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Trial record 2 of 3 for:    DI-Leu16-IL2

Open-Label Extension Study of De-immunized DI-Leu16-IL2 Immunocytokine Administered in Participants With B-cell NHL

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ClinicalTrials.gov Identifier: NCT02151903
Recruitment Status : Terminated (Clinical benefit was noted before the scheduled completion of the trial and the extension study was terminated early.)
First Posted : June 2, 2014
Results First Posted : November 27, 2020
Last Update Posted : November 27, 2020
Sponsor:
Information provided by (Responsible Party):
Alopexx Oncology, LLC

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.

Condition or disease Intervention/treatment Phase
B-cell Non-Hodgkin Lymphoma Drug: DI-Leu16-IL2 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Extension Study of De-immunized DI-Leu16-IL2 Immunocytokine Administered in Patients With B-cell Non-Hodgkin Lymphoma (NHL)
Actual Study Start Date : November 4, 2014
Actual Primary Completion Date : July 11, 2016
Actual Study Completion Date : July 11, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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.
Drug: DI-Leu16-IL2
DI-Leu16-IL2 will be administered per dose and schedule specified in the arm.

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.
Drug: DI-Leu16-IL2
DI-Leu16-IL2 will be administered per dose and schedule specified in the arm.




Primary Outcome Measures :
  1. 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) ]
    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.

  2. 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) ]
    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.

  3. 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) ]
    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


Secondary Outcome Measures :
  1. 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) ]
    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.

  2. 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) ]
    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.

  3. Number of Participants With a Clinically Significant Abnormal Physical Exam [ Time Frame: First dose of study drug up to EOS (up to 20 months) ]
    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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02151903


Locations
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United States, California
City of Hope
Duarte, California, United States, 91010
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Alopexx Oncology, LLC
Investigators
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Study Director: Daniel Vlock, MD Alopexx Oncology, LLC
Additional Information:
Publications:
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Responsible Party: Alopexx Oncology, LLC
ClinicalTrials.gov Identifier: NCT02151903    
Other Study ID Numbers: AO-101-EXT
First Posted: June 2, 2014    Key Record Dates
Results First Posted: November 27, 2020
Last Update Posted: November 27, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alopexx Oncology, LLC:
NHL
Immunocytokine
Lymphoma
Non-Hodgkin
B-cell
IL (interleukin)
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases