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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02151903
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : March 17, 2017
Information provided by (Responsible Party):
Alopexx Oncology, LLC

Brief Summary:
An open-label extension study enrolling patients experiencing clinical benefit following 6 cycles of DI-Leu16-IL2 while enrolled in the Alopexx Oncology AO-101 study. Patients will be permitted to continue to receive DI-Leu16-IL2 at the same dose, schedule, and route of administration they received while on the parent protocol. Prior pre-treatment (e.g. Rituximab) will continue as before.

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

Detailed Description:
  1. Primary Endpoints:

    • To continue to provide DI-Leu16-IL2 to patients currently enrolled in Alopexx Oncology trial AO-101 who are experiencing clinical benefit.

  2. Secondary Endpoints:

    • To continue to evaluate the safety of DI-Leu16-IL2.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group 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)
Study Start Date : November 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: DI-Leu16-IL2
Patients will receive DI-Leu16-IL2 at the same assigned dose level, dosing schedule, and route of administration that they received during the parent clinical trial AO-101. Patients may continue to receive therapy through the duration of the study as long as they are having clinical benefit and not experiencing any untoward side effects.
Drug: DI-Leu16-IL2

Primary Outcome Measures :
  1. Tumor response in patients [ Time Frame: up to 12 months ]
    Tumor measurements will be performed by radiologic imaging techniques at every other monthly visit. The International Workshop for NHL Response Criteria will be used to evaluate the response.

Secondary Outcome Measures :
  1. Safety assessment in patients monitoring adverse events [ Time Frame: up to 12 months ]
  2. Safety assessment in patients monitoring clinical laboratory tests [ Time Frame: up to 12 months ]
  3. Safety assessment in patients monitoring physical exams [ Time Frame: up to 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients currently entered on Alopexx Oncology Protocol AO-101
  2. Patient has received 6 cycles of DI-Leu16-IL2 on Protocol 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. Patients must have received prior Rituximab-containing therapy.
  6. Patients participating in the study are to use adequate birth control measures (abstinence, oral contraceptives, barrier method with spermicide or surgical sterilization) during study participation. Females of childbearing potential must have a negative serum pregnancy test on the days of dosing. A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., 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). (Patients who are sero-positive only, i.e., 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 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 identifier (NCT number): NCT02151903

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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
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Study Director: Daniel Vlock, MD Alopexx Oncology, LLC

Additional Information:
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Responsible Party: Alopexx Oncology, LLC Identifier: NCT02151903     History of Changes
Other Study ID Numbers: AO-101-EXT
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: March 17, 2017
Last Verified: March 2017

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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:
IL (interleukin)
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs