Clinical trial NCT02151903: Open-Label Extension Study of De-immunized DI-Leu16-IL2 Immunocytokine Administered in Participants With B-cell NHL
Official title: An Open-Label Extension Study of De-immunized DI-Leu16-IL2 Immunocytokine Administered in Patients With B-cell Non-Hodgkin Lymphoma (NHL)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: B-cell Non-Hodgkin Lymphoma
Keywords: NHL
Immunocytokine
Lymphoma
Non-Hodgkin
B-cell
IL (interleukin)
Lead sponsor: Alopexx Oncology, LLC
Sponsor class: INDUSTRY
First posted: 2014-06-02
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Participants currently entered on Alopexx Oncology Study AO-101
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:

1. Pregnant or lactating female
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.

Primary outcomes:
measure: Number of Participants With Best Overall Response (BOR) Assessed Per International Workshop for Non-Hodgkin Lymphoma (NHL) Response Criteria
timeFrame: First dose of study drug until first appearance of CR, CRu, PR, SD, or PD (up to 20 months)
measure: Tumor Measurement: Percent Change From Baseline in Sum of Product of Diameters at the End of Study
timeFrame: Baseline, end of study (EOS) (up to approximately 32 months)
measure: Tumor Measurement: Percent Change From Baseline in Sum of Longest Diameters at the End of Study
timeFrame: Baseline, EOS (up to approximately 32 months)
Secondary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: First dose of study drug up to EOS (up to 20 months)
measure: Number of Participants With a TEAE That Was Considered Related to a Clinically Significant Hematology or Serum Chemistry Abnormality
timeFrame: First dose of study drug up to EOS (up to 20 months)
measure: Number of Participants With a Clinically Significant Abnormal Physical Exam
timeFrame: First dose of study drug up to EOS (up to 20 months)
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Alopexx Oncology, LLC
name: Daniel Vlock, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.