Leukemia, Myeloid, AcutePhase 2NCT00798213
SCH 727965 in Patients With Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia (P04717AM2)(TERMINATED)
A Phase 2 study testing SCH 727965 and Gemtuzumab ozogamicin in people with Leukemia, Myeloid, Acute and Lymphoblastic Leukemia, Acute, run by Merck Sharp & Dohme LLC.
Trial summary
Participants with acute myelogenous leukemia (AML) will be randomized to SCH 727965 or gemtuzumab ozogamicin. All participants with acute lymphoblastic leukemia (ALL) will receive SCH 727965. Part 1 of the study will determine the activity of SCH 727965 treatment in participants with AML and participants with ALL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Myeloid, Acute, Lymphoblastic Leukemia, Acute
- What is being tested?
- SCH 727965 and Gemtuzumab ozogamicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Apr 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
- For participants with AML:
- Age >=60 years, either sex, any race.
- Diagnosis of CD33-positive AML by World Health Organization criteria.
- Must be in first or second relapse, or have primary refractory or refractory disease at first salvage, and not be considered a candidate for transplant.
- Acute promyelocytic leukemia who has relapsed following treatment with both all trans retinoic acid (tretinoin) and arsenic trioxide-based therapy is eligible.
- For participants with ALL:
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- Age >=18 years, either sex, any race.
- Diagnosis of ALL by World Health Organization criteria.
- Must be in first or second relapse, or have primary refractory or refractory disease at first salvage, and not be considered a candidate for potentially curative therapy.
- Eastern Cooperative Oncology group performance status of 0 or 1.
- Adequate hematologic, renal, and hepatic organ function and laboratory parameters.
- Receiving treatment with hydroxyurea or leukapheresis to reduce elevated white blood cell count to <=30 x 10^9 is eligible, provided hydroxyurea and leukapheresis are discontinued at least 24 hours before initiation of study drug.
Who cannot join
- Known central nervous system leukemia.
- Previous hematopoietic stem cell transplantation.
- Previous treatment with SCH 727965 or other cyclin-dependent kinase inhibitors.
- For AML, previous treatment with gemtuzumab ozogamicin.
- Known HIV infection.
- Known active hepatitis B or C.
About this study
Official title: A Phase 2 Study of SCH 727965 in Subjects With Relapsed and Refractory Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia
Participants with acute myelogenous leukemia (AML) will be randomized to SCH 727965 or gemtuzumab ozogamicin. All participants with acute lymphoblastic leukemia (ALL) will receive SCH 727965. Part 1 of the study will determine the activity of SCH 727965 treatment in participants with AML and participants with ALL. Part 2 of the study will determine the activity of SCH 727965 treatment in participants with AML who experienced disease progression after standard treatment with gemtuzumab ozogamicin during Part 1.
- Being tested
- SCH 727965, Gemtuzumab ozogamicin
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma
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.
Gemtuzumab ozogamicinDrug
Also called Mylotarg
Gemtuzumab ozogamicin 9 mg/m2 IV on Day 1 and Day 15.
| Study group | Role | What they receive |
|---|---|---|
| Participants with AML randomized to SCH 727965 | Experimental | Not described Receives: Drug: SCH 727965 |
| Participants with AML randomized to gemtuzumab ozogamicin | Active comparator | Not described Receives: Drug: Gemtuzumab ozogamicin |
| AML treated w/ SCH 727965 after prog. on gemtuzumab ozogamicin | Experimental | Not described Receives: Drug: SCH 727965 |
| Participants with ALL treated with SCH 727965 | Experimental | Not described Receives: Drug: SCH 727965 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate of initial treatment with SCH 727965 in subjects with AML or ALL.
Measured: Time to identified response or disease progression on SCH 727965 in Part 1 (approx. 5 months).
Overall response rate in participants with AML treated with SCH 727965 after disease progression on comparator.
Measured: Time to identified response or disease progression on SCH 727965 in Part 2 (approx. 5 months).
Secondary outcomes (4)
Time to disease progression for initial treatment with SCH 727965 in subjects with AML or ALL.
Measured: Time to identified disease progression on SCH 727965 in Part 1 (approx. 5 months).
Overall response rate and time to progression of treatment with gemtuzumab ozogamicin in subjects with AML.
Measured: Time to identified response or disease progression on gemtuzumab ozogamicin (approx. 5 months).
Time to disease progression for treatment with gemtuzumab ozogamicin in participants with AML.
Measured: Time to identified disease progression on gemtuzumab ozogamicin (approx. 5 months).
