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

Primary Purpose

Mature B-Cell Leukemia Burkitt Type, Burkitt Lymphoma (BL), Unclassifiable Lymphoma Between DCBL and BL

Status
Recruiting
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Rituximab
Methotrexate
Dexamethasone
Iphosphamid
Vincristine
Etoposide
Cytarabine
Cyclophosphamide
Doxorubicin
Vindesine
Cytarabine
Methotrexate
Hydrocortisone
Prednisone
Sponsored by
PETHEMA Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mature B-Cell Leukemia Burkitt Type focused on measuring Mature B-ALL, Burkitt lymphoma, Adult

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Germans Trias i PujolRecruiting
  • Hospital de Sant PauRecruiting
  • Hospital del MarRecruiting
  • Hospital Universitari Vall d'HebronRecruiting
  • ICO-Hospital Duran i ReynalsRecruiting
  • Hospital Universitario de BasurtoRecruiting
  • Hospital San Pedro de AlcántaraRecruiting
  • Hospital Reina SofíaRecruiting
  • Hospital Universitario de DonostiaRecruiting
  • Hospital Universitario de Gran Canaria Dr NegrínRecruiting
  • Hospital Arnau de Vilanova (Lleida)Recruiting
  • Hospital 12 De OctubreRecruiting
  • Hospital Gregorio MarañónRecruiting
  • Hospital La ZarzuelaRecruiting
  • Hospital Madrid Norte SanchinarroRecruiting
  • Hospital Ramón y CajalRecruiting
  • Hospital Universitario La PrincesaRecruiting
  • Hospital Clínico de MálagaRecruiting
  • Hospital Central de AsturiasRecruiting
  • Son LlàtzerRecruiting
  • Hospital Universitario de SalamancaRecruiting
  • Hospital Universitario Infanta SofíaRecruiting
  • Complexo Hospitalario Santiago de CompostelaRecruiting
  • ICO-Hospital Joan XXIIIRecruiting
  • Mútua de TerrassaRecruiting
  • Hospital Universitario de TorrejónRecruiting
  • Hospital Clínico Universitario de ValenciaRecruiting
  • Hospital Universitario La FeRecruiting
  • Hospital Nuestra Señora de SonsolesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chemotherapy

Arm 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.

Outcomes

Primary Outcome Measures

Overall Survival (OS)
Defined as the time from diagnosis to death by any cause or last follow-up.

Secondary Outcome Measures

Progression Free Survival (PFS)
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.
Number of patients experiencing different toxicities during the treatment period, classified according to severity and graded according to NCTCAE V4.0

Full Information

First Posted
September 8, 2021
Last Updated
September 17, 2021
Sponsor
PETHEMA Foundation
Collaborators
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
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1. Study Identification

Unique Protocol Identification Number
NCT05049473
Brief Title
Treatment of Mature B-ALL and Burkitt Lymphoma (BL) in Adult Patients. BURKIMAB-14.
Official Title
Treatment of Mature B-ALL and Burkitt Lymphoma (BL) in Adult Patients. BURKIMAB-14.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 2014 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PETHEMA Foundation
Collaborators
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mature B-Cell Leukemia Burkitt Type, Burkitt Lymphoma (BL), Unclassifiable Lymphoma Between DCBL and BL
Keywords
Mature B-ALL, Burkitt lymphoma, Adult

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chemotherapy
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
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*
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
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*.
Intervention Type
Drug
Intervention Name(s)
Iphosphamid
Intervention Description
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*.
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Description
Vincristine 2 mg IV bolus. Day 2. Cycles: A1, B1, A2, B2 Vincristine 1 mg IV bolus. Day 2. Cycles: B1*, B2*, B3*
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Description
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*.
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Intervention Description
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*
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
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*
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
Doxorubicin 25 mg/m² IV in 15 min. Days 5 and 6. Cycles: B1/B1*, B2, B2*, B3*
Intervention Type
Drug
Intervention Name(s)
Vindesine
Intervention Description
Vindesine 3 mg/m2 (max 5 mg) IV bolus. Day 2. Cycles: C1, C2
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Intervention Description
Cytarabine 30 mg IT. Days 2 and 6. Cycles A1, B1, A2, B2
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
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*
Intervention Type
Drug
Intervention Name(s)
Hydrocortisone
Intervention Description
Hydrocortisone 20 mg IT. Days 2 and 6. Cycles: A1, B1, A2, B2
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Prednisone 60 mg/m2 PO or IV bolus. Days 1 to 5. Pre-phase.
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Defined as the time from diagnosis to death by any cause or last follow-up.
Time Frame
Throughout the study period. Approximately 3 years
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
Defined as the time from diagnosis to progression disease, relapse or death by any cause or last follow-up.
Time Frame
Throughout the study period. Approximately 3 years
Title
Number of patients with toxicity during the treatment period.
Description
Number of patients experiencing different toxicities during the treatment period, classified according to severity and graded according to NCTCAE V4.0
Time Frame
Throughout the study period. Approximately 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carmen López-Carrero
Email
carmen@fundacionpethema.es
First Name & Middle Initial & Last Name or Official Title & Degree
Olga García Calduch
Email
olga.garcia.calduch@fundacionpethema.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JOSEP MARIA RIBERA SANTASUSANA, M.D.; Ph.D.
Organizational Affiliation
ICO-Hospital Germans Trias i Pujol
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
JUAN MANUEL SANCHO CIA, M.D.; Ph.D.
Organizational Affiliation
ICO-Hospital Germans Trias i Pujol
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JOSEP MARIA RIBERA SANTASUSANA
Phone
934978987
Email
jribera@iconcologia.net
First Name & Middle Initial & Last Name & Degree
JOSEP MARIA RIBERA SANTASUSANA
First Name & Middle Initial & Last Name & Degree
JUAN MANUEL SANCHO CIA
Facility Name
Hospital de Sant Pau
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodrigo Martino
First Name & Middle Initial & Last Name & Degree
Rodrigo Martino
First Name & Middle Initial & Last Name & Degree
Irene García Cadenas
Facility Name
Hospital del Mar
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Gimeno
First Name & Middle Initial & Last Name & Degree
Eva Gimeno
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pere Barba
First Name & Middle Initial & Last Name & Degree
Pere Barba
First Name & Middle Initial & Last Name & Degree
Pau Abrisqueta
Facility Name
ICO-Hospital Duran i Reynals
City
Bellvitge
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Santiago Mercadal
First Name & Middle Initial & Last Name & Degree
Santiago Mercadal
First Name & Middle Initial & Last Name & Degree
Clara Maluquer
Facility Name
Hospital Universitario de Basurto
City
Bilbao
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina Barrenetxea
First Name & Middle Initial & Last Name & Degree
Cristina Barrenetxea
Facility Name
Hospital San Pedro de Alcántara
City
Cáceres
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Miguel Bergua
First Name & Middle Initial & Last Name & Degree
Juan Miguel Bergua
Facility Name
Hospital Reina Sofía
City
Córdoba
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josefina Serrano
First Name & Middle Initial & Last Name & Degree
Josefina Serrano
Facility Name
Hospital Universitario de Donostia
City
Donostia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Izaskun Ceberio
First Name & Middle Initial & Last Name & Degree
