Waldenström's MacroglobulinemiaPhase 3NCT01788020
Efficacy of First Line DRC +/- Bortezomib for Patients With Waldenström's Macroglobulinemia
A Phase 3 study testing Dexamethasone, Rituximab, Cyclophosphamide and Dexamethasone, Rituximab, Cyclophosphamide, Bortezomib in people with Waldenström's Macroglobulinemia, run by University of Ulm at 1 site in Germany.
Trial summary
In Waldenström macroglobulinemia (WM) conventional chemotherapy induces only low CR rates and responses of short duration compared to other indolent lymphomas. Thus innovative approaches are needed which combine excellent activity and tolerability in patients with WM, who are mostly of advanced age. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Waldenström's Macroglobulinemia
- What is being tested?
- Dexamethasone, Rituximab, Cyclophosphamide and Dexamethasone, Rituximab, Cyclophosphamide, Bortezomib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2013to Apr 2024
- 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
- Clinicopathological diagnosis of WM as defined by consensus panel one of the Second International Workshop on WM. Pathological diagnosis has to occur before study inclusion and randomization. In addition, pathological specimens have to be sent to the national pathological reference center at study inclusion and randomization. The positivity for CD20 can be assumed from any previous bone marrow immunohistochemistry or flow cytometry analysis performed up to 6 months prior to enrollment. Inclusion in the study will be based on morphological and immunological criteria. Immunophenotyping will be performed in each center and saved locally. Flow cytometry of bone marrow and blood cells will include at least one double staining and assess the expression of the following antigens: surface immunoglobulin, CD19, CD20, CD5, CD10 and CD23. Patients are eligible if tumor cells express the following antigens: CD19, CD20, and if they are negative for CD5, CD10 and CD23 expression. Patients with tumor cells positive for CD5 and/or CD23 and morphologically similar to WM cells may be included after ruling out other low grade B-cell malignancies.
- Presence of at least one criterion for initiation of therapy, according to the 2nd Workshop on WM:
- Recurrent fever, night sweats, weight loss, fatigue
- Hyperviscosity
- Lymphadenopathy which is either symptomatic or bulky (≥5 cm in maximum diameter)
- Symptomatic hepatomegaly and/or splenomegaly
Show all 29Show fewer
- Symptomatic organomegaly and/or organ or tissue infiltration
- Peripheral neuropathy due to WM
- Symptomatic cryoglobulinemia
- Cold agglutinin anemia
- IgM related immune hemolytic anemia and/or thrombocytopenia
- Nephropathy related to WM
- Amyloidosis related to WM
- Hemoglobin ≤10g/dL
- Platelet count <100x10^9/L
- Serum monoclonal protein >5g/dL, even with no overt clinical symptoms Cumulative illness rating scale (CIRS) score less than 6
- World Health Organization (WHO)/ECOG performance status 0 to 2.
- Other criteria:
- Age ≥ than 18 years
- Life expectancy >3 months.
- Baseline platelet count ≥ 50 ×10^9/L, absolute neutrophil count ≥ 0.75×10^9/L (if not due to BM infiltration by the lymphoma).
- Meet the following pretreatment laboratory criteria at the Screening visit conducted within 28 days of study enrollment:
- ASAT (SGOT): ≤3 times the upper limit of institutional laboratory normal value
- ALAT (SGPT): ≤3 times the upper limit of institutional laboratory normal value
- Total Bilirubin: ≤20 mg/L or 2 times the upper limit of institutional laboratory normal value, unless clearly related to the disease (except if due to Gilbert's syndrome)
- Serum creatinine: ≤ 2mg/dl
- Premenopausal fertile females must agree to use a highly effective method of birth control for the duration of the therapy up to 6 months after end of therapy. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.
- Men must agree not to father a child for the duration of therapy and 6 months after and must agree to advice a female partner to use a highly effective method of birth control.
- Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
Who cannot join
- Prior systemic treatment of the WM (plasmapheresis and short- term administration of corticosteroids < 4 weeks administered at a dose equivalent to < 20 mg/day prednisone is allowed)
- Patient with hypersensitivity to dexamethasone.
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- Uncontrolled bacterial, viral or fungal infection
- Active HIV, HBV or HCV infection
- Known interstitial lung disease
Show all 24Show fewer
- Prior allergic reaction or severe anaphylactic reaction related to humanized or murine monoclonal antibody.
- Central Nervous System involvement by lymphoma
- Prior history of malignancies 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 histologic finding of prostate cancer (TNM stage of T1a or T1b).
- Uncontrolled illness including, but not limited to:
- Uncontrolled diabetes mellitus mellitus (as indicated by metabolic derangements and/or severe diabetes mellitus related uncontrolled organ complications)
- Chronic symptomatic congestive heart failure (Class NYHA III or IV).
- Unstable angina pectoris, angioplasty, stenting, or myocardial infarction within 6 months
- Clinically significant cardiac arrhythmia that is symptomatic or requires treatment, or asymptomatic sustained ventricular tachycardia.
- Known pericardial disease
- Subjects with ≥ Grade 2 neuropathy.
- Women who are pregnant as well as women who are breastfeeding and do not consent to discontinue breast-feeding.
- Participation in another clinical trial within four weeks before randomization in this study
- No consent for registration, storage and processing of the individual disease-characteristics and course as well as information of the family physician about study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of First Line Dexamethasone, Rituximab and Cyclophosphamide (DRC) +/- Bortezomib for Patients With Waldenström's Macroglobulinemia
In Waldenström macroglobulinemia (WM) conventional chemotherapy induces only low CR rates and responses of short duration compared to other indolent lymphomas. Thus innovative approaches are needed which combine excellent activity and tolerability in patients with WM, who are mostly of advanced age. The immunochemotherapy DRC (dexamethasone, rituximab, cyclophosphamide) was shown to be highly effective in patients with WM without inducing major hematological toxicities. On the other hand the proteasome inhibitor Bortezomib showed substantial activity as a single agent in WM with only very few side effects when given in a weekly schedule. Based on these observations it is the aim of this study to test whether the efficacy of the well tolerated DRC regime can be further improved by adding Bortezomib.
Read the detailed description
Waldenström's macroglobulinemia (WM) is defined by a bone marrow infiltration by lymphoplasmacytic cells and the presence of a monoclonal immunoglobulin (Ig) M gammopathy in the peripheral blood. The clinical understanding of the disease has been greatly improved by the identification of internationally recognized criteria for initiating therapy, the description of an international prognostic index for patients requiring a first-line therapy and the definition of response criteria. These criteria are mainly based on the evolution of serum IgM concentration. However, delayed IgM monoclonal protein responses may cause important difficulties in response assessment. In addition, discrepancies between the kinetics of serum M protein reduction and the clearance of monoclonal B-cells from the bone marrow have been reported. Despite continuing advances in the therapy of WM, the disease remains incurable with a median survival of 5 to 8 years from the time of diagnosis thereby necessitating the development and evaluation of novel treatment approaches.
- Conditions
- Waldenström's Macroglobulinemia
- Being tested
- Dexamethasone, Rituximab, Cyclophosphamide, Dexamethasone, Rituximab, Cyclophosphamide, Bortezomib
- Keywords
- DRC, Bortezomib, Oncology
- Medical subject headings
- Waldenstrom Macroglobulinemia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone, Rituximab, CyclophosphamideDrug
Dexamethasone, Rituximab, Cyclophosphamide, BortezomibDrug
| Study group | Role | What they receive |
|---|---|---|
| DRC+Bortezomib | Experimental | Induction experimental arm (Arm B):
Cycle 1:
Bortezomib 1.6 mg/m2 s.c. Day 1,8,15; Dexamethasone 20 mg p.o. Day 1; Rituximab 375 mg/m2 i.v. Day 1; Cyclophosphamide 100 mg/m2 x 2 p.o. Day 1-5
Cycle 2-6:
Bortezomib 1.6 mg/m2 s.c. Day 1,8,15; Dexamethasone 20 mg p.o. Day 1; Rituximab 1400 mg absolute sc Day 1; Cyclophosphamide 100 mg/m2 x 2 p.o. Day 1-5; Repeat day 29. Receives: Drug: Dexamethasone, Rituximab, Cyclophosphamide, Bortezomib |
| DRC | Active comparator | Induction standard arm (Arm A)
Cycle 1:
Dexamethasone 20 mg p.o. Day 1; Rituximab 375 mg/m2 i.v. Day 1; Cyclophosphamide 100 mg/m2 x 2 p.o. Day 1-5;
Cycle 2-6:
Dexamethasone 20 mg p.o. Day 1; Rituximab 1400 mg absolute sc Day 1; Cyclophosphamide 100 mg/m2 x 2 p.o. Day 1-5; Repeat day 29. Receives: Drug: Dexamethasone, Rituximab, Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
PFS will be calculated from the date of inclusion/randomisation to the following events: the date of progression and the date of death if it occurred earlier. In the absence of progression and death, PFS duration will be censored at the stopping date or the date of last follow-up.
