scholarly journals Autologous Follicular Lymphoma-Derived Idiotype Vaccine

2020 ◽  
Author(s):  
Keyword(s):  
Follicular Lymphoma ◽  
Idiotype Vaccine

Idiotypic Vaccination of Patients with Relapsed Follicular Lymphoma Using a Novel Vaccine Formulation Including a Tobacco Plant-Produced Tumor Specific Idiotype

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 1649-1649
Author(s):  
Maurizio Bendandi ◽  
Carlos Becerra ◽  
Joseph Kuhn ◽  
Suncica Hukic ◽  
Nyla Langford ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Follicular Lymphoma ◽  
Injection Site ◽  
Conflicts Of Interest ◽  
Hematologic Toxicity ◽  
Vaccine Formulation ◽  
The Novel ◽  
Single Chain ◽  
Idiotype Vaccine ◽  
Grade 3

Abstract Abstract 1649 Idiotypic vaccination has shown evidence of biological efficacy, clinical efficacy and clinical benefit in some subsets of patients with follicular lymphoma. A phase-I clinical trial is currently being conducted to assess safety and immunogenicity of a novel, recombinant idiotype vaccine in which the idiotype protein is produced in tobacco plants. Previous animal and clinical studies with plant-produced single-chain variable fragment lymphoma vaccines have demonstrated specific immunogenicity and safety. However, the expression levels of such fragments were highly variable and required complex engineering of the linkers. Moreover, the downstream processing could not be built around standard methods like protein A affinity capture. Our novel vaccine manufacturing process by magnICONR technology is devoid of such shortcomings and allows consistent and efficient expression in plants of idiotype-containing, whole immunoglobulins. Safety and tolerability of the novel vaccine formulation is the subject of this report. Patients eligible for the study are those with relapsed follicular lymphoma whose prior treatment has included rituximab. Patients receive salvage therapy with bendamustine and prednisone. Use of rituximab is prohibited on this trial due to the prolonged B-cell depletion that characteristically follows its administration. Subjects enrolled in the study who achieve and maintain either a complete (CR) or partial (PR) response for at least 4 months following BP therapy undergo idiotype vaccination. Six patients have received a variable number of monthly doses of the novel, first-in-human, magnICONR produced idiotype vaccine. Each dose includes a conjugate of 0.5 mg of idiotype and 0.5 mg of keyhole limpet hemocyanin on day 1. A dose of 0.125mg of GM-CSF is administered with the idiotype vaccine on day 1 and alone subcutaneously at the same injection site on day 2 through 4. Each vaccination cycle is repeated every four weeks. The vaccination schedule as defined by the protocol outlines eight monthly vaccination cycles followed by four bi-monthly vaccination cycles for a total of 12 vaccinations. No patient has yet completed the entire vaccination protocol and no patient has relapsed/progressed while receiving vaccine. Two patients have received eight vaccinations. The remaining four patients have received five, four, two and one vaccination, respectively. The patient who received two vaccinations was removed from the study after the development of progressive multifocal leukoencephalopathy Undefined symptoms had appeared prior to the initiation of vaccine and PML was subsequently attributed to previous, prolonged maintenance treatment with rituximab received prior to the enrollment in this clinical trial. Toxicity data are available for 28 doses of idiotype vaccine. There has been no grade 4–5 hematologic and non-hematologic toxicity. Grade 3 non-hematologic toxicity was recorded in 1/6 (17%) patients and in 1/28 (4%) cycles, respectively, consisting of generalized pain during one day. Grade 1–2 non-hematologic toxicities were recorded in all six patients and virtually in all cycles. The most common of them were fatigue, pain at the injection site, myalgia, diarrhea, headache and generalized pain. Grade 3 hematologic toxicity was recorded in 2/6 (33%) patients and in 2/28 (7%) cycles, respectively, and consisted predominantly of leucopenia. Grade 1–2 hematologic toxicities were common, most often consisting of anemia and thrombocytopenia. These preliminary data indicate that this novel idiotype vaccine is well tolerated in patients with relapsed follicular lymphoma following chemotherapy with BP. Studies of vaccine-induced humoral and cellular immune responses are ongoing. Results will be updated at the time of the meeting. The authors wish to acknowledge Drs. Ralph Heaven, Larry Barker, Jairo Olivares, Thomas Anderson, Carl Chakmakjian, Barry Cooper, Amir Faridi, Vinay Jain, Pankaj Khandelwal, Janice Marshall, Anton Melnyk, Robert Mennel, James Turner. Disclosures: No relevant conflicts of interest to declare.

