600 - Level 2 | Dose level 1: Rituximab 375mg/m2 IV q7 days x 4 doses, PF-04518600 0.3mg/kg IV q14 days
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40 |
| OG004 | Rituximab/Utomilumab/PF04518600 - Level 3 | Dose level 2: Rituximab 375mg/m2 IV q7 days x 4 doses, PF-04518600 0.3mg/kg IV q14 days, utomilumab 100mg IV q28 days
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40 |
| OG005 | Rituximab/PF04518600/Avelumab - Level 1 | Dose level 1: Rituximab 375mg/m2 IV q7 days x 4 doses, PF-04518600 0.3mg/kg IV q14 days, avelumab 3mg/kg IV q14 days
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40 Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug |
| OG006 | Rituximab/PF04518600/Avelumab - Level 2 | Dose level 2: Rituximab 375mg/m2 IV q7 days x 4 doses, PF-04518600 0.3mg/kg IV q14 days, avelumab 10mg/kg IV q14 days
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40 Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug |
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| Primary | Number of Participants With Complete Response Per Lugano Criteria | Per 2014 Lugano criteria, a complete response is defined as PET-CT, score 1, 2, or 3* with or without a residual mass on 5PS Or on CT, target nodes/nodal masses must regress to ≤ 1.5 cm in LDi, and no extralymphatic sites of disease | All patients treated with any amount of study treatment. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg) | Posted | Count of Participants | Participants | Response assessed after completing treatment (6 months) |
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| Secondary | Number of Participants With Partial Response Per Lugano Criteria | Per 2014 Lugano criteria, partial response is defined as PET-CT Score 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size Or On CT ≥ 50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; no increase in non-measured lesions; spleen if enlarged must have regressed by >50% in length beyond normal | All patients treated with any amount of study treatment. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg) | Posted | Count of Participants | Participants | Response assessed after completing treatment (6 months) |
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| Secondary | Number of Participants With Objective Response Per Lugano Criteria | Objective response rate is defined as complete + partial response (CR + PR) Per 2014 Lugano criteria, CR is defined as PET-CT, score 1, 2, or 3* with or without a residual mass on 5PS Or on CT, target nodes/nodal masses must regress to ≤ 1.5 cm in LDi, and no extralymphatic sites of disease Per 2014 Lugano criteria, PR is defined as PET-CT Score 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size. Or On CT ≥ 50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; no increase in non-measured lesions; spleen if enlarged must have regressed by >50% in length beyond normal | All patients treated with any amount of study treatment. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg) | Posted | Count of Participants | Participants | Response assessed after completing treatment (6 months) |
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| Secondary | Number of Participants With Objective Response Per LYRIC Criteria | Objective response rate is defined as complete + partial response (CR + PR) Per LYRIC criteria, CR is defined as PET-CT, score 1, 2, or 3* with or without a residual mass on 5PS Or on CT, target nodes/nodal masses must regress to ≤ 1.5 cm in LDi, and no extralymphatic sites of disease Per LYRIC criteria, PR is defined as PET-CT Score 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size. Or On CT ≥ 50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; no increase in non-measured lesions; spleen if enlarged must have regressed by >50% in length beyond normal | All patients treated with any amount of study treatment. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg) | Posted | Count of Participants | Participants | Response assessed after completing treatment (6 months) |
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| Secondary | Number of Participants With Complete Response Per LYRIC Criteria | Per LYRIC criteria, complete response is defined as PET-CT, score 1, 2, or 3* with or without a residual mass on 5PS Or on CT, target nodes/nodal masses must regress to ≤ 1.5 cm in LDi, and no extralymphatic sites of disease | All patients treated with any amount of study treatment. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg) | Posted | Count of Participants | Participants | Response assessed after completing treatment (6 months) |
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| Secondary | Progression-Free Survival Per Lugano Criteria | Time from registration until earlier of progression (Lugano criteria) or death from any cause, censored at date last known alive and progression-free | All patients treated with any amount of study treatment. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg) | Posted | Median | Full Range | months | 6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months |
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| Secondary | Progression-Free Survival Per LYRIC Criteria | Time from registration until earlier of progression (LYRIC criteria) or death from any cause, censored at date last known alive and progression-free | All patients treated with any amount of study treatment. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg) | Posted | Median | Full Range | months | 6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months |
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| Secondary | Overall Survival | Time from registration until death from any cause, censored at date last known alive | All patients treated with any amount of study treatment. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg) | Posted | Median | Full Range | months | 6 cycles (approximately 6 months) of treatment followed by 24 months of active follow-up with contact every 3 months followed by 3-year survival follow-up with contact every 6 months |
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| Secondary | Number of Participants With Grade 3 and Higher Toxicities | Number of patients who experience any adverse event with grade 3 or higher regardless of attribution to one or more study treatments | All patients treated with any amount of study treatment. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg) | Posted | Count of Participants | Participants | 6 cycles (approximately 6 months) of treatment |
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| Secondary | Number of Participants With Grade 3 and Higher Related Toxicities | Number of patients who experience any adverse event with grade 3 or higher related to one or more study treatments | All patients treated with any amount of study treatment. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg) | Posted | Count of Participants | Participants | 6 cycles (approximately 6 months) of treatment |
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| Secondary | Number of Participants With Grade 2 or Higher Toxicity | Number of patients who experience any adverse event with grade 2 or higher regardless of treatment attribution | All patients treated with any amount of study treatment. One patient was included separately in arms 1 (Rituximab+Utomilumab+Avelumab-3mg) and 3 (PF04518600-0.3mg) | Posted | Count of Participants | Participants | 6 cycles (approximately 6 months) of treatment followed |
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| 2 |
| 6 |
| 4 |
| 6 |
| 4 |
| 6 |
| EG001 | Rituximab+Utomilumab+Avelumab-10mg |
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug -PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg | 1 | 4 | 0 | 4 | 3 | 4 |
| EG002 | PF04518600-0.3mg | PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40 | 0 | 3 | 0 | 3 | 2 | 3 |
| EG003 | Rituximab+PF04518600-0.3mg |
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40 | 0 | 3 | 1 | 3 | 3 | 3 |
| EG004 | Rituximab+Utomilumab+PF04518600-0.3mg |
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment Utomilumab: Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40 | 0 | 9 | 1 | 9 | 6 | 9 |
| EG005 | Rituximab+PF04518600-0.3mg+Avelumab-3mg |
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40 Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug | 0 | 0 | 0 | 0 | 0 | 0 |
| EG006 | Rituximab+PF04518600-0.3mg+Avelumab-10mg |
Rituximab: Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment PF04518600: In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40 Avelumab: Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug | 0 | 0 | 0 | 0 | 0 | 0 |
| Obstruction gastric | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypertriglyceridemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Intracranial hemorrhage | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
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| Infections and infestations - Other, specify | Infections and infestations | CTCAE (4.0) | Systematic Assessment | COVID-19 |
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| Infusion related reaction | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
|
| Lymph node pain | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| White blood cell decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment | Increased Lymphadenopathy |
|
| Chills | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | CTCAE (4.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Esophageal stenosis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flushing | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| General disorders and administration site conditions - Other, specify | General disorders | CTCAE (4.0) | Systematic Assessment | General Discomfort |
|
| Hot flashes | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperuricemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Periorbital edema | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Photophobia | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Watering eyes | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |