Childhood Acute Lymphoblastic LeukemiaALL-MB 2008NCT01953770
Childhood Acute Lymphoblastic Leukemia Treatment Protocol Moscow-Berlin 2008
A study testing PEG-L-asparaginase ind, PEG-L-asparaginase cons and E.coli L-asparaginase in people with Childhood Acute Lymphoblastic Leukemia, run by Federal Research Institute of Pediatric Hematology, Oncology and Immunology at 46 sites in 3 countries.
Trial summary
QUESTIONS AND OBJECTIVES OF ALL-MB-2008 STUDY 1. Whether the early PEG-asparaginase in induction will lead to the earlier achievement of remission, improvement of days 8 and 15 responses leading to an earlier reconstitution of bone marrow and immunocompetence, decrease of severe infections and early mortality rate? 2. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Childhood Acute Lymphoblastic Leukemia
- What is being tested?
- PEG-L-asparaginase ind, PEG-L-asparaginase cons and E.coli L-asparaginase
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 46 sitesin 3 countries
- Study dates
- Feb 2008to Jul 2020
- Phase
- Interventional
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age at diagnosis at 1 to 18 years.
- The start of induction therapy within a time interval of study recruitment phase.
- The diagnosis of ALL is to be proved by the morphological, cytochemical, and immunological analysis of tumor cells in bone marrow.
- Informed consent of the parents (guardians) of the patient to be treated in one of the clinics included in this multicenter study.
Who cannot join
- ALL is a second malignant tumor;
- The disease is a relapse of previously misdiagnosed and, therefore, inadequately treated ALL;
- There is severe concomitant disease, which significantly impedes chemotherapy protocol (such as multiple malformations, heart diseases, metabolic disorders, etc.);
- There is a lack of important basic data needed for the exact adherence to the cytostatic therapy according to a specific protocol of chemotherapy (differential diagnosis of acute lymphoblastic/myeloid leukemia is not possible, stratification according to risk group is not possible);
- The patient was treated before for a long time with cytotoxic drugs;
- There were deviations in the treatment not covered by the protocol and/or not due to side effects of treatment and/or complications of the disease
Trial locations and contacts
46 sites in 3 countries.
46 sites in 3 countries
Russia42 sites
Arkhangelsk Regional Children's Hospital
Arkhangelsk
Regional Children's Hospital
Astrakhan
Moscow Regional Cancer Dispensary
Balashikha
Amur Regional Children's Hospital
Blagoveshchensk
Chelyabinsk Regional Children's Clinical Hospital
Chelyabinsk
Irkutsk Regional Children Clinical Hospital
Irkutsk
Regional Clinical Hospital
Ivanovo
Regional Children's Clinical Hospital
Khabarovsk
Kirov Research Institute of Hematology and Blood Transfusion
Kirov
Regional Children's Hospital
Krasnodar
Krasnoyarsk Territorial Clinical Children Hospital
Krasnoyarsk
Regional Children's Hospital
Kursk
Republic Children's Clinical Hospital
Makhachkala
Morozov Children's Clinical Hospital
Moscow
Research Institute of Pediatric Hematology, Oncology and Immunology named after Dmitry Rogachev
Moscow
Russian Children's Clinic Hospital
Moscow
Republic Children's Clinical Hospital
Nal'chik
District Children's Clinic Hospital
Nizhnevartovsk
Regional Children's Clinic Hospital
Nizhny Novgorod
Municipal Children's Clinic Hospital №4
Novokuznetsk
Novosibirsk Central District Hospital
Novosibirsk
Regional Clinical Oncology Dispensary
Orenburg
Perm Regional Children's Clinic Hospital
Perm
Regional Children's Hospital
Rostov-on-Don
Rostov Research Institute of Oncology
Rostov-on-Don
N. Dmitrieva Ryazan Regional Children's Hospital
Ryazan
Children's Municipal Hospital №1
Saint Petersburg
Municipal Hospital №31
Saint Petersburg
R. Gorbacheva Research Institute of Pediatric Hematology and Transfusiology; Pavlov State Medical University of Saint-Petersburg
Saint Petersburg
Children's Municipal Clinical Hospital №1
Samara
Profpathology and Hematology Clinic; Saratov State Medical University
Saratov
Regional Children's Clinical Hospital
Stavropol
Surgut Central District Clinical Hospital
Surgut
Tomsk Regional Clinical Hospital
Tomsk
Tula Regional Children's Hospital
Tula
Republic Children's Clinical Hospital
Ulan-Ude
Ulyanovsk Regional Children's Clinical Hospital
Ulyanovsk
Municipal Children's City Hospital, Territorial Children's Hematological Center
Vladivostok
Voronezh Regional Children Clinical Hospital №1
Voronezh
Republic Hospital №1 - National Medicine Centre
Yakutsk
Regional Children's Clinical Hospital
Yaroslavl
Regional Children's Clinical Hospital № 1
Yekaterinburg
Belarus3 sites
Republican Research and Practical Center of Radiation Medicine
Homyel
Republic Research and Practical Center of Pediatric Oncology and Hematology
Minsk
Mogilev Regional Children's Hospital
Mogilev
Uzbekistan1 site
Research Institute of Hematology and Blood Transfusion
Tashkent
About this study
Official title: Moscow-Berlin 2008 Multicenter Randomised Study for Treatment of Acute Lymphoblastic Leukemia in Children and Adolescents
QUESTIONS AND OBJECTIVES OF ALL-MB-2008 STUDY
- Whether the early PEG-asparaginase in induction will lead to the earlier achievement of remission, improvement of days 8 and 15 responses leading to an earlier reconstitution of bone marrow and immunocompetence, decrease of severe infections and early mortality rate?
- Whether the use of PEG-asparaginase in induction will allow to avoid the anthracyclines in standard risk group patients and to reduce treatment myelotoxicity?
- Whether the administration of 9 doses of PEG-asparaginase 1,000 U/m2 instead of 18 doses of E.coli L-asparaginase 5,000 U/m2 in standard risk patients will improve treatment outcome?
- Whether the administrations of high dose methotrexate (2 g/m2 in 24 hours) during 1-st consolidation in intermediate risk patients will result in decrease of central nervous system relapse incidence and improvement of event-free and overall survival? Whether the increase of 6-mercaptopurine starting dose up to 50 mg/m2 in 1-st consolidation phase (instead of 25 mg/m2) will decrease in relapse risk, but would not be accompanied with enhanced toxicity?
- Is it possible to completely avoid the cranial irradiation in intermediate risk patients? In some subgroup of intermediate risk patients? Is it enough to control neuroleukemia in these patients to introduce additional TIT in the consolidation phase of treatment? How will change the possible late effects in these patients according to the third arm of randomization?
- Will the new risk group stratification to improve overall and event-free survival?
- Conditions
- Childhood Acute Lymphoblastic Leukemia
- Being tested
- PEG-L-asparaginase ind, PEG-L-asparaginase cons, E.coli L-asparaginase, High-dose Methotrexate, Low-dose Methotrexate
- Keywords
- Acute lymphoblastic leukemia, children, adolescents, L-asparaginase, methotrexate
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-L-asparaginase indDrug
1,000 U/m2 on day 3 of induction therapy, intravenously, in 200 ml of saline, during 1 hour
PEG-L-asparaginase consDrug
1,000 U/m2 intravenously, in 200 ml of saline, during 1 hour, 24 hours after methotrexate on weeks 7, 9, and 11 - days 44, 58, and 72 (phase S1), weeks 15, 17, and 19 - days 100, 114, 128 (phase S2), weeks 23, 25, and 27 - days 156, 170, 184 (phase S3).
E.coli L-asparaginaseDrug
Also called Asparaginase Medac
E.coli L-asparaginase (asparaginase medac) 5,000 U/m2 intramuscularly weekly, 24 hours after methotrexate dose, from week 7 to week 12 - days 44, 51, 58. 65, 72, 79 (phase S1), from week 15 to week 20 - days 100, 107, 114, 121, 128, 135 (phase S2), from week 23 to week 28 - days 156, 163, 170, 177, 184, 191 (phase S3).
High-dose MethotrexateDrug
2,000 mg/m2 per 24 hours is given at days 43, 57, and 71 (weeks 7, 9, and 11). 1/5 of the total dose is given as slow intravenous bolus over 3-5 minutes. 4/5 of the total dose of methotrexate is injected as continuous 24 hours infusion.
Low-dose MethotrexateDrug
30 mg/м2 is given intramuscularly 1 time weekly - days 43, 50, 57, 64, 71, and 78 (weeks 7, 8, 9, 10, 11, and 12).
Triple intrathecal therapyDrug
Also called Methotrexate/Cytarabine/Prednisone i.th.
Intrathecal injection of 3 drugs is additionally given three times during phase S-2 (weeks 15, 17, and 19 - days 99, 113, and 127), and three times during phase S-3 (weeks 23, 25, and 27 - days 155, 169, and 183).
Cranial irradiationRadiation
12 Gy cranial irradiation is conducted at weeks 31-32 of the Protocol in patients >3 years of age
DaunorubicinDrug
Daunorubicin at a dose of 45 mg/m2 i.v. for 6 hours on day 8 of induction therapy
| Study group | Role | What they receive |
|---|---|---|
| Cranial irradiation | Active comparator | Consolidation therapy with cranial irradiation in intermediate risk group patients Receives: Radiation: Cranial irradiation |
| Additional TIT | Experimental | Consolidation therapy with additional triple intrathecal therapy (N6) and without cranial irradiation in intermediate risk group patients Receives: Drug: Triple intrathecal therapy |
| MTX 2,000 mg/m2 | Experimental | Consolidation therapy with High-dose Methotrexate 2,000 mg/m2/24 h i.v. biweekly in intermediate risk group patients Receives: Drug: High-dose Methotrexate |
| MTX 30 mg/m2 | Active comparator | Consolidation therapy with Low-dose Methotrexate 30 mg/m2 i.m. weekly in intermediate risk group patients Receives: Drug: Low-dose Methotrexate |
| PEG-asp 1,000 U/m2 | Experimental | Consolidation therapy with PEG-L-asparaginase cons 1,000 U/m2 biweekly in standard risk group patients Receives: Drug: PEG-L-asparaginase cons |
| L-asp 5,000 U/m2 | Active comparator | Consolidation therapy with E.coli L-asparaginase 5,000 U/m2 weekly in standard risk group patients Receives: Drug: E.coli L-asparaginase |
| PEG-DNR+ | Active comparator | Induction therapy without PEG-L-asparaginase and with Daunorubicin 45 mg/m2 in standard and intermediate risk group patients Receives: Drug: Daunorubicin |
| PEG+DNR+ | Experimental | Induction therapy with PEG-L-asparaginase ind (1,000 U/m2 on day 3 of therapy)and daunorubicin 45 mg/m2 in standard and intermediate risk group patients Receives: Drug: PEG-L-asparaginase ind; Drug: Daunorubicin |
| PEG+DNR- | Experimental | Induction therapy with PEG-L-asparaginase ind (1,000 U/m2 on day 3 of therapy) without daunorubicin on day 8 in standard risk group patients Receives: Drug: PEG-L-asparaginase ind |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival
Measured: 3 years, 5 years and 10 years after study start
overall survival
Measured: 3 years, 5 years and 10 years after study start
cumulative incidence of relapse
Measured: 3 years, 5 years and 10 years after study start
Secondary outcomes (2)
early death rate
Measured: 3 years, 5 years and 10 years after study start
remission death rate
Measured: 3 years, 5 years and 10 years after study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2013 (estimated)
- Study startFeb 2008
- Primary completionJan 2015
- Study completionJul 2020 (estimated)
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 Childhood Acute Lymphoblastic 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and Immunology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karachunskiy Alexander, Federal Research Institute of Pediatric Hematology, Oncology and Immunology
- Investigators
- Alexander I. Karachunskiy, Professor, Principal investigator, Research Institute of Pediatric Hematology, Oncology and Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01953770
- Sponsor's protocol ID
- ALL-MB 2008
- Acronym
- ALL-MB 2008
- Status last verified
- Feb 2020
- First submitted
- 26 Sep 2013
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Popov A, Henze G, Tsaur G, Budanov O, Roumiantseva J, Belevtsev M, Verzhbitskaya T, Movchan L, Lagoyko S, Zharikova L, Olshanskaya Y, Riger T, Valochnik A, Miakova N, Litvinov D, Khlebnikova O, Streneva O, Stolyarova E, Ponomareva N, Novichkova G, Aleinikova O, Fechina L, Karachunskiy A. Flow cytometric minimal residual disease measurement accounting for cytogenetics in children with non-high-risk acute lymphoblastic leukemia treated according to the ALL-MB 2008 protocol. Cancer Med. 2024 Apr;13(8):e7172. doi: 10.1002/cam4.7172.
