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Childhood Acute Lymphoblastic Leukemia Treatment Protocol Moscow-Berlin 2008

Information source: Federal Research Institute of Pediatric Hematology, Oncology and Immunology
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Childhood Acute Lymphoblastic Leukemia

Intervention: PEG-L-asparaginase ind (Drug); PEG-L-asparaginase cons (Drug); E.coli L-asparaginase (Drug); High-dose Methotrexate (Drug); Low-dose Methotrexate (Drug); Triple intrathecal therapy (Drug); Cranial irradiation (Radiation); Daunorubicin (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Official(s) and/or principal investigator(s):
Alexander I. Karachunskiy, Professor, Principal Investigator, Affiliation: Research Institute of Pediatric Hematology, Oncology and Immunology

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. Whether the use of PEG-asparaginase in induction will allow to avoid the anthracyclines in standard risk group patients and to reduce treatment myelotoxicity? 3. 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? 4. 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? 5. 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? 6. Will the new risk group stratification to improve overall and event-free survival?

Clinical Details

Official title: Moscow-Berlin 2008 Multicenter Randomised Study for Treatment of Acute Lymphoblastic Leukemia in Children and Adolescents

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Event-free survival

overall survival

cumulative incidence of relapse

Secondary outcome:

early death rate

remission death rate

Eligibility

Minimum age: 1 Year. Maximum age: 18 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Age at diagnosis at 1 to 18 years. 2. The start of induction therapy within a time interval of study recruitment phase. 3. The diagnosis of ALL is to be proved by the morphological, cytochemical, and immunological analysis of tumor cells in bone marrow. 4. Informed consent of the parents (guardians) of the patient to be treated in one of the clinics included in this multicenter study. Exclusion Criteria: 1. ALL is a second malignant tumor; 2. The disease is a relapse of previously misdiagnosed and, therefore, inadequately treated ALL; 3. There is severe concomitant disease, which significantly impedes chemotherapy protocol (such as multiple malformations, heart diseases, metabolic disorders, etc.); 4. 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); 5. The patient was treated before for a long time with cytotoxic drugs; 6. 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

Locations and Contacts

Republican Research and Practical Center of Radiation Medicine, Gomel, Belarus

Republic Research and Practical Center of Pediatric Oncology and Hematology, Minsk, Belarus

Mogilev Regional Children's Hospital, Mogilev, Belarus

Arkhangelsk Regional Children's Hospital, Arkhangelsk, Russian Federation

Regional Children's Hospital, Astrakhan, Russian Federation

Moscow Regional Cancer Dispensary, Balashikha, Russian Federation

Amur Regional Children's Hospital, Blagoveshchensk, Russian Federation

Chelyabinsk Regional Children's Clinical Hospital, Chelyabinsk, Russian Federation

Irkutsk Regional Children Clinical Hospital, Irkutsk, Russian Federation

Regional Clinical Hospital, Ivanovo, Russian Federation

Regional Children's Clinical Hospital, Khabarovsk, Russian Federation

Kirov Research Institute of Hematology and Blood Transfusion, Kirov, Russian Federation

Regional Children's Hospital, Krasnodar, Russian Federation

Krasnoyarsk Territorial Clinical Children Hospital, Krasnoyarsk, Russian Federation

Regional Children's Hospital, Kursk, Russian Federation

Republic Children's Clinical Hospital, Makhachkala, Russian Federation

Morozov Children's Clinical Hospital, Moscow, Russian Federation

Research Institute of Pediatric Hematology, Oncology and Immunology named after Dmitry Rogachev, Moscow, Russian Federation

Russian Children's Clinic Hospital, Moscow, Russian Federation

Republic Children's Clinical Hospital, Nalchik, Russian Federation

District Children's Clinic Hospital, Nizhnevartovsk, Russian Federation

Regional Children's Clinic Hospital, Nizhny Novgorod, Russian Federation

Municipal Children's Clinic Hospital №4, Novokuznetsk, Russian Federation

Novosibirsk Central District Hospital, Novosibirsk, Russian Federation

Regional Clinical Oncology Dispensary, Orenburg, Russian Federation

Perm Regional Children's Clinic Hospital, Perm, Russian Federation

Regional Children's Hospital, Rostov-on-Don, Russian Federation

Rostov Research Institute of Oncology, Rostov-on-Don, Russian Federation

N. Dmitrieva Ryazan Regional Children's Hospital, Ryazan, Russian Federation

Children's Municipal Hospital №1, Saint Petersburg, Russian Federation

Municipal Hospital №31, Saint Petersburg, Russian Federation

R. Gorbacheva Research Institute of Pediatric Hematology and Transfusiology; Pavlov State Medical University of Saint-Petersburg, Saint Petersburg, Russian Federation

Children's Municipal Clinical Hospital №1, Samara, Russian Federation

Profpathology and Hematology Clinic; Saratov State Medical University, Saratov, Russian Federation

Regional Children's Clinical Hospital, Stavropol, Russian Federation

Surgut Central District Clinical Hospital, Surgut, Russian Federation

Tomsk Regional Clinical Hospital, Tomsk, Russian Federation

Tula Regional Children's Hospital, Tula, Russian Federation

Republic Children's Clinical Hospital, Ulan-Ude, Russian Federation

Ulyanovsk Regional Children's Clinical Hospital, Ulyanovsk, Russian Federation

Municipal Children's City Hospital, Territorial Children's Hematological Center, Vladivostok, Russian Federation

Voronezh Regional Children Clinical Hospital №1, Voronezh, Russian Federation

Republic Hospital №1 - National Medicine Centre, Yakutsk, Russian Federation

Regional Children's Clinical Hospital, Yaroslavl, Russian Federation

Regional Children's Clinical Hospital № 1, Yekaterinburg, Russian Federation

Research Institute of Hematology and Blood Transfusion, Tashkent, Uzbekistan

Additional Information

Study web-site

Starting date: February 2008
Last updated: March 10, 2015

Page last updated: August 20, 2015

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