Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Follicular

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Follicular Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Epratuzumab

Veltuzumab

1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid

Antineoplastic Agents, Immunological

Chelating Agents

two weekly infusions of 90Y-epratuzumab tetraxetan in combination with four weekly infusions of 200 mg/m2 veltuzumab.

The 90Y-epratuzumab treatment will begin one week after the 4th veltuzumab injection. Patients will receive unlabeled, unconjugated epratuzumab (1.5 mg/kg) that will be infused over \~30 minutes. All patients will then receive a 90Y-epratuzumab dose. Dose will be escalated by patient cohort either at 15 mCi/m2 or 20 mCi/m2. The second 90Y-epratuzumab treatment will be given at the same dose, 1 week after the first 90Y-epratuzumab dose.

90Y-epratuzumab tetraxetan

Veltuzumab is given in 4 weekly doses, each 200 mg/m2.

veltuzumab

Peter Martin, MD

A Phase I/II clinical trial using a fractionated dosing regimen of 90Y-epratuzumab (anti-CD22) has showed encouraging responses in follicular and aggressive NHL with an ability to administer safely 2 injections of 20 mCi/m2 spaced 1 week apart. The investigators propose to combine this active 90Y-epratuzumab treatment with a regimen of veltuzumab that was also found active in Phase I/II trials.

The goal of this study is to determine the safety and efficacy of 90Y-epratuzumab when used in combination with veltuzumab. The primary objective is to determine the response rate of this combination treatment. Secondary objectives are to assess safety, pharmacokinetics and targeting of 90Y-epratuzumab . Veltuzumab blood levels and anti-antibody responses will also be monitored at various times.

The treatment regimen consists of 2 elements. The first element is represented by one courses of veltuzumab (4 weekly injections of 200 mg/m2). 90Y-epratuzumab will be given as 2 injections at escalating doses 1 week apart and administered starting one week following the 4th veltuzumab injection.

After confirming eligibility and undergoing baseline assessments, the treatment starts with an imaging study using 111In-epratuzumab (5-mCi 111In-DOTA-epratuzumab co-infused with a total of 1.5 mg/kg unlabeled epratuzumab). Blood samples (\~7 samples, 5 mL each) for pharmacokinetic analysis will be collected over 5-7 days, and patients will be imaged on 4 separate occasions (e.g., the day of injection (Day 0), Day 1, Day 3, 4, or 5, and day 6 or 7).

The patient will then initiate veltuzumab treatments starting 7 days after the 111In-epratuzumab injection. Veltuzumab is given in 4 weekly doses, each 200 mg/m2. A single blood sample will be taken before each veltuzumab dose to assess residual veltuzumab concentrations in the serum, and then at 1 h later to determine peak values. Patients will receive unlabeled, unconjugated epratuzumab (1.5 mg/kg) that will be infused over \~30 minutes. Patients will also receive 111In-epratuzumab immediately following the unlabeled epratuzumab. Blood samples will be collected at the same intervals as after the first 111In-epratuzumab. Only 2 imaging sessions will be required, on Day 1 and then again on day 6 or 7 (these days should match those obtained after the first 111In-epratuzumab injection).

The 90Y-epratuzumab treatment will begin one week after the 4th veltuzumab injection. Patients will receive unlabeled, unconjugated epratuzumab (1.5 mg/kg) that will be infused over \~30 minutes. All patients will then receive a 90Y-epratuzumab dose. Dose will be escalated by patient cohort starting at 2x15 mCi/m2 and, at 2x 20 mCi/m2, and 2x 25 mCi/m2.. Blood samples will be collected at the same intervals as after each 111In-epratuzumab.Patients will also receive 111In-epratuzumab immediately following the unlabeled epratuzumab and immediately before the 90Y-epratuzumab injection. Blood samples will be collected at the same intervals as after the first 111In-epratuzumab. Only 2 imaging sessions will be required, on Day 1 and then again on day 6 or 7 (these days should match those obtained after the first 111In-epratuzumab injection).

The second 90Y-epratuzumab treatment will be given at the same dose, 1 week after the first 90Y-epratuzumab dose. CBC will be checked prior to administration of this second dose to ensure blood counts continue to meet criteria for treatment as specified in inclusion criteria. Blood samples will again be collected over the same period as the first injection, but no imaging studies are required.

