Chronic Lymphocytic LeukemiaPhase 1NCT00850057
Pharmacodynamic (PD) Study of Intranodal Adenovirus-CD154 (Ad-ISF35) in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
A Phase 1 study testing Intranodal injection of Ad-ISF35 in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by University of California, San Diego at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
- What is being tested?
- Intranodal injection of Ad-ISF35
- Type of treatment
- Injection or infusion
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Oct 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
- Intermediate or High risk, poor prognosis CLL/SLL
- Indication for treatment as defined by the NCI Working Group Guidelines:
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- 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.
- Males and females 18 years of age and older
- 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
- ECOG Performance Status ≤ 2
- Anticipated survival of at least 3 months
- For men and women of child-producing potential, use of effective barrier contraceptive methods during the study and for one month following treatment.
- 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.
- 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.).
Who cannot join
- Pregnant or nursing women
- Treatment with chemotherapy or monoclonal antibody within 28 days prior to entering the study.
- Treatment with chemotherapy or monoclonal antibody during the time of participation in this trial.
- Grade 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
- Severe or debilitating pulmonary disease (dyspnea at rest, significant shortness of breath, COPD)
- 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)
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- History of malignancy other than CLL within five years of registration, except patients with adequately treated basal, squamous cell carcinoma or localized cervical cancer.
- Active symptomatic fungal, bacterial and/or viral infection including active HIV or viral (A, B or C) hepatitis.
- Any illness or condition that in the opinion of the Investigator may affect safety of treatment or evaluation of any the study's endpoints.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego Moores Cancer Center
La Jolla, California, 92093
About this study
Official title: 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.
- Being tested
- Intranodal injection of Ad-ISF35
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranodal injection of Ad-ISF35Biological
Ad-ISF35, a replication-defective recombinant type V adenovirus encoding a recombinant humanized CD154 homolog (ISF35).
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the safety and maximum tolerated dose (MTD) of Adenovirus-CD154 (Ad-ISF35) when injected directly into lymph nodes of patients with CLL/SLL.
Measured: 2 years
Secondary outcomes (2)
Determine and monitor clinical and biological responses in patients treated with intranodal injections of Ad-ISF35.
Measured: 2 years
Determine pharmacodynamic (PD) parameters in patients treated with intranodal injections of ISF35.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2009 (estimated)
- Study startFeb 2006
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Memgen, LLC
- Responsible party
- Sponsor
- Investigators
- Januario Castro, M.D., Principal investigator, Assistant Clinical Professor in the Blood and Marrow Transplantation Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00850057
- Sponsor's protocol ID
- UCSD-060201
- Status last verified
- Jul 2019
- First submitted
- 20 Feb 2009
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00850057
- Acronym / sponsor ID
- UCSD-060201
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Memgen, LLC
- Study start
- Feb 2006
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 24 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Diagnosis of B-cell CLL/SLL including
- 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.
- Intermediate or High risk, poor prognosis CLL/SLL
- Indication for treatment as defined by the NCI Working Group Guidelines:
- Males and females 18 years of age and older
Key exclusion criteria (9 listed)
- Pregnant or nursing women
- Treatment with chemotherapy or monoclonal antibody within 28 days prior to entering the study.
- Treatment with chemotherapy or monoclonal antibody during the time of participation in this trial.
- Grade 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
- Severe or debilitating pulmonary disease (dyspnea at rest, significant shortness of breath, COPD)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intranodal injection of Ad-ISF35Ad-ISF35, a replication-defective recombinant type V adenovirus encoding a recombinant humanized CD154 homolog (ISF35). | Biological | – |
Primary outcome
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 secondary outcomes
Determine and monitor clinical and biological responses in patients treated with intranodal injections of Ad-ISF35.
Time frame: 2 years
Determine pharmacodynamic (PD) parameters in patients treated with intranodal injections of ISF35.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Januario Castro, M.D. principal investigator
Assistant Clinical Professor in the Blood and Marrow Transplantation Division
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intranodal injection of Ad-ISF35 in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2019.