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AzTrials

Mature B-Cell Leukemia Burkitt TypePhase 2NCT05049473

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

A Phase 2 study testing Rituximab, Methotrexate and Dexamethasone in people with Mature B-Cell Leukemia Burkitt Type and Burkitt Lymphoma (BL), run by PETHEMA Foundation at 29 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Rituximab, Methotrexate and Dexamethasone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
29 sitesSpain
Study dates
Jan 2014to Jan 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 11Show fewer
  • Hypersensitivity to foreign proteins
  • Previous treatment with cytotoxic drugs
  • Pregnancy/breastfeeding
  • Severe psychiatric disease
  • Lack of social or familiar support

Trial locations and contacts

29 sites in 1 country.

Carmen López-Carrero contact

carmen@fundacionpethema.es

Olga García Calduch contact

olga.garcia.calduch@fundacionpethema.es

29 sites in 1 country

Spain29 sites, 29 recruiting

  • Hospital Nuestra Señora de Sonsoles

    Ávila

    Maria Paz Martínez Badas

    Maria Paz Martínez Badas

    Recruiting

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916

    JOSEP MARIA RIBERA SANTASUSANA, 934978987, jribera@iconcologia.net

    JOSEP MARIA RIBERA SANTASUSANA

    Recruiting

  • Hospital de Sant Pau

    Barcelona

    Rodrigo Martino

    Rodrigo Martino

    Recruiting

  • Hospital del Mar

    Barcelona

    Eva Gimeno

    Eva Gimeno

    Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona

    Pere Barba

    Pere Barba

    Recruiting

  • ICO-Hospital Duran i Reynals

    Bellvitge

    Santiago Mercadal

    Santiago Mercadal

    Recruiting

  • Hospital Universitario de Basurto

    Bilbao

    Cristina Barrenetxea

    Cristina Barrenetxea

    Recruiting

  • Hospital San Pedro de Alcántara

    Cáceres

    Juan Miguel Bergua

    Juan Miguel Bergua

    Recruiting

  • Hospital Reina Sofía

    Córdoba

    Josefina Serrano

    Josefina Serrano

    Recruiting

  • Hospital Universitario de Donostia

    Donostia / San Sebastian

    Izaskun Ceberio

    Izaskun Ceberio

    Recruiting

  • Hospital Universitario de Gran Canaria Dr Negrín

    Las Palmas de Gran Canaria

    Carlos Rodríguez

    Carlos Rodríguez

    Recruiting

  • Hospital Arnau de Vilanova (Lleida)

    Lleida

    Antoni Garcia Guiñon

    Antoni Garcia Guiñon

    Recruiting

  • Hospital 12 De Octubre

    Madrid

    Buenaventura Buendía

    Buenaventura Buendía

    Recruiting

  • Hospital Gregorio Marañón

    Madrid

    Mariana Bastos

    Mariana Bastos

    Recruiting

  • Hospital La Zarzuela

    Madrid

    Daniel García Belmonte

    Recruiting

  • Hospital Madrid Norte Sanchinarro

    Madrid

    Laura Llorente

    Laura Llorente

    Recruiting

  • Hospital Ramón y Cajal

    Madrid

    PIlar Herrera

    Pilar Herrera

    Recruiting

  • Hospital Universitario La Princesa

    Madrid

    Reyes Arranz

    Reyes Arranz

    Recruiting

  • Hospital Clínico de Málaga

    Málaga

    Maria Paz Queipo de Llano

    Maria Paz Queipo de Llano

    Recruiting

  • Hospital Central de Asturias

    Oviedo

    Teresa Bernal

    Teresa Bernal

    Recruiting

  • Son Llàtzer

    Palma de Mallorca

    Antònia Cladera

    Antònia Cladera

    Recruiting

  • Hospital Universitario de Salamanca

    Salamanca

    Jesús María Hernández-Rivas

    Jesús Maria Hernández-Rivas

    Recruiting

  • Hospital Universitario Infanta Sofía

    San Sebastián de los Reyes

    Maria José Penalva

    Maria José Penalva

    Recruiting

  • Complexo Hospitalario Santiago de Compostela

    Santiago de Compostela

    Natalia Alonso

    Natalia Alonso

    Recruiting

  • ICO-Hospital Joan XXIII

    Tarragona

    Marta Cervera

    Marta Cervera

    Recruiting

  • Mútua de Terrassa

    Terrassa

    Ferran Vall-Llovera

    Ferran Vall-Llovera

    Recruiting

  • Hospital Universitario de Torrejón

    Torrejón de Ardoz

    Ana Sebrango

    Ana Sebrango

    Recruiting

  • Hospital Clínico Universitario de Valencia

    Valencia

    Maria José Terol

    Maria José Terol

    Recruiting

  • Hospital Universitario La Fe

    Valencia

    Pau Montesinos

    Pau Montesinos

    Recruiting

Other trials in Spain

About this study

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.

Read the 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.

Being tested
Rituximab, Methotrexate, Dexamethasone, Iphosphamid, Vincristine
Keywords
Mature B-ALL, Burkitt lymphoma, Adult
Medical subject headings
Burkitt Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RituximabDrug

    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.

  • MethotrexateDrug

    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*

  • DexamethasoneDrug

    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*.

  • IphosphamidDrug

    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*.

  • VincristineDrug

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

  • EtoposideDrug

    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*.

  • CytarabineDrug

    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*

  • CyclophosphamideDrug

    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*

  • DoxorubicinDrug

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

  • VindesineDrug

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

  • CytarabineDrug

    Cytarabine 30 mg IT. Days 2 and 6. Cycles A1, B1, A2, B2

  • MethotrexateDrug

    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*

  • HydrocortisoneDrug

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

  • PrednisoneDrug

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

Study groups in NCT05049473
Study groupRoleWhat they receive
ChemotherapyExperimentalPts 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.
Receives: Drug: Rituximab; Drug: Methotrexate; Drug: Dexamethasone; Drug: Iphosphamid; Drug: Vincristine; Drug: Etoposide; Drug: Cytarabine; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vindesine; Drug: Hydrocortisone; Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    Defined as the time from diagnosis to death by any cause or last follow-up.

