Chronic Lymphocytic LeukemiaPhase 1/2NCT00078234
Genasense® (Oblimersen Sodium), Fludarabine, and Rituximab in Subjects With Chronic Lymphocytic Leukemia
A Phase 1/2 study testing Oblimersen-rituximab-fludarabine in people with Chronic Lymphocytic Leukemia, run by Genta Incorporated at 3 sites in United States.
Trial summary
The treatment combination of Rituxan® (rituximab) and fludarabine has previously been reported to produce a high percentage of responses with less toxicity than other combination treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- What is being tested?
- Oblimersen-rituximab-fludarabine
- Type of treatment
- Injection or infusion
- How many people
- 25 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2003to Sep 2010
- Phase
- Phase 1/2
- 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
- Absolute lymphocyte count of > 10,000 cells/mm3 or history of ALC >10,000 cell/mm3
- Platelets > 50,000 cells/mm3
- Tumor lymphocytes expressing surface CD5, CD19, CD20 and CD23
- Creatinine < 1.5 mg.dL
Who cannot join
- Less than 3 weeks from any prior major surgery or other therapy for CLL including radiation therapy, chemotherapy, high-dose steroid therapy, immunotherapy, cytokine, biologic or vaccine therapy.
- History of autoimmune hemolytic anemia
- Prior allogeneic transplant
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Roswell Park Cancer Institute
Buffalo, New York, 14263
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
Georgetown University Medical Center/Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
About this study
Official title: A Pilot Study of Genasense® (G3139, Oblimersen Sodium, Bcl-2 Antisense Oligonucleotide), Fludarabine and Rituximab in Previously Treated Subjects With Chronic Lymphocytic Leukemia
The treatment combination of Rituxan® (rituximab) and fludarabine has previously been reported to produce a high percentage of responses with less toxicity than other combination treatments. However, some leukemia subjects continue to have leukemia despite treatment with these standard anticancer drug therapies, or they may work for only a short period of time. In some subjects, when the leukemia does not respond well to therapy the leukemia cells may be over-producing one or more proteins. One of these proteins is called Bcl-2. Bcl-2 is a protein that appears to protect cancer cells from being killed and thus lengthens the life of the cancer cells. Genasense® (oblimersen sodium) is a compound that blocks production of the Bcl-2 protein. By first lowering levels of Bcl-2, it is possible that chemotherapy drugs may work more effectively as a cancer treatment. Genasense® may also directly kill CLL cells. This study will test whether treating subjects with Genasense®, fludarabine and rituximab is safe and effective.
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- Oblimersen-rituximab-fludarabine
- Keywords
- CLL, Leukemia, Chronic, Cancer, Adult, Lymphocytic, Genasense, G3139, Genta, Bcl-2, Antisense, Oligonucleotide, oblimersen
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Bronchiolitis Obliterans Syndrome, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oblimersen-rituximab-fludarabineDrug
28-day cycles; Cycle 1: oblimersen by continuous IV infusion 1.5 mg/kg/d for 7 consecutive days, completing on Day 8; rituximab by IV infusion on Day 4 (125 mg/m2) and Day 6 (250 mg/m2); fludarabine 25 mg/m2 by IV infusion for 3 days, starting on Day 6. Subsequent cycles: oblimersen 3 mg/kg/d, completing on Day 8; rituximab 375 mg/m2 on Day 5; fludarabine 25 mg/m2 for 3 days starting the same day as rituximab
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and complete response rate
Measured: Monthly for response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2004 (estimated)
- Study startNov 2003
- Primary completionSep 2008
- Study completionSep 2010
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genta Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00078234
- Sponsor's protocol ID
- GL217
- Status last verified
- May 2009
- First submitted
- 20 Feb 2004
- Last updated
- 7 Nov 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Genasense® (G3139, Oblimersen Sodium, Bcl-2 Antisense Oligonucleotide), Fludarabine and Rituximab in Previously Treated Subjects With Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT00078234
- Acronym / sponsor ID
- GL217
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- CLL, Leukemia, Chronic, Cancer, Adult, Lymphocytic, Genasense, G3139
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Genta IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 23 Feb 2004 (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.
The treatment combination of Rituxan® (rituximab) and fludarabine has previously been reported to produce a high percentage of responses with less toxicity than other combination treatments. However, some leukemia subjects continue to have leukemia despite treatment with these standard anticancer drug therapies, or they may work for only a short period of time. In some subjects, when the leukemia does not respond well to therapy the leukemia cells may be over-producing one or more proteins. One of these proteins is called Bcl-2. Bcl-2 is a protein that appears to protect cancer cells from being killed and thus lengthens the life of the cancer cells. Genasense® (oblimersen sodium) is a compound that blocks production of the Bcl-2 protein. By first lowering levels of Bcl-2, it is possible that chemotherapy drugs may work more effectively as a cancer treatment. Genasense® may also directly kill CLL cells. This study will test whether treating subjects with Genasense®, fludarabine and rituximab is safe and effective.
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 (4 listed)
- Absolute lymphocyte count of > 10,000 cells/mm3 or history of ALC >10,000 cell/mm3
- Platelets > 50,000 cells/mm3
- Tumor lymphocytes expressing surface CD5, CD19, CD20 and CD23
- Creatinine < 1.5 mg.dL
Key exclusion criteria (3 listed)
- Less than 3 weeks from any prior major surgery or other therapy for CLL including radiation therapy, chemotherapy, high-dose steroid therapy, immunotherapy, cytokine, biologic or vaccine therapy.
- History of autoimmune hemolytic anemia
- Prior allogeneic transplant
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 |
|---|---|---|
| Oblimersen-rituximab-fludarabine28-day cycles; Cycle 1: oblimersen by continuous IV infusion 1.5 mg/kg/d for 7 consecutive days, completing on Day 8; rituximab by IV infusion on Day 4 (125 mg/m2) and Day 6 (250 mg/m2); fludarabine 25 mg/m2 by IV infusion for 3 days, starting on Day 6. Subsequent cycles: oblimersen 3 mg/kg/d, completing on Day 8; rituximab 375 mg/m2 on Day 5; fludarabine 25 mg/m2 for 3 days starting the same day as rituximab | Drug | – |
Primary outcome
Safety and complete response rate
Time frame: Monthly for response
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 7 Nov 2011.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Oblimersen-rituximab-fludarabine in people with Chronic Lymphocytic Leukemia, run by Genta Incorporated 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 4 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 7 Nov 2011. 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 combined 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.
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?
Safety and complete response rate (time frame: Monthly for response). 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 7 Nov 2011.