Lymphoma, FollicularPhase 2NCT00427856
Safety and Efficacy of Single Agent Obatoclax Mesylate (GX15-070MS) Followed by a Combination With Rituximab for Previously-untreated Follicular Lymphoma (FL)
A Phase 2 study testing Obatoclax mesylate and Rituximab in people with Lymphoma, Follicular, run by Gemin X at 1 site in United States.
Trial summary
Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogenic signal is present. Obatoclax is designed to restore apoptosis through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process of cell death that is often inhibited in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Follicular
- What is being tested?
- Obatoclax mesylate and Rituximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Jul 2009
- 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
- Pathological confirmation of Follicular Lymphoma (FL)
- Must have advanced stage disease
- Must not have received any prior chemotherapy or immunotherapy for lymphoma, including steroids
- Must have adequate organ function
- Must have the ability to understand and willingness to sign a written informed consent form
Who cannot join
- No other agents or therapies administered with the intent to treat malignancy
- Uncontrolled, intercurrent illness
- Pregnant women and women who are breast feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
The Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
About this study
Official title: A Multi-Center, Open-Label, Phase II Study of Sequential, Single-Agent Obatoclax Mesylate (GX15-070MS)Followed by a Combination With Rituximab to Patients With Previously-Untreated Follicular Lymphoma (FL)
Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogenic signal is present. Obatoclax is designed to restore apoptosis through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process of cell death that is often inhibited in cancer cells.
Read the detailed description
This is a multi-center, open-label, Phase II study of obatoclax administered alone as a weekly, 3-hour or 24-hour infusion for 12 weeks followed by a combination with rituximab to patients with previously-untreated Follicular Lymphoma. For purposes of clinical evaluations, treatment cycles will occur in 4-week periods. Treatment may be administered on an outpatient basis. No investigational or commercial agents or therapies other than those described may be administered with the intent to treat the patient's malignancy.
- Conditions
- Lymphoma, Follicular
- Being tested
- Obatoclax mesylate, Rituximab
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obatoclax mesylateDrug
Also called (GX15-070MS)
Obatoclax mesylate 40mg, and 60mg
RituximabDrug
Rituximab
| Study group | Role | What they receive |
|---|---|---|
| Obatoclax mesylate 40mg | Experimental | 40 mg over 3 hrs q/weekly for 12 weeks, 4 weeks combo with rituximab, another 8 weeks single-agent obatoclax Receives: Drug: Obatoclax mesylate; Drug: Rituximab |
| Obatoclax mesylate 60mg | Experimental | 60 mg obatoclax mesylate over 24 hours, q/weekly for 12 weeks, 4 weeks combo with rituximab, another 8 weeks single-agent obatoclax Receives: Drug: Obatoclax mesylate; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Measured: 12 weeks
Secondary outcomes (1)
Time to Tumor Progression.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2007 (estimated)
- Study startMar 2007
- Primary completionFeb 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, FollicularStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gemin X
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean Viallet, MD, Study director, Gemin X, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00427856
- Sponsor's protocol ID
- GEM014
- Status last verified
- Jul 2016
- First submitted
- 25 Jan 2007
- Last updated
- 22 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Open-Label, Phase II Study of Sequential, Single-Agent Obatoclax Mesylate (GX15-070MS)Followed by a Combination With Rituximab to Patients With Previously-Untreated Follicular Lymphoma (FL)
- ClinicalTrials.gov ID
- NCT00427856
- Acronym / sponsor ID
- GEM014
- Conditions
- Lymphoma, Follicular
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Gemin XIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 29 Jan 2007 (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.
Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogenic signal is present. Obatoclax is designed to restore apoptosis through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process of cell death that is often inhibited in cancer cells.
Detailed description
This is a multi-center, open-label, Phase II study of obatoclax administered alone as a weekly, 3-hour or 24-hour infusion for 12 weeks followed by a combination with rituximab to patients with previously-untreated Follicular Lymphoma. For purposes of clinical evaluations, treatment cycles will occur in 4-week periods. Treatment may be administered on an outpatient basis. No investigational or commercial agents or therapies other than those described may be administered with the intent to treat the patient's malignancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obatoclax mesylate 40mg | Experimental | Drug: Obatoclax mesylate, Drug: Rituximab40 mg over 3 hrs q/weekly for 12 weeks, 4 weeks combo with rituximab, another 8 weeks single-agent obatoclax |
| Obatoclax mesylate 60mg | Experimental | Drug: Obatoclax mesylate, Drug: Rituximab60 mg obatoclax mesylate over 24 hours, q/weekly for 12 weeks, 4 weeks combo with rituximab, another 8 weeks single-agent obatoclax |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pathological confirmation of Follicular Lymphoma (FL)
- Must have advanced stage disease
- Must not have received any prior chemotherapy or immunotherapy for lymphoma, including steroids
- Must have adequate organ function
- Must have the ability to understand and willingness to sign a written informed consent form
Key exclusion criteria (3 listed)
- No other agents or therapies administered with the intent to treat malignancy
- Uncontrolled, intercurrent illness
- Pregnant women and women who are breast feeding
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 |
|---|---|---|
| Obatoclax mesylateAlso: (GX15-070MS)Obatoclax mesylate 40mg, and 60mg | Drug | Obatoclax mesylate 40mg, Obatoclax mesylate 60mg |
| RituximabRituximab | Drug | Obatoclax mesylate 40mg, Obatoclax mesylate 60mg |
Primary outcome
Response rate
Time frame: 12 weeks
1 secondary outcome
Time to Tumor Progression.
Time frame: 20 weeks
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 22 Jul 2016.
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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.
Jean Viallet, MD study director
Gemin X, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Obatoclax mesylate and Rituximab in people with Lymphoma, Follicular, run by Gemin X 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 5 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 22 Jul 2016. 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 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?
Response rate (time frame: 12 weeks). 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 22 Jul 2016.