Chronic Lymphocytic LeukemiaPhase 3NCT01556776
A Study of Lenalidomide Maintenance for High-risk Patients With CLL Following First-line Therapy
A Phase 3 study testing lenalidomide in people with Chronic Lymphocytic Leukemia, run by German CLL Study Group at 2 sites in Germany.
Trial summary
CLLM1 is a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study that compares the efficacy and safety of oral lenalidomide maintenance therapy to that of placebo maintenance therapy in high-risk subjects with Chronic Lymphocytic Leukemia (CLL) who have achieved at least a partial… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- What is being tested?
- lenalidomide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 2 sitesGermany
- Study dates
- 20 Jul 2012to 14 Jan 2021
- Phase
- Phase 3
- 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 understand and voluntarily sign an informed consent form.
- Age ≥ 18 years at the time of signing the informed consent form.
- Must be able to adhere to the study visit schedule and other protocol requirements.
- Must have a documented diagnosis of CLL (IWCLL guidelines for the diagnosis and treatment of chronic lymphocytic leukemia1.
- Must have been treated with one of the first line induction therapies: fludarabine/cyclophosphamide, fludarabine/rituximab, fludarabine/cyclophosphamide/rituximab, pentostatin/cyclophosphamide/rituximab or bendamustine/rituximab.
- Must have achieved a response of at least PR ((IWCLL guidelines for the diagnosis and treatment of chronic lymphocytic leukemia )following completion (minimum 4 cycles) of first line induction therapy prior to randomization, and have either:
Show all 24Show fewer
- MRD levels in the peripheral blood at final restaging of ≥10-2 or
- MRD levels in the peripheral blood at final restaging of ≥10-4 - <10-2 combined with an unmutated IGHV-status or 17p-deletion or TP53 mutation.
- Must have completed last cycle of at least 4 cycles of first-line induction no less than 8 weeks (56 days) and no greater than 20 weeks (140 days) prior to randomization.
- Subjects who completed first-line induction treatment with less than 6 cycles but at least 4 cycles should document reason for early discontinuation.
- Must have an Eastern Cooperative Oncology Group (ECOG see appendix 11.13) performance status score of ≤2.
- Negative serological Hepatitis B test or negative PCR in case of positive serological test without evidence of an active infection, negative testing of Hepatitis C RNA, negative HIV test within 6 weeks prior to randomization.
- Females of childbearing potential (FCBP)† must:
- Have two negative medically supervised pregnancy tests prior to starting of study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the subject practices complete and continued sexual abstinence.
- Either commit to continued abstinence from heterosexual intercourse (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, two reliable forms of effective contraception simultaneously to achieve a PEARL-Index <1 without without interruption (Highly effective methods: Intrauterine device (IUD), Hormonal (birth control pills, injections, implants), Tubal ligation, Partner's vasectomy, Additional effective methods: Male condom, Diaphragm, Cervical Cap). 28 days prior to starting study drug, during the study therapy (including dose interruptions), and for 28 days after discontinuation of study therapy.
- Male subjects must:
- Agree to use a condom during sexual contact with a FCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and after cessation of study therapy.
- Agree to not donate semen during study drug therapy and for a period after end of study drug therapy.
- All subjects must:
- Have an understanding that the study drug could have a potential teratogenic risk.
- Agree to abstain from donating blood while taking study drug therapy and following discontinuation of study drug therapy.
- Agree not to share study medication with another person.
- Be counseled about pregnancy precautions and risks of fetal exposure.
- Willingness to inform the general practitioner
Who cannot join
- A CIRS Score of more than 6 or a single score of 4 for an organ system limiting the ability to receive an intensive treatment
- Active infections requiring systemic antibiotics.
- Systemic infection CTC grade 3 or 4 that has not resolved > 2 months prior to randomization in spite of adequate anti-infective therapy.
- Autologous or allogeneic bone marrow transplant as first line therapy.
- Pregnant or lactating females.
- Systemic treatment for CLL in the interval between completing the last cycle of first-line induction therapy and randomization.
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- Participation in any clinical study or having taken any investigational therapy which would interfere with the study drug for a disease other than CLL within 28 days prior to initiating maintenance therapy.
