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

NCT05049473 | Unknown Phase 2

• 1 other identifier: BURKIMAB-14
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 29

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.

Conditions

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

Keywords

Mature B-ALL; Burkitt lymphoma; Adult

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Progression Free Survival (PFS)

  Throughout the study period. Approximately 3 years

• Number of patients with toxicity during the treatment period.

  Throughout the study period. Approximately 3 years

Study Arms (1)

Chemotherapy

EXPERIMENTAL

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; Drug: Methotrexate; Drug: Dexamethasone; Drug: Iphosphamid; Drug: Vincristine; Drug: Etoposide; Drug: Cytarabine; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vindesine; Drug: Hydrocortisone; Drug: Prednisone

Interventions

Rituximab DRUG

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.

Chemotherapy

Methotrexate DRUG

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\*

Chemotherapy

Dexamethasone DRUG

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\*.

Chemotherapy

Iphosphamid DRUG

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\*.

Chemotherapy

Vincristine DRUG

Vincristine 2 mg IV bolus. Day 2. Cycles: A1, B1, A2, B2 Vincristine 1 mg IV bolus. Day 2. Cycles: B1\*, B2\*, B3\*

Chemotherapy

Etoposide DRUG

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\*.

Chemotherapy

Cytarabine DRUG

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\*

Chemotherapy

Cyclophosphamide DRUG

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\*

Chemotherapy

Doxorubicin DRUG

Doxorubicin 25 mg/m² IV in 15 min. Days 5 and 6. Cycles: B1/B1\*, B2, B2\*, B3\*

Chemotherapy

Vindesine DRUG

Vindesine 3 mg/m2 (max 5 mg) IV bolus. Day 2. Cycles: C1, C2

Chemotherapy

Hydrocortisone DRUG

Hydrocortisone 20 mg IT. Days 2 and 6. Cycles: A1, B1, A2, B2

Chemotherapy

Prednisone DRUG

Prednisone 60 mg/m2 PO or IV bolus. Days 1 to 5. Pre-phase.

Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• PETHEMA Foundation: lead
• Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea: collaborator

Study Sites (29)

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

RECRUITING

Hospital Nuestra Señora de Sonsoles

Ávila, Spain

RECRUITING

Hospital de Sant Pau

Barcelona, Spain

RECRUITING

Hospital del Mar

Barcelona, Spain

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, Spain

RECRUITING

ICO-Hospital Duran i Reynals

Bellvitge, Spain

RECRUITING

Hospital Universitario de Basurto

Bilbao, Spain

RECRUITING

Hospital San Pedro de Alcántara

Cáceres, Spain

RECRUITING

Hospital Reina Sofía

Córdoba, Spain

RECRUITING

Hospital Universitario de Donostia

Donostia / San Sebastian, Spain

RECRUITING

Hospital Universitario de Gran Canaria Dr Negrín

Las Palmas de Gran Canaria, Spain

RECRUITING

Hospital Arnau de Vilanova (Lleida)

Lleida, Spain

RECRUITING

Hospital 12 De Octubre

Madrid, Spain

RECRUITING

Hospital Gregorio Marañón

Madrid, Spain

RECRUITING

Hospital La Zarzuela

Madrid, Spain

RECRUITING

Hospital Madrid Norte Sanchinarro

Madrid, Spain

RECRUITING

Hospital Ramón y Cajal

Madrid, Spain

RECRUITING

Hospital Universitario La Princesa

Madrid, Spain

RECRUITING

Hospital Clínico de Málaga

Málaga, Spain

RECRUITING

Hospital Central de Asturias

Oviedo, Spain

RECRUITING

Son Llàtzer

Palma de Mallorca, Spain

RECRUITING

Hospital Universitario de Salamanca

Salamanca, Spain

RECRUITING

Hospital Universitario Infanta Sofía

San Sebastián de los Reyes, Spain

RECRUITING

Complexo Hospitalario Santiago de Compostela

Santiago de Compostela, Spain

RECRUITING

ICO-Hospital Joan XXIII

Tarragona, Spain

RECRUITING

Mútua de Terrassa

Terrassa, Spain

RECRUITING

Hospital Universitario de Torrejón

Torrejón de Ardoz, Spain

RECRUITING

Hospital Clínico Universitario de Valencia

Valencia, Spain

RECRUITING

Hospital Universitario La Fe

Valencia, Spain

RECRUITING

Related Publications (22)

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  BACKGROUND

• Intermesoli T, Rambaldi A, Rossi G, Delaini F, Romani C, Pogliani EM, Pagani C, Angelucci E, Terruzzi E, Levis A, Cassibba V, Mattei D, Gianfaldoni G, Scattolin AM, Di Bona E, Oldani E, Parolini M, Gokbuget N, Bassan R. High cure rates in Burkitt lymphoma and leukemia: a Northern Italy Leukemia Group study of the German short intensive rituximab-chemotherapy program. Haematologica. 2013 Nov;98(11):1718-25. doi: 10.3324/haematol.2013.086827. Epub 2013 Jun 10.

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  PMID: 37560813 DERIVED

MeSH Terms

Conditions

Burkitt Lymphoma

Interventions

Rituximab; Methotrexate; Dexamethasone; Ifosfamide; Vincristine; Etoposide; Cytarabine; Cyclophosphamide; Doxorubicin; Vindesine; Hydrocortisone; Prednisone

Condition Hierarchy (Ancestors)

Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Glucosides; Glycosides; Carbohydrates; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Daunorubicin; Anthracyclines; Naphthacenes; Aminoglycosides; Pregnenediones; Pregnenes; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Pregnadienediols

Study Officials

• 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

  STUDY CHAIR

Central Study Contacts

Carmen López-Carrero

CONTACT

carmen@fundacionpethema.es

Olga García Calduch

CONTACT

olga.garcia.calduch@fundacionpethema.es

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 20, 2021
• Study Start: January 1, 2014
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: September 20, 2021

Record last verified: 2021-09

Locations

ES (29)