Time to disease progression in participants with AML treated with SCH 727965 after disease progression on gemtuzumab ozogamicin
Measured: Time to identified disease progression on SCH 727965 in Part 2 (approx. 5 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2008 (estimated)
- Study startJan 2009
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Leukemia, Myeloid, AcuteStudies 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
- 29 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
- NCT00798213
- Sponsor's protocol ID
- P04717
- Status last verified
- Feb 2015
- First submitted
- 25 Nov 2008
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Gojo I, Sadowska M, Walker A, Feldman EJ, Iyer SP, Baer MR, Sausville EA, Lapidus RG, Zhang D, Zhu Y, Jou YM, Poon J, Small K, Bannerji R. Clinical and laboratory studies of the novel cyclin-dependent kinase inhibitor dinaciclib (SCH 727965) in acute leukemias. Cancer Chemother Pharmacol. 2013 Oct;72(4):897-908. doi: 10.1007/s00280-013-2249-z. Epub 2013 Aug 15.
PubMed 23949430
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of SCH 727965 in Subjects With Relapsed and Refractory Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT00798213
- Acronym / sponsor ID
- P04717
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 26 Nov 2008 (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 with acute myelogenous leukemia (AML) will be randomized to SCH 727965 or gemtuzumab ozogamicin. All participants with acute lymphoblastic leukemia (ALL) will receive SCH 727965. Part 1 of the study will determine the activity of SCH 727965 treatment in participants with AML and participants with ALL. Part 2 of the study will determine the activity of SCH 727965 treatment in participants with AML who experienced disease progression after standard treatment with gemtuzumab ozogamicin during Part 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Participants with AML randomized to SCH 727965 | Experimental | Drug: SCH 727965 |
| Participants with AML randomized to gemtuzumab ozogamicin | Active comparator | Drug: Gemtuzumab ozogamicin |
| AML treated w/ SCH 727965 after prog. on gemtuzumab ozogamicin | Experimental | Drug: SCH 727965 |
| Participants with ALL treated with SCH 727965 | 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 (12 listed)
- For participants with AML:
- For participants with ALL:
Key exclusion criteria (6 listed)
- Known central nervous system leukemia.
- Previous hematopoietic stem cell transplantation.
- Previous treatment with SCH 727965 or other cyclin-dependent kinase inhibitors.
- For AML, previous treatment with gemtuzumab ozogamicin.
- 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 | AML treated w/ SCH 727965 after prog. on gemtuzumab ozogamicin, Participants with ALL treated with SCH 727965, Participants with AML randomized to SCH 727965 |
| Gemtuzumab ozogamicinAlso: MylotargGemtuzumab ozogamicin 9 mg/m2 IV on Day 1 and Day 15. | Drug | Participants with AML randomized to gemtuzumab ozogamicin |
Primary outcome
Overall response rate of initial treatment with SCH 727965 in subjects with AML or ALL.
Time frame: Time to identified response or disease progression on SCH 727965 in Part 1 (approx. 5 months).
Overall response rate in participants with AML treated with SCH 727965 after disease progression on comparator.
Time frame: Time to identified response or disease progression on SCH 727965 in Part 2 (approx. 5 months).
4 secondary outcomes
Time to disease progression for initial treatment with SCH 727965 in subjects with AML or ALL.
Time frame: Time to identified disease progression on SCH 727965 in Part 1 (approx. 5 months).
Overall response rate and time to progression of treatment with gemtuzumab ozogamicin in subjects with AML.
Time frame: Time to identified response or disease progression on gemtuzumab ozogamicin (approx. 5 months).
Time to disease progression for treatment with gemtuzumab ozogamicin in participants with AML.
Time frame: Time to identified disease progression on gemtuzumab ozogamicin (approx. 5 months).
Time to disease progression in participants with AML treated with SCH 727965 after disease progression on gemtuzumab ozogamicin
Time frame: Time to identified disease progression on SCH 727965 in Part 2 (approx. 5 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 4 Feb 2015.
- Results publication: PubMed 23949430Gojo I, Sadowska M, Walker A, Feldman EJ, Iyer SP, Baer MR, Sausville EA, Lapidus RG, Zhang D, Zhu Y, Jou YM, Poon J, Small K, Bannerji R. Clinical and laboratory studies of the novel cyclin-dependent kinase inhibitor dinaciclib (SCH 727965) in acute leukemias. Cancer Chemother Pharmacol. 2013 Oct;72(4):897-908. doi: 10.1007/s00280-013-2249-z. Epub 2013 Aug 15.
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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 and Gemtuzumab ozogamicin in people with Leukemia, Myeloid, Acute and Lymphoblastic Leukemia, Acute, 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 12 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 4 Feb 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?
Overall response rate of initial treatment with SCH 727965 in subjects with AML or ALL. (time frame: Time to identified response or disease progression on SCH 727965 in Part 1 (approx. 5 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?
On the ClinicalTrials.gov record for NCT00798213, which also lists 1 linked publication.
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 4 Feb 2015.