Measured: participants will be followed for their participation in the trial, an expected average of 5.5 years
Secondary outcomes (8)
Response rate
The response rates (CR,VGPR, PR, MR) and overall response rate (CR, VGPR, PR, MR) are evaluated 4 weeks after the end of induction treatment.
Measured: 24 weeks
Best response
Best response is determined in the time interval from the start of induction therapy to end of follow-up.
Measured: 24 weeks
Time to best response
Time to best response is defined as the time from the start of induction to best response the patient achieves (CR, VGPR, PR, MR).
Measured: 24 weeks
Time to first response
Time to first response is defined as the time from the start of induction to first response (MR, PR, VGPR or CR).
Measured: 24 weeks
Time to treatment failure
Time to treatment failure (TTF) is defined as the time of randomization to discontinuation of therapy for any reason including death from any cause, progression, toxicity or add-on of new anti-cancer therapy. Patients alive without treatment failure are censored at the latest tumor assessment date.
Measured: participants will be followed for their participation in the trial, an expected average of 5.5 years
Remission duration
Remission duration will be calculated in patients with response (CR, VGPR, PR, MR) to induction from end of induction to the date of progression, relapse or death from any cause. Patients alive without progression and relapse will be censored at the latest tumor assessment date or the stopping date.
Measured: participants will be followed for their participation in the trial (from date of response), an expected average of 5 years
Cause specific survival (CSS)
Cause specific survival is defined as the period from the induction randomization to death from lymphoma or lymphoma related cause; death unrelated to WM is considered as a competing event.
Measured: participants will be followed for their participation in the trial, an expected average of 5.5 years
Overall survival (OS)
Overall survival is defined as the period from the induction randomization to death from any cause. Patients who have not died until the time of the analysis will be censored at their last contact date.
Measured: participants will be followed for their participation in the trial, an expected average of 5.5 years]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startNov 2013
- Primary completionNov 2018
- Study completionApr 2024
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 Waldenström's MacroglobulinemiaStudies 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
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier de Lens (Co-Sponsor)
- Responsible party
- Principal investigator, Christian Buske, University of Ulm
- Investigators
- Martin Dreyling, MD, Principal investigator, National Co-Coordinating Investigator - Germany University Hospital Großhadern, MunichVeronique Leblond, MD, Principal investigator, National Co-Coordinating Investigator - Groupe Hospitalier Pitié Salpêtrière France (Paris)Pierre Morel, MD, Principal investigator, National Co-Coordinating Investigator - Centre Hospitalier Schaffner France (Lens cedex)Garcia Sanz, MD, Principal investigator, National Co-Coordinating Investigator - University Hospital Salamanca SpainMaria da Silva, MD, Principal investigator, National Co-Coordinating Investigator - Portuguese Institute of Oncology PortugalMeletios Dimopoulos, MD, Principal investigator, National Co-Coordinating Investigator - University of Athens School of Medicine Athens GreeceEva Kimby, MD, Principal investigator, National Co-Coordinating Investigator - Sweden, Denmark, Norway Hematology and Internal Medicine Karolinska Institutet Stockholm SwedenRoman Hajek, MD, Principal investigator, National Co-Coordinating Investigator - Department of Haematooncology Ostrava Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01788020
- Sponsor's protocol ID
- ECWM-1
- Other IDs
- 2013-000506-37
- Status last verified
- May 2024
- First submitted
- 1 Feb 2013
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Buske C, Dimopoulos MA, Grunenberg A, Kastritis E, Tomowiak C, Mahe B, Troussard X, Hajek R, Viardot A, Tournilhac O, Aurran T, Lepretre S, Zerazhi H, Hivert B, Leblond V, de Guibert S, Brandefors L, Garcia-Sanz R, Gomes da Silva M, Kimby E, Schmelzle B, Kaszynski D, Dreyhaupt J, Muche R, Morel P. Bortezomib-Dexamethasone, Rituximab, and Cyclophosphamide as First-Line Treatment for Waldenstrom's Macroglobulinemia: A Prospectively Randomized Trial of the European Consortium for Waldenstrom's Macroglobulinemia. J Clin Oncol. 2023 May 10;41(14):2607-2616. doi: 10.1200/JCO.22.01805. Epub 2023 Feb 10.
PubMed 36763945
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of First Line Dexamethasone, Rituximab and Cyclophosphamide (DRC) +/- Bortezomib for Patients With Waldenström's Macroglobulinemia
- ClinicalTrials.gov ID
- NCT01788020
- Acronym / sponsor ID
- ECWM-1
- Conditions
- Waldenström's Macroglobulinemia
- Keywords
- DRC, Bortezomib, Oncology
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Collaborators
- Centre Hospitalier de Lens (Co-Sponsor)
- Study start
- Nov 2013
- Primary completion
- Nov 2018 (actual)
- Study completion
- Apr 2024 (actual)
- First posted
- 11 Feb 2013 (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.
In Waldenström macroglobulinemia (WM) conventional chemotherapy induces only low CR rates and responses of short duration compared to other indolent lymphomas. Thus innovative approaches are needed which combine excellent activity and tolerability in patients with WM, who are mostly of advanced age. The immunochemotherapy DRC (dexamethasone, rituximab, cyclophosphamide) was shown to be highly effective in patients with WM without inducing major hematological toxicities. On the other hand the proteasome inhibitor Bortezomib showed substantial activity as a single agent in WM with only very few side effects when given in a weekly schedule. Based on these observations it is the aim of this study to test whether the efficacy of the well tolerated DRC regime can be further improved by adding Bortezomib.
Detailed description
Waldenström's macroglobulinemia (WM) is defined by a bone marrow infiltration by lymphoplasmacytic cells and the presence of a monoclonal immunoglobulin (Ig) M gammopathy in the peripheral blood. The clinical understanding of the disease has been greatly improved by the identification of internationally recognized criteria for initiating therapy, the description of an international prognostic index for patients requiring a first-line therapy and the definition of response criteria. These criteria are mainly based on the evolution of serum IgM concentration. However, delayed IgM monoclonal protein responses may cause important difficulties in response assessment. In addition, discrepancies between the kinetics of serum M protein reduction and the clearance of monoclonal B-cells from the bone marrow have been reported. Despite continuing advances in the therapy of WM, the disease remains incurable with a median survival of 5 to 8 years from the time of diagnosis thereby necessitating the development and evaluation of novel treatment approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DRC+Bortezomib | Experimental | Drug: Dexamethasone, Rituximab, Cyclophosphamide, BortezomibInduction experimental arm (Arm B): Cycle 1: Bortezomib 1.6 mg/m2 s.c. Day 1,8,15; Dexamethasone 20 mg p.o. Day 1; Rituximab 375 mg/m2 i.v. Day 1; Cyclophosphamide 100 mg/m2 x 2 p.o. Day 1-5 Cycle 2-6: Bortezomib 1.6 mg/m2 s.c. Day 1,8,15; Dexamethasone 20 mg p.o. Day 1; Rituximab 1400 mg absolute sc Day 1; Cyclophosphamide 100 mg/m2 x 2 p.o. Day 1-5; Repeat day 29. |
| DRC | Active comparator | Drug: Dexamethasone, Rituximab, CyclophosphamideInduction standard arm (Arm A) Cycle 1: Dexamethasone 20 mg p.o. Day 1; Rituximab 375 mg/m2 i.v. Day 1; Cyclophosphamide 100 mg/m2 x 2 p.o. Day 1-5; Cycle 2-6: Dexamethasone 20 mg p.o. Day 1; Rituximab 1400 mg absolute sc Day 1; Cyclophosphamide 100 mg/m2 x 2 p.o. Day 1-5; Repeat day 29. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Clinicopathological diagnosis of WM as defined by consensus panel one of the Second International Workshop on WM. Pathological diagnosis has to occur before study inclusion and randomization. In addition, pathological specimens have to be sent to the national pathological reference center at study inclusion and randomization. The positivity for CD20 can be assumed from any previous bone marrow immunohistochemistry or flow cytometry analysis performed up to 6 months prior to enrollment. Inclusion in the study will be based on morphological and immunological criteria. Immunophenotyping will be performed in each center and saved locally. Flow cytometry of bone marrow and blood cells will include at least one double staining and assess the expression of the following antigens: surface immunoglobulin, CD19, CD20, CD5, CD10 and CD23. Patients are eligible if tumor cells express the following antigens: CD19, CD20, and if they are negative for CD5, CD10 and CD23 expression. Patients with tumor cells positive for CD5 and/or CD23 and morphologically similar to WM cells may be included after ruling out other low grade B-cell malignancies.
