Last reviewed · How we verify
NCT05518383
B-cell Mature Non-Hodgkin's Lymphoma Treatment Protocol in Children and Adolescents 2021
Phase 4 trial testing Cyclophosphamide, Cytarabine, Dexamethasone, Etoposide, Ifosfamide, Methotrexate in Non-hodgkin Lymphoma,B Cell in 300 participants. Currently enrolling.
16 May 2025
Quick facts
| Lead sponsor | Federal Research Institute of Pediatric Hematology, Oncology and Immunology |
|---|---|
| Phase | Phase 4 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 300 |
| Start date | 25 May 2022 |
| Primary completion | 16 May 2025 |
| Estimated completion | 16 May 2027 |
| Sites | 1 location across Russia |
Drugs / interventions tested
- Cyclophosphamide, Cytarabine, Dexamethasone, Etoposide, Ifosfamide, Methotrexate — full drug profile →
- Cyclophosphamide, Cytarabine, Dexamethasone, Etoposide, Ifosfamide, Methotrexate, Vincristine — full drug profile →
- Cyclophosphamide, Cytarabine, Dexamethasone, Doxorubicin hydrochloride, Etoposide, Ifosfamide, Methotrexate, vincristine
- Cyclophosphamide , Cytarabine, Dexamethasone, Doxorubicin hydrochloride, Etoposide, Ifosfamide, Methotrexate, Vincristine, Сarboplatine, CCNU/ BCNU, Melphalan, Idarubicin
Conditions studied
- Non-hodgkin Lymphoma,B Cell — all drugs for Non-hodgkin Lymphoma,B Cell →
- Burkitt Lymphoma — all drugs for Burkitt Lymphoma →
- Primary Mediastinal Lymphoma — all drugs for Primary Mediastinal Lymphoma →
- Primary CNS Lymphoma — all drugs for Primary CNS Lymphoma →
Sponsor
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Who can join
Adults 1 Day to 18, any sex, with Non-hodgkin Lymphoma,B Cell or Burkitt Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of the trial is to evaluate the molecular characteristics and MDD/MRD of B-NHL in pediatric patients in order to identify on the one hand the very high risk group and to prescribe them more intensive treatment on the other hand to identify those patients who don't need very aggressive therapy. One more study question is to evaluate the role of PET/CT in assessment of the completeness of remission. The following primary study questions are going to be analyzed: * the effectiveness (event-free survival) in pediatric patients with very limited mature B-NHL (R1 - stage I and II R) of substituting anthracyclines and vincristine by the rituximab without compromising survival rates. * the effectiveness (event-free survival) in pediatric patients with limited mature B-NHL (R2 - stage I and II NR) of substituting anthracyclines by the rituximab without compromising survival rates. * the effectiveness (event-free survival) in pediatric patients with advanced VHR mature B-NHL (R4 - stages with unfavourable genetics of substituting standard chemotherapy by "second-line" block VICI in order to improve results Secondary study questions will address * additional parameters for immune reconstitution, lymphocyte subpopulations, immunoglobulin levels, vaccination titers and infection rates * kinetics of immune reconstitution after treatment
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Pediatric Drug Development: Reviewing Challenges and Opportunities by Tracking Innovative Therapies.
Domingues C, Jarak I, Veiga F, Dourado M, et al · · 2023 · cited 33× · PMID 37896191 · DOI 10.3390/pharmaceutics15102431
Verify or expand the search:
- PubMed search for NCT05518383
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Non-hodgkin Lymphoma,B Cell
Currently open trials in the same condition.
- NCT06838832 — Novel Allogenic CD19-targeting CAR-γδT Cell Therapy (QH103E) in r/r NHL · Phase 1, PHASE2 · recruiting
- NCT07248163 — Universal CAR-T Cell Therapy for NHL · NA · recruiting
- NCT06716164 — Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of r/r B-NHL Clinical Research · EARLY_PHASE1 · recruiting
- NCT05909059 — CAR T-cell Therapy in Patients With Renal Dysfunction · Phase 2 · recruiting
- NCT06346912 — CD19-BAFF CAR-T Cells Therapy for Patients With Relapsed / Refractory B-cell ALL and B-cell NHL · EARLY_PHASE1 · recruiting
Other Federal Research Institute of Pediatric Hematology, Oncology and Immunology trials
Trials by the same sponsor.
- NCT07316595 — Study of Treosulfan-Based Conditioning for HSCT in Nijmegen Breakage Syndrome · Phase 2 · not yet recruiting
- NCT07375563 — Chemoimmunotherapy Combined With Autologous NK Cell Therapy for Pediatric Patients With Refractory and Relapsed High-Ris · Phase 3 · recruiting
- NCT07366801 — Co-infusion of Treg-enriched Donor Lymphocytes With CD3-depleted Hematopoietic Stem Cell Graft to Prevent Graft-versus H · Phase 2, PHASE3 · recruiting
- NCT07232134 — The Efficacy of Therapy in Patients With Acute Myeloid Leukemia and Down Syndrome in Russia · Phase 3 · recruiting
- NCT06587191 — Emapalumab Efficacy in Children With Primary Hemophagocytic Lymphohistiocytosis · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05518383 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Federal Research Institute of Pediatric Hematology, Oncology and Immunology
- Last refreshed: 26 August 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05518383.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing