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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-03150 | Registry Identifier | Clinical Trial Reporting Program |
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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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A phase I dose escalation study of veltuzumab and milatuzumab in relapsed and refractory B-cell NHL. The phase I study will be followed by a pilot phase II study.
A phase I/II study of veltuzumab combined with milatuzumab in relapsed and refractory non-Hodgkin's lymphoma. Both agents are well-tolerated in early phase clinical testing with infusion reactions as the primary observed toxicity. Preclinical testing in vitro and in vivo have demonstrated single agent activity for both veltuzumab and milatuzumab. In mantle cell lymphoma cell lines and SCID mouse models, synergist effects were observed when milatuzumab was combined with rituximab. Veltuzumab has several advantages over rituximab including slower off-rates, shorter infusion times, higher potency, and improved therapeutic responses in animal models. Previous and ongoing clinical investigations support the concept of combining monoclonal antibodies in NHL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I | Experimental | Phase I portion of the study, a standard 3+3 dose escalation schema will be followed. Patients will receive veltuzumab IV weekly on day 1 for 4 doses and milatuzumab weekly on for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab alone on day 1 and milatuzumab alone on day 2 to prevent overlapping infusion reactions. Starting week 2, veltuzumab will be given on day 1 and milatuzumab will be given on day 4. |
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| Phase II | Experimental | Patients will receive veltuzumab IV weekly for 4 doses and milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy. Patients may continue on therapy to receive extended induction therapy provided they do not experience significant toxicity or rapid disease progression during the initial 4 week induction. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| milatuzumab | Biological | Patient will receive milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive milatuzumab on day 2. Starting in week 2, milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with extended induction therapy, consisting of veltuzumab day 1 and milatuzumab day 4 of weeks 12, 20, 28, and 36. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicity (DLT) for Phase I Patients | Dose-limiting toxicity was assessed during induction therapy for phase I. | up to 2 years |
| Maximum Tolerated Dose (MTD)for Phase I Patients | Patients received a fixed dose of Veltuzumab IV 200 mg/m2 and Milatuzumab was dose escalated | up to 2 years |
| Overall Objective Response Rate | Per International Response Criteria (Cheson JCO 2007) for target lesions and assessed by CT, MRI or PET: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses; Overall Response (OR) = CR + PR. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | Progression is defined using International Response Criteria (Cheson JCO 2007), as a >= 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or at least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis, or the size of other lesions (eg, splenic or hepatic nodules), or the appearance of new lesions. |
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Inclusion Criteria:
Histologically confirmed B-cell non-Hodgkin lymphoma (NHL), including any of the following:
Relapsed or refractory disease after ≥ 1 prior therapy
Patients with rituximab-refractory disease (defined as having less than a partial response to the prior rituximab-containing regimen) or rituximab-sensitive disease (defined as having a complete response or partial response to the last rituximab-containing regimen [provided it has been ≥ 3 months since the last dose of rituximab]) are eligible.
Age >18 years.
Eastern Cooperative Oncology Group (ECOG)performance status 0-2.
Patients must have normal organ and marrow function as defined below:
Patients who have relapsed after stem cell transplant are eligible for this trial.
Patients with active Hepatitis B infection are not eligible.
Non-pregnant and non-nursing. Women of child bearing potential and men must agree to use contraception prior to study entry and for duration of study participation.
Must possess the ability to understand and the willingness to sign a written informed consent document.
Phase II
-Must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension >10 mm or in the case of Waldenstrom's macroglobulinemia, the presence of an IgM paraprotein level 2x the upper limit of normal.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beth Christian, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25847298 | Result | Christian BA, Poi M, Jones JA, Porcu P, Maddocks K, Flynn JM, Benson DM Jr, Phelps MA, Wei L, Byrd JC, Wegener WA, Goldenberg DM, Baiocchi RA, Blum KA. The combination of milatuzumab, a humanized anti-CD74 antibody, and veltuzumab, a humanized anti-CD20 antibody, demonstrates activity in patients with relapsed and refractory B-cell non-Hodgkin lymphoma. Br J Haematol. 2015 Jun;169(5):701-10. doi: 10.1111/bjh.13354. Epub 2015 Apr 7. |
| Label | URL |
|---|---|
| Jamesline | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase I | Phase I portion of the study, a standard 3+3 dose escalation schema will be followed. Patients will receive veltuzumab IV weekly on day 1 for 4 doses and milatuzumab weekly on for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab alone on day 1 and milatuzumab alone on day 2 to prevent overlapping infusion reactions. Starting week 2, veltuzumab will be given on day 1 and milatuzumab will be given on day 4. milatuzumab: Patient will receive milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive milatuzumab on day 2. Starting in week 2, milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| veltuzumab | Biological | Patient will receive veltuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with extended induction therapy, consisting of veltuzumab day 1 and milatuzumab day 4 of weeks 12, 20, 28, and 36. |
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| Correlative/Special Studies | Procedure | To correlate Fcγ receptor polymorphisms with response to treatment with the combination of veltuzumab and milatuzumab. Whole blood will be collected pre-treatment on day 1. |
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| Quantitative T-, B-, and NK cell subsets | Procedure | Quantitative T-, B-, and NK- cell subsets will be assessed using flow cytometry to quantify the percentage and absolute number of cells expressing CD4, CD8, CD56, CD16, CD19, and CD20 pre-treatment on day 1, after induction (week 5, day 1), and prior to the start of therapy on day 1 week 12, day 1 week 36, and then every 4 months for one year. |
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| Pharmacokinetics | Procedure | To assess the pharmacokinetics of veltuzumab in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma. Pharmacokinetics will be assessed with blood samples collected at the following time points: immediately pre- and post-infusion on day 1 of weeks 1, 2, 4, 12 and 36. One additional sample will be collected each of weeks 5 through 10 (sample may be collected any day during each of these weeks). |
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| Pharmacokinetics | Procedure | To assess the pharmacokinetics of milatuzumab in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma. Pharmacokinetics will be assessed with blood samples collected at the following time points: immediately pre- and post-infusion on day 2 of week 1 and day 1 of weeks 2, 4, 12 and 36. Additional samples will be collected days 3 through 6 of week 1. |
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| Human Anti-Human Antibodies | Procedure | To monitor for the development of human anti-veltuzumab antibodies and human anti-milatuzumab antibodies (HAHA) in patients receiving treatment with veltuzumab and milatuzumab. Patients will be monitored for the development of HAHA at the following timepoints: pre-treatment on day 1 of week 1, pre-treatment on day 1 of week 4, pre-treatment on day 1 of week 12, and pre-treatment on day 1 of week 36. |
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| veltuzumab and milatuzumab | Biological | Patient will receive veltuzumab and milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab on day 1 and milatuzumab on day 2. Starting in week 2, veltuxumab will be given on day 1 and milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with extended induction therapy, consisting of veltuzumab day 1 and milatuzumab day 4 of weeks 12, 20, 28, and 36. |
|
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| up to 2 years |
| Fcγ-receptor Polymorphism Response to Treatment | The relationship between overall response rate (ORR) and Fcy receptor status. A two-sided chi-square test or exact test with α = 0.05 will be used to test the homogeneity of the ORR among the three genotypes. | up to 2 years |
| Quantitative T-, B-, and NK-cell Subsets Using Flow Cytometry | Quantitative T-, B-, and NK- cell subsets will be assessed using flow cytometry to quantify the percentage and absolute number of cells expressing CD4, CD8, CD56, CD16, CD19, and CD20 at screening, after induction, and prior to the start of therapy on day 1 week 12, day 1 week 28, and then every 4 months for one year. | up to 1 year |
| Access Pharmacokinetics Through AUC0-∞ (Area Under Curve) | Evaluation of pharmacokinetics (Pk) of veltuzumab and milatuzumab was performed for patients included in the trial. Statistically, descriptive data of PK parameters will be computed. Relationships between such parameters as dose and AUC, volume of distribution, clearance, and others will be evaluated, but be preliminary due to the small sample size. | 0, 24, 48, 72, 96 and 120 hours post-does |
| Access Pharmacokinetics Through Cmax | Evaluation of pharmacokinetics of veltuzumab and milatuzumab was performed for patients included in the trial. Statistically, descriptive data of PK parameters will be computed. Relationships between such parameters as dose and AUC, volume of distribution, clearance, and others will be evaluated, but be preliminary due to the small sample size. | 0, 24, 48, 72, 96 and 120 hours post-dose |
| Monitor Human Anti-veltuzumab Antibodies and Human Anti-milatuzumab (HAHA) | Patients will be monitored for the development of human anti-veltuzumab antibodies and human anti-milatuzumab antibodies (HAHA). | up to 36 weeks |
| FG001 | Phase II | Patients will receive veltuzumab IV weekly for 4 doses and milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy. Patients may continue on therapy to receive extended induction therapy provided they do not experience significant toxicity or rapid disease progression during the initial 4 week induction. veltuzumab and milatuzumab: Patient will receive veltuzumab and milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab on day 1 and milatuzumab on day 2. Starting in week 2, veltuxumab will be given on day 1 and milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with extended induction therapy, consisting of veltuzumab day 1 and milatuzumab day 4 of weeks |
| COMPLETED |
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| NOT COMPLETED |
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Patients with histologically confirmed B-cell NHL including marginal zone lymphoma, Waldenstrom's macroglobulinemia or lymphoplasmacytic lymphoma, follicular lymphoma, or mantle cell lymphoma by WHO criteria.
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase I | Phase I portion of the study, a standard 3+3 dose escalation schema will be followed. Patients will receive veltuzumab IV weekly on day 1 for 4 doses and milatuzumab weekly on for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab alone on day 1 and milatuzumab alone on day 2 to prevent overlapping infusion reactions. Starting week 2, veltuzumab will be given on day 1 and milatuzumab will be given on day 4. milatuzumab: Patient will receive milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive milatuzumab on day 2. Starting in week 2, milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with |
| BG001 | Phase II | Patients will receive veltuzumab IV weekly for 4 doses and milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy. Patients may continue on therapy to receive extended induction therapy provided they do not experience significant toxicity or rapid disease progression during the initial 4 week induction. veltuzumab and milatuzumab: Patient will receive veltuzumab and milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab on day 1 and milatuzumab on day 2. Starting in week 2, veltuxumab will be given on day 1 and milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with extended induction therapy, consisting of veltuzumab day 1 and milatuzumab day 4 of weeks |
| 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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| Gender | Count of Participants | Participants |
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| Region of Enrollment | Number | patients |
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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 | Dose Limiting Toxicity (DLT) for Phase I Patients | Dose-limiting toxicity was assessed during induction therapy for phase I. | Posted | Number | patients | up to 2 years |
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| Primary | Maximum Tolerated Dose (MTD)for Phase I Patients | Patients received a fixed dose of Veltuzumab IV 200 mg/m2 and Milatuzumab was dose escalated | Posted | Number | mg/kg | up to 2 years |
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| Primary | Overall Objective Response Rate | Per International Response Criteria (Cheson JCO 2007) for target lesions and assessed by CT, MRI or PET: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses; Overall Response (OR) = CR + PR. | Posted | Number | percent of patients | Up to 2 years |
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| Secondary | Progression-free Survival (PFS) | Progression is defined using International Response Criteria (Cheson JCO 2007), as a >= 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or at least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis, or the size of other lesions (eg, splenic or hepatic nodules), or the appearance of new lesions. | Posted | Median | 95% Confidence Interval | months | up to 2 years |
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| Secondary | Fcγ-receptor Polymorphism Response to Treatment | The relationship between overall response rate (ORR) and Fcy receptor status. A two-sided chi-square test or exact test with α = 0.05 will be used to test the homogeneity of the ORR among the three genotypes. | This data is not available due to analysis was not performed. The response rate was to low for the analysis to yield results to report for this trial. | Posted | up to 2 years |
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| Secondary | Quantitative T-, B-, and NK-cell Subsets Using Flow Cytometry | Quantitative T-, B-, and NK- cell subsets will be assessed using flow cytometry to quantify the percentage and absolute number of cells expressing CD4, CD8, CD56, CD16, CD19, and CD20 at screening, after induction, and prior to the start of therapy on day 1 week 12, day 1 week 28, and then every 4 months for one year. | This data is not available due to analysis was not performed. The response rate was to low for the analysis to yield results to report for this trial. | Posted | up to 1 year |
| ||||||||||||||||||||||||||||||
| Secondary | Access Pharmacokinetics Through AUC0-∞ (Area Under Curve) | Evaluation of pharmacokinetics (Pk) of veltuzumab and milatuzumab was performed for patients included in the trial. Statistically, descriptive data of PK parameters will be computed. Relationships between such parameters as dose and AUC, volume of distribution, clearance, and others will be evaluated, but be preliminary due to the small sample size. | AUC0-∞ for patients dosed at 20 mg/kg | Posted | Mean | Standard Deviation | d*ug/ml | 0, 24, 48, 72, 96 and 120 hours post-does |
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| Secondary | Access Pharmacokinetics Through Cmax | Evaluation of pharmacokinetics of veltuzumab and milatuzumab was performed for patients included in the trial. Statistically, descriptive data of PK parameters will be computed. Relationships between such parameters as dose and AUC, volume of distribution, clearance, and others will be evaluated, but be preliminary due to the small sample size. | Cmax for patients dosed at 20 mg/kg | Posted | Mean | Standard Deviation | ug/ml | 0, 24, 48, 72, 96 and 120 hours post-dose |
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| Secondary | Monitor Human Anti-veltuzumab Antibodies and Human Anti-milatuzumab (HAHA) | Patients will be monitored for the development of human anti-veltuzumab antibodies and human anti-milatuzumab antibodies (HAHA). | HAHA titres were assayed for patients in Phase I and Phase II | Posted | Number | patients | up to 36 weeks |
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Not provided
Adverse event grading was done according to NCI CTCAE version 3.0 as classified either possibly, probably, or definitely related to study treatment.
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 | All Patients From Phase I and Phase II | Toxicities were graded according to NCI Common Toxicity Criteria for Adverse Events version 3.0 and classified as either unrelated, unlikely, possibly, probably or definitely related to study treatment. | 3 | 35 | 35 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary embolus | Respiratory, thoracic and mediastinal disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Infusion Reaction | Injury, poisoning and procedural complications | CTCAE version 3.0 | Systematic Assessment |
| |
| Bacteremia | Blood and lymphatic system disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Death | General disorders | CTCAE version 3.0 | Systematic Assessment | due to disease progression within 30 days of treatment |
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| Fatigue | General disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Hyperbilirubinemia | Metabolism and nutrition disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Fever without neutropenia | General disorders | CTCAE version 3.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | CTCAE version 3.0 | Systematic Assessment |
| |
| Infusion Reactions | Injury, poisoning and procedural complications | CTCAE version 3.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Chills | General disorders | CTCAE version 3.0 | Systematic Assessment |
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| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE version 3.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Beth Christian | The Ohio State University Comprehensive Cancer Center | 614-293-8858 | beth.christian@osumc.edu |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D020522 | Lymphoma, Mantle-Cell |
| D008224 | Lymphoma, Follicular |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D008258 | Waldenstrom Macroglobulinemia |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D016393 | Lymphoma, B-Cell |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C540932 | milatuzumab |
| D000911 | Antibodies, Monoclonal |
| C493846 | veltuzumab |
| D001800 | Blood Specimen Collection |
| D010599 | Pharmacokinetics |
| ID | Term |
|---|---|
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D008660 | Metabolism |
| D002620 | Pharmacological and Toxicological Phenomena |
| D010829 | Physiological Phenomena |
Not provided
Not provided
| Male |
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| Phase II |
Patients will receive veltuzumab IV weekly for 4 doses and milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy. Patients may continue on therapy to receive extended induction therapy provided they do not experience significant toxicity or rapid disease progression during the initial 4 week induction. veltuzumab and milatuzumab: Patient will receive veltuzumab and milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab on day 1 and milatuzumab on day 2. Starting in week 2, veltuxumab will be given on day 1 and milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with extended induction therapy, consisting of veltuzumab day 1 and milatuzumab day 4 of weeks |
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