Diffuse Large B-cell Lymphoma Clinical Trial
Official title:
Phase I/II Study of Veltuzumab Combined With 90Y-Epratuzumab Tetraxetan in Patients With Relapsed/Refractory, Aggressive Non- Hodgkin's Lymphoma
Verified date | December 2020 |
Source | Gilead Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Gilead Sciences |
United States,
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
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 |
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 |