Chronic Lymphocytic LeukemiaPhase 1NCT00419250
A Dose Escalation Study of Lenalidomide in Relapsed or Refractory B-cell Chronic Lymphocytic Leukemia
A Phase 1 study testing lenalidomide in people with Chronic Lymphocytic Leukemia and Leukemia, B-Cell, Chronic, run by Celgene at 35 sites in 7 countries.
Trial summary
The purpose of this study is to evaluate the safety of lenalidomide and to define the maximum tolerated escalation dose level (MTEDL) when administered by a stepwise dose-escalation schedule in subjects with relapsed or refractory B-cell CLL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Leukemia, B-Cell, Chronic
- What is being tested?
- lenalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 35 sitesin 7 countries
- Study dates
- 1 Dec 2006to 1 Jun 2010
- 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
- Documented diagnosis of B-cell CLL that has relapsed after or is refractory to at least one prior regimen. The prior regimen(s) must have included an alkylating agent and fludarabine (used in combination or separately)
- ECOG < or = 2
- Willing to agree to follow the pregnancy precautions.
Who cannot join
- Pregnant or nursing women
- Systemic treatment for B-cell CLL within 28 days of study start
- Central nervous system involvement
- History of renal failure requiring dialysis
- Prior treatment with lenalidomide
- Alemtuzumab therapy within 56 days of initiating lenalidomide treatment
Show all 14Show fewer
- ANC < 1000 / ul
- Platelet count < 50,000 / ul
- Calculated creatinine clearance < 60 mL/min (Cockroft-Gault method)
- AST or ALT > 3.0 x upper limit of normal
- Serum total bilirubin > 2.0 mg/dl
- Neuropathy > or = Grade 2
- Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
- Richter's transformation (active)
Trial locations and contacts
35 sites in 7 countries.
35 sites in 7 countries
United States20 sites
Alta Bates Summit Comprehensive Cancer Center
Berkeley, California, 94704
Mountain States Tumor Institute
Boise, Idaho, 83712
Roswell Park Cancer Institute
Buffalo, New York, 14263
Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois, 60611
University of Chicago Medical Center
Chicago, Illinois, 60637-1470
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Karmanos Cancer Institute/Wayne State University School of Medicine
Detroit, Michigan, 48201
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Indiana University Medical center
Indianapolis, Indiana, 46202-5149
Baptist Cancer Institute
Jacksonville, Florida, 32207
Cancer & Blood Disease Center
Lecanto, Florida, 34461
Northwest Georgia Oncology Centers, PC., Wellstar Health System
Marietta, Georgia, 30060
Weill Medical College of Cornell University, Division of Hematology & Oncology
New York, New York, 10021
Desert Hematology Oncology Medical Group, Inc.
Rancho Mirage, California, 92270
Swedish Cancer Institute
Seattle, Washington, 98104
LSU Health Sciences Center, Feist-Weiller Cancer Center
Shreveport, Louisiana, 71130
SUNY Upstate Medical Center
Syracuse, New York, 13210
Arizona Cancer Center
Tucson, Arizona, 85724
Abington Hematology Oncology Assoc., Inc.
Willow Grove, Pennsylvania, 19090
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157
Canada5 sites
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
London Helath Science Centre
London, Ontario, N6C 6B5
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
Cancer Care Manitoba
Winnipeg, Manitoba, R3E 0V9
Germany4 sites
Uniklinik Köln, Klinik I für Innere Medizin, Klinisches Studienzentrum Hämatologie
Bettenhaus Ebene 04, Raum 001/048, Kerpener Str. 62, Koln, 50924
University of Schleswig Holstein, Director Medizinische Klinik II
Campus Kiel, Chemnitzstrasse 33, Kiel, 24116
Charité, Campus Benjamin Franklin, Medizinische Klinik III
Hindenburgdamm 30, State of Berlin, 12203
University of Ulm, Abteilung Innere Medizin III, Robert-Koch-Strasse 8
Ulm, 89081
United Kingdom3 sites
St James's Institute of Oncology, Dept. of Haematology, Level 3, Bexley Wing, Beckett Street
Leeds, LS9 7TF
Bart's and the London NHS Trust, St. Bartholomew's Hospital, 7th Floor Gloucester House, Cancer Services
London, EC1A 7BE
Christie Hospital NHS Foundation Trust, Haematology and Transplant Unit,
Manchester, M20 4BX
Italy1 site
Clinica Ematologica- A.O.U. San Martino, Clinica Ematologica Dipartimento di Medicina Interna
Genova, 16132
Spain1 site
Hospital Clinic Provincial de Barcelona, Servicio de Hematología, Institute of Haematology and Oncology
Villaroel, 170, Barcelona, 8036
Sweden1 site
Karolinska Universitetssjukhuset, Hematologiskt Centrum, Karolinska Universitetssjukhuset,
Stockholm, 141 86
About this study
Official title: A Phase 1, Multi-center, Open-label Study of the Safety and Efficacy of a Stepwise Dose-escalation Schedule of Lenalidomide Monotherapy in Subjects With Relapsed or Refractory B-cell Chronic Lymphocytic Leukemia
The purpose of this study is to evaluate the safety of lenalidomide and to define the maximum tolerated escalation dose level (MTEDL) when administered by a stepwise dose-escalation schedule in subjects with relapsed or refractory B-cell CLL.
- Being tested
- lenalidomide
- Keywords
- relapsed, refractory, fludarabine, Revlimid, lenalidomide, CLL, B-cell CLL, CC-5013, Chronic Lymphocytic Leukemia
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Recurrence, Leukemia, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lenalidomideDrug
Also called Revlimid, CC-5013
lenalidomideDrug
Also called Revlimid, CC-5013
lenalidomideDrug
Also called Revlimid, CC-5013
lenalidomideDrug
Also called Revlimid, CC-5013
lenalidomideDrug
Also called Revlimid, CC-5013
| Study group | Role | What they receive |
|---|---|---|
| dose-escalation to 5 mg lenalidomide (len) | Experimental | escalate up to 5 mg once daily / 28-day cycle Receives: Drug: lenalidomide |
| dose-escalation to 10 mg lenalidomide (len) | Experimental | escalate up to 10 mg once daily / 28-day cycle Receives: Drug: lenalidomide |
| dose-escalation to 15 mg lenalidomide (len) | Experimental | escalate up to 15 mg once daily / 28-day cycle Receives: Drug: lenalidomide |
| dose-escalation to 20 mg lenalidomide (len) | Experimental | escalate up to 20 mg once daily / 28-day cycle Receives: Drug: lenalidomide |
| dose-escalation to 25 mg lenalidomide (len) | Experimental | escalate up to 25 mg once daily / 28-day cycle Receives: Drug: lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Measured: February 2010
Secondary outcomes (7)
Response
Measured: February 2010
Duration of response
Measured: February 2010
Time to response
Measured: February 2010
Progression free survival
Measured: February 2010
Overall survival
Measured: February 2010
Absolute lymphocyte count
Measured: February 2010
Evaluation of minimal residual disease (MRD) by flow cytometry
Measured: February 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2007 (estimated)
- Study start1 Dec 2006
- Primary completion1 Feb 2010
- Study completion1 Jun 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 Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by CelgeneThe 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elayne Lombardy, MD, Study director, Celgene CorporationAsher Chanan-Khan, MD, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00419250
- Sponsor's protocol ID
- CC-5013-CLL-001
- Status last verified
- Nov 2019
- First submitted
- 5 Jan 2007
- Last updated
- 8 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wendtner CM, Hillmen P, Mahadevan D, Buhler A, Uharek L, Coutre S, Frankfurt O, Bloor A, Bosch F, Furman RR, Kimby E, Gribben JG, Gobbi M, Dreisbach L, Hurd DD, Sekeres MA, Ferrajoli A, Shah S, Zhang J, Moutouh-de Parseval L, Hallek M, Heerema NA, Stilgenbauer S, Chanan-Khan AA. Final results of a multicenter phase 1 study of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia. Leuk Lymphoma. 2012 Mar;53(3):417-23. doi: 10.3109/10428194.2011.618232. Epub 2011 Nov 15.
PubMed 21879809
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multi-center, Open-label Study of the Safety and Efficacy of a Stepwise Dose-escalation Schedule of Lenalidomide Monotherapy in Subjects With Relapsed or Refractory B-cell Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT00419250
- Acronym / sponsor ID
- CC-5013-CLL-001
- Keywords
- relapsed, refractory, fludarabine, Revlimid, lenalidomide, CLL, B-cell CLL, CC-5013
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2006 (actual)
- Primary completion
- 1 Feb 2010 (actual)
- Study completion
- 1 Jun 2010 (actual)
- First posted
- 8 Jan 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.
The purpose of this study is to evaluate the safety of lenalidomide and to define the maximum tolerated escalation dose level (MTEDL) when administered by a stepwise dose-escalation schedule in subjects with relapsed or refractory B-cell CLL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| dose-escalation to 5 mg lenalidomide (len) | Experimental | Drug: lenalidomideescalate up to 5 mg once daily / 28-day cycle |
| dose-escalation to 10 mg lenalidomide (len) | Experimental | Drug: lenalidomideescalate up to 10 mg once daily / 28-day cycle |
| dose-escalation to 15 mg lenalidomide (len) | Experimental | Drug: lenalidomideescalate up to 15 mg once daily / 28-day cycle |
| dose-escalation to 20 mg lenalidomide (len) | Experimental | Drug: lenalidomideescalate up to 20 mg once daily / 28-day cycle |
| dose-escalation to 25 mg lenalidomide (len) | Experimental | Drug: lenalidomideescalate up to 25 mg once daily / 28-day cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Documented diagnosis of B-cell CLL that has relapsed after or is refractory to at least one prior regimen. The prior regimen(s) must have included an alkylating agent and fludarabine (used in combination or separately)
- ECOG < or = 2
- Willing to agree to follow the pregnancy precautions.
Key exclusion criteria (14 listed)
- Pregnant or nursing women
- Systemic treatment for B-cell CLL within 28 days of study start
- Central nervous system involvement
- History of renal failure requiring dialysis
- Prior treatment with lenalidomide
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 |
|---|---|---|
| lenalidomideAlso: Revlimid, CC-5013 | Drug | dose-escalation to 5 mg lenalidomide (len) |
| lenalidomideAlso: Revlimid, CC-5013 | Drug | dose-escalation to 10 mg lenalidomide (len) |
| lenalidomideAlso: Revlimid, CC-5013 | Drug | dose-escalation to 15 mg lenalidomide (len) |
| lenalidomideAlso: Revlimid, CC-5013 | Drug | dose-escalation to 20 mg lenalidomide (len) |
| lenalidomideAlso: Revlimid, CC-5013 | Drug | dose-escalation to 25 mg lenalidomide (len) |
Primary outcome
Safety
Time frame: February 2010
7 secondary outcomes
Response
Time frame: February 2010
Duration of response
Time frame: February 2010
Time to response
Time frame: February 2010
Progression free survival
Time frame: February 2010
Overall survival
Time frame: February 2010
Absolute lymphocyte count
Time frame: February 2010
Evaluation of minimal residual disease (MRD) by flow cytometry
Time frame: February 2010
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 8 Nov 2019.
- Background: PubMed 21879809Wendtner CM, Hillmen P, Mahadevan D, Buhler A, Uharek L, Coutre S, Frankfurt O, Bloor A, Bosch F, Furman RR, Kimby E, Gribben JG, Gobbi M, Dreisbach L, Hurd DD, Sekeres MA, Ferrajoli A, Shah S, Zhang J, Moutouh-de Parseval L, Hallek M, Heerema NA, Stilgenbauer S, Chanan-Khan AA. Final results of a multicenter phase 1 study of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia. Leuk Lymphoma. 2012 Mar;53(3):417-23. doi: 10.3109/10428194.2011.618232. Epub 2011 Nov 15.
Related trials for Chronic Lymphocytic Leukemia
Enrolling by invitationObservational study
Gene Therapy Follow-up Protocol for People Previously Enrolled in CAR-T Cell Studies
Lyphoma, B-Cell, Leukemia, B-cell
Active, not recruitingObservational study
Clinical, Laboratory and Epidemiologic Characterization of Individuals and Families at High Risk of Hematologic Cancer
Waldenstrom Macroglobulinemia, Chronic Lymphocytic Leukemia
RecruitingObservational study
Benefits of Individual Physical Activity Intervention on Health-related Quality of Life in Participants With Chronic Lymphocytic Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
RecruitingPhase 2
Phase II Study of Combined Pirtobrutinib, Venetoclax and Obinutuzumab (PVO) Time-limited Treatment for Patients With Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL).
Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia (SLL)
Active, not recruitingPhase 3
A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Leukemia, Lymphocytic, Chronic, B-Cell
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.
Elayne Lombardy, MD study director
Celgene Corporation
Asher Chanan-Khan, MD principal investigator
Roswell Park Cancer Institute
35 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing lenalidomide in people with Chronic Lymphocytic Leukemia and Leukemia, B-Cell, Chronic, run by Celgene at 35 sites in 7 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 3 inclusion and 14 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 8 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Canada, Germany, United Kingdom, Italy and 2 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 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?
Safety (time frame: February 2010). 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 NCT00419250, 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 8 Nov 2019.