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

September 17, 2021 updated by: PETHEMA Foundation
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Barcelona, Spain
        • Recruiting
        • Hospital de Sant Pau
        • Contact:
          • Rodrigo Martino
        • Principal Investigator:
          • Rodrigo Martino
        • Principal Investigator:
          • Irene García Cadenas
      • Barcelona, Spain
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Principal Investigator:
          • Pere Barba
        • Contact:
          • Pere Barba
        • Principal Investigator:
          • Pau Abrisqueta
      • Barcelona, Spain
        • Recruiting
        • Hospital del Mar
        • Contact:
          • Eva Gimeno
        • Principal Investigator:
          • Eva Gimeno
      • Bellvitge, Spain
        • Recruiting
        • ICO-Hospital Duran i Reynals
        • Contact:
          • Santiago Mercadal
        • Principal Investigator:
          • Santiago Mercadal
        • Sub-Investigator:
          • Clara Maluquer
      • Bilbao, Spain
        • Recruiting
        • Hospital Universitario de Basurto
        • Contact:
          • Cristina Barrenetxea
        • Principal Investigator:
          • Cristina Barrenetxea
      • Cáceres, Spain
        • Recruiting
        • Hospital San Pedro de Alcántara
        • Contact:
          • Juan Miguel Bergua
      • Córdoba, Spain
        • Recruiting
        • Hospital Reina Sofia
        • Contact:
          • Josefina Serrano
        • Principal Investigator:
          • Josefina Serrano
      • Donostia, Spain
        • Recruiting
        • Hospital Universitario DE Donostia
        • Contact:
          • Izaskun Ceberio
        • Principal Investigator:
          • Izaskun Ceberio
        • Principal Investigator:
          • Nerea Caminos
        • Principal Investigator:
          • Maialen Sirvent
        • Principal Investigator:
          • Maria Teresa Artola
      • Las Palmas De Gran Canaria, Spain
        • Recruiting
        • Hospital Universitario de Gran Canaria Dr Negrin
        • Principal Investigator:
          • Carlos Rodriguez
        • Contact:
          • Carlos Rodríguez
      • Lleida, Spain
        • Recruiting
        • Hospital Arnau de Vilanova (Lleida)
        • Principal Investigator:
          • Antoni García Guiñón
        • Contact:
          • Antoni García Guiñón
      • Madrid, Spain
        • Recruiting
        • Hospital Gregorio Marañon
        • Principal Investigator:
          • Mariana Bastos
      • Madrid, Spain
        • Recruiting
        • Hospital Ramón y Cajal
        • Contact:
          • Pilar Herrera
        • Principal Investigator:
          • Pilar Herrera
      • Madrid, Spain
        • Recruiting
        • Hospital 12 de Octubre
        • Contact:
          • Buenaventura Buendía
        • Principal Investigator:
          • Buenaventura Buendía
        • Principal Investigator:
          • Ana Jiménez
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario La Princesa
        • Contact:
          • Reyes Arranz
        • Principal Investigator:
          • Reyes Arranz
      • Madrid, Spain
        • Recruiting
        • Hospital la Zarzuela
        • Contact:
          • Daniel García Belmonte
      • Madrid, Spain
        • Recruiting
        • Hospital Madrid Norte Sanchinarro
        • Contact:
          • Laura Llorente
        • Principal Investigator:
          • Laura Llorente
      • Málaga, Spain
        • Recruiting
        • Hospital Clínico de Malaga
        • Contact:
          • Maria Paz Queipo de Llano
        • Principal Investigator:
          • Maria Paz Queipo de Llano
      • Oviedo, Spain
        • Recruiting
        • Hospital Central de Asturias
        • Principal Investigator:
          • Teresa Bernal
        • Contact:
          • Teresa Bernal
      • Palma De Mallorca, Spain
        • Recruiting
        • Son Llatzer
        • Contact:
          • Antònia Cladera
        • Principal Investigator:
          • Antonia Cladera
      • Salamanca, Spain
        • Recruiting
        • Hospital Universitario de Salamanca
        • Contact:
          • Jesús María Hernández-Rivas
        • Principal Investigator:
          • Jesús Maria Hernández-Rivas
      • San Sebastián De Los Reyes, Spain
        • Recruiting
        • Hospital Universitario Infanta Sofía
        • Contact:
          • Maria José Penalva
        • Principal Investigator:
          • Maria José Penalva
      • Santiago De Compostela, Spain
        • Recruiting
        • Complexo Hospitalario Santiago de Compostela
        • Contact:
          • Natalia Alonso
        • Principal Investigator:
          • Natalia Alonso
      • Tarragona, Spain
        • Recruiting
        • ICO-Hospital Joan XXIII
        • Contact:
          • Marta Cervera
        • Principal Investigator:
          • Marta Cervera
        • Principal Investigator:
          • Ana Vicent
      • Terrassa, Spain
        • Recruiting
        • Mútua de Terrassa
        • Contact:
          • Ferran Vall-Llovera
        • Principal Investigator:
          • Ferran Vall-Llovera
      • Torrejón De Ardoz, Spain
        • Recruiting
        • Hospital Universitario de Torrejón
        • Contact:
          • Ana Sebrango
        • Principal Investigator:
          • Ana Sebrango
      • Valencia, Spain
        • Recruiting
        • Hospital Clinico Universitario de Valencia
        • Contact:
          • Maria José Terol
        • Principal Investigator:
          • Maria José Terol
      • Valencia, Spain
        • Recruiting
        • Hospital Universitario la Fe
        • Principal Investigator:
          • Pau Montesinos
        • Contact:
          • Pau Montesinos
      • Ávila, Spain
        • Recruiting
        • Hospital Nuestra Señora de Sonsoles
        • Contact:
          • Maria Paz Martínez Badas
        • Principal Investigator:
          • Maria Paz Martínez Badas
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Recruiting
        • Hospital Germans Trias i Pujol
        • Contact:
        • Principal Investigator:
          • JOSEP MARIA RIBERA SANTASUSANA
        • Principal Investigator:
          • JUAN MANUEL SANCHO CIA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chemotherapy

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.
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.
Drug: 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*
Drug: 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*.
Drug: 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*.

Drug: Vincristine
Vincristine 2 mg IV bolus. Day 2. Cycles: A1, B1, A2, B2 Vincristine 1 mg IV bolus. Day 2. Cycles: B1*, B2*, B3*
Drug: 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*.
Drug: 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*
Drug: 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*
Drug: Doxorubicin
Doxorubicin 25 mg/m² IV in 15 min. Days 5 and 6. Cycles: B1/B1*, B2, B2*, B3*
Drug: Vindesine
Vindesine 3 mg/m2 (max 5 mg) IV bolus. Day 2. Cycles: C1, C2
Drug: Cytarabine
Cytarabine 30 mg IT. Days 2 and 6. Cycles A1, B1, A2, B2
Drug: 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*
Drug: Hydrocortisone
Hydrocortisone 20 mg IT. Days 2 and 6. Cycles: A1, B1, A2, B2
Drug: Prednisone
Prednisone 60 mg/m2 PO or IV bolus. Days 1 to 5. Pre-phase.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Throughout the study period. Approximately 3 years
Defined as the time from diagnosis to death by any cause or last follow-up.
Throughout the study period. Approximately 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: 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.
Throughout the study period. Approximately 3 years
Number of patients with toxicity during the treatment period.
Time Frame: 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
Throughout the study period. Approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PETHEMA Foundation

Collaborators

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Investigators

  • Study Chair: JOSEP MARIA RIBERA SANTASUSANA, M.D.; Ph.D., ICO-HOSPITAL GERMANS TRIAS I PUJOL
  • Study Chair: JUAN MANUEL SANCHO CIA, M.D.; Ph.D., ICO-HOSPITAL GERMANS TRIAS I PUJOL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

September 8, 2021

First Submitted That Met QC Criteria

September 17, 2021

First Posted (Actual)

September 20, 2021

Study Record Updates

Last Update Posted (Actual)

September 20, 2021

Last Update Submitted That Met QC Criteria

September 17, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BURKIMAB-14

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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