PubMed 38651186
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moscow-Berlin 2008 Multicenter Randomised Study for Treatment of Acute Lymphoblastic Leukemia in Children and Adolescents
- ClinicalTrials.gov ID
- NCT01953770
- Acronym / sponsor ID
- ALL-MB 2008 / ALL-MB 2008
- Conditions
- Childhood Acute Lymphoblastic Leukemia
- Keywords
- Acute lymphoblastic leukemia, children, adolescents, L-asparaginase, methotrexate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and ImmunologyUniversity, hospital or other
- Study start
- Feb 2008 (actual)
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jul 2020 (estimated)
- First posted
- 1 Oct 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.
QUESTIONS AND OBJECTIVES OF ALL-MB-2008 STUDY
- Whether the early PEG-asparaginase in induction will lead to the earlier achievement of remission, improvement of days 8 and 15 responses leading to an earlier reconstitution of bone marrow and immunocompetence, decrease of severe infections and early mortality rate?
- Whether the use of PEG-asparaginase in induction will allow to avoid the anthracyclines in standard risk group patients and to reduce treatment myelotoxicity?
- Whether the administration of 9 doses of PEG-asparaginase 1,000 U/m2 instead of 18 doses of E.coli L-asparaginase 5,000 U/m2 in standard risk patients will improve treatment outcome?
- Whether the administrations of high dose methotrexate (2 g/m2 in 24 hours) during 1-st consolidation in intermediate risk patients will result in decrease of central nervous system relapse incidence and improvement of event-free and overall survival? Whether the increase of 6-mercaptopurine starting dose up to 50 mg/m2 in 1-st consolidation phase (instead of 25 mg/m2) will decrease in relapse risk, but would not be accompanied with enhanced toxicity?
- Is it possible to completely avoid the cranial irradiation in intermediate risk patients? In some subgroup of intermediate risk patients? Is it enough to control neuroleukemia in these patients to introduce additional TIT in the consolidation phase of treatment? How will change the possible late effects in these patients according to the third arm of randomization?
- Will the new risk group stratification to improve overall and event-free survival?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Cranial irradiation | Active comparator | Radiation: Cranial irradiationConsolidation therapy with cranial irradiation in intermediate risk group patients |
| Additional TIT | Experimental | Drug: Triple intrathecal therapyConsolidation therapy with additional triple intrathecal therapy (N6) and without cranial irradiation in intermediate risk group patients |
| MTX 2,000 mg/m2 | Experimental | Drug: High-dose MethotrexateConsolidation therapy with High-dose Methotrexate 2,000 mg/m2/24 h i.v. biweekly in intermediate risk group patients |
| MTX 30 mg/m2 | Active comparator | Drug: Low-dose MethotrexateConsolidation therapy with Low-dose Methotrexate 30 mg/m2 i.m. weekly in intermediate risk group patients |
| PEG-asp 1,000 U/m2 | Experimental | Drug: PEG-L-asparaginase consConsolidation therapy with PEG-L-asparaginase cons 1,000 U/m2 biweekly in standard risk group patients |
| L-asp 5,000 U/m2 | Active comparator | Drug: E.coli L-asparaginaseConsolidation therapy with E.coli L-asparaginase 5,000 U/m2 weekly in standard risk group patients |
| PEG-DNR+ | Active comparator | Drug: DaunorubicinInduction therapy without PEG-L-asparaginase and with Daunorubicin 45 mg/m2 in standard and intermediate risk group patients |
| PEG+DNR+ | Experimental | Drug: PEG-L-asparaginase ind, Drug: DaunorubicinInduction therapy with PEG-L-asparaginase ind (1,000 U/m2 on day 3 of therapy)and daunorubicin 45 mg/m2 in standard and intermediate risk group patients |
| PEG+DNR- | Experimental | Drug: PEG-L-asparaginase indInduction therapy with PEG-L-asparaginase ind (1,000 U/m2 on day 3 of therapy) without daunorubicin on day 8 in standard risk group patients |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age at diagnosis at 1 to 18 years.
- The start of induction therapy within a time interval of study recruitment phase.
- The diagnosis of ALL is to be proved by the morphological, cytochemical, and immunological analysis of tumor cells in bone marrow.
- Informed consent of the parents (guardians) of the patient to be treated in one of the clinics included in this multicenter study.
Key exclusion criteria (6 listed)
- ALL is a second malignant tumor;
- The disease is a relapse of previously misdiagnosed and, therefore, inadequately treated ALL;
- There is severe concomitant disease, which significantly impedes chemotherapy protocol (such as multiple malformations, heart diseases, metabolic disorders, etc.);
- There is a lack of important basic data needed for the exact adherence to the cytostatic therapy according to a specific protocol of chemotherapy (differential diagnosis of acute lymphoblastic/myeloid leukemia is not possible, stratification according to risk group is not possible);
- The patient was treated before for a long time with cytotoxic drugs;
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 |
|---|---|---|
| PEG-L-asparaginase ind1,000 U/m2 on day 3 of induction therapy, intravenously, in 200 ml of saline, during 1 hour | Drug | PEG+DNR+, PEG+DNR- |
| PEG-L-asparaginase cons1,000 U/m2 intravenously, in 200 ml of saline, during 1 hour, 24 hours after methotrexate on weeks 7, 9, and 11 - days 44, 58, and 72 (phase S1), weeks 15, 17, and 19 - days 100, 114, 128 (phase S2), weeks 23, 25, and 27 - days 156, 170, 184 (phase S3). | Drug | PEG-asp 1,000 U/m2 |
| E.coli L-asparaginaseAlso: Asparaginase MedacE.coli L-asparaginase (asparaginase medac) 5,000 U/m2 intramuscularly weekly, 24 hours after methotrexate dose, from week 7 to week 12 - days 44, 51, 58. 65, 72, 79 (phase S1), from week 15 to week 20 - days 100, 107, 114, 121, 128, 135 (phase S2), from week 23 to week 28 - days 156, 163, 170, 177, 184, 191 (phase S3). | Drug | L-asp 5,000 U/m2 |
| High-dose Methotrexate2,000 mg/m2 per 24 hours is given at days 43, 57, and 71 (weeks 7, 9, and 11). 1/5 of the total dose is given as slow intravenous bolus over 3-5 minutes. 4/5 of the total dose of methotrexate is injected as continuous 24 hours infusion. | Drug | MTX 2,000 mg/m2 |
| Low-dose Methotrexate30 mg/м2 is given intramuscularly 1 time weekly - days 43, 50, 57, 64, 71, and 78 (weeks 7, 8, 9, 10, 11, and 12). | Drug | MTX 30 mg/m2 |
| Triple intrathecal therapyAlso: Methotrexate/Cytarabine/Prednisone i.th.Intrathecal injection of 3 drugs is additionally given three times during phase S-2 (weeks 15, 17, and 19 - days 99, 113, and 127), and three times during phase S-3 (weeks 23, 25, and 27 - days 155, 169, and 183). | Drug | Additional TIT |
| Cranial irradiation12 Gy cranial irradiation is conducted at weeks 31-32 of the Protocol in patients >3 years of age | Radiation | Cranial irradiation |
| DaunorubicinDaunorubicin at a dose of 45 mg/m2 i.v. for 6 hours on day 8 of induction therapy | Drug | PEG+DNR+, PEG-DNR+ |
Primary outcome
Event-free survival
Time frame: 3 years, 5 years and 10 years after study start
overall survival
Time frame: 3 years, 5 years and 10 years after study start
cumulative incidence of relapse
Time frame: 3 years, 5 years and 10 years after study start
2 secondary outcomes
early death rate
Time frame: 3 years, 5 years and 10 years after study start
remission death rate
Time frame: 3 years, 5 years and 10 years after study start
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Derived from this study: PubMed 38651186Popov A, Henze G, Tsaur G, Budanov O, Roumiantseva J, Belevtsev M, Verzhbitskaya T, Movchan L, Lagoyko S, Zharikova L, Olshanskaya Y, Riger T, Valochnik A, Miakova N, Litvinov D, Khlebnikova O, Streneva O, Stolyarova E, Ponomareva N, Novichkova G, Aleinikova O, Fechina L, Karachunskiy A. Flow cytometric minimal residual disease measurement accounting for cytogenetics in children with non-high-risk acute lymphoblastic leukemia treated according to the ALL-MB 2008 protocol. Cancer Med. 2024 Apr;13(8):e7172. doi: 10.1002/cam4.7172.
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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.
Alexander I. Karachunskiy, Professor principal investigator
Research Institute of Pediatric Hematology, Oncology and Immunology
46 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEG-L-asparaginase ind, PEG-L-asparaginase cons and E.coli L-asparaginase in people with Childhood Acute Lymphoblastic Leukemia, run by Federal Research Institute of Pediatric Hematology, Oncology and Immunology at 46 sites in 3 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in Russia, Belarus, Uzbekistan. 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.
Are results available for this study?
Results are not available in the source record.
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?
Event-free survival (time frame: 3 years, 5 years and 10 years after study start). The study lists 3 primary outcomes in all. 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 NCT01953770, 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 5 Feb 2020.