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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

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

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

NCT ID

NCT05049473

First Posted

September 8, 2021

Last Updated

September 17, 2021

Sponsor

PETHEMA Foundation

Collaborators

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

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

carmen@fundacionpethema.es

First Name & Middle Initial & Last Name or Official Title & Degree

Olga García Calduch

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

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

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

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

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

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Arm 1

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