NCT03390387: ALL-MB 2015

Moscow-Berlin 2015 Multicenter Randomized Study for Treatment of Acute Lymphoblastic Leukemia in Children, Adolescents and Young Adults

Status unknown NA Last updated 4 February 2020

What this trial tests

NA trial testing Dexamethasone continuous in Childhood Acute Lymphoblastic Leukemia in 4,000 participants. Status unknown.

Timeline

1 November 2015

Primary endpoint
1 November 2020

1 November 2025

Quick facts

Lead sponsor	Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	4,000
Start date	1 November 2015
Primary completion	1 November 2020
Estimated completion	1 November 2025
Sites	58 locations across Armenia, Belarus, Kyrgyzstan, Russia, Uzbekistan

Drugs / interventions tested

• Dexamethasone continuous
• Dexamethasone intermittent — full drug profile →
• Dexamethasone (dexamethasone) — full drug profile →
• Methylprednisolone (methylprednisolone) — full drug profile →
• Daunorubicin (daunorubicin) — full drug profile →
• Idarubicin
• Bortezomib (bortezomib) — full drug profile →
• Second phase of induction
• Standard induction therapy
• Standard consolidation therapy

Conditions studied

• Childhood Acute Lymphoblastic Leukemia — all drugs for Childhood Acute Lymphoblastic Leukemia →

Sponsor

Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Who can join

Adults 1 to 50, any sex, with Childhood Acute Lymphoblastic Leukemia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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?

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Molecular Approaches to Treating Pediatric Leukemias.
   Kuhlen M, Klusmann JH, Hoell JI. · · 2019 · cited 33× · PMID 31555628 · DOI 10.3389/fped.2019.00368
2. Using GPCRs as Molecular Beacons to Target Ovarian Cancer with Nanomedicines.
   Khetan R, Dharmayanti C, Gillam TA, Kübler E, et al · · 2022 · cited 15× · PMID 35625966 · DOI 10.3390/cancers14102362
3. Overcoming Steroid Resistance in Pediatric Acute Lymphoblastic Leukemia-The State-of-the-Art Knowledge and Future Prospects.
   Kośmider K, Karska K, Kozakiewicz A, Lejman M, et al · · 2022 · cited 12× · PMID 35409154 · DOI 10.3390/ijms23073795
4. Beyond Corticoresistance, A Paradoxical Corticosensitivity Induced by Corticosteroid Therapy in Pediatric Acute Lymphoblastic Leukemias.
   Angot L, Schneider P, Vannier JP, Abdoul-Azize S. · · 2023 · cited 2× · PMID 37345151 · DOI 10.3390/cancers15102812
5. <i>TP53</i> variants underlying pediatric low-hypodiploidy B-cell acute lymphoblastic leukemia demonstrate diverse origins and may persist as a hematopoietic clone in remission.
   Itov A, Ilyasova K, Soldatkina O, Kazakova A, et al · · 2024 · cited 1× · PMID 39415918 · DOI 10.1002/jha2.986
6. Prognostic impact and clinical value of low levels of flow cytometric MRD at the end of induction in childhood B-lineage acute lymphoblastic leukemia: Results of study ALL-MB 2015.
   Popov A, Henze G, Roumiantseva J, Budanov O, et al · · 2025 · PMID 40620735 · DOI 10.1002/hem3.70162