Pharmacodynamic (PD) Study of Intranodal Adenovirus-CD154 (Ad-ISF35) in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

July 10, 2019 updated by: University of California, San Diego

A Phase 1, Open Label, Dose-escalation, Pharmacodynamic Study of Intranodal Injection of Adenovirus-CD154 (Ad-ISF35) in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Primary Objectives

  • To determine the safety and maximum tolerated dose (MTD) of Adenovirus-CD154 (Ad-ISF35) when it is injected directly into the lymph nodes of patients with CLL or SLL.

Secondary Objectives

  • To determine and monitor clinical and biological responses in patients treated with injections of Ad-ISF35.
  • To determine how ISF35 works in CLL/SLL patients' cells.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • 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

  • United States
    • California
      • La Jolla, California, United States, 92093
        • University of California, San Diego Moores Cancer Center

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:

  1. Diagnosis of B-cell CLL/SLL including

    • Lymphocytosis of monoclonal B-cells co-expressing ≥ one B-cell marker (CD19, CD20, or CD23) and CD5 in peripheral blood or lymph node AND
    • Bone marrow with ≥ 30% mononuclear cells having the CLL/SLL phenotype.
  2. Presence of at least ONE single accessible AND palpable lymph node in the cervical, supraclavicular, axillary, or inguinal regions. The size of the lymph nodes must be larger than 2x2 cm in the horizontal and perpendicular axes.
  3. Intermediate or High risk, poor prognosis CLL/SLL

  4. Indication for treatment as defined by the NCI Working Group Guidelines:

    • Massive (i.e. > 6 cm below the left costal margin) or progressive splenomegaly OR
    • Massive lymph nodes or nodal clusters (i.e. > 10 cm in longest diameter), or progressive lymphadenopathy OR
    • Grade 2 or 3 fatigue OR
    • Fever ≥ 100.5˚F or night sweats for greater than 2 weeks without documented infection OR
    • Presence of weight loss ≥ 10% over the preceding 6 months OR
    • Progressive lymphocytosis with an increase of ≥ 50% over a 2-month period or an anticipated doubling time of less than 6 months.
    • Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and / or thrombocytopenia.
    • Autoimmune anemia and / or thrombocytopenia poorly responsive to corticosteroid therapy.
  5. Males and females 18 years of age and older

  6. Laboratory parameters as specified below:

    • Hematologic: Hemoglobin ≥ 10 g/dL (may be post-transfusion); platelet count ≥ 50 x103/mm3
    • Hepatic: Total Bilirubin < 2 X ULN, and ALT and AST < 2 x ULN
    • Renal: Creatinine ≤ 2 X ULN
  7. ECOG Performance Status ≤ 2
  8. Anticipated survival of at least 3 months
  9. For men and women of child-producing potential, use of effective barrier contraceptive methods during the study and for one month following treatment.
  10. Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return for the required assessments.
  11. Negative test results for current/active infection with HIV-1, HIV-2, HTLV-1, HTLV-2, hepatitis A, B, C within 30 days of registration. (Antibody, antigen and nucleic acid tests acceptable, depending on institutional standards.).

Exclusion Criteria:

  1. Pregnant or nursing women
  2. Treatment with chemotherapy or monoclonal antibody within 28 days prior to entering the study.
  3. Treatment with chemotherapy or monoclonal antibody during the time of participation in this trial.
  4. Grade 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
  5. Severe or debilitating pulmonary disease (dyspnea at rest, significant shortness of breath, COPD)
  6. Participation in any investigational drug study within 28 days prior to ISF35 administration. (Patient must have recovered from all acute effects of previously administered investigational agents)
  7. History of malignancy other than CLL within five years of registration, except patients with adequately treated basal, squamous cell carcinoma or localized cervical cancer.
  8. Active symptomatic fungal, bacterial and/or viral infection including active HIV or viral (A, B or C) hepatitis.
  9. Any illness or condition that in the opinion of the Investigator may affect safety of treatment or evaluation of any the study's endpoints.

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: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine the safety and maximum tolerated dose (MTD) of Adenovirus-CD154 (Ad-ISF35) when injected directly into lymph nodes of patients with CLL/SLL.
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Determine and monitor clinical and biological responses in patients treated with intranodal injections of Ad-ISF35.
Time Frame: 2 years
2 years
Determine pharmacodynamic (PD) parameters in patients treated with intranodal injections of ISF35.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

Memgen, LLC

Investigators

  • Principal Investigator: Januario Castro, M.D., Assistant Clinical Professor in the Blood and Marrow Transplantation Division

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

February 1, 2006

Primary Completion (ACTUAL)

October 1, 2009

Study Completion (ACTUAL)

October 1, 2009

Study Registration Dates

First Submitted

February 20, 2009

First Submitted That Met QC Criteria

February 20, 2009

First Posted (ESTIMATE)

February 24, 2009

Study Record Updates

Last Update Posted (ACTUAL)

July 12, 2019

Last Update Submitted That Met QC Criteria

July 10, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCSD-060201

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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