Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01101581
Other study ID # IM-T-hA20/90Y-hLL2-01
Secondary ID
Status Withdrawn
Phase Phase 1/Phase 2
First received
Last updated
Start date May 2010
Est. completion date March 2017

Study information

Verified date December 2020
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 ยด 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. - 3 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 Exclusion Criteria: - 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. - Use of systemic corticosteroids within 2 weeks, except low dose regimens (prednisone, <20 mg/day, or equivalent) which may continue if unchanged. - Prior malignancies (other than non-melanoma skin cancer or carcinoma in situ of the cervix) unless disease free for 5 years. - Prior malignancy with less than a 5-year disease-free interval, excluding nonmelanoma skin cancers and carcinoma in situ of the cervix. - Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations

Study Design


Intervention

Drug:
Veltuzumab and 90Y-Epratuzumab Tetraxetan
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).
90Y-epratuzumab tetraxetan

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

Locations

Country Name City State
United States Goshen Center for Cancer Care Goshen Indiana
United States Weill Med College of Cornell Univ/NYH New York New York
United States Helen F. Graham Cancer Center Newark Delaware
United States MDACC Orlando Orlando Florida
United States University of Pennsylvania Cancer Center Philadelphia Pennsylvania
United States Mayo Clinic Rochester Minnesota
United States Moffitt Cancer Center Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

References & Publications (3)

Goldenberg 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. Review. — View Citation

Morschhauser F, Kraeber-Bodéré F, Wegener WA, Harousseau JL, Petillon MO, Huglo D, Trümper 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Efficacy 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.
12 weeks-5 years
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT01804686 - A Long-term Extension Study of PCI-32765 (Ibrutinib) Phase 3
Recruiting NCT05823701 - Chidamide, Azacitidine Combined With GM Regimen for Relapsed and Refractory DLBCL Patients Phase 2
Completed NCT01691898 - A Study of Pinatuzumab Vedotin (DCDT2980S) Combined With Rituximab or Polatuzumab Vedotin (DCDS4501A) Combined With Rituximab or Obinutuzumab in Participants With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma (NHL) Phase 1/Phase 2
Recruiting NCT03656835 - Nanochip Technology in Monitoring Treatment Response and Detecting Relapse in Participants With Diffuse Large B-Cell Lymphoma N/A
Terminated NCT02877082 - Tacrolimus, Bortezomib, & Thymoglobulin in Preventing Low Toxicity GVHD in Donor Blood Stem Cell Transplant Patients Phase 2
Active, not recruiting NCT02060656 - Phase II Study Comparing LR-GEM to R-GEM-P in Second-line Treatment of Diffuse Large B-cell Lymphoma (LEGEND) Phase 2
Active, not recruiting NCT01653067 - STORM: Temsirolimus, Rituximab and DHAP for Relapsed and Refractory Diffuse Large B-cell Lymphoma Phase 2
Enrolling by invitation NCT00846157 - Biocell Natural Killer Mixture in Diffuse Large B Cell Lymphoma (DLBCL) Patients Phase 3
Completed NCT00440583 - The Response Study of Yt90-Zevalin in Patients With Diffuse Large B-cell Lymphoma After 6 Cycles of CHOP Phase 2
Completed NCT01851551 - Phase 1/2 Study of VSLI Plus Rituximab in Patients With Relapsed and/or Refractory NHL Phase 1/Phase 2
Recruiting NCT04981795 - realMIND: Observational Study on Safety and Effectiveness of Tafasitamab in Combination With Lenalidomide in Patients With Relapsed or Refractory DLBCL
Completed NCT01186978 - Reduced Radiation in Patients With Diffuse Large B-cell Lymphoma N/A
Completed NCT01197560 - Study of Lenalidomide to Evaluate Safety and Effectiveness in Patients With Diffuse Large B-Cell Lymphoma (DLBCL) Phase 2/Phase 3
Recruiting NCT03246906 - Comparison of Triple GVHD Prophylaxis Regimens for Nonmyeloablative or Reduced Intensity Conditioning Unrelated Mobilized Blood Cell Transplantation Phase 2
Not yet recruiting NCT05990985 - The Efficacy and Safety of the RCMOP Sequential Therapy as a First-line Treatment for Patients With Intermediate-to-high Risk Diffuse Large B-cell Lymphoma Who Had Incomplete Remission. N/A
Completed NCT02890602 - Erythropoietin for Management of Anemia Caused by Chemotherapy Phase 2
Completed NCT03630159 - Study of Tisagenlecleucel in Combination With Pembrolizumab in r/r Diffuse Large B-cell Lymphoma Patients Phase 1
Active, not recruiting NCT04529772 - A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312) Phase 3
Active, not recruiting NCT02900651 - Safety and Efficacy of MAK683 in Adult Patients With Advanced Malignancies Phase 1
Active, not recruiting NCT02481310 - Combination Chemotherapy, Rituximab, and Ixazomib Citrate in Treating Patients With Non-Hodgkin Lymphoma Phase 1/Phase 2