Patients are closely monitored during all infusions, and then at intervals over a 12-weeks post-treatment evaluation period, with evaluation procedures including vital signs, physical examination, CT (chest, abdomen, pelvis, other regions of involvement), CBC, serum chemistries, serum immunoglobulins, urinalysis, peripheral blood B-cell levels (immunophenotyping based on CD19), and serum samples for HAHA (veltuzumab and epratuzumab ELISA to be analyzed by Immunomedics). Follow-up evaluations then continue every 3 months for up to 5 years or until progression occurs or until resolution of treatment-related toxicity.

Combination Veltuzumab and Fractionated 90Y- Epratuzumab Radioimmunotherapy in Follicular Lymphoma

Phase I/II Study of Combination Veltuzumab (Anti-CD20) and Fractionated 90Y- Epratuzumab (Anti-CD22) Radioimmunotherapy in Patients With Follicular Lymphoma

NCI CTC version 3.0 is used to grade all adverse events and to provide management guidelines for infusional toxicity. Dose-limiting toxicity (DLT) is defined as follows:

Hematologic: Grade 4 toxicity \>7 days, as specified by hemoglobin levels, platelet counts or absolute neutrophil count (ANC) or failure of hemoglobin levels, platelet counts or ANC to recover to Grade 1 levels within 12 weeks of completing the treatment cycle (with the use of RBC and platelet transfusions or growth factors during the 12 weeks if necessary, but at least one week without any support prior to qualifying Grade 1 levels).

Non-Hematologic: Any Grade 3 or Grade 4. Other: Any Grade 2 autoimmune reactions, or the occurrence of Grade 2 immediate-type allergic/hypersensitivity reactions (e.g., urticaria, wheezing, hypoxia and dyspnea) will be considered DLT and will also require the infusion to be permanently terminated.

Occurrence of DLT requires a patient's treatment to be permanently discontinued

Gilead Sciences

Weill Medical College of Cornell University

veltzumab: 200 mg/m2 Unconjugated epratuzumab: 1.5 mg/kg 111-In-epratuzumab: 5 mCi 90-Y-epratuzumab: 15 mCi/m2

Dose Level 1

veltzumab: 200 mg/m2 Unconjugated epratuzumab: 1.5 mg/kg 111-In-epratuzumab: 5 mCi 90-Y-epratuzumab: 10 mCi/m2

Dose Level -1

two weekly infusions of 90Y-epratuzumab tetraxetan in combination with four weekly infusions of 200 mg/m2 veltuzumab.

90Y-epratuzumab tetraxetan: The 90Y-epratuzumab treatment will begin one week after the 4th veltuzumab injection. Patients will receive unlabeled, unconjugated epratuzumab (1.5 mg/kg) that will be infused over \~30 minutes. All patients will then receive a 90Y-epratuzumab dose. Dose will be escalated by patient cohort either at 15 mCi/m2 or 20 mCi/m2. The second 90Y-epratuzumab treatment will be given at the same dose, 1 week after the first 90Y-epratuzumab dose.

veltuzumab: Veltuzumab is given in 4 weekly doses, each 200 mg/m2.

All Subjects

Patients by Age

Age, Customized

Sex: Female, Male

Determine the Maximum Tolerated 90Y Dose

Dose-limiting Toxicity

Safety

The Primary Objective of the Phase II Portion of the Study is to Determine the Anti-tumor Efficacy, as Measured by Response Rate, of Fractionated 90Y-epratutumab IgG Given in Combination With Veltuzumab Anti-CD20 IgG Therapy

Behaviors and Mental Disorders

Nervous System Diseases

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Aggression

Dementia

Aberrant Motor Behavior in Dementia

Behavioral Symptoms

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Veltuzumab and 90Y-Epratuzumab Tetraxetan target different b-cells. Veltuzumab will be administered in all 4 weekly study drug treatments. 90Y-Epratuzumab Tetraxetan will be administered only on days 8 \& 15. The dose of veltuzumab remains the same for all patients.

90Y-epratuzumab tetraxetan will be administered 6 mCi/m2 on days 8 and 15.