- Known presence of alcohol and/or drug abuse.
- Central nervous system (CNS) involvement as documented by spinal fluid cytology or imaging. Subjects who have signs or symptoms suggestive of leukemic meningitis or a history of leukemic meningitis must have a lumbar puncture procedure performed within two weeks prior to randomization.
- Prior history of malignancies, other than CLL, unless the subject has been free of the disease for ≥5 years. Exceptions include the following:
- Basal cell carcinoma of the skin
- Squamous cell carcinoma of the skin
- Carcinoma in situ of the cervix
- Carcinoma in situ of the breast
- Incidental histological finding of prostate cancer (TNM stage of T1a or T1b)
- History of renal failure requiring dialysis.
- Prior therapy with lenalidomide.
- Any of the following laboratory abnormalities:
- Calculated (method of Cockcroft-Gault) creatinine clearance of <60 mL/min
- Absolute neutrophil count (ANC) < 1,000/μL (1.0 X 109/L)
- Platelet count < 50,000/μL (50 X 109/L)
- Serum aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) > 3.0 x upper limit of normal (ULN)
- Serum total bilirubin > 2.0 mg/dL (with the exception of Gilbert's Syndrome)
- Uncontrolled hyperthyroidism or hypothyroidism.
- Venous thromboembolism within one year.
- ≥ Grade-2 neuropathy.
- Uncontrolled autoimmune hemolytic anemia or thrombocytopenia.
- Disease transformation (active) (i.e. Richter's Syndrome, prolymphocytic leukemia).
- Known allergy to allopurinol if the subject has bulky disease.
- Prisoners, or subjects who are institutionalized by regulatory or court order or persons who are who are in dependence to the sponsor or an investigator.
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University Hospital Cologne
Cologne, 50924
German CLL Study Group
Cologne, 50937
About this study
Official title: CLLM1-Protocol of the German CLL-Study Group (GCLLSG) A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of the Efficacy and Safety of Lenalidomide (Revlimid®) as Maintenance Therapy for High-risk Patients With Chronic Lymphocytic Leukemia Following First-line Therapy
CLLM1 is a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study that compares the efficacy and safety of oral lenalidomide maintenance therapy to that of placebo maintenance therapy in high-risk subjects with Chronic Lymphocytic Leukemia (CLL) who have achieved at least a partial response (PR) and either:
- MRD levels of ≥ 10-2 or
- MRD levels of ≥ 10-4 - < 10-2 combined with at least one of the following factors:
- an unmutated IGHV-status
- 17p-deletion or
- TP53 mutation after first line therapy with FCR, FR, BR or FC (in case of of contraindications to receive Rituximab).
Read the detailed description
CLLM1 is a phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of lenalidomide administered as maintenance treatment to subjects with CLL who have responded to first-line therapy (induction) achieving a response of at least PR and are at high risk of early progression. This study will compare the efficacy of lenalidomide maintenance treatment versus placebo at prolonging progression free survival (PFS); and as secondary endpoints assess overall survival, the safety of lenalidomide treatment and evaluate Minimal residual disease (MRD) kinetics in peripheral blood whilst subjects are on maintenance.
Although maintenance therapy has been established in recent years for the treatment of a subset of subjects with Non-Hodgkin's Lymphoma (NHL), it is a novel concept in the management of CLL. It is not regularly used and only a limited number of small studies have been conducted evaluating consolidation/maintenance therapy for limited periods of time with alemtuzumab or rituximab. Based on the limited amount of available data, it appears that maintenance therapy may improve the quality of remission in CLL subjects and prolong progression-free survival (PFS). A large phase 3 trial investigating lenalidomide as maintenance following response to second line therapy is ongoing. However, a large well-controlled study has not been conducted to investigate the beneficial effect of maintenance therapy following front line therapy; specifically in subjects with aggressive disease. This phase 3 study will evaluate whether lenalidomide maintenance therapy will prolong PFS in CLL subjects with a high risk of early progression following first line treatment.
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- lenalidomide, Placebo
- Keywords
- CLL, High Risk, Maintenance
- 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.
lenalidomideDrug
Also called Revlimid
placebo or lenalidomide 5 mg daily on days 1-28 of the first 28-day cycle. If the 5 mg dose level is well tolerated, escalation to 10 mg daily on days 1-28 of cycle 2-6 is permitted; further escalations starting with the 7th cycle and up to the 12th cycle to 15 mg daily is permitted. If after 12 cycles of treatment subjects still present with MRD levels of ≥ 10-4 in peripheral blood and previous dose levels are well tolerated, starting with the 13th cycle up to progression 20 mg daily is permitted. If after 18 cycles of treatment for subjects still present with MRD.levels of ≥ 10-4 in peripheral blood and previous dose levels are well tolerated, starting with the 19th cycle up to progression 25 mg daily is permitted. 25 mg is the maximal daily dose of lenalidomide
PlaceboDrug
placebo or lenalidomide 5 mg daily on days 1-28 of the first 28-day cycle. If the 5 mg dose level is well tolerated, escalation to 10 mg daily on days 1-28 of cycle 2-6 is permitted; further escalations starting with the 7th cycle and up to the 12th cycle to 15 mg daily is permitted. If after 12 cycles of treatment subjects still present with MRD levels of ≥ 10-4 in peripheral blood and previous dose levels are well tolerated, starting with the 13th cycle up to progression 20 mg daily is permitted. If after 18 cycles of treatment for subjects still present with MRD.levels of ≥ 10-4 in peripheral blood and previous dose levels are well tolerated, starting with the 19th cycle up to progression 25 mg daily is permitted. 25 mg is the maximal daily dose of lenalidomide
| Study group | Role | What they receive |
|---|---|---|
| Lenalidomide | Experimental | lenalidomide maintenance following firstline treatment with FCR, BR, FR, or FC(if Rituximab is contraindicated) Receives: Drug: lenalidomide |
| Placebo | Placebo comparator | placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) based on independent review committee
Time from the date of randomization to the date of first documented disease progression (as defined by the iWCLL response criteria, see section 4.11.1.2) or death by any cause, whichever occurs first.
Measured: up to 6 years
Secondary outcomes (4)
Progression-free survival (PFS) based on investigator's assessment
Time from the date of randomization to the date of first documented disease progression (as defined by the iWCLL response criteria, see section 4.11.1.2) or death by any cause, whichever occurs first.
Measured: up to 6 years
Overall survival (OS)
Time from the date of randomization to the date of death due to any cause
Measured: up to 6 years
Safety - adverse events (AEs)
Type, frequency and severity of adverse events (AEs) and relationship of AEs to lenalidomide or placebo; premature withdrawals
Measured: up to 6 years
Miminimal residual disease (MRD) levels in peripheral blood (PB)
MRD levels assessed by quantitative highly sensitive flow cytometry (MRD flow) of the PB
Measured: up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2012 (estimated)
- Study start20 Jul 2012
- Primary completionMar 2016
- Study completion14 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- German CLL Study Group
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene
- Responsible party
- Sponsor
- Investigators
- Anna Fink, MD, Study chair, German CLL Study GroupBarbara Eichhorst, MD, Principal investigator, German CLL Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01556776
- Sponsor's protocol ID
- CLLM1
- Other IDs
- 2011-004698-98, RV-CLL-GCLLSG-0725
- Status last verified
- Aug 2021
- First submitted
- 14 Mar 2012
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Fink AM, Bahlo J, Robrecht S, Al-Sawaf O, Aldaoud A, Hebart H, Jentsch-Ullrich K, Dorfel S, Fischer K, Wendtner CM, Nosslinger T, Ghia P, Bosch F, Kater AP, Dohner H, Kneba M, Kreuzer KA, Tausch E, Stilgenbauer S, Ritgen M, Bottcher S, Eichhorst B, Hallek M. Lenalidomide maintenance after first-line therapy for high-risk chronic lymphocytic leukaemia (CLLM1): final results from a randomised, double-blind, phase 3 study. Lancet Haematol. 2017 Oct;4(10):e475-e486. doi: 10.1016/S2352-3026(17)30171-0. Epub 2017 Sep 12.
