| ID | Type | Description | Link |
|---|---|---|---|
| 00-C-0133 |
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This study will evaluate the safety and effectiveness of an experimental cancer vaccine for mantle cell lymphoma a form of cancer of the white blood cells called lymphocytes. Although standard treatments for lymphoma may achieve disease remission, none provides a cure.
Patients with mantle cell lymphoma 18 years and older who have not been treated previously with chemotherapy may participate in this study. Candidates will be screened for eligibility with a medical history and physical examination. Other tests that may be required include blood and urine tests; lung function studies; imaging tests such as magnetic resonance imaging, computed tomography and X-rays; and biopsy (surgical removal of a small tissue sample) of tumor, bone marrow, or other tissue.
Patients enrolled in the study will begin treatment with chemotherapy designed to reduce disease to a minimum that is, to achieve remission or shrink the tumor as much as possible. Chemotherapy will be administered on an outpatient basis over a period of around 12 to 18 weeks in 3-week cycles as follows: prednisone by mouth on days 1 through 5; etoposide, doxorubicin and vincristine intravenously through (a vein) on days 1 through 5; and cyclophosphamide intravenously on day 5. Starting day 6, patients receive no chemotherapy for 16 days. In addition, an antibody called rituximab, which attaches to lymphoma cells and may increase the effectiveness of the chemotherapy, will be given on day 1 of the cycle. Patients will also receive a protein called granulocyte colony-stimulating factor (G-CSF) starting day 6 of the cycle and continuing until the white blood cell count recovers or until day 19. G-CSF is naturally produced by bone marrow and may boost the immune system. The chemotherapy drugs and rituximab are infused through a vein by means of a lightweight portable pump, which patients are taught how to use. Patients are also how taught how to give themselves G-CSF injections under the skin, similar to insulin injections.
The first vaccination will be given at least 3 months after chemotherapy ends and will be repeated every 4 weeks for a maximum of 5 vaccinations. The vaccinations will be given in the clinic. Patients will also receive daily injections of granulocyte-macrophage colony-stimulating factor (GM-CSF), a growth factor naturally produced by bone marrow that can boost the immune system. These injections will be given the day of the vaccination and for the next 3 days.
When vaccine therapy is completed, patients who were treated successfully will be followed with periodic clinic visits for follow-up examinations and tests. Patients in whom the lymphoma did not disappear entirely or who have a recurrence of disease will be advised of further treatment possibilities....
Background:
Objectives:
Eligibility:
Design:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab | Experimental | Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) followed by idiotype vaccine and granulocyte-macrophage colony-stimulating factor (GM-CSF). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EPOCH-R | Drug | EPOCH-R for 6 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Median Progression-free Survival (PFS) in Participants Treated With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (EPOCH-R) | PFS is time from on study date until disease relapse or progression, death, or date of last follow-up. Progression was measured by the International Workshop to Standardize Response Criteria for non-Hodgkin's Lymphoma and is defined as ≥50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously involved node or the appearance of any new lesion. | From participants on study date until date of disease relapse or progression, death, or date of last follow-up, assessed up to 245.8 months |
| Percentage of Participants With an Antibody Response to Idiotype Vaccine | Participants with an immune response to idiotype vaccine measured by enzyme-linked immunosorbent assay (ELISA) to detect antibody binding to tumor cells. Positive response was defined as at least a fourfold increase in antibody titer. | Weeks 12 to 32 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Whose Cancer Shrinks or Disappears After Treatment With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (EPOCH-R) | Response was measured by the International Workshop to Standardize Response Criteria for non-Hodgkin's Lymphoma. Complete Response (CR) is a complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities (e.g., Lactate dehydrogenase (LDH) definitely assignable to the lymphoma. Complete Response Unconfirmed (CRu) is as per CR criteria except that if a residual node is > 1.5cm, it must have regressed by > 75% in the sum of the products of the greatest diameters (SPD). Partial Response (PR) is ≥50% decreased in the SPD of 6 largest dominant nodes or nodal masses. Stable Disease (SD) is defined as less than a PR but not progressive disease. Progression is ≥50% increase from nadir in the SPD of any previously involved node or the appearance of any new lesion. |
| Measure | Description | Time Frame |
|---|---|---|
| Here is the Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Toxicity Criteria (CTC v2.0). | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Toxicity Criteria (CTC v2.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
Tissue diagnosis of mantle cell lymphoma (confirmed in Laboratory of Pathology). Blastic cell variant will be eligible.