Idiotype vaccine therapy (BiovaxID) in follicular lymphoma in first complete remission: Phase III clinical trial results

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 2-2
Author(s):  
S. J. Schuster ◽  
S. S. Neelapu ◽  
B. L. Gause ◽  
F. M. Muggia ◽  
J. P. Gockerman ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Complete Remission ◽  
Follicular Lymphoma ◽  
Phase Iii ◽  
Phase Iii Clinical Trial ◽  
Idiotype Vaccine ◽  
Remission Phase ◽  
Clinical Trial Results ◽  
Final Text ◽  
First Complete Remission

2 The full, final text of this abstract will be available in Part II of the 2009 ASCO Annual Meeting Proceedings, distributed onsite at the Meeting on May 30, 2009, and as a supplement to the June 20, 2009, issue of the Journal of Clinical Oncology. [Table: see text]

Single Agent Bendamustine Is An Effective Pre-Vaccine Treatment for Patients with Relapsed Follicular Lymphoma Undergoing Idiotypic Vaccination

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 2691-2691 ◽  
Author(s):  
Maurizio Bendandi ◽  
Carlos Becerra ◽  
Joseph Kuhn ◽  
Suncica Hukic ◽  
Nyla Langford ◽  
...  
Keyword(s):  
Follicular Lymphoma ◽  
Conflicts Of Interest ◽  
Single Agent ◽  
Hematologic Toxicity ◽  
Variable Intensity ◽  
Vaccine Treatment ◽  
Common Grade ◽  
Idiotype Vaccine ◽  
Grade 3 ◽  
Abstract Submission