Veltuzumab will be administered subcutaneously in phase 2. 90Y-Epratuzumab tetraxetan will be administered intravenously. Veltuzumab is given once weekly for 4 weeks. 90Y-Epratuzumab is also given at treatment weeks 2 \& 3 (days 8 \& 15).

Veltuzumab and 90Y-Epratuzumab Tetraxetan

Veltuzumab will be administered subcutaneously on days 1, 8, 15 and 23

William Wegener, MD, PhD

The goal of this study is to evaluate a new approach to immunotherapy in NHL by combining two antibodies, veltuzumab and epratuzumab. For treatment, epratuzumab has also been attached to a radioactive isotope called 90yttrium (90Y-epratuzumab). Veltuzumab and 90Y-epratuzumab attack different areas on lymphoma cells. Because of this, treatment with the combination may provide more effective treatment in NHL than either veltuzumab or 90Y-epratuzumab given alone.

The treatment portion of this study consists of study drug administrations each week for four weeks in a row (a total of 4 treatment days). Patients will then return at intervals up to 12 weeks for blood samples and for evaluations to see if their disease responded and to monitor any adverse effects related to treatment. Some blood tests may then need to be repeated at least a few times and/or until any abnormal findings at earlier evaluations have resolved. Otherwise, patients will continue to be evaluated every 3 months for two years, then every 6 months up to 5 years or until the disease worsens. Participation in the study will end when NHL disease worsens.

Study of Veltuzumab and 90Y-Epratuzumab in Relapsed/Refractory, Aggressive NHL

Phase I/II Study of Veltuzumab Combined With 90Y-Epratuzumab Tetraxetan in Patients With Relapsed/Refractory, Aggressive Non- Hodgkin's Lymphoma

Patients are closely monitored during and after all infusions, and then at intervals over a 12-week post-treatment evaluation period. Safety evaluations required in all patients include vital signs, physical examination, CBC, serum chemistries, serum immunoglobulins, urinalysis, peripheral blood B-cell levels (immunophenotyping based on CD19), and HAHA (to be analyzed by Sponsor). Adverse events and abnormal laboratories will be graded for toxicity according to NCI CTC v3.0 criteria.

CT or PET/CT imaging will be used to quantify changes in index lesions identified on baseline imaging, with responses classified according to revised response criteria for NHL (Cheson, 2007).

Patients with stable disease or objective responses continue limited follow-up evaluations, including CT evaluations, physical examinations and serum laboratories every 3 months for the first year and then every 6 months up to a total of 5 years or until progression of disease.

Musculoskeletal Diseases

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Arthritis

Necrosis

Arthritis, Rheumatoid

Joint Diseases

Rheumatic Diseases

Collagen Diseases

Connective Tissue Diseases

Autoimmune Diseases

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

Antibodies

Antibodies, Monoclonal

Methotrexate

Immunoglobulins

administered once weekly (days 1, 8, 15 and 22) by subcutaneous injection

This is a multi-national, multi-centre, placebo-controlled, double-blind, randomized, 4-arm parallel group trial, comparing three different dose levels (80 mg, 160 mg and 320 mg) of veltuzumab to placebo, administered weekly (days 1, 8, 15 and 22) by subcutaneous (sc) injection to subjects with moderate to severe rheumatoid arthritis (RA) (cumulative veltuzumab doses 320 mg, 640 mg, and 1280 mg, respectively). All subjects will be on continued stable co-medication with methotrexate (MTX).

The trial comprises a screening phase (4 to 12 weeks prior to first administration of veltuzumab), a 4-week treatment phase (weeks 1 to 4), a core phase from week 4 to week 24, and a follow-up phase from week 24 to week 48. The primary end-point, the American College of Rheumatology 20 (ACR 20) response rate, will be evaluated at week 24.

The objectives of this trial are:

* To investigate the efficacy, safety and tolerability at week 24 of three different sc dose levels of the humanized anti-CD20 antibody veltuzumab as an add-on treatment to MTX compared to MTX alone in subjects with moderate to severe RA
* To evaluate the durability of the clinical response and safety of veltuzumab over 48 weeks
* To identify the dosage(s) of veltuzumab with the most favourable benefit-risk profile to be further evaluated in the subsequent phase II/III clinical program in subjects with moderate to severe RA.

