Chronic Lymphocytic LeukemiaPhase 1NCT01650727
A Study of Dinaciclib in Combination With Rituximab in Participants With Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (P07974)
A Phase 1 study testing Dinaciclib and Rituximab in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to determine the maximum-tolerated dose (MTD) of dinaciclib therapy in combination with rituximab in chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
- What is being tested?
- Dinaciclib and Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Oct 2013
- Phase
- Phase 1
- 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
- Must have received at least one prior therapy that includes either
- fludarabine or equivalent nucleoside analogue or an alternative regimen
- Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic
- lymphoma (SLL)
- Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2
- Women of child-bearing potential who are sexually active, ,including both female subjects and the female sexual partners of male subjects, must agree to use a medically accepted method of contraception prior to enrollment, while receiving protocol-specified treatment, and for 12 months after stopping study treatment.
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- Women of child-bearing potential who are not currently sexually active must
- agree to use a medically accepted method of contraception should they become
- sexually active while participating in the study.
- Life expectancy ≥12 weeks
Who cannot join
- Symptomatic brain metastases or primary central nervous system malignancy
- Treatment with any chemotherapy or biologic therapy within 4 weeks prior to enrollment
- Non-hematological toxicities from prior therapy
- Presence of any serious or uncontrolled infection defined as infection requiring hospital admission and/or parenteral antibiotics
- Known human immunodeficiency virus (HIV) infection or a known HIV-related
- malignancy
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- Clinically active hepatitis B or C defined as disease that requires
- therapy
- Women who are breast-feeding, pregnant, or intend to become pregnant
- Prior allogeneic bone marrow transplant (auto hematopoietic stem cell
- transplantation [HSCT] is allowed if fully recovered)
- Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer from which the subject is
- considered by his or her physician to have a 2 year survival expectation
- Any investigational drugs within 4 weeks prior to the start of treatment
- Concurrently receiving treatment in any other clinical study
- Previously treated with a cyclin dependent kinase (CDK) inhibitor (e.g., dinaciclib or flavopiridol)
- Active autoimmune anemia or idiopathic thrombocytopenic purpura (ITP) unless
- stable, defined as being responsive to corticosteroids or other standard therapy
About this study
Official title: A Phase 1b Trial of Dinaciclib in Combination With Rituximab in Subjects With Relapsed and Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
The purpose of this study is to determine the maximum-tolerated dose (MTD) of dinaciclib therapy in combination with rituximab in chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
- Being tested
- Dinaciclib, Rituximab
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DinaciclibDrug
Also called SCH 727965, MK-7965
Dinaciclib is given as a single intravenous (IV) dose on Days 1, 8, and 15 in Cycle 2 through Cycle 13 (28 day cycles) at a starting dose of 7 mg/m^2 up to a maximum dose of 14 mg/m^2.
RituximabBiological
Also called Rituxan®
Rituximab 375 mg/m^2 will be administered IV on Day 1, 8, 15 and 22 in Cycle 1 (28 day cycle) and on Day 1 in Cycles 3-13 (28 day cycles).
| Study group | Role | What they receive |
|---|---|---|
| Dinaciclib + Rituximab | Experimental | Rituximab will be administered in Cycles 1 and 3-13.
Dinaciclib will be administered in Cycles 2-13. Receives: Drug: Dinaciclib; Biological: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing a Dose Limiting Toxicity (DLT)
Measured: Cycles 2 & 3 (Days 29-84)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2013
- Study completionOct 2013
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 Chronic Lymphocytic LeukemiaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 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
- NCT01650727
- Sponsor's protocol ID
- P07974
- Other IDs
- 2012-001437-14, MK-7965-011
- Status last verified
- Feb 2015
- First submitted
- 24 Jul 2012
- Last updated
- 10 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Fabre C, Gobbi M, Ezzili C, Zoubir M, Sablin MP, Small K, Im E, Shinwari N, Zhang D, Zhou H, Le Tourneau C. Clinical study of the novel cyclin-dependent kinase inhibitor dinaciclib in combination with rituximab in relapsed/refractory chronic lymphocytic leukemia patients. Cancer Chemother Pharmacol. 2014 Nov;74(5):1057-64. doi: 10.1007/s00280-014-2583-9. Epub 2014 Sep 13.
PubMed 25217392
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Trial of Dinaciclib in Combination With Rituximab in Subjects With Relapsed and Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
- ClinicalTrials.gov ID
- NCT01650727
- Acronym / sponsor ID
- P07974
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 26 Jul 2012 (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 purpose of this study is to determine the maximum-tolerated dose (MTD) of dinaciclib therapy in combination with rituximab in chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dinaciclib + Rituximab | Experimental | Drug: Dinaciclib, Biological: RituximabRituximab will be administered in Cycles 1 and 3-13. Dinaciclib will be administered in Cycles 2-13. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Must have received at least one prior therapy that includes either
- fludarabine or equivalent nucleoside analogue or an alternative regimen
- Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic
- lymphoma (SLL)
- Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2
Key exclusion criteria (18 listed)
- Symptomatic brain metastases or primary central nervous system malignancy
- Treatment with any chemotherapy or biologic therapy within 4 weeks prior to enrollment
- Non-hematological toxicities from prior therapy
- Presence of any serious or uncontrolled infection defined as infection requiring hospital admission and/or parenteral antibiotics
- Known human immunodeficiency virus (HIV) infection or a known HIV-related
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 |
|---|---|---|
| DinaciclibAlso: SCH 727965, MK-7965Dinaciclib is given as a single intravenous (IV) dose on Days 1, 8, and 15 in Cycle 2 through Cycle 13 (28 day cycles) at a starting dose of 7 mg/m^2 up to a maximum dose of 14 mg/m^2. | Drug | Dinaciclib + Rituximab |
| RituximabAlso: Rituxan®Rituximab 375 mg/m^2 will be administered IV on Day 1, 8, 15 and 22 in Cycle 1 (28 day cycle) and on Day 1 in Cycles 3-13 (28 day cycles). | Biological | Dinaciclib + Rituximab |
Primary outcome
Number of Participants Experiencing a Dose Limiting Toxicity (DLT)
Time frame: Cycles 2 & 3 (Days 29-84)
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 10 Feb 2015.
- Results publication: PubMed 25217392Fabre C, Gobbi M, Ezzili C, Zoubir M, Sablin MP, Small K, Im E, Shinwari N, Zhang D, Zhou H, Le Tourneau C. Clinical study of the novel cyclin-dependent kinase inhibitor dinaciclib in combination with rituximab in relapsed/refractory chronic lymphocytic leukemia patients. Cancer Chemother Pharmacol. 2014 Nov;74(5):1057-64. doi: 10.1007/s00280-014-2583-9. Epub 2014 Sep 13.
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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 1 study testing Dinaciclib and Rituximab in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, 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 10 inclusion and 18 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 10 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 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.
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?
Number of Participants Experiencing a Dose Limiting Toxicity (DLT) (time frame: Cycles 2 & 3 (Days 29-84)). 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 NCT01650727, 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 10 Feb 2015.