Age greater than or equal to 18.
Previously untreated with cytotoxic chemotherapy. Patients may have received local radiation or a short course of steroids for control of symptoms.
All stages of disease.
Lymph node of greater than or equal to 2 cm accessible for biopsy/harvest or greater than 1000/microliters of circulating tumor cells in the blood.
Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 3.
Adequate major organ function (serum creatinine 1.5 mg/dl or creatinine clearance greater than 60 ml/min; bilirubin less than 2 mg/dl (total) except less than 5 mg/dl in patients with Gilbert's syndrome as defined by greater than 80% unconjugated; absolute neutrophil count (ANC) greater than 1000 and platelets greater than 100,000) unless impairment due to organ involvement by lymphoma.
No active symptomatic ischemic heart disease, myocardial infarction or congestive heart failure within the past year. If multigated acquisition (MUGA) scan is obtained, the left ventricular ejection fraction (LVEF) should exceed 40%.
Ability to give informed consent.
EXCLUSION CRITERIA:
Antibodies to human immunodeficiency virus (HIV) or presence of hepatitis B surface antigen.
Pregnant or lactating.
Prior malignancy in past 5 years except squamous or basal cell carcinoma or curatively treated in situ of the cervix.
Involvement of central nervous system by lymphoma.
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| Name | Affiliation | Role |
|---|---|---|
| Christopher J Melani, M.D. | National Cancer Institute (NCI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8639796 | Background | Pittaluga S, Bijnens L, Teodorovic I, Hagenbeek A, Meerwaldt JH, Somers R, Thomas J, Noordijk EM, De Wolf-Peeters C. Clinical analysis of 670 cases in two trials of the European Organization for the Research and Treatment of Cancer Lymphoma Cooperative Group subtyped according to the Revised European-American Classification of Lymphoid Neoplasms: a comparison with the Working Formulation. Blood. 1996 May 15;87(10):4358-67. | |
| 9830633 |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) followed by idiotype vaccine and granulocyte-macrophage colony-stimulating factor (GM-CSF). EPOCH-R: EPOCH-R for 6 cycles GM-CSF: Granulocyte-macrophage colony-stimulating factor (GM-CSF) monthly with the vaccine for 5 doses Idiotype vaccine: 1 injection of vaccine monthly for 5 doses |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| EPOCH-R Administration |
| |||||||||||||
| Vaccine Administration Following EPOCH-R |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) followed by idiotype vaccine and granulocyte-macrophage colony-stimulating factor (GM-CSF). EPOCH-R: EPOCH-R for 6 cycles GM-CSF: Granulocyte-macrophage colony-stimulating factor (GM-CSF) monthly with the vaccine for 5 doses Idiotype vaccine: 1 injection of vaccine monthly for 5 doses |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Median Progression-free Survival (PFS) in Participants Treated With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (EPOCH-R) | PFS is time from on study date until disease relapse or progression, death, or date of last follow-up. Progression was measured by the International Workshop to Standardize Response Criteria for non-Hodgkin's Lymphoma and is defined as ≥50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously involved node or the appearance of any new lesion. | Posted | Median | Full Range | Months | From participants on study date until date of disease relapse or progression, death, or date of last follow-up, assessed up to 245.8 months |
|
Up to 30 days after last intervention, up to 12.5 months or 1.04 years for serious and/or non-serious adverse events and up to 250 months for all-cause mortality.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab | Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) followed by idiotype vaccine and granulocyte-macrophage colony-stimulating factor (GM-CSF). EPOCH-R: EPOCH-R for 6 cycles GM-CSF: Granulocyte-macrophage colony-stimulating factor (GM-CSF) monthly with the vaccine for 5 doses Idiotype vaccine: 1 injection of vaccine monthly for 5 doses |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTC 2.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death unrelated to research and related to disease progression | General disorders | CTC 2.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christopher J. Melani | National Cancer Institute | 240-760-6057 | christopher.melani@nih.gov |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 19, 2019 | Aug 16, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 25, 2018 | Aug 16, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D005047 | Etoposide |
| D011241 | Prednisone |
| D014750 | Vincristine |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D000069283 | Rituximab |
| D016178 | Granulocyte-Macrophage Colony-Stimulating Factor |
| C081222 | sargramostim |
| ID | Term |
|---|---|
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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| GM-CSF | Biological | Granulocyte-macrophage colony-stimulating factor (GM-CSF) monthly with the vaccine for 5 doses |
|
|
| Idiotype vaccine | Biological | 1 injection of vaccine monthly for 5 doses |
|
| After 6 cycles of EPOCH-R therapy, an average of 18 weeks |
| Percentage of Participants With Grade 3 or Higher Serious and/or Non-serious Toxicity That Occurred That is at Least Possibly Related to Drug or Vaccine | Serious and/or non-serious adverse events were assessed by the Common Toxicity Criteria (CTC v2.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to adverse event. | Up to 30 days after last intervention, up to 12.5 months or 1.04 years |
| Overall Survival (OS) | OS was determined by the Kaplan-Meier method and is defined as the time from treatment start date until date of death or last follow-up. | Time from treatment start date until date of death or date last follow-up, up to 250 months |
| Progression Free Survival (PFS) in Participants Who Received Idiotype Vaccine | PFS is defined as the time from start of treatment until disease relapse or progression, death, or last follow-up. Progression was measured by the International Workshop to Standardize Response Criteria for non-Hodgkin's Lymphoma and is defined as ≥50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously involved node or the appearance of any new lesion | Time from treatment start date until date of disease relapse or progression, death, or date last follow-up, an average of 25 months |
| Percentage of Participants With Antibodies to Keyhole Limpet Haemocyanin (KLH) | Participants with an immune response against carrier molecule KLH measured by enzyme-linked immunosorbent assay (ELISA) to detect antibody binding to tumor cells. Positive response was defined as at least a fourfold increase in antibody titer. | After vaccinations administered at 0, 1, 2, 3 and 5 months |
| Percentage of Participants With Induction of Type 1 Cytokine T-cell Response | Participants with tumor specific T-cell responses during B-cell recovery was assessed in a Clinical Laboratory Improvement Amendments (CLIA) certified lab and were measured by flow cytometry and/or enzyme-linked immunosorbent spot (ELISPOT). A positive response required the response to be at least twice the negative controls. | After vaccinations administered at 0, 1, 2, 3 and 5 months |
| Time to Recovery of CD4 T Lymphocytes (CD4+) | Recovery of CD4+ was measured by flow cytometry. Blood samples were collected via apheresis and analyzed by multicolor flow cytometry in peripheral blood mononuclear cells (PBMCs) for cluster of differentiation 4 (CD4). Time to recovery of CD4 T lymphocytes was defined as the time required for CD4 T lymphocytes to increase above the lower limit of normal of the normal laboratory value range of 359 cells/mcL | After chemotherapy before vaccination, up to 6 months |
| Up to 30 days after last intervention, up to 12.5 months or 1.04 years |
| Background |
| Armitage JO. Management of mantle cell lymphoma. Oncology (Williston Park). 1998 Oct;12(10 Suppl 8):49-55. |
| 8639814 | Background | Weisenburger DD, Armitage JO. Mantle cell lymphoma-- an entity comes of age. Blood. 1996 Jun 1;87(11):4483-94. No abstract available. |
| Result | Grant C, Neelapu SS, MD2, Kwak LW, Dunleavy K, White T, Miller BW, Jaffe ES, Steinberg SM, Healey Bird B, MB, Wilson WH. Eleven-Year Follow-up of Idiotype Vaccine and DA-EPOCH-Rituximab in Untreated Mantle Cell Lymphoma: Correlation of Survival with Idiotype Immune Response. Blood (ASH Annual Meeting Abstracts) 2011 118: Abstract 2707. |
| 16116429 | Result | Neelapu SS, Kwak LW, Kobrin CB, Reynolds CW, Janik JE, Dunleavy K, White T, Harvey L, Pennington R, Stetler-Stevenson M, Jaffe ES, Steinberg SM, Gress R, Hakim F, Wilson WH. Vaccine-induced tumor-specific immunity despite severe B-cell depletion in mantle cell lymphoma. Nat Med. 2005 Sep;11(9):986-91. doi: 10.1038/nm1290. Epub 2005 Aug 21. |
| Result | Roschewski M, Dunleavy K, Neelapu SS, Pittaluga S, Melani CJ, Jaffe ES, Shovlin M, Crossley B, Kong K, Jacob A, Kwak L, Wilson WH. Quantitative Baseline Circulating Tumor DNA Levels Correlate with GM-CSF Response to Idiotype Vaccine in Untreated Mantle Cell Lymphoma (ASH Annual Meeting Abstracts). Blood. 2016;128:2943-2943. |
| Result | Wilson WH, Neelapu S, White T, et al: Idiotype Vaccine Following EPOCH-Rituximab Treatment in Untreated Mantle Cell Lymphoma. Pro Am Soc Heme, 2002. |
| Result | Neelapu S, Wilson WH, Baskar W, et at: Induction of T-cell responses by tumor antigen vaccination in mantle cell lymphoma following rituximab-based treatment. Pro Am Soc Clin Oncol, 2003. |
| 12620412 | Result | Rosenwald A, Wright G, Wiestner A, Chan WC, Connors JM, Campo E, Gascoyne RD, Grogan TM, Muller-Hermelink HK, Smeland EB, Chiorazzi M, Giltnane JM, Hurt EM, Zhao H, Averett L, Henrickson S, Yang L, Powell J, Wilson WH, Jaffe ES, Simon R, Klausner RD, Montserrat E, Bosch F, Greiner TC, Weisenburger DD, Sanger WG, Dave BJ, Lynch JC, Vose J, Armitage JO, Fisher RI, Miller TP, LeBlanc M, Ott G, Kvaloy S, Holte H, Delabie J, Staudt LM. The proliferation gene expression signature is a quantitative integrator of oncogenic events that predicts survival in mantle cell lymphoma. Cancer Cell. 2003 Feb;3(2):185-97. doi: 10.1016/s1535-6108(03)00028-x. |
| Result | Wilson WH, Neelapu S, Rosenwald A, et al: Idiotype Vaccine and Dose-Adjusted EPOCH-Rituximab Treatment in Untreated Mantle Cell Lymphoma: Preliminary Report on Clinical Outcome and Analysis of Immune Response. 2003, Blood 102 (11) #358. |
| 16123218 | Result | Fu K, Weisenburger DD, Greiner TC, Dave S, Wright G, Rosenwald A, Chiorazzi M, Iqbal J, Gesk S, Siebert R, De Jong D, Jaffe ES, Wilson WH, Delabie J, Ott G, Dave BJ, Sanger WG, Smith LM, Rimsza L, Braziel RM, Muller-Hermelink HK, Campo E, Gascoyne RD, Staudt LM, Chan WC; Lymphoma/Leukemia Molecular Profiling Project. Cyclin D1-negative mantle cell lymphoma: a clinicopathologic study based on gene expression profiling. Blood. 2005 Dec 15;106(13):4315-21. doi: 10.1182/blood-2005-04-1753. Epub 2005 Aug 25. |
| 17299095 | Result | Wiestner A, Tehrani M, Chiorazzi M, Wright G, Gibellini F, Nakayama K, Liu H, Rosenwald A, Muller-Hermelink HK, Ott G, Chan WC, Greiner TC, Weisenburger DD, Vose J, Armitage JO, Gascoyne RD, Connors JM, Campo E, Montserrat E, Bosch F, Smeland EB, Kvaloy S, Holte H, Delabie J, Fisher RI, Grogan TM, Miller TP, Wilson WH, Jaffe ES, Staudt LM. Point mutations and genomic deletions in CCND1 create stable truncated cyclin D1 mRNAs that are associated with increased proliferation rate and shorter survival. Blood. 2007 Jun 1;109(11):4599-606. doi: 10.1182/blood-2006-08-039859. Epub 2007 Feb 13. |
| Result | Dunleavy K, Neelapu SS, Kwak LW, Grant C, Santos CF, Popa M, White T, Miller B, Jaffe ES, Steinberg SM and Wilson WH. Association of idiotype vaccine-induced T-cell response with improved survival and time-to-next treatment (TTNT) in untreated mantle cell lymphoma (MCL). Journal of Clinical Oncology, 2012 ASCO Annual Meeting Proceedings (Post-Meeting Edition).Vol 30, No 15_suppl (May 20 Supplement), 2012: 2528. |
| 35882475 | Derived | Lai C, Cole DE, Steinberg SM, Lucas N, Dombi E, Melani C, Roschewski M, Balis F, Widemann BC, Wilson WH. Doxorubicin pharmacokinetics and toxicity in patients with aggressive lymphoma and hepatic impairment. Blood Adv. 2023 Feb 28;7(4):529-532. doi: 10.1182/bloodadvances.2022007431. |
|
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Mantle Cell Lymphoma International Prognostic Index (MIPI) | MIPI is a prognostic score (i.e., risk groups) for participants with mantle cell lymphoma. Low- risk scores (i.e., 0-3) indicate better survival and high-risk scores (i.e., 6-11) indicate lower survival. Intermediate-risk scores (i.e., 4-5) is neither low nor high with intermediate survival. | Count of Participants | Participants |
|
| Performance Status | ECOG score is an indication of a participant's functional status. An ECOG score of 0 indicates a participant is fully active without any performance restrictions. An ECOG score of 1 indicates a participant is restricted in physically strenuous activity but ambulatory and able to carry out light work. An ECOG score of 2 indicates a participant is capable of self-care but unable to carry out any work activities and is up and about greater than 50% of waking hours. | Median | Full Range | score on a scale |
|
|
|
| Primary | Percentage of Participants With an Antibody Response to Idiotype Vaccine | Participants with an immune response to idiotype vaccine measured by enzyme-linked immunosorbent assay (ELISA) to detect antibody binding to tumor cells. Positive response was defined as at least a fourfold increase in antibody titer. | 23/26 participants were analyzed because vaccine was unable to be produced in two participants and one participant progressed prior to receiving the last vaccine dose. | Posted | Number | percentage of participants | Weeks 12 to 32 |
|
|
|
| Secondary | Percentage of Participants Whose Cancer Shrinks or Disappears After Treatment With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (EPOCH-R) | Response was measured by the International Workshop to Standardize Response Criteria for non-Hodgkin's Lymphoma. Complete Response (CR) is a complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities (e.g., Lactate dehydrogenase (LDH) definitely assignable to the lymphoma. Complete Response Unconfirmed (CRu) is as per CR criteria except that if a residual node is > 1.5cm, it must have regressed by > 75% in the sum of the products of the greatest diameters (SPD). Partial Response (PR) is ≥50% decreased in the SPD of 6 largest dominant nodes or nodal masses. Stable Disease (SD) is defined as less than a PR but not progressive disease. Progression is ≥50% increase from nadir in the SPD of any previously involved node or the appearance of any new lesion. | Posted | Number | percentage of participants | After 6 cycles of EPOCH-R therapy, an average of 18 weeks |
|
|
|
| Secondary | Percentage of Participants With Grade 3 or Higher Serious and/or Non-serious Toxicity That Occurred That is at Least Possibly Related to Drug or Vaccine | Serious and/or non-serious adverse events were assessed by the Common Toxicity Criteria (CTC v2.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to adverse event. | Posted | Number | percentage of participants | Up to 30 days after last intervention, up to 12.5 months or 1.04 years |
|
|
|
| Secondary | Overall Survival (OS) | OS was determined by the Kaplan-Meier method and is defined as the time from treatment start date until date of death or last follow-up. | Posted | Median | Full Range | Months | Time from treatment start date until date of death or date last follow-up, up to 250 months |
|
|
|
| Secondary | Progression Free Survival (PFS) in Participants Who Received Idiotype Vaccine | PFS is defined as the time from start of treatment until disease relapse or progression, death, or last follow-up. Progression was measured by the International Workshop to Standardize Response Criteria for non-Hodgkin's Lymphoma and is defined as ≥50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously involved node or the appearance of any new lesion | 23/26 participants were analyzed because vaccine was unable to be produced in two participants and one participant progressed prior to receiving the last vaccine. | Posted | Median | Full Range | Months | Time from treatment start date until date of disease relapse or progression, death, or date last follow-up, an average of 25 months |
|
|
|
| Secondary | Percentage of Participants With Antibodies to Keyhole Limpet Haemocyanin (KLH) | Participants with an immune response against carrier molecule KLH measured by enzyme-linked immunosorbent assay (ELISA) to detect antibody binding to tumor cells. Positive response was defined as at least a fourfold increase in antibody titer. | 23/26 participants were analyzed because vaccine was unable to be produced in two participants and one participant progressed prior to receiving the last vaccine. | Posted | Number | percentage of participants | After vaccinations administered at 0, 1, 2, 3 and 5 months |
|
|
|