Current status of the trial: Following the voluntary temporary halt of the VELVET dose range finding trial, the sponsor has decided to redesign the protocol and start a new trial as soon as possible.

All patients treated prior to the voluntary halt have completed their safety assessments. It was decided to terminate the VELVET trial and consequently not to recommence enrollment.

In the VELVET trial, a total of 11 patients received trial medication prior to the voluntary temporary halt. No efficacy conclusions according to protocol can be drawn from the 11 patients treated. Based on the collected clinical data from this trial, there is no clinical safety signal and no increased clinical safety risk observed to date that precludes continued clinical investigation of veltuzumab.

VELVET, a Dose Range Finding Trial of Veltuzumab in Subjects With Moderate to Severe Rheumatoid Arthritis

VELVET (Veltuzumab Various Doses Exploratory Trial), a Randomized, Double Blind, Placebo Controlled, Multicentre, Multinational Phase II Dose Range Finding Trial in Subjects With Moderate to Severe Rheumatoid Arthritis Insufficiently Controlled With Either Methotrexate Alone or Methotrexate Plus Anti-tumour Necrosis Factor Biological Treatment, Comparing 3 Different Subcutaneous Dosages of Anti-CD20 Monoclonal Antibody Veltuzumab to Placebo as an add-on Therapy to Methotrexate.

ACR20 response rate is defined as improvement from baseline to endpoint fulfilling the following criteria:

* ≥ 20 percent reduction in the Tender joint count (TJC) (66/68 joint count system)
* ≥ 20 percent reduction in the Swollen joint count (SJC) (66/68 joint count system)
* ≥ 20 percent reduction in three of the following additional measures:

  * Patient's assessment of pain
  * Patient's global assessment of disease activity
  * Physician's global assessment of disease activity
  * Degree of disability
  * Level of acute-phase reactant (CRP)

ACR50/70 response rate is defined as improvement from baseline to endpoint fulfilling the following criteria:

* 50/70 percent reduction in the TJC (66/68 joint count system)
* 50/70 percent reduction in the SJC (66/68 joint count system)
* 50/70 percent in three of the following additional measures:

  * Patient's assessment of pain
  * Patient's global assessment of disease activity
  * Physician's global assessment of disease activity
  * Degree of disability
  * Level of acute-phase reactant (CRP)

ACR20 response rate is defined as improvement from baseline to endpoint fulfilling the following criteria:

* 20 percent reduction in the TJC (66/68 joint count system)
* 20 percent reduction in the SJC (66/68 joint count system)
* 20 percent reduction in three of the following additional measures:

  * Patient's assessment of pain
  * Patient's global assessment of disease activity
  * Physician's global assessment of disease activity
  * Degree of disability
  * Level of acute-phase reactant (CRP)

To further demonstrate efficacy of veltuzumab

Takeda

Lymphoma, Mantle-Cell

Lymphoma, B-Cell, Marginal Zone

Mantle Cell Lymphoma

Marginal Zone Lymphoma

Immunomodulating Agents

once weekly intravenous dosing for 4 weeks

This study is being done to assess the safety and tolerance of different doses of humanized hA20 in patients with NHL.

Safety Study of Different Doses of hA20 (Veltuzumab) in CD20+ Non-Hodgkin's Lymphoma

A Phase I Study of Immunotherapy With hA20 Administered Once Weekly for 4 Consecutive Weeks in Patients With CD20+ Non- Hodgkin's Lymphoma

Heart and Blood Diseases

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Leukemia, Prolymphocytic

Leukemia, B-Cell

Waldenstrom Macroglobulinemia

Hematologic Diseases

Chronic Disease

Disease Attributes

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

veltuzumab is a humanized CD20 antibody administered subcutaneously in this study.

veltuzumab (hA20) will be studied at different dose levels, administered subcutaneously once a week for 4 weeks.

The purpose of this study is to determine if a subcutaneous (SC) dosing schedule of veltuzumab can be established in NHL or CLL patients and to confirm the safety and efficacy of veltuzumab that was previously established when administered intravenously.