- Presence of at least one criterion for initiation of therapy, according to the 2nd Workshop on WM:
- World Health Organization (WHO)/ECOG performance status 0 to 2.
- Other criteria:
- Premenopausal fertile females must agree to use a highly effective method of birth control for the duration of the therapy up to 6 months after end of therapy. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.
Key exclusion criteria (24 listed)
- Prior systemic treatment of the WM (plasmapheresis and short- term administration of corticosteroids < 4 weeks administered at a dose equivalent to < 20 mg/day prednisone is allowed)
- Patient with hypersensitivity to dexamethasone.
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- Uncontrolled bacterial, viral or fungal infection
- Active HIV, HBV or HCV 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 |
|---|---|---|
| Dexamethasone, Rituximab, Cyclophosphamide | Drug | DRC |
| Dexamethasone, Rituximab, Cyclophosphamide, Bortezomib | Drug | DRC+Bortezomib |
Primary outcome
Progression Free Survival
Time frame: participants will be followed for their participation in the trial, an expected average of 5.5 years
PFS will be calculated from the date of inclusion/randomisation to the following events: the date of progression and the date of death if it occurred earlier. In the absence of progression and death, PFS duration will be censored at the stopping date or the date of last follow-up.
8 secondary outcomes
Response rate
Time frame: 24 weeks
Best response
Time frame: 24 weeks
Time to best response
Time frame: 24 weeks
Time to first response
Time frame: 24 weeks
Time to treatment failure
Time frame: participants will be followed for their participation in the trial, an expected average of 5.5 years
Remission duration
Time frame: participants will be followed for their participation in the trial (from date of response), an expected average of 5 years
Cause specific survival (CSS)
Time frame: participants will be followed for their participation in the trial, an expected average of 5.5 years
Overall survival (OS)
Time frame: participants will be followed for their participation in the trial, an expected average of 5.5 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 13 May 2024.
- Background: PubMed 36763945Buske C, Dimopoulos MA, Grunenberg A, Kastritis E, Tomowiak C, Mahe B, Troussard X, Hajek R, Viardot A, Tournilhac O, Aurran T, Lepretre S, Zerazhi H, Hivert B, Leblond V, de Guibert S, Brandefors L, Garcia-Sanz R, Gomes da Silva M, Kimby E, Schmelzle B, Kaszynski D, Dreyhaupt J, Muche R, Morel P. Bortezomib-Dexamethasone, Rituximab, and Cyclophosphamide as First-Line Treatment for Waldenstrom's Macroglobulinemia: A Prospectively Randomized Trial of the European Consortium for Waldenstrom's Macroglobulinemia. J Clin Oncol. 2023 May 10;41(14):2607-2616. doi: 10.1200/JCO.22.01805. Epub 2023 Feb 10.
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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.
Martin Dreyling, MD principal investigator
National Co-Coordinating Investigator - Germany University Hospital Großhadern, Munich
Veronique Leblond, MD principal investigator
National Co-Coordinating Investigator - Groupe Hospitalier Pitié Salpêtrière France (Paris)
Pierre Morel, MD principal investigator
National Co-Coordinating Investigator - Centre Hospitalier Schaffner France (Lens cedex)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone, Rituximab, Cyclophosphamide and Dexamethasone, Rituximab, Cyclophosphamide, Bortezomib in people with Waldenström's Macroglobulinemia, run by University of Ulm at 1 site 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 29 inclusion and 24 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 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 (time frame: participants will be followed for their participation in the trial, an expected average of 5.5 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 NCT01788020, 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 13 May 2024.