Izaskun Ceberio
First Name & Middle Initial & Last Name & Degree
Nerea Caminos
First Name & Middle Initial & Last Name & Degree
Maialen Sirvent
First Name & Middle Initial & Last Name & Degree
Maria Teresa Artola
Facility Name
Hospital Universitario de Gran Canaria Dr Negrín
City
Las Palmas De Gran Canaria
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Rodríguez
First Name & Middle Initial & Last Name & Degree
Carlos Rodríguez
Facility Name
Hospital Arnau de Vilanova (Lleida)
City
Lleida
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoni Garcia Guiñon
First Name & Middle Initial & Last Name & Degree
Antoni Garcia Guiñon
Facility Name
Hospital 12 De Octubre
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Buenaventura Buendía
First Name & Middle Initial & Last Name & Degree
Buenaventura Buendía
First Name & Middle Initial & Last Name & Degree
Ana Jiménez
Facility Name
Hospital Gregorio Marañón
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariana Bastos
First Name & Middle Initial & Last Name & Degree
Mariana Bastos
Facility Name
Hospital La Zarzuela
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel García Belmonte
Facility Name
Hospital Madrid Norte Sanchinarro
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Llorente
First Name & Middle Initial & Last Name & Degree
Laura Llorente
Facility Name
Hospital Ramón y Cajal
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PIlar Herrera
First Name & Middle Initial & Last Name & Degree
Pilar Herrera
Facility Name
Hospital Universitario La Princesa
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reyes Arranz
First Name & Middle Initial & Last Name & Degree
Reyes Arranz
Facility Name
Hospital Clínico de Málaga
City
Málaga
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Paz Queipo de Llano
First Name & Middle Initial & Last Name & Degree
Maria Paz Queipo de Llano
Facility Name
Hospital Central de Asturias
City
Oviedo
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teresa Bernal
First Name & Middle Initial & Last Name & Degree
Teresa Bernal
Facility Name
Son Llàtzer
City
Palma De Mallorca
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antònia Cladera
First Name & Middle Initial & Last Name & Degree
Antònia Cladera
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesús María Hernández-Rivas
First Name & Middle Initial & Last Name & Degree
Jesús Maria Hernández-Rivas
Facility Name
Hospital Universitario Infanta Sofía
City
San Sebastián De Los Reyes
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria José Penalva
First Name & Middle Initial & Last Name & Degree
Maria José Penalva
Facility Name
Complexo Hospitalario Santiago de Compostela
City
Santiago De Compostela
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalia Alonso
First Name & Middle Initial & Last Name & Degree
Natalia Alonso
Facility Name
ICO-Hospital Joan XXIII
City
Tarragona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marta Cervera
First Name & Middle Initial & Last Name & Degree
Marta Cervera
First Name & Middle Initial & Last Name & Degree
Ana Vicent
Facility Name
Mútua de Terrassa
City
Terrassa
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ferran Vall-Llovera
First Name & Middle Initial & Last Name & Degree
Ferran Vall-Llovera
Facility Name
Hospital Universitario de Torrejón
City
Torrejón De Ardoz
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Sebrango
First Name & Middle Initial & Last Name & Degree
Ana Sebrango
Facility Name
Hospital Clínico Universitario de Valencia
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria José Terol
First Name & Middle Initial & Last Name & Degree
Maria José Terol
Facility Name
Hospital Universitario La Fe
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pau Montesinos
First Name & Middle Initial & Last Name & Degree
Pau Montesinos
Facility Name
Hospital Nuestra Señora de Sonsoles
City
Ávila
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Paz Martínez Badas
First Name & Middle Initial & Last Name & Degree
Maria Paz Martínez Badas

12. IPD Sharing Statement

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Ribera JM, Garcia O, Grande C, Esteve J, Oriol A, Bergua J, Gonzalez-Campos J, Vall-Llovera F, Tormo M, Hernandez-Rivas JM, Garcia D, Brunet S, Alonso N, Barba P, Miralles P, Llorente A, Montesinos P, Moreno MJ, Hernandez-Rivas JA, Bernal T. Dose-intensive chemotherapy including rituximab in Burkitt's leukemia or lymphoma regardless of human immunodeficiency virus infection status: final results of a phase 2 study (Burkimab). Cancer. 2013 May 1;119(9):1660-8. doi: 10.1002/cncr.27918. Epub 2013 Jan 29.
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Treatment of Mature B-ALL and Burkitt Lymphoma (BL) in Adult Patients. BURKIMAB-14.

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