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Clinical benefit was noted before the scheduled completion of the trial and the extension study was terminated early.
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This is an open-label extension study enrolling participants experiencing clinical benefit following 6 cycles of DI-Leu16-IL2 while enrolled in the Alopexx Oncology Dose-Escalation AO-101 study (NCT01874288). Participants will be permitted to continue to receive DI-Leu16-IL2 at the same dose, schedule, and route of administration they received during Study AO-101 (Main Study). Prior pre-treatment (for example, Rituximab) will continue as before.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DI-Leu16-IL2 1.0 mg/m^2 | Experimental | Participants will receive DI-Leu16-IL2 1.0 milligrams per square meter (mg/m^2) subcutaneously (SC) for 3 consecutive days every 3 weeks (21-day cycle). Participants will continue to receive therapy through the duration of the study as long as they will have clinical benefit and will not experience any untoward side effects. |
|
| DI-Leu16-IL2 2.0 mg/m^2 | Experimental | Participants will receive DI-Leu16-IL2 2.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle). Participants will continue to receive therapy through the duration of the study as long as they will have clinical benefit and will not experience any untoward side effects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DI-Leu16-IL2 | Drug | DI-Leu16-IL2 will be administered per dose and schedule specified in the arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Best Overall Response (BOR) Assessed Per International Workshop for Non-Hodgkin Lymphoma (NHL) Response Criteria | BOR included complete response (CR), unconfirmed CR (CRu), partial response (PR), stable disease (SD), and progressive disease (PD). CR: 1)Disappearance of all detectable clinical and radiological evidence of disease; 2)lymph nodes (LN) regressed to normal size; 3)other organs (spleen, liver, kidneys) that were enlarged before therapy must have decreased in size; 4)clear bone marrow(BM) infiltrate. CRu: must meet CR criteria 1 and 3, as well as ≥1 of following: residual LN mass >1.5 centimeters (cm) in greatest transverse diameter; individual nodes that were previously confluent regressed by >75% in sum of product diameters (SPD); or indeterminate BM. PR: 6 largest dominant nodes or nodal masses decreased by ≤50% in SPD; no increase in size of other nodes; liver or spleen; splenic and hepatic nodules regressed ≥50% in SPD; and no new disease. SD: less than a PR but not PD. PD: 50% increase from nadir in SPD of any abnormal node for PR or nonresponders and appearance of any new lesion. | First dose of study drug until first appearance of CR, CRu, PR, SD, or PD (up to 20 months) |
| Tumor Measurement: Percent Change From Baseline in Sum of Product of Diameters at the End of Study | Sum of product diameters sums the product of the 2 tumor measurements on each lesion. If only 1 measurement was available, it was used as the longest length and the product of the lengths in the sum. Baseline value is the last non-missing measurement prior to receiving study drug injection in the Main Study AO-101. | Baseline, end of study (EOS) (up to approximately 32 months) |
| Tumor Measurement: Percent Change From Baseline in Sum of Longest Diameters at the End of Study | Sum of longest diameters is the sum of the longest measured length of each tumor lesion. Baseline value is the last non-missing measurement prior to receiving study drug injection in the Main Study AO-101. None of the participants were considered evaluable in 'DI-Leu16-IL2 2.0 mg/m^2' arm for this outcome measure at the end of study, and therefore, data were not collected for that arm | Baseline, EOS (up to approximately 32 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as AEs with onset at the time of or following the start of treatment with study drug, or AEs starting before the start of treatment but increasing in severity or relationship at the time of or following the start of treatment. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Vlock, MD | Alopexx Oncology, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| University of Minnesota |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15076141 | Background | Ko YJ, Bubley GJ, Weber R, Redfern C, Gold DP, Finke L, Kovar A, Dahl T, Gillies SD. Safety, pharmacokinetics, and biological pharmacodynamics of the immunocytokine EMD 273066 (huKS-IL2): results of a phase I trial in patients with prostate cancer. J Immunother. 2004 May-Jun;27(3):232-9. doi: 10.1097/00002371-200405000-00008. | |
| 15483010 |
| Label | URL |
|---|---|
| Sponsor website | View source |
Not provided
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Participants who, in the opinion of the Investigator, exhibited a beneficial effect without a dose-limiting toxicity (DLT) in the dose-escalation Study AO-101 (NCT01874288) (Main Study) were allowed to continue treatment with DI-Leu16-IL2 in this open-label extension study.
