Lymphoma, Mantle-CellPhase 2NCT00871546
SCH 727965 in Patients With Mantle Cell Lymphoma or B-Cell Chronic Lymphocytic Leukemia (Study P04715)
A Phase 2 study testing SCH 727965, Bortezomib and Alemtuzumab in people with Lymphoma, Mantle-Cell and Leukemia, Lymphocytic, Chronic, B-Cell, run by Merck Sharp & Dohme LLC.
Trial summary
Participants will be randomized to SCH 727965 or a comparator drug (bortezomib for mantle cell lymphoma [MCL] or alemtuzumab for B cell chronic lymphocytic leukemia [B CLL]). Part 1 of the study will determine the activity of SCH 727965 treatment in participants with MCL and participants with B-CLL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Mantle-Cell, Leukemia, Lymphocytic, Chronic, B-Cell
- What is being tested?
- SCH 727965, Bortezomib and Alemtuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Dec 2010
- 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
- Age >=18 years, either sex, any race.
- Eastern Cooperative Oncology group performance status of 0 or 1.
- Adequate hematologic, renal, and hepatic organ function and laboratory parameters.
- For subjects with MCL:
- Diagnosis of MCL according to the World Health Organization (WHO) criteria.
- Received at least one prior chemotherapeutic regimen, but no more than two regimens including stem cell transplantation..
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- Measurable or assessable disease by the Revised Response Criteria for Malignant Lymphoma.
- For subjects with B-CLL
- Documented B-CLL according to the National Cancer Institute Working Group (NCI-WG) criteria.
- Received at least one prior alkylating agent-based regimen and one fludarabine- or pentostatin-containing regimen, but must not have received more than two prior regimens.
- Measurable or assessable disease by NCI-WG criteria.
Who cannot join
- Known central nervous system involvement of MCL or B-CLL.
- Previous treatment with SCH 727965 or other cyclin-dependent kinase inhibitors.
- For MCL, previous treatment with bortezomib.
- For B-CLL, previous treatment with alemtuzumab.
- Known HIV infection.
- Known active hepatitis B or C.
About this study
Official title: A Randomized Phase 2 Study of SCH 727965 in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (MCL) or B-Cell Chronic Lymphocytic Leukemia (B-CLL)
Participants will be randomized to SCH 727965 or a comparator drug (bortezomib for mantle cell lymphoma [MCL] or alemtuzumab for B cell chronic lymphocytic leukemia [B CLL]). Part 1 of the study will determine the activity of SCH 727965 treatment in participants with MCL and participants with B-CLL. Part 2 of the study will determine the activity of SCH 727965 treatment in participants who experienced disease progression after standard treatment with the comparator drug during Part 1.
- Being tested
- SCH 727965, Bortezomib, Alemtuzumab
- Medical subject headings
- Lymphoma, Mantle-Cell, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCH 727965Drug
SCH 727965 50 mg/m2 IV on Day 1 of each 21-day cycle until disease progression.
BortezomibDrug
Also called Velcade
Bortezomib 1.3 mg/m2 IV on Days 1, 4, 8, and 11 of each 21-day cycle until disease progression.
AlemtuzumabBiological
Also called Campath
Alemtuzumab dose-titrated to the goal maintenance dose of 30 mg/day IV or SC three times a week on alternate days for a total of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Participants with MCL randomized to SCH 727965 | Experimental | Not described Receives: Drug: SCH 727965 |
| Participants with MCL randomized to bortezomib | Active comparator | Not described Receives: Drug: Bortezomib |
| MCL treated w/SCH 727965 after progression on bortezomib | Experimental | Not described Receives: Drug: SCH 727965 |
| Participants with B-CLL randomized to SCH 727965 | Experimental | Not described Receives: Drug: SCH 727965 |
| Participants with B-CLL randomized to alemtuzumab | Active comparator | Not described Receives: Biological: Alemtuzumab |
| B-CLL treated w/ SCH 727965 after progression on alemtuzumab | Experimental | Not described Receives: Drug: SCH 727965 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate of initial treatment with SCH 727965 in subjects with MCL or B-CLL.
Measured: Time to identified disease progression on SCH 727965 in Part 1 (approx. 6 months)
Response rate in subjects treated with SCH 727965 after disease progression on comparator drug.
Measured: Time to identified disease progression on SCH 727965 in Part 2 (approx. 6 months)
Secondary outcomes (4)
Time to disease progression for initial treatment with SCH 727965.
Measured: Time to identified disease progression on SCH 727965 in Part 1 (approx. 6 months)
Time to disease progression and response rate for treatment with the comparator drug.
Measured: Time to identified disease progression on comparator drug (bortezomib for MCL or alemtuzumab for B-CLL).
Response rate for treatment with the comparator drug.
Measured: Time to identified disease progression on comparator drug (bortezomib for MCL or alemtuzumab for B-CLL).
Time to disease progression in participants treated with SCH 727965 after disease progression on comparator drug.
Measured: Time to identified disease progression on SCH 727965 in Part 2 (approx. 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Mantle-CellStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00871546
- Sponsor's protocol ID
- P04715
- Status last verified
- Aug 2015
- First submitted
- 26 Mar 2009
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 2 Study of SCH 727965 in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (MCL) or B-Cell Chronic Lymphocytic Leukemia (B-CLL)
- ClinicalTrials.gov ID
- NCT00871546
- Acronym / sponsor ID
- P04715
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 30 Mar 2009 (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.
Participants will be randomized to SCH 727965 or a comparator drug (bortezomib for mantle cell lymphoma [MCL] or alemtuzumab for B cell chronic lymphocytic leukemia [B CLL]). Part 1 of the study will determine the activity of SCH 727965 treatment in participants with MCL and participants with B-CLL. Part 2 of the study will determine the activity of SCH 727965 treatment in participants who experienced disease progression after standard treatment with the comparator drug during Part 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Participants with MCL randomized to SCH 727965 | Experimental | Drug: SCH 727965 |
| Participants with MCL randomized to bortezomib | Active comparator | Drug: Bortezomib |
| MCL treated w/SCH 727965 after progression on bortezomib | Experimental | Drug: SCH 727965 |
| Participants with B-CLL randomized to SCH 727965 | Experimental | Drug: SCH 727965 |
| Participants with B-CLL randomized to alemtuzumab | Active comparator | Biological: Alemtuzumab |
| B-CLL treated w/ SCH 727965 after progression on alemtuzumab | Experimental | Drug: SCH 727965 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age >=18 years, either sex, any race.
- Eastern Cooperative Oncology group performance status of 0 or 1.
- Adequate hematologic, renal, and hepatic organ function and laboratory parameters.
- For subjects with MCL:
- For subjects with B-CLL
Key exclusion criteria (6 listed)
- Known central nervous system involvement of MCL or B-CLL.
- Previous treatment with SCH 727965 or other cyclin-dependent kinase inhibitors.
- For MCL, previous treatment with bortezomib.
- For B-CLL, previous treatment with alemtuzumab.
- Known HIV infection.
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 |
|---|---|---|
| SCH 727965SCH 727965 50 mg/m2 IV on Day 1 of each 21-day cycle until disease progression. | Drug | B-CLL treated w/ SCH 727965 after progression on alemtuzumab, MCL treated w/SCH 727965 after progression on bortezomib, Participants with B-CLL randomized to SCH 727965, Participants with MCL randomized to SCH 727965 |
| BortezomibAlso: VelcadeBortezomib 1.3 mg/m2 IV on Days 1, 4, 8, and 11 of each 21-day cycle until disease progression. | Drug | Participants with MCL randomized to bortezomib |
| AlemtuzumabAlso: CampathAlemtuzumab dose-titrated to the goal maintenance dose of 30 mg/day IV or SC three times a week on alternate days for a total of 12 weeks. | Biological | Participants with B-CLL randomized to alemtuzumab |
Primary outcome
Response rate of initial treatment with SCH 727965 in subjects with MCL or B-CLL.
Time frame: Time to identified disease progression on SCH 727965 in Part 1 (approx. 6 months)
Response rate in subjects treated with SCH 727965 after disease progression on comparator drug.
Time frame: Time to identified disease progression on SCH 727965 in Part 2 (approx. 6 months)
4 secondary outcomes
Time to disease progression for initial treatment with SCH 727965.
Time frame: Time to identified disease progression on SCH 727965 in Part 1 (approx. 6 months)
Time to disease progression and response rate for treatment with the comparator drug.
Time frame: Time to identified disease progression on comparator drug (bortezomib for MCL or alemtuzumab for B-CLL).
Response rate for treatment with the comparator drug.
Time frame: Time to identified disease progression on comparator drug (bortezomib for MCL or alemtuzumab for B-CLL).
Time to disease progression in participants treated with SCH 727965 after disease progression on comparator drug.
Time frame: Time to identified disease progression on SCH 727965 in Part 2 (approx. 6 months)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SCH 727965, Bortezomib and Alemtuzumab in people with Lymphoma, Mantle-Cell and Leukemia, Lymphocytic, Chronic, B-Cell, run by Merck Sharp & Dohme LLC.
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 11 inclusion and 6 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 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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. 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.
What does the primary outcome measure?
Response rate of initial treatment with SCH 727965 in subjects with MCL or B-CLL. (time frame: Time to identified disease progression on SCH 727965 in Part 1 (approx. 6 months)). 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 7 Aug 2015.