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Childhood Acute Lymphoblastic Leukemia Treatment Protocol Moscow-Berlin 2008 (ALL-MB 2008)

F

Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Status

Unknown

Conditions

Childhood Acute Lymphoblastic Leukemia

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT01953770
ALL-MB 2008

Details and patient eligibility

About

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?

Enrollment

3,000 estimated patients

Sex

All

Ages

1 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

3,000 participants in 9 patient groups

Cranial irradiation
Active Comparator group
Description:
Consolidation therapy with cranial irradiation in intermediate risk group patients
Treatment:
Radiation: Cranial irradiation
Additional TIT
Experimental group
Description:
Consolidation therapy with additional triple intrathecal therapy (N6) and without cranial irradiation in intermediate risk group patients
Treatment:
Drug: Triple intrathecal therapy
MTX 2,000 mg/m2
Experimental group
Description:
Consolidation therapy with High-dose Methotrexate 2,000 mg/m2/24 h i.v. biweekly in intermediate risk group patients
Treatment:
Drug: High-dose Methotrexate
MTX 30 mg/m2
Active Comparator group
Description:
Consolidation therapy with Low-dose Methotrexate 30 mg/m2 i.m. weekly in intermediate risk group patients
Treatment:
Drug: Low-dose Methotrexate
PEG-asp 1,000 U/m2
Experimental group
Description:
Consolidation therapy with PEG-L-asparaginase cons 1,000 U/m2 biweekly in standard risk group patients
Treatment:
Drug: PEG-L-asparaginase cons
L-asp 5,000 U/m2
Active Comparator group
Description:
Consolidation therapy with E.coli L-asparaginase 5,000 U/m2 weekly in standard risk group patients
Treatment:
Drug: E.coli L-asparaginase
PEG-DNR+
Active Comparator group
Description:
Induction therapy without PEG-L-asparaginase and with Daunorubicin 45 mg/m2 in standard and intermediate risk group patients
Treatment:
Drug: Daunorubicin
PEG+DNR+
Experimental group
Description:
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
Treatment:
Drug: PEG-L-asparaginase ind
Drug: Daunorubicin
PEG+DNR-
Experimental group
Description:
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
Treatment:
Drug: PEG-L-asparaginase ind

Trial contacts and locations

46

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Data sourced from clinicaltrials.gov

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