- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02151903
Open-Label Extension Study of De-immunized DI-Leu16-IL2 Immunocytokine Administered in Participants With B-cell NHL
November 2, 2020 updated by: Alopexx Oncology, LLC
An Open-Label Extension Study of De-immunized DI-Leu16-IL2 Immunocytokine Administered in Patients With B-cell Non-Hodgkin Lymphoma (NHL)
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Duarte, California, United States, 91010
- City of Hope
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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New Hampshire
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Lebanon, New Hampshire, United States, 03756
- Dartmouth-Hitchcock Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participants currently entered on Alopexx Oncology Study AO-101
- Participants who received 6 cycles of DI-Leu16-IL2 on Study AO-101.
- Documented clinical benefit following 6th cycle of DI-Leu16-IL2
- Able to begin extension study within 8 weeks of receiving 6th cycle of DI-Leu16-IL2
- Participants must have received prior Rituximab-containing therapy.
- Participants in this extension study are to use adequate birth control measures (abstinence, oral contraceptives, barrier method with spermicide or surgical sterilization) during the study. Females of childbearing potential must have a negative serum pregnancy test on the days of dosing. A female of childbearing potential: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (that is, has had menses at any time in the preceding 24 consecutive months.
- Provide written informed consent prior to any study procedures.
Exclusion Criteria:
- Pregnant or lactating female
- An immediate need for palliative radiotherapy or systemic corticosteroid therapy.
- Actively infected with or chronic carriers of hepatitis B virus (HBV) as demonstrated by positive hepatitis B core antibody (HbcAb) or hepatitis B surface antigen (HbsAg). Participants who are sero-positive only, that is, surface antibody positive [HbsAb], are permitted.
- Other significant active infection
- Major surgery, chemotherapy, investigational agent, or radiation within 30 days of Day 1
- Uncontrolled hypertension (diastolic ≥ 100 millimeters of mercury [mmHg]) or hypotension (systolic ≤ 90 mmHg)
- History of prior therapy or a serious, uncontrolled medical disorder that in the Investigator's opinion would impair participation in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DI-Leu16-IL2 1.0 mg/m^2
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 will be administered per dose and schedule specified in the arm.
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Experimental: DI-Leu16-IL2 2.0 mg/m^2
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.
|
DI-Leu16-IL2 will be administered per dose and schedule specified in the arm.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Best Overall Response (BOR) Assessed Per International Workshop for Non-Hodgkin Lymphoma (NHL) Response Criteria
Time Frame: First dose of study drug until first appearance of CR, CRu, PR, SD, or PD (up to 20 months)
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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.
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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
Time Frame: Baseline, end of study (EOS) (up to approximately 32 months)
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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.
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Baseline, end of study (EOS) (up to approximately 32 months)
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Tumor Measurement: Percent Change From Baseline in Sum of Longest Diameters at the End of Study
Time Frame: Baseline, EOS (up to approximately 32 months)
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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
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Baseline, EOS (up to approximately 32 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: First dose of study drug up to EOS (up to 20 months)
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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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First dose of study drug up to EOS (up to 20 months)
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Number of Participants With a TEAE That Was Considered Related to a Clinically Significant Hematology or Serum Chemistry Abnormality
Time Frame: First dose of study drug up to EOS (up to 20 months)
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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.
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First dose of study drug up to EOS (up to 20 months)
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Number of Participants With a Clinically Significant Abnormal Physical Exam
Time Frame: First dose of study drug up to EOS (up to 20 months)
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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.
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First dose of study drug up to EOS (up to 20 months)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 4, 2014
Primary Completion (Actual)
July 11, 2016
Study Completion (Actual)
July 11, 2016
Study Registration Dates
First Submitted
May 23, 2014
First Submitted That Met QC Criteria
May 28, 2014
First Posted (Estimate)
June 2, 2014
Study Record Updates
Last Update Posted (Actual)
November 27, 2020
Last Update Submitted That Met QC Criteria
November 2, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AO-101-EXT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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