Treatment of Mature B-ALL and Burkitt Lymphoma (BL) in Adult Patients. BURKIMAB-14.

Burkitt Lymphoma (BL) Clinical Trial

Official title:

Treatment of Mature B-ALL and Burkitt Lymphoma (BL) in Adult Patients. BURKIMAB-14.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05049473
• Other study ID #: BURKIMAB-14
• Status: Recruiting
• Phase: Phase 2
• Start date: January 2014
• Est. completion date: January 2024

Study information

• Verified date: September 2021
• Source: PETHEMA Foundation
• Contact: Carmen López-Carrero
• Email: carmen[@]fundacionpethema.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burkitt Lymphoma
• Burkitt Lymphoma (BL)
• Leukemia, B-Cell
• Leukemia, Lymphocytic, Chronic, B-Cell
• Lymphoma

Intervention

Drug:
• Rituximab
Rituximab 375 mg/m² IV. Day 1. Cycles: A1/A1*, B1/B1*, C1/A2*, A2/B2*, B2/A3*, C2/B3*. Two additional doses after 6 cycles in case of localized stage patients without CR after four cycles or advanced stage patients.
• Methotrexate
Methotrexate 1500 mg/m² IV 24h-infusion. Day 2. Cycles: A1, B1, C1 (1000 mg/m² if patient in CR) , A2 (1000 mg/m² if patient in CR), B2 (1000 mg/m² if patient in CR) , C2 (1000 mg/m² if patient in CR) Methotrexate 500 mg/m² IV 24h-infusion. Day 2. Cycles: A1*, B1*, A2*, B2*, A3*, B3*
• Dexamethasone
Dexamethasone 10 mg/m² PO or IV bolus. Days: 2 to 6. Cycles: A1/A1*, B1/B1*, C1/A2*, A2/B2*, B2/A3*, C2/B3*.
• Iphosphamid
Iphosphamid 800 mg/m² IV in 1 hour. Days: 2 to 6. Cycles: A1, A2 (500 mg/m² if patient in CR). Iphosphamid 400 mg/m² IV in 1 hour. Days: 2 to 6. Cycles: A1*.
• Vincristine
Vincristine 2 mg IV bolus. Day 2. Cycles: A1, B1, A2, B2 Vincristine 1 mg IV bolus. Day 2. Cycles: B1*, B2*, B3*
• Etoposide
Etoposide (VP16) 100 mg/m² IV in 1 hour. Days: 5, 6. Cycle: A1, A2. Etoposide (VP16) 250 mg/m² IV in 1 hour. Days: 5, 6. Cycle: C1, C2. Etoposide (VP16) 60 mg/m² IV in 1 hour. Days: 5, 6. Cycle: A1*, A2*, A3*.
• Cytarabine
Cytarabine 150 mg/m² IV in 1 hour every 12 hours. Days: 5, 6. Cycles: A1, A2 Cytarabine 2 g/m² IV in 3 hours every 12 hours. Day: 6. Cycle: C1 (1.5 g/m² if patient in CR), C2 (1.5 g/m² if patient in CR) Cytarabine 60 mg/m² IV in 1 hour every 12 hours. Days: 5, 6. Cycles: A1*, A2*, A3*
• Cyclophosphamide
Cyclophosphamide 200 mg/m² IV in 1 hour. Days 1 to 5. Pre-phase. Cyclophosphamide 200 mg/m² IV in 1 hour. Days 2 to 6. Cycles: B1, B2, B1*, B2*, B3*
• Doxorubicin
Doxorubicin 25 mg/m² IV in 15 min. Days 5 and 6. Cycles: B1/B1*, B2, B2*, B3*
• Vindesine
Vindesine 3 mg/m2 (max 5 mg) IV bolus. Day 2. Cycles: C1, C2
• Cytarabine
Cytarabine 30 mg IT. Days 2 and 6. Cycles A1, B1, A2, B2
• Methotrexate
Methotrexate 12 mg IT. Day 1. Pre-phase Methotrexate 12 mg IT. Days 2 and 6. Cycles: A1, B1, A2, B2 Methotrexate 15 mg IT. Day 2. Cycles: A1*, B1*, A2*, B2*, A3*, B3*
• Hydrocortisone
Hydrocortisone 20 mg IT. Days 2 and 6. Cycles: A1, B1, A2, B2
• Prednisone
Prednisone 60 mg/m2 PO or IV bolus. Days 1 to 5. Pre-phase.

Locations

Country	Name	City	State
Spain	Hospital Nuestra Señora de Sonsoles	Ávila
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital de Sant Pau	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	ICO-Hospital Duran i Reynals	Bellvitge
Spain	Hospital Universitario de Basurto	Bilbao
Spain	Hospital San Pedro de Alcántara	Cáceres
Spain	Hospital Reina Sofía	Córdoba
Spain	Hospital Universitario de Donostia	Donostia
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 Gregorio Marañón	Madrid
Spain	Hospital La Zarzuela	Madrid
Spain	Hospital Madrid Norte Sanchinarro	Madrid
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Universitario La Princesa	Madrid
Spain	Hospital Clínico de Málaga	Málaga
Spain	Hospital Central de Asturias	Oviedo
Spain	Son Llàtzer	Palma De Mallorca
Spain	Hospital Universitario de Salamanca	Salamanca
Spain	Hospital Universitario Infanta Sofía	San Sebastián De Los Reyes
Spain	Complexo Hospitalario Santiago de Compostela	Santiago De Compostela
Spain	ICO-Hospital Joan XXIII	Tarragona
Spain	Mútua de Terrassa	Terrassa
Spain	Hospital Universitario de Torrejón	Torrejón De Ardoz
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	Hospital Universitario La Fe	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
PETHEMA Foundation	Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Country where clinical trial is conducted

Spain, 

References & Publications (21)

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* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	Defined as the time from diagnosis to death by any cause or last follow-up.	Throughout the study period. Approximately 3 years
Secondary	Progression Free Survival (PFS)	Defined as the time from diagnosis to progression disease, relapse or death by any cause or last follow-up.	Throughout the study period. Approximately 3 years
Secondary	Number of patients with toxicity during the treatment period.	Number of patients experiencing different toxicities during the treatment period, classified according to severity and graded according to NCTCAE V4.0	Throughout the study period. Approximately 3 years