Open-Label Extension Study of De-immunized DI-Leu16-IL2 Immunocytokine Administered in Participants With B-cell NHL
NCT ID: NCT02151903
Last Updated: 2020-11-27
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
5 participants
INTERVENTIONAL
2014-11-04
2016-07-11
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
DI-Leu16-IL2 will be administered per dose and schedule specified in the arm.
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
DI-Leu16-IL2 will be administered per dose and schedule specified in the arm.
Interventions
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DI-Leu16-IL2
DI-Leu16-IL2 will be administered per dose and schedule specified in the arm.
Eligibility Criteria
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Inclusion Criteria
2. Participants who received 6 cycles of DI-Leu16-IL2 on Study AO-101.
3. Documented clinical benefit following 6th cycle of DI-Leu16-IL2
4. Able to begin extension study within 8 weeks of receiving 6th cycle of DI-Leu16-IL2
5. Participants must have received prior Rituximab-containing therapy.
6. 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.
7. Provide written informed consent prior to any study procedures.
Exclusion Criteria
2. An immediate need for palliative radiotherapy or systemic corticosteroid therapy.
3. 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.
4. Other significant active infection
5. Major surgery, chemotherapy, investigational agent, or radiation within 30 days of Day 1
6. Uncontrolled hypertension (diastolic ≥ 100 millimeters of mercury \[mmHg\]) or hypotension (systolic ≤ 90 mmHg)
7. History of prior therapy or a serious, uncontrolled medical disorder that in the Investigator's opinion would impair participation in the study.
18 Years
ALL
No
Sponsors
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Alopexx Oncology, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel Vlock, MD
Role: STUDY_DIRECTOR
Alopexx Oncology, LLC
Locations
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City of Hope
Duarte, California, United States
University of Minnesota
Minneapolis, Minnesota, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Countries
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References
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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.
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.
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.
Related Links
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Sponsor website
National Cancer Institute at the National Institute of Health
Other Identifiers
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AO-101-EXT
Identifier Type: -
Identifier Source: org_study_id