Study Stopped
No subjects enrolled
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
1 other identifier
interventional
N/A
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2010
Longer than P75 for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2010
CompletedFirst Posted
Study publicly available on registry
April 12, 2010
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedAugust 18, 2021
December 1, 2020
6.6 years
March 16, 2010
August 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety/dose limiting toxicity
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.
12 weeks
Secondary Outcomes (1)
Efficacy
12 weeks-5 years
Study Arms (2)
Veltuzumab and 90Y-Epratuzumab Tetraxetan
EXPERIMENTALVeltuzumab 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
EXPERIMENTAL90Y-epratuzumab tetraxetan will be administered 6 mCi/m2 on days 8 and 15.
Interventions
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 will be administered subcutaneously on days 1, 8, 15 and 23
Eligibility Criteria
You may qualify if:
- Male or female, \>18 years old
- Histological diagnosis of CD20+ B-cell NHL, with DLBCL or other aggressive lymphomas by WHO lymphoma criteria including mantle cell lymphoma and transformed follicular lymphoma.
- Failed at least one prior standard treatment regimen for NHL
- If DLBCL, either received, ineligible for or refused high-dose chemotherapy with stem cell transplant
- Measurable NHL disease by CT, with at least one lesion \>1.5 cm in one dimension
- Adequate performance status (\>70 Karnofsky scale, 0-1 ECOG)\* with an estimated life expectancy of at least 6 months
- Laboratory parameters:
- Adequate hematology (Hemoglobin \>/= 10 g/dL, ANC \>/= 1.5 ´ 109/L, platelets \>/=100 x 109/L) without ongoing transfusional support
- Adequate renal and liver function (creatinine and bilirubin \</= 1.5 x IULN; AST and ALT \</= 2.5 x IULN)
- Otherwise, \<Grade 1 toxicity at study entry by NCI CTC version 3.0.
- months beyond any prior rituximab or veltuzumab treatment, 12 weeks beyond autologous stem cell transplant and 4 weeks beyond chemotherapy, other experimental treatments, or any radiation therapy to the index lesion(s).
- Screened for hepatitis B (no time limit) and negative by tests included in NCCN guidelines (hepatitis B surface antigen/antibodies, core antigen/antibodies, hepatitis B e-antigen).
- Patients of childbearing potential must be willing to practice birth control during the study until at least 12 weeks after last veltuzumab infusion; women of childbearing potential must have a negative urine or serum pregnancy test to enter the study.
- Ability to provide signed, informed consent
You may not qualify if:
- Pregnant or lactating women. Women of childbearing potential are required to have a negative pregnancy test
- NCI CTC Grade 3 or 4 infusion reaction to prior anti-CD20 antibodies (rituximab, veltuzumab, etc.)
- A known anti-antibody response to prior antiCD20 antibodies (HACA positive, HAHA positive, etc)
- Prior radioimmunotherapy, including Zevalin or Bexxar.
- Prior high-dose chemotherapy with peripheral blood stem cell transplant.
- Prior therapy with other human or humanized monoclonal antibodies, unless HAHA tested and negative
- Primary CNS lymphoma, HIV lymphoma or transformed lymphoma, or presence of symptomatic CNS metastases or carcinomatous meningitis.
- Rituximab or veltuzumab resistant, defined as having progressed during or within 6 months of any prior rituximab or veltuzumab treatment.
- Bulky disease by CT, defined as any single mass \>10 cm in its greatest diameter
- Bone marrow involvement ≥25%
- Prior external beam radiation therapy to \>30% bone marrow.
- Pleural effusion with positive cytology for lymphoma
- Patients known to be HIV positive, hepatitis B positive, or hepatitis C positive
- Known autoimmune disease or presence of autoimmune phenomena.
- Evidence of infection or requiring antibiotics within 7 days.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (7)
Helen F. Graham Cancer Center
Newark, Delaware, 19713, United States
MDACC Orlando
Orlando, Florida, 32806, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Goshen Center for Cancer Care
Goshen, Indiana, 46526, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Weill Med College of Cornell Univ/NYH
New York, New York, 10021, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Related Publications (3)
Morschhauser F, Leonard JP, Fayad L, Coiffier B, Petillon MO, Coleman M, Schuster SJ, Dyer MJ, Horne H, Teoh N, Wegener WA, Goldenberg DM. Humanized anti-CD20 antibody, veltuzumab, in refractory/recurrent non-Hodgkin's lymphoma: phase I/II results. J Clin Oncol. 2009 Jul 10;27(20):3346-53. doi: 10.1200/JCO.2008.19.9117. Epub 2009 May 18.
PMID: 19451441BACKGROUNDGoldenberg DM, Morschhauser F, Wegener WA. Veltuzumab (humanized anti-CD20 monoclonal antibody): characterization, current clinical results, and future prospects. Leuk Lymphoma. 2010 May;51(5):747-55. doi: 10.3109/10428191003672123.
PMID: 20214444BACKGROUNDMorschhauser F, Kraeber-Bodere F, Wegener WA, Harousseau JL, Petillon MO, Huglo D, Trumper LH, Meller J, Pfreundschuh M, Kirsch CM, Naumann R, Kropp J, Horne H, Teoh N, Le Gouill S, Bodet-Milin C, Chatal JF, Goldenberg DM. High rates of durable responses with anti-CD22 fractionated radioimmunotherapy: results of a multicenter, phase I/II study in non-Hodgkin's lymphoma. J Clin Oncol. 2010 Aug 10;28(23):3709-16. doi: 10.1200/JCO.2009.27.7863. Epub 2010 Jul 12.
PMID: 20625137BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
William Wegener, MD, PhD
Gilead Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2010
First Posted
April 12, 2010
Study Start
May 1, 2010
Primary Completion
December 1, 2016
Study Completion
March 1, 2017
Last Updated
August 18, 2021
Record last verified: 2020-12