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| ID | Title | Description |
|---|---|---|
| FG000 | DI-Leu16-IL2 1.0 mg/m^2 | Participants received DI-Leu16-IL2 1.0 milligrams per square meter (mg/m^2) subcutaneously (SC) for 3 consecutive days every 3 weeks (21-day cycle). Participants continued to receive therapy through the duration of the study as long as they were having clinical benefit and not experiencing any untoward side effects. |
| FG001 | DI-Leu16-IL2 2.0 mg/m^2 | Participants received DI-Leu16-IL2 2.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle). Participants continued to receive therapy through the duration of the study as long as they were having clinical benefit and not experiencing any untoward side effects. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population included all enrolled participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | DI-Leu16-IL2 1.0 mg/m^2 | Participants received DI-Leu16-IL2 1.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle). Participants continued to receive therapy through the duration of the study as long as they were having clinical benefit and not experiencing any untoward side effects. |
| BG001 |
| 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 | Number of Participants With Best Overall Response (BOR) Assessed Per International Workshop for Non-Hodgkin Lymphoma (NHL) Response Criteria | BOR included complete response (CR), unconfirmed CR (CRu), partial response (PR), stable disease (SD), and progressive disease (PD). CR: 1)Disappearance of all detectable clinical and radiological evidence of disease; 2)lymph nodes (LN) regressed to normal size; 3)other organs (spleen, liver, kidneys) that were enlarged before therapy must have decreased in size; 4)clear bone marrow(BM) infiltrate. CRu: must meet CR criteria 1 and 3, as well as ≥1 of following: residual LN mass >1.5 centimeters (cm) in greatest transverse diameter; individual nodes that were previously confluent regressed by >75% in sum of product diameters (SPD); or indeterminate BM. PR: 6 largest dominant nodes or nodal masses decreased by ≤50% in SPD; no increase in size of other nodes; liver or spleen; splenic and hepatic nodules regressed ≥50% in SPD; and no new disease. SD: less than a PR but not PD. PD: 50% increase from nadir in SPD of any abnormal node for PR or nonresponders and appearance of any new lesion. | Safety population included all enrolled participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | First dose of study drug until first appearance of CR, CRu, PR, SD, or PD (up to 20 months) |
First dose of study drug up to EOS (up to 20 months)
Safety population included all enrolled participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DI-Leu16-IL2 1.0 mg/m^2 | Participants received DI-Leu16-IL2 1.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle). Participants continued to receive therapy through the duration of the study as long as they were having clinical benefit and not experiencing any untoward side effects. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
Clinical benefit was noted before the scheduled completion of the trial, hence; the study was terminated early.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Alopexx Oncology, LLC | daniel.vlock@alopexx.com |
Not provided
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| First dose of study drug up to EOS (up to 20 months) |
| Number of Participants With a TEAE That Was Considered Related to a Clinically Significant Hematology or Serum Chemistry Abnormality | TEAEs were defined as AEs with onset at the time of or following the start of treatment with study drug, or AEs starting before the start of treatment but increasing in severity or relationship at the time of or following the start of treatment. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. Clinically significant hematology and serum chemistry abnormalities were identified at the Investigator's discretion. | First dose of study drug up to EOS (up to 20 months) |
| Number of Participants With a Clinically Significant Abnormal Physical Exam | Clinically significant abnormal physical exams included extremities, head, ears, eyes, nose, throat, abdomen, respiratory system, lymphatic system, and integumentary system. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. Clinically significant abnormal physical exams were identified at the Investigator's discretion. | First dose of study drug up to EOS (up to 20 months) |
| Minneapolis |
| Minnesota |
| 55455 |
| United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| King DM, Albertini MR, Schalch H, Hank JA, Gan J, Surfus J, Mahvi D, Schiller JH, Warner T, Kim K, Eickhoff J, Kendra K, Reisfeld R, Gillies SD, Sondel P. Phase I clinical trial of the immunocytokine EMD 273063 in melanoma patients. J Clin Oncol. 2004 Nov 15;22(22):4463-73. doi: 10.1200/JCO.2004.11.035. Epub 2004 Oct 13. |
| 7522629 | Background | Maloney DG, Liles TM, Czerwinski DK, Waldichuk C, Rosenberg J, Grillo-Lopez A, Levy R. Phase I clinical trial using escalating single-dose infusion of chimeric anti-CD20 monoclonal antibody (IDEC-C2B8) in patients with recurrent B-cell lymphoma. Blood. 1994 Oct 15;84(8):2457-66. |
| National Cancer Institute at the National Institute of Health | View source |
| DI-Leu16-IL2 2.0 mg/m^2 |
Participants received DI-Leu16-IL2 2.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle). Participants continued to receive therapy through the duration of the study as long as they were having clinical benefit and not experiencing any untoward side effects. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Primary | Tumor Measurement: Percent Change From Baseline in Sum of Product of Diameters at the End of Study | Sum of product diameters sums the product of the 2 tumor measurements on each lesion. If only 1 measurement was available, it was used as the longest length and the product of the lengths in the sum. Baseline value is the last non-missing measurement prior to receiving study drug injection in the Main Study AO-101. | Safety population included all enrolled participants who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. None of the participants were considered evaluable in 'DI-Leu16-IL2 2.0 mg/m^2' arm for this outcome measure at the end of study, and therefore, data were not collected for that arm. | Posted | Mean | Standard Deviation | percent change | Baseline, end of study (EOS) (up to approximately 32 months) |
|
|
|
| Primary | Tumor Measurement: Percent Change From Baseline in Sum of Longest Diameters at the End of Study | Sum of longest diameters is the sum of the longest measured length of each tumor lesion. Baseline value is the last non-missing measurement prior to receiving study drug injection in the Main Study AO-101. None of the participants were considered evaluable in 'DI-Leu16-IL2 2.0 mg/m^2' arm for this outcome measure at the end of study, and therefore, data were not collected for that arm | Safety population included all enrolled participants who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | percent change | Baseline, EOS (up to approximately 32 months) |
|
|
|
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as AEs with onset at the time of or following the start of treatment with study drug, or AEs starting before the start of treatment but increasing in severity or relationship at the time of or following the start of treatment. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. | Safety population included all enrolled participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | First dose of study drug up to EOS (up to 20 months) |
|
|
|
| Secondary | Number of Participants With a TEAE That Was Considered Related to a Clinically Significant Hematology or Serum Chemistry Abnormality | TEAEs were defined as AEs with onset at the time of or following the start of treatment with study drug, or AEs starting before the start of treatment but increasing in severity or relationship at the time of or following the start of treatment. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. Clinically significant hematology and serum chemistry abnormalities were identified at the Investigator's discretion. | Safety population included all enrolled participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | First dose of study drug up to EOS (up to 20 months) |
|
|
|
| Secondary | Number of Participants With a Clinically Significant Abnormal Physical Exam | Clinically significant abnormal physical exams included extremities, head, ears, eyes, nose, throat, abdomen, respiratory system, lymphatic system, and integumentary system. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. Clinically significant abnormal physical exams were identified at the Investigator's discretion. | Safety population included all enrolled participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | First dose of study drug up to EOS (up to 20 months) |
|
|
|
| 0 |
| 3 |
| 2 |
| 3 |
| 3 |
| 3 |
| EG001 | DI-Leu16-IL2 2.0 mg/m^2 | Participants received DI-Leu16-IL2 2.0 mg/m^2 SC for 3 consecutive days every 3 weeks (21-day cycle). Participants continued to receive therapy through the duration of the study as long as they were having clinical benefit and not experiencing any untoward side effects. | 0 | 2 | 0 | 2 | 1 | 2 |
| Melena | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Injection site oedema | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Hematocrit decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Protein total increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Neurotoxicity | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Nystagmus | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Chromaturia | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Urine odour abnormal | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Ligament injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cerumen impaction | Ear and labyrinth disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA 15.1 | Systematic Assessment |
|
| Injection site inflammation | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Injection site mass | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypogammaglobulinaemia | Immune system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Otitis media acute | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Acoustic neuroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
Not provided
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |