Leukemia, Lymphocytic, ChronicPhase 2NCT00464633
Alvocidib in Patients With Previously Treated Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia Arising From Chronic Lymphocytic Leukemia (CLL)
A Phase 2 study testing alvocidib in people with Leukemia, Lymphocytic, Chronic, run by Sanofi at 34 sites in 9 countries.
Trial summary
Multicenter, open-label, study of alvocidib in previously treated chronic lymphocytic leukemia patients. Primary objective is to determine overall response rate. The secondary objectives are: to assess overall safety, to assess duration of response, progression free survival, and overall survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Lymphocytic, Chronic
- What is being tested?
- alvocidib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 34 sitesin 9 countries
- Study dates
- Mar 2007to Dec 2011
- 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
- Patient must have documentation of histologically confirmed and measurable Chronic Lymphocytic Leukemia (CLL) or Prolymphocytic Leukemia (PLL) arising from CLL;
- Patient must have symptomatic and progressive disease;
- Patient must have received prior alkylating agent(s) and be fludarabine refractory;
- Patient must have the adequate organ functions;
- Patient's Eastern Cooperative Oncology Group performance (ECOG) status must be 0-2;
Who cannot join
- Patient with de novo PLL;
- Patient with secondary malignancy that will limit survival ≤5 years;
- Patient with prior allogenic or autologous bone marrow transplant or peripheral blood stem cell transplant ≤12 months;
- Patient receiving an investigational agent or an approved agent for an investigational purpose within last 4 weeks prior to study entry;
- Patient with known history of glucose-6-phosphate dehydrogenase deficiency;
- Patient with autoimmune hemolytic anemia;
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- Patient with known Central Nervous System involvement;
- Patient with active, uncontrolled serious bacterial, viral or fungal infections
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
34 sites in 9 countries.
34 sites in 9 countries
United States13 sites
Sanofi-Aventis Investigational Site Number 840023
Ann Arbor, Michigan, 48109-0759
Sanofi-Aventis Investigational Site Number 840001
Boston, Massachusetts, 02115
Sanofi-Aventis Investigational Site Number 840010
Chicago, Illinois, 60611
Sanofi-Aventis Investigational Site Number 840012
Chicago, Illinois, 60637
Sanofi-Aventis Investigational Site Number 840018
Cleveland, Ohio, 44106
Sanofi-Aventis Investigational Site Number 840002
Columbus, Ohio, 43210
Sanofi-Aventis Investigational Site Number 840003
Durham, North Carolina, 27710
Sanofi-Aventis Investigational Site Number 840017
Indianapolis, Indiana, 46202
Sanofi-Aventis Investigational Site Number 840005
New York, New York, 10021
Sanofi-Aventis Investigational Site Number 840006
New York, New York, 10029-6574
Sanofi-Aventis Investigational Site Number 840020
Philadelphia, Pennsylvania, 19104
Sanofi-Aventis Investigational Site Number 840008
San Diego, California, 92103
Sanofi-Aventis Investigational Site Number 840022
San Francisco, California, 94143
Belgium5 sites
Sanofi-Aventis Investigational Site Number 056006
Bruges, 8000
Sanofi-Aventis Investigational Site Number 056001
Brussels, 1000
Sanofi-Aventis Investigational Site Number 056004
Ghent, 9000
Sanofi-Aventis Investigational Site Number 056003
Leuven, 3000
Sanofi-Aventis Investigational Site Number 056002
Yvoir, 5530
France3 sites
Sanofi-Aventis Investigational Site Number 250001
Paris, 75651
Sanofi-Aventis Investigational Site Number 250003
Pierre-Bénite, 69495
Sanofi-Aventis Investigational Site Number 250002
Tours, 37044
Germany3 sites
Sanofi-Aventis Investigational Site Number 276001
Cologne, 50937
Sanofi-Aventis Investigational Site Number 276004
Kiel, 24116
Sanofi-Aventis Investigational Site Number 276002
Ulm, 89081
Netherlands3 sites
Sanofi-Aventis Investigational Site Number 528003
Amsterdam, 1081 HV
Sanofi-Aventis Investigational Site Number 528001
Groningen, 9713 GZ
Sanofi-Aventis Investigational Site Number 528002
Rotterdam, 3015 CE
United Kingdom3 sites
Sanofi-Aventis Investigational Site Number 826005
Aberdeen, AB25 2ZN
Sanofi-Aventis Investigational Site Number 826002
Birmingham, B9 5SS
Sanofi-Aventis Investigational Site Number 826004
Bournemouth, BH7 7DW
Italy2 sites
Sanofi-Aventis Investigational Site Number 380002
Bologna, 40138
Sanofi-Aventis Investigational Site Number 380001
Milan, 20132
Australia1 site
Sanofi-Aventis Investigational Site Number 036001
St Leonards, 2065
Puerto Rico1 site
Sanofi-Aventis Investigational Site Number 630001
San Juan, 00927
About this study
Official title: A Multicenter, Open-label, Single Arm Study of Weekly Alvocidib in Patients With Previously Treated B-Cell Chronic Lymphocytic Leukemia (CLL) or Prolymphocytic Leukemia (PLL) Arising From CLL
Multicenter, open-label, study of alvocidib in previously treated chronic lymphocytic leukemia patients.
Primary objective is to determine overall response rate.
The secondary objectives are:
- to assess overall safety,
- to assess duration of response, progression free survival, and overall survival.
Clinical benefit and pharmacokinetics parameters are also evaluated.
Read the detailed description
Treatment until disease progression or no evidence of treatment response; occurrence of unacceptable toxicity, intercurrent medical problem, or adverse event (AE); or a maximum of 6 cycles.
Follow-up of 6 months after the last treatment with alvocidib.
The maximum duration of the study participation for patient will be about 15 months.
- Conditions
- Leukemia, Lymphocytic, Chronic
- Being tested
- alvocidib
- Keywords
- CLL, PLL, flavopiridol
- 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.
alvocidibDrug
Also called HMR1275
1st dose: 30 mg/m2 as a 30-minute intravenous (IV) infusion followed by 30 mg/m2 as a 4-hour continuous infusion
Then, every treatment week, depending upon the patient's objective response to initial therapy:
- 30 mg/m2 over 30 minutes followed by 50 mg/m2 over 4 hours or
- 30 mg/m2 over 30 minutes followed by 30 mg/m2 over 4 hours.
| Study group | Role | What they receive |
|---|---|---|
| Alvocidib | Experimental | Cycles with 4-week treatment with alvocidib followed by 2-week rest period for up to a maximum of 6 cycles Receives: Drug: alvocidib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best overall objective response rate
Objective Response Rate (ORR) is defined as the proportion of participants with complete response or partial response (including nodular partial response) relative to the total number of participants.
Response assessment is based on evaluation of nodal disease by Computerized Tomography (CT) and National Cancer Institute Working Group 96 criteria (NCI-96) for assessment of liver, spleen, constitutional symptoms, peripheral blood (±) bone marrow.
Measured: Up to a maximum of 6 cycles
Secondary outcomes (4)
Progression-free survival
Progression-free survival (PFS) is defined as the time from the date of first administration of study drug to the first documentation of progressive disease or death due to any cause in the absence of previous documentation of objective progression.
Measured: Up to a maximum of 6 cycles
Duration of objective response
Duration of objective response is defined from the time of first occurrence of complete response or partial response (including nodular partial response) to the first documentation of progressive disease or death due to any cause in the absence of previous documentation of objective progression.
Measured: Up to a maximum of 6 cycles
Overall survival
Overall survival (OS) is defined as the time from the date of first administration of study drug to death.
Measured: Up to a maximum of 6 cycles
Overview of adverse events
Measured: from study drug administration up to 30 days after last study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2007 (estimated)
- Study startMar 2007
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Lymphocytic, ChronicStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00464633
- Sponsor's protocol ID
- EFC6663
- Other IDs
- 2006-006152-34
- Status last verified
- Feb 2013
- First submitted
- 20 Apr 2007
- Last updated
- 12 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Single Arm Study of Weekly Alvocidib in Patients With Previously Treated B-Cell Chronic Lymphocytic Leukemia (CLL) or Prolymphocytic Leukemia (PLL) Arising From CLL
- ClinicalTrials.gov ID
- NCT00464633
- Acronym / sponsor ID
- EFC6663
- Conditions
- Leukemia, Lymphocytic, Chronic
- Keywords
- CLL, PLL, flavopiridol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 23 Apr 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.
Multicenter, open-label, study of alvocidib in previously treated chronic lymphocytic leukemia patients.
Primary objective is to determine overall response rate.
The secondary objectives are:
- to assess overall safety,
- to assess duration of response, progression free survival, and overall survival.
Clinical benefit and pharmacokinetics parameters are also evaluated.
Detailed description
Treatment until disease progression or no evidence of treatment response; occurrence of unacceptable toxicity, intercurrent medical problem, or adverse event (AE); or a maximum of 6 cycles.
Follow-up of 6 months after the last treatment with alvocidib.
The maximum duration of the study participation for patient will be about 15 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alvocidib | Experimental | Drug: alvocidibCycles with 4-week treatment with alvocidib followed by 2-week rest period for up to a maximum of 6 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient must have documentation of histologically confirmed and measurable Chronic Lymphocytic Leukemia (CLL) or Prolymphocytic Leukemia (PLL) arising from CLL;
- Patient must have symptomatic and progressive disease;
- Patient must have received prior alkylating agent(s) and be fludarabine refractory;
- Patient must have the adequate organ functions;
- Patient's Eastern Cooperative Oncology Group performance (ECOG) status must be 0-2;
Key exclusion criteria (9 listed)
- Patient with de novo PLL;
- Patient with secondary malignancy that will limit survival ≤5 years;
- Patient with prior allogenic or autologous bone marrow transplant or peripheral blood stem cell transplant ≤12 months;
- Patient receiving an investigational agent or an approved agent for an investigational purpose within last 4 weeks prior to study entry;
- Patient with known history of glucose-6-phosphate dehydrogenase deficiency;
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 |
|---|---|---|
| alvocidibAlso: HMR12751st dose: 30 mg/m2 as a 30-minute intravenous (IV) infusion followed by 30 mg/m2 as a 4-hour continuous infusion Then, every treatment week, depending upon the patient's objective response to initial therapy: * 30 mg/m2 over 30 minutes followed by 50 mg/m2 over 4 hours or * 30 mg/m2 over 30 minutes followed by 30 mg/m2 over 4 hours. | Drug | Alvocidib |
Primary outcome
Best overall objective response rate
Time frame: Up to a maximum of 6 cycles
Objective Response Rate (ORR) is defined as the proportion of participants with complete response or partial response (including nodular partial response) relative to the total number of participants. Response assessment is based on evaluation of nodal disease by Computerized Tomography (CT) and National Cancer Institute Working Group 96 criteria (NCI-96) for assessment of liver, spleen, constitutional symptoms, peripheral blood (±) bone marrow.
4 secondary outcomes
Progression-free survival
Time frame: Up to a maximum of 6 cycles
Duration of objective response
Time frame: Up to a maximum of 6 cycles
Overall survival
Time frame: Up to a maximum of 6 cycles
Overview of adverse events
Time frame: from study drug administration up to 30 days after last study drug administration
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 12 Feb 2013.
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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.
Clinical Sciences & Operations study director
Sanofi
34 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing alvocidib in people with Leukemia, Lymphocytic, Chronic, run by Sanofi at 34 sites in 9 countries.
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 9 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 12 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Belgium, France, Germany, Netherlands and 4 more countries. 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?
Best overall objective response rate (time frame: Up to a maximum of 6 cycles). 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 12 Feb 2013.