Hodgkin LymphomaPhase 2NCT01263899
A Safety and Efficacy Study of SB1518 for the Treatment of Advanced Lymphoid Malignancies
A Phase 2 study testing SB1518 in people with Hodgkin Lymphoma and Mantle Cell Lymphoma, run by S*BIO at 5 sites in 2 countries.
Trial summary
This is a Phase 2 study to assess the efficacy of SB1518 in the treatment of patients with advanced lymphoid malignancies including Hodgkin Lymphoma, Mantle Cell Lymphoma and Indolent Lymphoma (follicular lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma and small lymphocytic lymphoma). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin Lymphoma, Mantle Cell Lymphoma, Indolent Lymphoma
- What is being tested?
- SB1518
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Dec 2010to Feb 2012
- 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
- Patients with histologically documented diagnosis of one of the following lymphoid malignancies:
- Hodgkin Lymphoma;
- Mantle Cell Lymphoma;
- Indolent Lymphoma (including follicular lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma and small lymphocytic lymphoma);
- Patients must have received at least one prior treatment regimen; patients with Hodgkin Lymphoma must have received an autologous stem cell transplant, refused or been deemed ineligible for stem cell transplant;
- Able to understand and willing to sign the informed consent form.
Who cannot join
- Any histology other than Hodgkin Lymphoma, Mantle Cell Lymphoma or Indolent Lymphoma;
- History of or active Central Nervous System (CNS) malignancy;
- Active graft-versus-host disease (GVHD);
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
MD Anderson Cancer Canter
Houston, Texas, 77030
Weill Medical College of Cornell
New York, New York, 10021
University of Nebraska Medical Center
Omaha, Nebraska, 68198
University of Rochester James P. Wilmot Cancer Center
Rochester, New York, 14642
Canada1 site
University of British Columbia
Vancouver, British Columbia, V5Z 4E6
About this study
Official title: A Phase 2 Safety and Efficacy Study of SB1518 for the Treatment of Advanced Lymphoid Malignancies
This is a Phase 2 study to assess the efficacy of SB1518 in the treatment of patients with advanced lymphoid malignancies including Hodgkin Lymphoma, Mantle Cell Lymphoma and Indolent Lymphoma (follicular lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma and small lymphocytic lymphoma).
- Conditions
- Hodgkin Lymphoma, Mantle Cell Lymphoma, Indolent Lymphoma
- Being tested
- SB1518
- Keywords
- Lymphoid malignancies, Hodgkin lymphoma, Mantle Cell Lymphoma, Indolent Lymphoma, SB1518
- Medical subject headings
- Hodgkin Disease, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB1518Drug
SB1518 taken orally daily for 28 consecutive days in a 28 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| SB1518 | Experimental | Not described Receives: Drug: SB1518 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess overall tumor response of SB1518 by CT/FDG-PET scan and bone marrow biopsy as applicable as a measure of efficacy
Outcome Measure - To assess the efficacy of SB1518 in the treatment of patients with advanced lymphoid malignancies including Hodgkin Lymphoma, Mantle Cell Lymphoma and Indolent Lymphoma (follicular lymphoma, lymphophasmacytic lymphoma, marginal zone lymphoma and small lymphocytic lymphoma).
Measured: Every even numbered cycle from baseline to 30 days after the last dose of study medication
Secondary outcomes (2)
Assess durability of response
To assess the durability of response following SB1518 treatment in patients with advanced lymphoid malignancies.
Measured: Every even numbered cycle from baseline to 30 days after the last dose of study medication
Assess number of patients with adverse events as a measure of safety and tolerability
To assess the safety and tolerability of SB1518 administered orally once daily in patients with advanced lymphoid malignancies.
Measured: Every even numbered cycle from baseline to 30 days after the last dose of study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin LymphomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- S*BIO
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anas Younes, MD, Principal investigator, MD Anderson Cancer Center at University of Texas, HoustonJonathan Friedberg, MD, Principal investigator, University of Rochester James P. Wilmot Cancer CenterPeter Martin, MD, Principal investigator, Weill Medical College of Cornell UniversityJulie Vose, MD, Principal investigator, University of NebraskaRichard Klasa, MD, Principal investigator, British Columbia Cancer Center - Vancouver Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01263899
- Sponsor's protocol ID
- SB1518-2010-005
- Status last verified
- Apr 2012
- First submitted
- 16 Dec 2010
- Last updated
- 20 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Safety and Efficacy Study of SB1518 for the Treatment of Advanced Lymphoid Malignancies
- ClinicalTrials.gov ID
- NCT01263899
- Acronym / sponsor ID
- SB1518-2010-005
- Conditions
- Hodgkin Lymphoma, Mantle Cell Lymphoma, Indolent Lymphoma
- Keywords
- Lymphoid malignancies, Hodgkin lymphoma, Mantle Cell Lymphoma, Indolent Lymphoma, SB1518
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- S*BIOIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 21 Dec 2010 (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 2 study to assess the efficacy of SB1518 in the treatment of patients with advanced lymphoid malignancies including Hodgkin Lymphoma, Mantle Cell Lymphoma and Indolent Lymphoma (follicular lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma and small lymphocytic lymphoma).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SB1518 | Experimental | Drug: SB1518 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with histologically documented diagnosis of one of the following lymphoid malignancies:
- Hodgkin Lymphoma;
- Mantle Cell Lymphoma;
- Indolent Lymphoma (including follicular lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma and small lymphocytic lymphoma);
- Patients must have received at least one prior treatment regimen; patients with Hodgkin Lymphoma must have received an autologous stem cell transplant, refused or been deemed ineligible for stem cell transplant;
Key exclusion criteria (3 listed)
- Any histology other than Hodgkin Lymphoma, Mantle Cell Lymphoma or Indolent Lymphoma;
- History of or active Central Nervous System (CNS) malignancy;
- Active graft-versus-host disease (GVHD);
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 |
|---|---|---|
| SB1518SB1518 taken orally daily for 28 consecutive days in a 28 day cycle. | Drug | SB1518 |
Primary outcome
Assess overall tumor response of SB1518 by CT/FDG-PET scan and bone marrow biopsy as applicable as a measure of efficacy
Time frame: Every even numbered cycle from baseline to 30 days after the last dose of study medication
Outcome Measure - To assess the efficacy of SB1518 in the treatment of patients with advanced lymphoid malignancies including Hodgkin Lymphoma, Mantle Cell Lymphoma and Indolent Lymphoma (follicular lymphoma, lymphophasmacytic lymphoma, marginal zone lymphoma and small lymphocytic lymphoma).
2 secondary outcomes
Assess durability of response
Time frame: Every even numbered cycle from baseline to 30 days after the last dose of study medication
Assess number of patients with adverse events as a measure of safety and tolerability
Time frame: Every even numbered cycle from baseline to 30 days after the last dose of study medication
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 20 Apr 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.
Anas Younes, MD principal investigator
MD Anderson Cancer Center at University of Texas, Houston
Jonathan Friedberg, MD principal investigator
University of Rochester James P. Wilmot Cancer Center
Peter Martin, MD principal investigator
Weill Medical College of Cornell University
5 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 SB1518 in people with Hodgkin Lymphoma and Mantle Cell Lymphoma, run by S*BIO at 5 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 6 inclusion and 3 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 20 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada. 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 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?
Assess overall tumor response of SB1518 by CT/FDG-PET scan and bone marrow biopsy as applicable as a measure of efficacy (time frame: Every even numbered cycle from baseline to 30 days after the last dose of study medication). 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 20 Apr 2012.