Leukemia, Lymphocytic, Chronic, B-CellPhase 1NCT01456182
Phase 1B- Open Label Dose-Ranging Study of Oral AFX-2 in Adults With Chronic Lymphocytic Leukemia
A Phase 1 study testing AFX-2 in people with Leukemia, Lymphocytic, Chronic, B-Cell, run by Afexa Life Sciences Inc at 3 sites in United States.
Trial summary
This trial will assess the tolerability and safety of AFX-2 over a range of five dose levels in adults with low-, intermediate- or high-risk Chronic Lymphocytic Leukemia (CLL). The trial will also determine the impact of dose on quality of life indices and on biological and immune responses, and will assess if there… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Lymphocytic, Chronic, B-Cell
- What is being tested?
- AFX-2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2011to May 2013
- 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
- Adult men and women >18 years of age
- Diagnosis of CLL per NCI Working Group Criteria; with phenotypic evidence (i.e.. flow cytometry or bone marrow biopsy) of chronic lymphocytic leukemia (MEDDRA Code - 10008960; ICD-O3-9823)
- Disease meets criteria for low-risk (Rai Stage 0), intermediate-risk (Rai Stage I- II), or high-risk (Rai Stage III-IV) disease
- Life expectancy of ≥ 3 months at Screening.
- ECOG performance status 0-3
- Laboratory parameters (taken < 14 days of Study Day 0):
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- Hematologic parameters: Hemoglobin > 9 gm/dL (stable, not dropping); Absolute Granulocyte Count (AGC) > 1.0 x 109/L; Platelets > 50 x 109/L; not requiring immediate transfusion.
- Coagulation: PT/PTT/INR: ± 10% of NL for lab; INR: 1.0-1.43
- BUN < 40; serum Creatinine ≤ 2.0 mg/dL, OR Creatinine Clearance > 90 mL/min/1.73m2 IF serum Creatinine > 2.0 mg/dL
- Liver function tests (AST, ALT, ALP, LDH): < 2.5 x institutional ULN; Total bilirubin: < 2.0 x institutional ULN
- Human Immunodeficiency Virus (HIV) negative
- Pregnancy test: negative urine pregnancy test for females of child-bearing potential,
- Free of disease from prior malignancy/ies for > 2 years, except for basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast.
- If not surgically sterile, or post-menopausal (> 12 months with no menstrual flow), willing to practice birth control (barrier + contraception) throughout duration of study.
- Able and willing to swallow capsules.
- Willing to limit alcohol intake during the study treatment period.
- Willing to sign the informed consent.
Who cannot join
- Lymphoproliferative disease other than CLL
- Prior use of the test article (AFX-2), or ginseng-containing products (American, Asian, etc.) ≤ 1 year prior to study entry.
- Known allergy to the test article or ginseng-containing products
- Active infection requiring systemic treatment
- Prior or current therapy:
- Splenectomy.
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- Currently requiring anticoagulant therapy
- Requiring active treatment for B-CLL or ≤ 28 days post-treatment for B-CLL or other condition requiring: chemotherapy, radiation therapy, monoclonal antibodies, systemic steroids, antihistamines or non-steroidal anti-inflammatory drugs, including ibuprofen, indomethacin, COX-2 inhibitors etc.
- ≤ 10 days: non-steroidal hormonal therapy (other than for contraception or thyroid)
- ≤ 10 days: antibiotic prophylaxis
- History of therapy with immunological reagents, such as allogeneic bone marrow transplant, monoclonal antibody therapy, intravenous immunoglobulin, or hematopoietic stem cell transplantation. (Note: Immunotherapy for allergies is permitted as long as the last treatment was both (a) prior to the CLL diagnosis and (b) > 5 years prior to trial enrollment.)
- < 90 days post treatment with chlorambucil
- < 90 days post general anesthesia
- Uncontrolled intercurrent condition, including, but not limited to, cardiovascular, pulmonary, renal, hepatic, GI, GU, neurologic, metabolic, psychiatric, etc.
- Current or prior investigational product or procedure < 56 days preceding study entry (Baseline -Visit 2; Study Day 0).
- Unwilling to discontinue use of nonprescription (OTC), nutritional or dietary supplements during the study period (as further defined by protocol).
- Pregnant, lactating.
- Any condition, personal or social situation that precludes or limits the ability of the participant to provide informed consent or comply with study requirements.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Saint Jospeh Mercy Health System
Ann Arbor, Michigan, 48106
Cancer Center of the Carolinas
Greenville, South Carolina, 29615
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
This trial will assess the tolerability and safety of AFX-2 over a range of five dose levels in adults with low-, intermediate- or high-risk Chronic Lymphocytic Leukemia (CLL). The trial will also determine the impact of dose on quality of life indices and on biological and immune responses, and will assess if there is a maximum tolerated dose and/or dose-limiting toxicity in this study population.
- Conditions
- Leukemia, Lymphocytic, Chronic, B-Cell
- Being tested
- AFX-2
- 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.
AFX-2Drug
Dose level 1
AFX-2Drug
Dose level 2
AFX-2Drug
Dose level 3
AFX-2Drug
Dose level 4
AFX-2Drug
Dose level 5
| Study group | Role | What they receive |
|---|---|---|
| Dose arm 1 | Other | Not described Receives: Drug: AFX-2 |
| Dose arm 2 | Other | Not described Receives: Drug: AFX-2 |
| Dose arm 3 | Other | Not described Receives: Drug: AFX-2 |
| Dose arm 4 | Other | Not described Receives: Drug: AFX-2 |
| Dose arm 5 | Other | Not described Receives: Drug: AFX-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability will be assessed based on the incidence, duration and intensity of adverse events
Adverse events will be graded according to NCI-CTC v4.
Measured: 0-8 weeks
Safety and tolerability will also be determined by assessing any changes in study test results from baseline values
Study tests that will determine safety include vital signs, clinical laboratory tests (hematology, serum chemistries, coagulation, urinalysis) and 12-lead EKG
Measured: 1 week, 4 weeks, 8 weeks
Secondary outcomes (3)
Quality of life indices
Measured: 1 week, 4 weeks, 8 weeks
Maximum tolerated dose and/or dose-limiting toxicity
Measured: 1 week, 4 weeks, 8 weeks
Biological and immune responses
Measured: 1 week, 4 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study startDec 2011
- Primary completionMar 2013 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Lymphocytic, Chronic, B-CellStudies of the same condition, open and under way.
- 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afexa Life Sciences Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leslie R Ellis, MD, Principal investigator, Wake Forest University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01456182
- Sponsor's protocol ID
- AFX-2-2010-1
- Status last verified
- Jan 2012
- First submitted
- 18 Oct 2011
- Last updated
- 25 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1B- Open Label Dose-Ranging Study of Oral AFX-2 in Adults With Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT01456182
- Acronym / sponsor ID
- AFX-2-2010-1
- Conditions
- Leukemia, Lymphocytic, Chronic, B-Cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Afexa Life Sciences IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Mar 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 20 Oct 2011 (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.
This trial will assess the tolerability and safety of AFX-2 over a range of five dose levels in adults with low-, intermediate- or high-risk Chronic Lymphocytic Leukemia (CLL). The trial will also determine the impact of dose on quality of life indices and on biological and immune responses, and will assess if there is a maximum tolerated dose and/or dose-limiting toxicity in this study population.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose arm 1 | Other | Drug: AFX-2 |
| Dose arm 2 | Other | Drug: AFX-2 |
| Dose arm 3 | Other | Drug: AFX-2 |
| Dose arm 4 | Other | Drug: AFX-2 |
| Dose arm 5 | Other | Drug: AFX-2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Adult men and women >18 years of age
- Diagnosis of CLL per NCI Working Group Criteria; with phenotypic evidence (i.e.. flow cytometry or bone marrow biopsy) of chronic lymphocytic leukemia (MEDDRA Code - 10008960; ICD-O3-9823)
- Disease meets criteria for low-risk (Rai Stage 0), intermediate-risk (Rai Stage I- II), or high-risk (Rai Stage III-IV) disease
- Life expectancy of ≥ 3 months at Screening.
- ECOG performance status 0-3
Key exclusion criteria (18 listed)
- Lymphoproliferative disease other than CLL
- Prior use of the test article (AFX-2), or ginseng-containing products (American, Asian, etc.) ≤ 1 year prior to study entry.
- Known allergy to the test article or ginseng-containing products
- Active infection requiring systemic treatment
- Prior or current therapy:
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 |
|---|---|---|
| AFX-2Dose level 1 | Drug | Dose arm 1 |
| AFX-2Dose level 2 | Drug | Dose arm 2 |
| AFX-2Dose level 3 | Drug | Dose arm 3 |
| AFX-2Dose level 4 | Drug | Dose arm 4 |
| AFX-2Dose level 5 | Drug | Dose arm 5 |
Primary outcome
Safety and tolerability will be assessed based on the incidence, duration and intensity of adverse events
Time frame: 0-8 weeks
Adverse events will be graded according to NCI-CTC v4.
Safety and tolerability will also be determined by assessing any changes in study test results from baseline values
Time frame: 1 week, 4 weeks, 8 weeks
Study tests that will determine safety include vital signs, clinical laboratory tests (hematology, serum chemistries, coagulation, urinalysis) and 12-lead EKG
3 secondary outcomes
Quality of life indices
Time frame: 1 week, 4 weeks, 8 weeks
Maximum tolerated dose and/or dose-limiting toxicity
Time frame: 1 week, 4 weeks, 8 weeks
Biological and immune responses
Time frame: 1 week, 4 weeks, 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2012.
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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.
Leslie R Ellis, MD principal investigator
Wake Forest University Health Sciences Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AFX-2 in people with Leukemia, Lymphocytic, Chronic, B-Cell, run by Afexa Life Sciences Inc at 3 sites 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 17 inclusion and 18 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: withdrawn, as of the sponsor's last update on 25 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 was withdrawn before enrolling participants, so there are no results.
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?
Safety and tolerability will be assessed based on the incidence, duration and intensity of adverse events (time frame: 0-8 weeks). The study lists 2 primary outcomes in all. 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 25 Jan 2012.