| Secondary | Percentage of Participants With Induction of Type 1 Cytokine T-cell Response | Participants with tumor specific T-cell responses during B-cell recovery was assessed in a Clinical Laboratory Improvement Amendments (CLIA) certified lab and were measured by flow cytometry and/or enzyme-linked immunosorbent spot (ELISPOT). A positive response required the response to be at least twice the negative controls. | 23/26 participants were analyzed because vaccine was unable to be produced in two participants and one participant progressed prior to receiving the last vaccine. | Posted | Number | percentage of participants | After vaccinations administered at 0, 1, 2, 3 and 5 months |
|
|
|
| Secondary | Time to Recovery of CD4 T Lymphocytes (CD4+) | Recovery of CD4+ was measured by flow cytometry. Blood samples were collected via apheresis and analyzed by multicolor flow cytometry in peripheral blood mononuclear cells (PBMCs) for cluster of differentiation 4 (CD4). Time to recovery of CD4 T lymphocytes was defined as the time required for CD4 T lymphocytes to increase above the lower limit of normal of the normal laboratory value range of 359 cells/mcL | Posted | Median | Full Range | Months | After chemotherapy before vaccination, up to 6 months |
|
|
|
| Other Pre-specified | Here is the Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Toxicity Criteria (CTC v2.0). | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Toxicity Criteria (CTC v2.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. | Posted | Count of Participants | Participants | Up to 30 days after last intervention, up to 12.5 months or 1.04 years |
|
|
|
| 17 |
| 26 |
| 14 |
| 26 |
| 26 |
| 26 |
| Febrile neutropenia | Infections and infestations | CTC 2.0 | Systematic Assessment |
|
| Infection | Infections and infestations | CTC 2.0 | Systematic Assessment |
|
| Infusion related reaction | General disorders | CTC 2.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTC 2.0 | Systematic Assessment |
|
| Alkaline phosphatase elevation | Hepatobiliary disorders | CTC 2.0 | Systematic Assessment |
|
| Allergic reaction | Immune system disorders | CTC 2.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTC 2.0 | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTC 2.0 | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | CTC 2.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTC 2.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTC 2.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTC 2.0 | Systematic Assessment |
|
| Bilirubin elevation | Hepatobiliary disorders | CTC 2.0 | Systematic Assessment |
|
| Blurred vision | Eye disorders | CTC 2.0 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | CTC 2.0 | Systematic Assessment |
|
| Bruising | Skin and subcutaneous tissue disorders | CTC 2.0 | Systematic Assessment |
|
| Cerebrovascular ischemia | Cardiac disorders | CTC 2.0 | Systematic Assessment |
|
| Confusion | Nervous system disorders | CTC 2.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTC 2.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTC 2.0 | Systematic Assessment |
|
| CPK elevation | Metabolism and nutrition disorders | CTC 2.0 | Systematic Assessment |
|
| Creatinine elevation | Renal and urinary disorders | CTC 2.0 | Systematic Assessment |
|
| Decreased libido | Reproductive system and breast disorders | CTC 2.0 | Systematic Assessment |
|
| Depression | Nervous system disorders | CTC 2.0 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTC 2.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTC 2.0 | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTC 2.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | CTC 2.0 | Systematic Assessment |
|
| Edema | Cardiac disorders | CTC 2.0 | Systematic Assessment |
|
| Eosinophilia | Blood and lymphatic system disorders | CTC 2.0 | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | CTC 2.0 | Systematic Assessment |
|
| Euphoria | Nervous system disorders | CTC 2.0 | Systematic Assessment |
|
| Fatigue | General disorders | CTC 2.0 | Systematic Assessment |
|
| Febrile neutropenia | Infections and infestations | CTC 2.0 | Systematic Assessment |
|
| Fever | General disorders | CTC 2.0 | Systematic Assessment |
|
| Floaters | Eye disorders | CTC 2.0 | Systematic Assessment |
|
| Flushing | Skin and subcutaneous tissue disorders | CTC 2.0 | Systematic Assessment |
|
| Gynecomastia | Endocrine disorders | CTC 2.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | CTC 2.0 | Systematic Assessment |
|
| Hearing impaired | Ear and labyrinth disorders | CTC 2.0 | Systematic Assessment |
|
| Hematochezia | Gastrointestinal disorders | CTC 2.0 | Systematic Assessment |
|
| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTC 2.0 | Systematic Assessment |
|
| Hot flashes | Endocrine disorders | CTC 2.0 | Systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | CTC 2.0 | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTC 2.0 | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTC 2.0 | Systematic Assessment |
|
| Hypermagnesemia | Metabolism and nutrition disorders | CTC 2.0 | Systematic Assessment |
|
| Hypertension | Cardiac disorders | CTC 2.0 | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTC 2.0 | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTC 2.0 | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTC 2.0 | Systematic Assessment |
|
| Hypothyroid | Endocrine disorders | CTC 2.0 | Systematic Assessment |
|
| Infection | Infections and infestations | CTC 2.0 | Systematic Assessment |
|
| Infusion related reaction | General disorders | CTC 2.0 | Systematic Assessment |
|
| Insomnia | Nervous system disorders | CTC 2.0 | Systematic Assessment |
|
| Leg pain | General disorders | CTC 2.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | CTC 2.0 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | CTC 2.0 | Systematic Assessment |
|
| Motor neuropathy | Nervous system disorders | CTC 2.0 | Systematic Assessment |
|
| Muscle cramp | Musculoskeletal and connective tissue disorders | CTC 2.0 | Systematic Assessment |
|
| Muscle weakness | Musculoskeletal and connective tissue disorders | CTC 2.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTC 2.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTC 2.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | CTC 2.0 | Systematic Assessment |
|
| Phlebitis | Cardiac disorders | CTC 2.0 | Systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | CTC 2.0 | Systematic Assessment |
|
| PT elevation | Blood and lymphatic system disorders | CTC 2.0 | Systematic Assessment |
|
| PTT elevation | Blood and lymphatic system disorders | CTC 2.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CTC 2.0 | Systematic Assessment |
|
| Sensory neuropathy | Nervous system disorders | CTC 2.0 | Systematic Assessment |
|
| SGOT elevation | Hepatobiliary disorders | CTC 2.0 | Systematic Assessment |
|
| SGPT elevation | Hepatobiliary disorders | CTC 2.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | CTC 2.0 | Systematic Assessment |
|
| Taste disturbance | Gastrointestinal disorders | CTC 2.0 | Systematic Assessment |
|
| Tearing | Eye disorders | CTC 2.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | CTC 2.0 | Systematic Assessment |
|
| Thrombosis | Cardiac disorders | CTC 2.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | CTC 2.0 | Systematic Assessment |
|
| Vaginal bleeding | Reproductive system and breast disorders | CTC 2.0 | Systematic Assessment |
|
| Visual loss | Eye disorders | CTC 2.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTC 2.0 | Systematic Assessment |
|
| Weight loss | General disorders | CTC 2.0 | Systematic Assessment |
|
| Chest pain | Musculoskeletal and connective tissue disorders | CTC 2.0 | Systematic Assessment |
|
Not provided
Not provided
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D000617 | Aminoglycosides |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D001685 | Biological Factors |
| Title | Measurements |
|---|---|
|
| Stable Disease |
|
| Progression |
|
| Title | Measurements |
|---|---|
|
| Febrile neutropenia |
|
| Leukopenia |
|
| Lymphopenia |
|
| Neutropenia |
|
| Thrombocytopenia |
|
| Thrombosis |
|
| Infusion related reaction |
|
| Serum glutamic oxaloacetic transaminase (SGOT) elevation |
|
| Serum glutamic pyruvic transaminase (SGPT) elevation |
|
| Infection |
|
| Hyperglycemia |
|
| Hypomagnesemia |
|
| Cerebrovascular ischemia |
|
| Motor neuropathy |
|
| Sensory neuropathy |
|
| Back pain |
|
| Dyspnea |
|
| Erectile dysfunction |
|
| Title | Measurements |
|---|---|
|
| Interferon-gamma (IFN-γ) |
|