Clinical trial · Interventional
Treatment of Mature B-ALL and Burkitt Lymphoma (BL) in Adult Patients. BURKIMAB-14.
NCT05049473CI-TRIAL-00053969unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Rituximab combined with a specific intensive chemotherapy is considered the standard treatment for newly diagnosed patients with mature B leukemia/lymphoma. However, the toxicity of this therapy is high. The purpose of this trial is to reduce the dose intensity of the chemotherapy blocks once the patient has achieved complete response. With this approach the investigators expect to maintain the efficacy and to reduce the toxicity of the chemotherapy, specially the rate of deaths in complete response.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Burkitt Lymphoma (BL) | Burkitt Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Mature B-Cell Leukemia Burkitt Type | — | UNRESOLVED | — |
| Unclassifiable Lymphoma Between DCBL and BL | — | UNRESOLVED | — |
Interventions
Interventions (12)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Hydrocortisone | Drug | — | UNRESOLVED |
| Iphosphamid | Drug | — | UNRESOLVED |
| Methotrexate | Drug | Methotrexate | ALIAS |
| Prednisone |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chemotherapy
- description
- Pts with biological age up to 55 y with advanced stage will receive 6 cycles of intensive treatment: blocks (A1-B1-C1-A2-B2-C2). If after A1 and B1 cycles CR is observed, the rest of the cycles will be administered with reduced doses. In pts with biological age \>55 y with advanced stage block will receive A and B with attenuated doses (A1\*-B1\*-A2\*-B2\*-A3\*-B3\*). Pts with biological age up to 55 y with localized stage (non-bulky I or II) with CR after 2 cycles will finish treatment after 4 blocks. If CR is not reached, patients will complete the 6 treatment cycles. Pts with a biological age \>55 y with localized stage (non-bulky I or II) with CR after 2 cycles will finish treatment after 4 attenuated blocks (A1\*-B1\*-A2\*-B2\*). If CR is not reached, patients will complete the 6 cycles of treatment.
- interventionNames
- Drug: Rituximab
- Drug: Methotrexate
- Drug: Dexamethasone
- Drug: Iphosphamid
- Drug: Vincristine
- Drug: Etoposide
- Drug: Cytarabine
- Drug: Cyclophosphamide
- Drug: Doxorubicin
- Drug: Vindesine
- Drug: Hydrocortisone
- Drug: Prednisone
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years old * Patients diagnosed with de novo mature B-ALL, Burkitt lymphoma (BL). Under physician's criteria, patients with unclassified B-lymphoma with intermediate characteristics between DLBCL and BL could be included. * Candidate to intensive treatment. Exclusion Criteria: * Other ALL subtype different from mature B-ALL/BL * Severe complications not due to mature B-ALL/BL (eg, sepsis, pneumonia, shock or hemorrhage) at diagnosis. * Renal failure not due to mature B-ALL /BL * Heart or liver failure * Severe lung disease * Secondary mature B-ALL/BL * Hypersensitivity to foreign proteins * Previous treatment with cytotoxic drugs * Pregnancy/breastfeeding * Severe psychiatric disease * Lack of social or familiar support
References
Publications (22)
- BACKGROUNDSancho JM, Ribera JM. Linfoma de Burkitt. En: Manual Práctico de Hematología Clínica. 4ª edición 2012.
- BACKGROUNDWHO Classification of Tumours of Haematopoietics and Lymphoid Tissues, 2008.
- BACKGROUNDKarantanis D, Durski JM, Lowe VJ, Nathan MA, Mullan BP, Georgiou E, Johnston PB, Wiseman GA. 18F-FDG PET and PET/CT in Burkitt's lymphoma. Eur J Radiol. 2010 Jul;75(1):e68-73. doi: 10.1016/j.ejrad.2009.07.035. Epub 2009 Aug 27. PMID 19716248
- BACKGROUNDZeng W, Lechowicz MJ, Winton E, Cho SM, Galt JR, Halkar R. Spectrum of FDG PET/CT findings in Burkitt lymphoma. Clin Nucl Med. 2009 Jun;34(6):355-8. doi: 10.1097/RLU.0b013e3181a34552. PMID 19487844
- BACKGROUNDJust PA, Fieschi C, Baillet G, Galicier L, Oksenhendler E, Moretti JL. 18F-fluorodeoxyglucose positron emission tomography/computed tomography in AIDS-related Burkitt lymphoma. AIDS Patient Care STDS. 2008 Sep;22(9):695-700. doi: 10.1089/apc.2008.0174. PMID 18793085
- BACKGROUNDHoelzer D, Ludwig WD, Thiel E, Gassmann W, Loffler H, Fonatsch C, Rieder H, Heil G, Heinze B, Arnold R, Hossfeld D, Buchner T, Koch P, Freund M, Hiddemann W, Maschmeyer G, Heyll A, Aul C, Faak T, Kuse R, Ittel TH, Gramatzki M, Diedrich H, Kolbe K, Fuhr HG, Fischer K, Schadeck-Gressel C, Weiss A, Strohscheer I, Metzner B, Fabry U, Gokbuget N, Volkers B, Messerer D, Uberla K. Improved outcome in adult B-cell acute lymphoblastic leukemia. Blood. 1996 Jan 15;87(2):495-508. PMID 8555471
- BACKGROUNDReiter A, Schrappe M, Tiemann M, Ludwig WD, Yakisan E, Zimmermann M, Mann G, Chott A, Ebell W, Klingebiel T, Graf N, Kremens B, Muller-Weihrich S, Pluss HJ, Zintl F, Henze G, Riehm H. Improved treatment results in childhood B-cell neoplasms with tailored intensification of therapy: A report of the Berlin-Frankfurt-Munster Group Trial NHL-BFM 90. Blood. 1999 Nov 15;94(10):3294-306. PMID 10552938