Childhood Acute Lymphoblastic Leukemia Treatment Protocol Moscow-Berlin 2015 (ALL-MB 2015)
- Conditions
- Childhood Acute Lymphoblastic Leukemia
- Interventions
- Drug: Second phase of inductionDrug: Standard induction therapyDrug: Standard consolidation therapy
- Registration Number
- NCT03390387
- Brief Summary
QUESTIONS AND OBJECTIVES OF ALL-MB 2015 STUDY
1. Will the new risk group stratification (especially of T-ALL) to improve overall and event-free survival?
2. Will the new protocol is effective and feasible in patients older than 15 years, and especially in young adults?
3. Whether the intermittent dexamethasone administration in induction will result in a decrease in toxicity and mortality without loss of efficacy?
4. Whether the methylprednisolone administration as basic glucocorticoids during induction, consolidation and maintenance therapy will lead to decrease of severe infections and early mortality rate, improve survival and therapy compliance in adolescents and young adults with B-precursor ALL?
5. Whether the administration of Bortezomib in patients with B-precursor ALL with initial WBC≥100,000/µl will improve treatment outcome?
6. Whether the administration of Idarubicin instead Daunorubicin in low-risk T-ALL patients and two-phase induction in intermediate-risk T-ALL patients will reduce relapse rate and improve survival?
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 4000
- Age at diagnosis at 1 to 50 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 (see "Diagnostics"). Patients with B-cell (Burkitt) ALL are excluded.
- Informed consent of the patient parents (guardians) to be treated in one of the clinics included in this multicenter study.
- ALL is a second malignancies;
- 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 data needed for the exact adherence to the cytostatic therapy according to a specific chemotherapy protocol (differential diagnosis of ALL-AML (acute myeloid leukemia) is not possible, stratification according to therapeutic group is not possible);
- The patient was treated before for a long time with cytotoxic drugs;
- There were treatment deviations not covered by the protocol and/or not due to side effects of treatment and/or complications of the disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dexa intermittent Dexamethasone intermittent Induction therapy with intermittent Dexamethasone administration (1-15 days - 6 mg/m2, 15-22 day - pause, 22-29 days - 6 mg/m2). Dexa constant Dexamethasone continuous Induction therapy with continuous Dexamethasone administration (6 mg/m2 1-29 days). Protocol Ib+ Second phase of induction Two-phase induction therapy (additional second phase of induction - protocol Ib) Protocol Ib- Standard induction therapy Standard induction therapy (without second phase) Bortezomib- Standard consolidation therapy Consolidation therapy without Bortezomib Dexa Dexamethasone Therapy with Dexamethasone (6 mg/m2) as basic glucocorticoid preparation. IDA Idarubicin Induction and consolidation therapy with Idarubicin DNR Daunorubicin Induction and consolidation therapy with Daunorubicin Bortezomib+ Bortezomib Consolidation therapy with Bortezomib 1.3 mg/m2 N12 (N4 in each reinduction) Medrol Methylprednisolone Therapy with Methylprednisolone (60 mg/m2) as basic glucocorticoid preparation.
- Primary Outcome Measures
Name Time Method Overall survival 3 years, 5 years and 10 years after study start Event-free survival 3 years, 5 years and 10 years after study start Cumulative incidence of relapse 3 years, 5 years and 10 years after study start
- Secondary Outcome Measures
Name Time Method Early death rate 3 years, 5 years and 10 years after study start Remission death rate 3 years, 5 years and 10 years after study start
Trial Locations
- Locations (48)
Morozov Children's Municipal Clinical Hospital
🇷🇺Moscow, Russian Federation
prof. R.O.Eolyan Hematology Center
🇦🇲Ereván, Armenia
Transbaikal Regional Oncology Dispensary
🇷🇺Chita, Russian Federation
Regional Clinical Children's Hospital
🇷🇺Yaroslavl, Russian Federation
National Oncology and Hematology Center, Ministry of Health of the Kyrgyz Republic
🇰🇬Bishkek, Kyrgyzstan
Municipal Clinical Hospital N31
🇷🇺Saint Petersburg, Russian Federation
N.N.Petrov National Medical Research Oncology Center
🇷🇺Saint Petersburg, Russian Federation
Altay Regional Clinical Children's Hospital
🇷🇺Barnaul, Russian Federation
Mogilev Regional Children's Hospital
🇧🇾Mogilev, Belarus
Research Institute of Hematology and Blood Transfusion
🇺🇿Tashkent, Uzbekistan
Ivanovo Regional Clinical Hospital
🇷🇺Ivanovo, Russian Federation
Irkutsk Regional Children Clinical Hospital
🇷🇺Irkutsk, Russian Federation
Kurgan Regional Clinical Children's Hospital
🇷🇺Kurgan, Russian Federation
Almazov National Medical Research Center
🇷🇺Saint Petersburg, Russian Federation
Children's Municipal Hospital N1
🇷🇺Saint Petersburg, Russian Federation
Nizhnevartovsk Regional Clinical Children's Hospital
🇷🇺Nizhnevartovsk, Russian Federation
Orenburg Regional Clinical Oncology Dispensary
🇷🇺Orenburg, Russian Federation
Perm Territorial Clinical Children's Hospital
🇷🇺Perm, Russian Federation
Rostov Research Institute of Oncology
🇷🇺Rostov-on-Don, Russian Federation
Republican Research and Practical Center of Radiation Medicine and Human Ecology
🇧🇾Gomel, Belarus
Research Institute of Pediatric Hematology, Oncology and Immunology named after Dmitry Rogachev
🇷🇺Moscow, Russian Federation
Regional Children's Hospital
🇷🇺Lipetsk, Russian Federation
Regional Children's Clinical Hospital
🇷🇺Stavropol, Russian Federation
Surgut Regional Clinical Hospital
🇷🇺Surgut, Russian Federation
Republic Children's Clinical Hospital
🇷🇺Makhachkala, Russian Federation
Municipal Clinical Children's Hospital N1
🇷🇺Samara, Russian Federation
Vologda Regional Clinical Children's Hospital
🇷🇺Vologda, Russian Federation
Voronezh Regional Clinical Children's Hospital N1
🇷🇺Voronezh, Russian Federation
Republic Hospital N1 - National Medicine Centre
🇷🇺Yakutsk, Russian Federation
Regional Children's Clinical Hospital N1, Territorial Children's Hematological Center
🇷🇺Vladivostok, Russian Federation
Regional Clinical Children's Hospital N1; Children Oncology and hematology Center
🇷🇺Yekaterinburg, Russian Federation
Republic Research and Practical Center of Pediatric Oncology, Hematology and Immunology
🇧🇾Minsk, Belarus
Kirov Research Institute of Hematology and Blood Transfusion
🇷🇺Kirov, Russian Federation
Arkhangelsk Regional Clinical Children's Hospital
🇷🇺Arkhangelsk, Russian Federation
Chelyabinsk Regional Clinical Children's Hospital
🇷🇺Chelyabinsk, Russian Federation
Krasnoyarsk Territorial Clinical Children's Hospital
🇷🇺Krasnoyarsk, Russian Federation
Republic Clinical Children's Hospital
🇷🇺Ulan-Ude, Russian Federation
Russian Children's Clinical Hospital
🇷🇺Moscow, Russian Federation
Novosibirsk Central District Clinical Hospital
🇷🇺Novosibirsk, Russian Federation
N. Dmitrieva Ryazan Regional Clinical Children's Hospital
🇷🇺Ryazan, Russian Federation
Novokuznetsk Municipal Clinical Children's Hospital N4
🇷🇺Novokuznetsk, Russian Federation
Ulyanovsk Regional Children's Clinical Hospital
🇷🇺Ulyanovsk, Russian Federation
Tula Regional Clinical Children's Hospital
🇷🇺Tula, Russian Federation
Bryansk Regional Children's Hospital
🇷🇺Bryansk, Russian Federation
Amur Regional Clinical Children's Hospital
🇷🇺Blagoveshchensk, Russian Federation
Murmansk Clinical Children's Hospital
🇷🇺Murmansk, Russian Federation
R. Gorbacheva Research Institute of Pediatric Hematology and Transfusiology; Pavlov First Saint-Petersburg State Medical University
🇷🇺Saint Petersburg, Russian Federation
Tomsk Regional Clinical Hospital
🇷🇺Tomsk, Russian Federation