Abstract Abstract 2691 Over the last two decades, idiotypic vaccination has shown evidence of biological efficacy, clinical efficacy and clinical benefit in some subsets of patients with follicular lymphoma. Despite this, no idiotype vaccine has yet obtained regulatory approval. A phase-I clinical trial is currently being conducted to assess safety and immunogenicity of therapy with bendamustine and prednisone (BP) followed by administration of a novel, recombinant idiotype vaccine in which the idiotype protein is produced in tobacco plants. Patients eligible for the study are those with relapsed follicular lymphoma whose prior treatment has included rituximab. Use of rituximab is prohibited in this trial due to its potentially negative interference with vaccination as a consequence of the prolonged B-cell depletion that characteristically follows its administration. Subjects enrolled in the study who achieve and maintain either a complete (CR) or partial (PR) response for at least 4 months following BP therapy undergo idiotype vaccination. The response to initial BP therapy prior to vaccine administration is the subject of this report. At the time of abstract submission, fourteen patients have completed four monthly cycles of bendamustine (120 mg/m2 IV on day 1 and 2) and prednisone (100 mg PO on day 1 through 5). Of the thirteen patients evaluable for clinical response, eleven (85%) have achieved a CR and two (15%) a PR. Six patients maintained their response for at least 4 months and went on to receive idiotypic vaccine. The other six patients are currently in the 4-month protocol specified off-therapy period between chemotherapy and vaccination. One patient, who achieved a CR, relapsed during this period and was not vaccinated. With this exception, and with an overall median follow-up of 5 months (range: 2–12 months), all other responses described above have been maintained. Currently, toxicity data are available for 54 cycles of BP. There was no grade 4–5 non-hematologic toxicity. Grade 3 non-hematologic toxicity was recorded in 5/14 (36%) patients and in 9/54 (17%) cycles, respectively, and included hyperglycemia, diarrhea, nausea, dehydration and hypotension. Grade 1–2 non-hematologic toxicities were relatively common and in line with those previously reported for the BP regimen. Only 1/54 BP cycles was delayed due to grade neutropenia. In this case, the planned cycle was administered two weeks later. Overall grade 4 hematologic toxicity was recorded in 4/14 (14%) patients and in 7/54 (13%) cycles, respectively, and included neutropenia and lymphopenia. Grade 3 hematologic toxicity was recorded in 9/14 (64%) patients and after 21/54 (39%) cycles, respectively, and included leukopenia, neutropenia, lymphopenia and thrombocytopenia. Overall, lymphopenia was the most common grade 3–4 hematologic toxicity. Grade 1–2 hematologic toxicities were common, expected, and included anemia, leukopenia, neutropenia, lymphopenia and, occasionally, thrombocytopenia. Data are available for four patients to analyze post-chemotherapy B- and T- cell recovery.Patientlymphocytes/mlCD3(+)CD4(+)CD8(+)CD19(+)nl range1000–4000960–2600540–1660270–930122–632pre*post*prepostprepostprepostprepostA71311664717702281402505953618B8892545711343445822672568076C878944632632360113272538132198D16627761080590698171399404266109*pre=before first dose of chemotherapy, post=4 months post chemotherapy These preliminary data indicate that BP is a very effective and well tolerated chemotherapy regimen in patients with relapsed follicular lymphoma who have been previously received rituximab therapy. Our data also suggest that, in some patients, BP can cause a lymphopenia of variable intensity that may not fully recover four months after the last chemotherapy cycle. Studies of idiotype vaccine-induced humoral and cellular immune responses and their correlation with the presence of lymphopenia are ongoing. Updated results will be available at the time of the meeting. The authors wish to acknowledge Drs. Ralph Heaven, Larry Barker, Jairo Olivares, Thomas Anderson, Carl Chakmakjian, Barry Cooper, Amir Faridi, Vinay Jain, Pankaj Khandelwal, Janice Marshall, Anton Melnyk, Robert Mennel, James Turner Disclosures: No relevant conflicts of interest to declare.

Idiotype vaccine strategies for treatment of follicular lymphoma

2011 ◽  
Vol 7 (1) ◽  
pp. 111-122 ◽  
Author(s):  
Hemchandra Mahaseth ◽  
Joshua D Brody ◽  
Rajni Sinha ◽  
Pareen J Shenoy ◽  
Christopher R Flowers
Keyword(s):  
Follicular Lymphoma ◽  
Idiotype Vaccine

Idiotype vaccine strategies for improving outcomes in follicular lymphoma

2008 ◽  
Vol 8 (8) ◽  
pp. 1213-1223 ◽  
Author(s):  
Rajni Sinha ◽  
Pareen J Shenoy ◽  
Christopher R Flowers
Keyword(s):  
Follicular Lymphoma ◽  
Idiotype Vaccine

Follicular lymphoma of the skin

1966 ◽  
Vol 93 (2) ◽  
pp. 177-183 ◽  
Author(s):  
J. Kwittken
Keyword(s):  
Follicular Lymphoma

Flow cytometry using the monoclonal antibody CD10-Pe/Cy5 is a useful tool to identify follicular lymphoma cells

2001 ◽  
Vol 66 (2) ◽  
pp. 100-106 ◽  
Author(s):  
M. Bellido ◽  
E. Rubiol ◽  
J. Ubeda ◽  
O. Lopez ◽  
C. Estivill ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Flow Cytometry ◽  
Follicular Lymphoma ◽  
Lymphoma Cells
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