Treatment of Mature B-ALL and Burkitt Lymphoma (BL) in Adult Patients. BURKIMAB-14.
Phase 2
- Conditions
- Mature B-Cell Leukemia Burkitt TypeBurkitt Lymphoma (BL)Unclassifiable Lymphoma Between DCBL and BL
- Interventions
- Registration Number
- NCT05049473
- Lead Sponsor
- PETHEMA Foundation
- Brief Summary
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.
- Detailed Description
Patients younger than 55 years in complete response after two blocks of rituximab and specific intensive chemotherapy will receive four additional blocks of rituximab and attenuated chemotherapy (reduction by 33% of the dose of cyclophosphamide, methotrexate and cytarabine) followed by additional rituximab doses as consolidation. Patients older than 55 years will receive the six blocks with attenuated chemotherapy.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Chemotherapy Iphosphamid 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. Chemotherapy Dexamethasone 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. Chemotherapy Cytarabine 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. Chemotherapy Rituximab 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. Chemotherapy Methotrexate 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. Chemotherapy Vincristine 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. Chemotherapy Etoposide 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. Chemotherapy Cyclophosphamide 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. Chemotherapy Doxorubicin 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. Chemotherapy Vindesine 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. Chemotherapy Prednisone 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. Chemotherapy Hydrocortisone 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.
- Primary Outcome Measures
Name Time Method Overall Survival (OS) Throughout the study period. Approximately 3 years Defined as the time from diagnosis to death by any cause or last follow-up.
- Secondary Outcome Measures
Name Time Method Progression Free Survival (PFS) Throughout the study period. Approximately 3 years Defined as the time from diagnosis to progression disease, relapse or death by any cause or last follow-up.
Number of patients with toxicity during the treatment period. Throughout the study period. Approximately 3 years Number of patients experiencing different toxicities during the treatment period, classified according to severity and graded according to NCTCAE V4.0
Trial Locations
- Locations (29)
Hospital Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
ICO-Hospital Duran i Reynals
🇪🇸Bellvitge, Spain
Hospital Universitario de Donostia
🇪🇸Donostia, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Gregorio Marañón
🇪🇸Madrid, Spain
Hospital Central de Asturias
🇪🇸Oviedo, Spain
Hospital Universitario de Salamanca
🇪🇸Salamanca, Spain
Hospital Universitario Infanta Sofía
🇪🇸San Sebastián De Los Reyes, Spain
Hospital de Sant Pau
🇪🇸Barcelona, Spain
Hospital Universitario de Basurto
🇪🇸Bilbao, Spain
Hospital San Pedro de Alcántara
🇪🇸Cáceres, Spain
Hospital Reina Sofía
🇪🇸Córdoba, Spain
Hospital Universitario de Gran Canaria Dr Negrín
🇪🇸Las Palmas De Gran Canaria, Spain
Hospital Arnau de Vilanova (Lleida)
🇪🇸Lleida, Spain
Hospital 12 De Octubre
🇪🇸Madrid, Spain
Hospital Madrid Norte Sanchinarro
🇪🇸Madrid, Spain
Hospital La Zarzuela
🇪🇸Madrid, Spain
Hospital Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Universitario La Princesa
🇪🇸Madrid, Spain
Hospital Clínico de Málaga
🇪🇸Málaga, Spain
Son Llàtzer
🇪🇸Palma De Mallorca, Spain
ICO-Hospital Joan XXIII
🇪🇸Tarragona, Spain
Complexo Hospitalario Santiago de Compostela
🇪🇸Santiago De Compostela, Spain
Hospital Nuestra Señora de Sonsoles
🇪🇸Ávila, Spain
Mútua de Terrassa
🇪🇸Terrassa, Spain
Hospital Universitario La Fe
🇪🇸Valencia, Spain
Hospital Clínico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Universitario de Torrejón
🇪🇸Torrejón De Ardoz, Spain