Leukemia, Myeloid, ChronicPhase 2NCT00058747
AG-858 in Patients Who Are Cytogenetically Positive After Treatment With Gleevec™
A Phase 2 study testing Autologous HSP-70 Protein-Peptide Complex (AG-858) Plus Gleevec™. in people with Leukemia, Myeloid, Chronic, run by Agenus Inc. at 13 sites in 2 countries.
Trial summary
This is a Phase II, exploratory, open-label study of the investigational product AG-858, in patients who are cytogenetically positive after treatment with Gleevec. The trial will consist of three independent Phase II evaluations of patient groups according to their cytogenetic status as defined in the eligibility… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Myeloid, Chronic
- What is being tested?
- Autologous HSP-70 Protein-Peptide Complex (AG-858) Plus Gleevec™.
- How many people
- 40 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Mar 2003to Apr 2006
- Phase
- Phase 2
- 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
- Must be Philadelphia chromosome positive chronic myelogenous leukemia in first chronic phase
- Must have a complete hematologic response
- Must have received Gleevec™, IFN-α, cytarabine, busulfan, hydroxyurea, Homoharringtonine (HHT) or any combination thereof as long as the combination has been discontinued and the dosing of Gleevec™ has been stable for 6 months or greater
- Must have one of the following cytogenetic statuses:
- Less than a CCR after receiving Gleevec™ for at least one year at a minimum dose of 400 mg/day. A stable dose of Gleevec™ must have been maintained for the last six months prior to eligibility testing OR (B) Stable cytogenetic status without CCR (no cytogenic response or progression) in three consecutive determinations over six months while on a stable dose of Gleevec™ (at a minimum of 400mg/day) for at least 6 months OR (C) Cytogenetic progression while on a stable dose of Gleevec™ (at a minimum dose of 400mg/day)for at least 2 consecutive evaluations at least one month apart
- ECOG performance score of 0 or 1
Show all 12Show fewer
- Must be at least 18 years old
- Not pregnant or breastfeeding and agree to use contraception during the course of the study
- No prior allogeneic bone marrow transplant or be candidates for curative BMT
- No immunodeficiency or other serious illness
- No current use of immunosuppressive medications
- No other cancer within the last five years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin
Who cannot join
None listed.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States11 sites
Study site
Birmingham, Alabama
Study site
Boston, Massachusetts
Study site
Chicago, Illinois
Study site
Denver, Colorado
Study site
Farmington, Connecticut
Study site
La Jolla, California
Study site
Los Angeles, California
Study site
New York, New York
Study site
Pittsburgh, Pennsylvania
Study site
Portland, Oregon
Study site
St Louis, Missouri
About this study
Official title: Phase II Exploratory Study Of AG-858 Plus Gleevec™ In Patients With Chronic Myelogenous Leukemia (CML) In Chronic Phase Who Are Cytogenetically Positive After Treatment With Gleevec™
This is a Phase II, exploratory, open-label study of the investigational product AG-858, in patients who are cytogenetically positive after treatment with Gleevec.
The trial will consist of three independent Phase II evaluations of patient groups according to their cytogenetic status as defined in the eligibility criteria (Eligibility Criteria 4a, 4b, and 4c).
Read the detailed description
The goals of this study are to determine the following:
- To estimate the proportion of patients with a complete cytogenetic response (CCR) within each patient group
- To estimate the proportion of patients with a substantial molecular response (SMR) within each patient group
- To evaluate the frequency and severity of adverse events.
- To assess the feasibility of AG-858 production.
- Conditions
- Leukemia, Myeloid, Chronic
- Being tested
- Autologous HSP-70 Protein-Peptide Complex (AG-858) Plus Gleevec™.
- Keywords
- Granulocytic Leukemia, Chronic, Leukemia, Granulocytic, Chronic, Leukemia, Myelocytic, Chronic, Leukemia, Myelogenous, Chronic, Myelocytic Leukemia, Chronic, Myelogenous Leukemia, Chronic, Myeloid Leukemia, Chronic
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous HSP-70 Protein-Peptide Complex (AG-858) Plus Gleevec™.Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2003 (estimated)
- Study startMar 2003
- Primary completionApr 2006
- Study completionApr 2006
Why it stopped: Business decision of the sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myeloid, ChronicStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Agenus Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00058747
- Sponsor's protocol ID
- C-300-01
- Status last verified
- Sep 2012
- First submitted
- 11 Apr 2003
- Last updated
- 7 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Exploratory Study Of AG-858 Plus Gleevec™ In Patients With Chronic Myelogenous Leukemia (CML) In Chronic Phase Who Are Cytogenetically Positive After Treatment With Gleevec™
- ClinicalTrials.gov ID
- NCT00058747
- Acronym / sponsor ID
- C-300-01
- Conditions
- Leukemia, Myeloid, Chronic
- Keywords
- Granulocytic Leukemia, Chronic, Leukemia, Granulocytic, Chronic, Leukemia, Myelocytic, Chronic, Leukemia, Myelogenous, Chronic, Myelocytic Leukemia, Chronic, Myelogenous Leukemia, Chronic, Myeloid Leukemia, Chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision of the sponsor
- Enrolment
- 40 participants
- Lead sponsor
- Agenus Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2003
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 15 Apr 2003 (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 is a Phase II, exploratory, open-label study of the investigational product AG-858, in patients who are cytogenetically positive after treatment with Gleevec.
The trial will consist of three independent Phase II evaluations of patient groups according to their cytogenetic status as defined in the eligibility criteria (Eligibility Criteria 4a, 4b, and 4c).
Detailed description
The goals of this study are to determine the following:
- To estimate the proportion of patients with a complete cytogenetic response (CCR) within each patient group
- To estimate the proportion of patients with a substantial molecular response (SMR) within each patient group
- To evaluate the frequency and severity of adverse events.
- To assess the feasibility of AG-858 production.
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 (12 listed)
- Must be Philadelphia chromosome positive chronic myelogenous leukemia in first chronic phase
- Must have a complete hematologic response
- Must have received Gleevec™, IFN-α, cytarabine, busulfan, hydroxyurea, Homoharringtonine (HHT) or any combination thereof as long as the combination has been discontinued and the dosing of Gleevec™ has been stable for 6 months or greater
- Must have one of the following cytogenetic statuses:
- Less than a CCR after receiving Gleevec™ for at least one year at a minimum dose of 400 mg/day. A stable dose of Gleevec™ must have been maintained for the last six months prior to eligibility testing OR (B) Stable cytogenetic status without CCR (no cytogenic response or progression) in three consecutive determinations over six months while on a stable dose of Gleevec™ (at a minimum of 400mg/day) for at least 6 months OR (C) Cytogenetic progression while on a stable dose of Gleevec™ (at a minimum dose of 400mg/day)for at least 2 consecutive evaluations at least one month apart
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Autologous HSP-70 Protein-Peptide Complex (AG-858) Plus Gleevec™. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Business decision of the sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2012.
- For more information regarding Gleevec™, please visit Novartis' websiteLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Autologous HSP-70 Protein-Peptide Complex (AG-858) Plus Gleevec™. in people with Leukemia, Myeloid, Chronic, run by Agenus Inc. at 13 sites in 2 countries.
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 12 inclusion and 0 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: stopped early, as of the sponsor's last update on 7 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 stopped early (reason given: Business decision of the sponsor). Results are not available in the source record.
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.
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 7 Sep 2012.