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

Last updated: September 17, 2021
Sponsor: PETHEMA Foundation
Overall Status: Active - Recruiting

Phase

2

Condition

Lymphoma

Lymphocytic Leukemia, Chronic

Chronic Lymphocytic Leukemia

Treatment

N/A

Clinical Study ID

NCT05049473
BURKIMAB-14
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years old
  • Patients diagnosed with de novo mature B-ALL, Burkitt lymphoma (BL). Under physician'scriteria, patients with unclassified B-lymphoma with intermediate characteristicsbetween DLBCL and BL could be included.
  • Candidate to intensive treatment.

Exclusion

Exclusion Criteria:

  • Other ALL subtype different from mature B-ALL/BL
  • Severe complications not due to mature B-ALL/BL (eg, sepsis, pneumonia, shock orhemorrhage) 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

Total Participants: 100
Study Start date:
January 01, 2014
Estimated Completion Date:
January 31, 2024

Study 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.

Connect with a study center

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona 08916
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital de Sant Pau

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital del Mar

    Barcelona,
    Spain

    Active - Recruiting

  • ICO-Hospital Duran i Reynals

    Bellvitge,
    Spain

    Active - Recruiting

  • Hospital Universitario de Basurto

    Bilbao,
    Spain

    Active - Recruiting

  • Hospital San Pedro de Alcántara

    Cáceres,
    Spain

    Active - Recruiting

  • Hospital Reina Sofía

    Córdoba,
    Spain

    Active - Recruiting

  • Hospital Universitario de Donostia

    Donostia,
    Spain

    Active - Recruiting

  • Hospital Universitario de Gran Canaria Dr Negrín

    Las Palmas De Gran Canaria,
    Spain

    Active - Recruiting

  • Hospital Arnau de Vilanova (Lleida)

    Lleida,
    Spain

    Active - Recruiting

  • Hospital 12 De Octubre

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Gregorio Marañón

    Madrid,
    Spain

    Active - Recruiting

  • Hospital La Zarzuela

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Madrid Norte Sanchinarro

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Ramón y Cajal

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario La Princesa

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Clínico de Málaga

    Málaga,
    Spain

    Active - Recruiting

  • Hospital Central de Asturias

    Oviedo,
    Spain

    Active - Recruiting

  • Son Llàtzer

    Palma De Mallorca,
    Spain

    Active - Recruiting

  • Hospital Universitario de Salamanca

    Salamanca,
    Spain

    Active - Recruiting

  • Hospital Universitario Infanta Sofía

    San Sebastián De Los Reyes,
    Spain

    Active - Recruiting

  • Complexo Hospitalario Santiago de Compostela

    Santiago De Compostela,
    Spain

    Active - Recruiting

  • ICO-Hospital Joan XXIII

    Tarragona,
    Spain

    Active - Recruiting

  • Mútua de Terrassa

    Terrassa,
    Spain

    Active - Recruiting

  • Hospital Universitario de Torrejón

    Torrejón De Ardoz,
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario de Valencia

    Valencia,
    Spain

    Active - Recruiting

  • Hospital Universitario La Fe

    Valencia,
    Spain

    Active - Recruiting

  • Hospital Nuestra Señora de Sonsoles

    Ávila,
    Spain

    Active - Recruiting

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