PubMed 28916311Furstenau M, Fink AM, Schilhabel A, Weiss J, Robrecht S, Eckert R, de la Serna J, Crespo M, Coscia M, Vitale C, Bottcher S, Weppner G, Ritgen M, Stilgenbauer S, Tausch E, Fischer K, Hallek M, Eichhorst B, Bruggemann M, Herling CD. B-cell acute lymphoblastic leukemia in patients with chronic lymphocytic leukemia treated with lenalidomide. Blood. 2021 Apr 22;137(16):2267-2271. doi: 10.1182/blood.2020008609. No abstract available.
PubMed 33512465
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLLM1-Protocol of the German CLL-Study Group (GCLLSG) A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of the Efficacy and Safety of Lenalidomide (Revlimid®) as Maintenance Therapy for High-risk Patients With Chronic Lymphocytic Leukemia Following First-line Therapy
- ClinicalTrials.gov ID
- NCT01556776
- Acronym / sponsor ID
- CLLM1
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- CLL, High Risk, Maintenance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- German CLL Study GroupUniversity, hospital or other
- Collaborators
- Celgene
- Study start
- 20 Jul 2012 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- 14 Jan 2021 (actual)
- First posted
- 16 Mar 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.
CLLM1 is a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study that compares the efficacy and safety of oral lenalidomide maintenance therapy to that of placebo maintenance therapy in high-risk subjects with Chronic Lymphocytic Leukemia (CLL) who have achieved at least a partial response (PR) and either:
- MRD levels of ≥ 10-2 or
- MRD levels of ≥ 10-4 - < 10-2 combined with at least one of the following factors:
- an unmutated IGHV-status
- 17p-deletion or
- TP53 mutation after first line therapy with FCR, FR, BR or FC (in case of of contraindications to receive Rituximab).
Detailed description
CLLM1 is a phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of lenalidomide administered as maintenance treatment to subjects with CLL who have responded to first-line therapy (induction) achieving a response of at least PR and are at high risk of early progression. This study will compare the efficacy of lenalidomide maintenance treatment versus placebo at prolonging progression free survival (PFS); and as secondary endpoints assess overall survival, the safety of lenalidomide treatment and evaluate Minimal residual disease (MRD) kinetics in peripheral blood whilst subjects are on maintenance.
Although maintenance therapy has been established in recent years for the treatment of a subset of subjects with Non-Hodgkin's Lymphoma (NHL), it is a novel concept in the management of CLL. It is not regularly used and only a limited number of small studies have been conducted evaluating consolidation/maintenance therapy for limited periods of time with alemtuzumab or rituximab. Based on the limited amount of available data, it appears that maintenance therapy may improve the quality of remission in CLL subjects and prolong progression-free survival (PFS). A large phase 3 trial investigating lenalidomide as maintenance following response to second line therapy is ongoing. However, a large well-controlled study has not been conducted to investigate the beneficial effect of maintenance therapy following front line therapy; specifically in subjects with aggressive disease. This phase 3 study will evaluate whether lenalidomide maintenance therapy will prolong PFS in CLL subjects with a high risk of early progression following first line treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lenalidomide | Experimental | Drug: lenalidomidelenalidomide maintenance following firstline treatment with FCR, BR, FR, or FC(if Rituximab is contraindicated) |
| Placebo | Placebo comparator | Drug: Placeboplacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Must understand and voluntarily sign an informed consent form.
- Age ≥ 18 years at the time of signing the informed consent form.
- Must be able to adhere to the study visit schedule and other protocol requirements.
- Must have a documented diagnosis of CLL (IWCLL guidelines for the diagnosis and treatment of chronic lymphocytic leukemia1.
- Must have been treated with one of the first line induction therapies: fludarabine/cyclophosphamide, fludarabine/rituximab, fludarabine/cyclophosphamide/rituximab, pentostatin/cyclophosphamide/rituximab or bendamustine/rituximab.
Key exclusion criteria (30 listed)
- A CIRS Score of more than 6 or a single score of 4 for an organ system limiting the ability to receive an intensive treatment
- Active infections requiring systemic antibiotics.
- Systemic infection CTC grade 3 or 4 that has not resolved > 2 months prior to randomization in spite of adequate anti-infective therapy.
- Autologous or allogeneic bone marrow transplant as first line therapy.
- Pregnant or lactating females.
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: Revlimidplacebo or lenalidomide 5 mg daily on days 1-28 of the first 28-day cycle. If the 5 mg dose level is well tolerated, escalation to 10 mg daily on days 1-28 of cycle 2-6 is permitted; further escalations starting with the 7th cycle and up to the 12th cycle to 15 mg daily is permitted. If after 12 cycles of treatment subjects still present with MRD levels of ≥ 10-4 in peripheral blood and previous dose levels are well tolerated, starting with the 13th cycle up to progression 20 mg daily is permitted. If after 18 cycles of treatment for subjects still present with MRD.levels of ≥ 10-4 in peripheral blood and previous dose levels are well tolerated, starting with the 19th cycle up to progression 25 mg daily is permitted. 25 mg is the maximal daily dose of lenalidomide | Drug | Lenalidomide |
| Placeboplacebo or lenalidomide 5 mg daily on days 1-28 of the first 28-day cycle. If the 5 mg dose level is well tolerated, escalation to 10 mg daily on days 1-28 of cycle 2-6 is permitted; further escalations starting with the 7th cycle and up to the 12th cycle to 15 mg daily is permitted. If after 12 cycles of treatment subjects still present with MRD levels of ≥ 10-4 in peripheral blood and previous dose levels are well tolerated, starting with the 13th cycle up to progression 20 mg daily is permitted. If after 18 cycles of treatment for subjects still present with MRD.levels of ≥ 10-4 in peripheral blood and previous dose levels are well tolerated, starting with the 19th cycle up to progression 25 mg daily is permitted. 25 mg is the maximal daily dose of lenalidomide | Drug | Placebo |
Primary outcome
Progression-free survival (PFS) based on independent review committee
Time frame: up to 6 years
Time from the date of randomization to the date of first documented disease progression (as defined by the iWCLL response criteria, see section 4.11.1.2) or death by any cause, whichever occurs first.
4 secondary outcomes
Progression-free survival (PFS) based on investigator's assessment
Time frame: up to 6 years
Overall survival (OS)
Time frame: up to 6 years
Safety - adverse events (AEs)
Time frame: up to 6 years
Miminimal residual disease (MRD) levels in peripheral blood (PB)
Time frame: up to 6 years
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 5 Jan 2022.
- Results publication: PubMed 28916311Fink AM, Bahlo J, Robrecht S, Al-Sawaf O, Aldaoud A, Hebart H, Jentsch-Ullrich K, Dorfel S, Fischer K, Wendtner CM, Nosslinger T, Ghia P, Bosch F, Kater AP, Dohner H, Kneba M, Kreuzer KA, Tausch E, Stilgenbauer S, Ritgen M, Bottcher S, Eichhorst B, Hallek M. Lenalidomide maintenance after first-line therapy for high-risk chronic lymphocytic leukaemia (CLLM1): final results from a randomised, double-blind, phase 3 study. Lancet Haematol. 2017 Oct;4(10):e475-e486. doi: 10.1016/S2352-3026(17)30171-0. Epub 2017 Sep 12.
- Results publication: PubMed 33512465Furstenau M, Fink AM, Schilhabel A, Weiss J, Robrecht S, Eckert R, de la Serna J, Crespo M, Coscia M, Vitale C, Bottcher S, Weppner G, Ritgen M, Stilgenbauer S, Tausch E, Fischer K, Hallek M, Eichhorst B, Bruggemann M, Herling CD. B-cell acute lymphoblastic leukemia in patients with chronic lymphocytic leukemia treated with lenalidomide. Blood. 2021 Apr 22;137(16):2267-2271. doi: 10.1182/blood.2020008609. No abstract available.
- Individual participant dataSharing planned: No
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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.
Anna Fink, MD study chair
German CLL Study Group
Barbara Eichhorst, MD principal investigator
German CLL Study Group
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing lenalidomide in people with Chronic Lymphocytic Leukemia, run by German CLL Study Group at 2 sites in Germany.
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 24 inclusion and 30 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 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Progression-free survival (PFS) based on independent review committee (time frame: up to 6 years). 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 NCT01556776, which also lists 2 linked publications.
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 5 Jan 2022.