The first study of veltuzumab given IV weekly in NHL patients (IM-T-hA20-01) has shown excellent tolerability and even efficacy at weekly intravenous doses as low as 80-120 mg/m2 over 4 consecutive weeks. These clinical results confirm experiments laboratory studies. Laboratory studies using Veltuzumab administered subcutaneously showed potent activity based on B-cell depletion. The current study's goal is to determine if a subcutaneous (SC) dosing schedule of veltuzumab can be established in patients with NHL or CLL

Ph I/II Study of Subcutaneously Administered Veltuzumab (hA20) in NHL and CLL

Phase I/II Study of Subcutaneously Administered Veltuzumab (hA20) in Patients With CD20+ Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

safety will be assessed by monitoring lab results and adverse events, which will be assessed every 3 months for up to 2 years.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Combination Veltuzumab and Fractionated 90Y- Epratuzumab Radioimmunotherapy in Follicular Lymphoma	NCT01147393	Follicular Lymp...	90Y-epratuzumab... veltuzumab	18 Years -	Weill Medical College of Cornell University
Study of Veltuzumab and 90Y-Epratuzumab in Relapsed/Refractory, Aggressive NHL	NCT01101581	Non Hodgkin's L... NHL Aggressive NHL Diffuse Large B...	Veltuzumab and ... 90Y-epratuzumab... veltuzumab	18 Years -	Gilead Sciences
VELVET, a Dose Range Finding Trial of Veltuzumab in Subjects With Moderate to Severe Rheumatoid Arthritis	NCT01390545	Rheumatoid Arth...	Veltuzumab	18 Years -	Takeda
Safety Study of Different Doses of hA20 (Veltuzumab) in CD20+ Non-Hodgkin's Lymphoma	NCT00596804	Non-Hodgkin's L... Lymphoma, Diffu... Lymphoma, Diffu...	veltuzumab	18 Years -	Gilead Sciences
Ph I/II Study of Subcutaneously Administered Veltuzumab (hA20) in NHL and CLL	NCT00546793	NHL Lymphoma, Non-H... Lymphoma, B-Cel... Lymphoma, Folli... Lymphoma, Inter... Lymphoma, Large... Lymphoma, Low-G... Lymphoma, Mixed... Lymphoma, Small... Leukemia, Lymph... Leukemia, B-Cel... Leukemia, Proly... Leukemia, Small... Lymphoma, Small... Lymphoma, Lymph... Lymphoplasmacyt... CLL SLL	veltuzumab	18 Years -	Gilead Sciences
Study of Veltuzumab and 90Y-Epratuzumab in Relapsed/Refractory, Aggressive NHL	NCT01101581	Non Hodgkin's L... NHL Aggressive NHL Diffuse Large B...	Veltuzumab and ... 90Y-epratuzumab... veltuzumab	18 Years -	Gilead Sciences
Study of Veltuzumab and 90Y-Epratuzumab in Relapsed/Refractory, Aggressive NHL	NCT01101581	Non Hodgkin's L... NHL Aggressive NHL Diffuse Large B...	Veltuzumab and ... 90Y-epratuzumab... veltuzumab	18 Years -	Gilead Sciences
Safety Study of Different Doses of hA20 (Veltuzumab) in CD20+ Non-Hodgkin's Lymphoma	NCT00596804	Non-Hodgkin's L... Lymphoma, Diffu... Lymphoma, Diffu...	veltuzumab	18 Years -	Gilead Sciences
Safety Study of Different Doses of hA20 (Veltuzumab) in CD20+ Non-Hodgkin's Lymphoma	NCT00596804	Non-Hodgkin's L... Lymphoma, Diffu... Lymphoma, Diffu...	veltuzumab	18 Years -	Gilead Sciences
Study of Veltuzumab and 90Y-Epratuzumab in Relapsed/Refractory, Aggressive NHL	NCT01101581	Non Hodgkin's L... NHL Aggressive NHL Diffuse Large B...	Veltuzumab and ... 90Y-epratuzumab... veltuzumab	18 Years -	Gilead Sciences
Safety Study of Different Doses of hA20 (Veltuzumab) in CD20+ Non-Hodgkin's Lymphoma	NCT00596804	Non-Hodgkin's L... Lymphoma, Diffu... Lymphoma, Diffu...	veltuzumab	18 Years -	Gilead Sciences

Spots Global Cancer Trial Database for veltuzumab

Every month we try and update this database with for veltuzumab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for veltuzumab

Every month we try and update this database with for veltuzumab cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for veltuzumab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.