    Measured: Throughout the study period. Approximately 3 years

Secondary outcomes (2)

  1. Progression Free Survival (PFS)

    Defined as the time from diagnosis to progression disease, relapse or death by any cause or last follow-up.

    Measured: Throughout the study period. Approximately 3 years

  2. 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

    Measured: Throughout the study period. Approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2021
  2. Study startJan 2014
  3. Primary completionJan 2024 (estimated)
  4. Study completionJan 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05049473
Sponsor's protocol ID
BURKIMAB-14
Status last verified
Sep 2021
First submitted
8 Sep 2021
Last updated
20 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Sancho JM, Ribera JM. Linfoma de Burkitt. En: Manual Práctico de Hematología Clínica. 4ª edición 2012.

  • WHO Classification of Tumours of Haematopoietics and Lymphoid Tissues, 2008.

  • Karantanis D, Durski JM, Lowe VJ, Nathan MA, Mullan BP, Georgiou E, Johnston PB, Wiseman GA. 18F-FDG PET and PET/CT in Burkitt's lymphoma. Eur J Radiol. 2010 Jul;75(1):e68-73. doi: 10.1016/j.ejrad.2009.07.035. Epub 2009 Aug 27.

    PubMed 19716248

  • Zeng W, Lechowicz MJ, Winton E, Cho SM, Galt JR, Halkar R. Spectrum of FDG PET/CT findings in Burkitt lymphoma. Clin Nucl Med. 2009 Jun;34(6):355-8. doi: 10.1097/RLU.0b013e3181a34552.

    PubMed 19487844

  • Just PA, Fieschi C, Baillet G, Galicier L, Oksenhendler E, Moretti JL. 18F-fluorodeoxyglucose positron emission tomography/computed tomography in AIDS-related Burkitt lymphoma. AIDS Patient Care STDS. 2008 Sep;22(9):695-700. doi: 10.1089/apc.2008.0174.

    PubMed 18793085

  • Hoelzer D, Ludwig WD, Thiel E, Gassmann W, Loffler H, Fonatsch C, Rieder H, Heil G, Heinze B, Arnold R, Hossfeld D, Buchner T, Koch P, Freund M, Hiddemann W, Maschmeyer G, Heyll A, Aul C, Faak T, Kuse R, Ittel TH, Gramatzki M, Diedrich H, Kolbe K, Fuhr HG, Fischer K, Schadeck-Gressel C, Weiss A, Strohscheer I, Metzner B, Fabry U, Gokbuget N, Volkers B, Messerer D, Uberla K. Improved outcome in adult B-cell acute lymphoblastic leukemia. Blood. 1996 Jan 15;87(2):495-508.

    PubMed 8555471

  • Reiter A, Schrappe M, Tiemann M, Ludwig WD, Yakisan E, Zimmermann M, Mann G, Chott A, Ebell W, Klingebiel T, Graf N, Kremens B, Muller-Weihrich S, Pluss HJ, Zintl F, Henze G, Riehm H. Improved treatment results in childhood B-cell neoplasms with tailored intensification of therapy: A report of the Berlin-Frankfurt-Munster Group Trial NHL-BFM 90. Blood. 1999 Nov 15;94(10):3294-306.

    PubMed 10552938

  • Thomas DA, Cortes J, O'Brien S, Pierce S, Faderl S, Albitar M, Hagemeister FB, Cabanillas FF, Murphy S, Keating MJ, Kantarjian H. Hyper-CVAD program in Burkitt's-type adult acute lymphoblastic leukemia. J Clin Oncol. 1999 Aug;17(8):2461-70. doi: 10.1200/JCO.1999.17.8.2461.

    PubMed 10561310

  • Adde M, Shad A, Venzon D, Arndt C, Gootenberg J, Neely J, Nieder M, Owen W, Seibel N, Wilson W, Horak ID, Magrath I. Additional chemotherapy agents improve treatment outcome for children and adults with advanced B-cell lymphomas. Semin Oncol. 1998 Apr;25(2 Suppl 4):33-9; discussion 45-8.

    PubMed 9578060

  • Lee EJ, Petroni GR, Schiffer CA, Freter CE, Johnson JL, Barcos M, Frizzera G, Bloomfield CD, Peterson BA. Brief-duration high-intensity chemotherapy for patients with small noncleaved-cell lymphoma or FAB L3 acute lymphocytic leukemia: results of cancer and leukemia group B study 9251. J Clin Oncol. 2001 Oct 15;19(20):4014-22. doi: 10.1200/JCO.2001.19.20.4014.

    PubMed 11600602

  • 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.

    PubMed 23361927

  • Hoelzer D, Walewski J, Döhner H, Schmid M, Hiddemann W, Baumann A, et al. Substantially improved outcome of adult Burkitt Non-Hodgkin lymphoma and leukemia patients with rituximab and a short-intensive chemotherapy; Report of a large prospective multicenter trial. Fifty-four annual meeting of American Society of Hematology. Abstract 667

  • 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.

    PubMed 23753030

  • Oriol A, Ribera JM, Esteve J, Sanz MA, Brunet S, Garcia-Boyero R, Fernandez-Abellan P, Marti JM, Abella E, Sanchez-Delgado M, Penarrubia MJ, Besalduch J, Moreno MJ, Borrego D, Feliu E, Ortega JJ; PETHEMA Group, Spanish Society of Hematology. Lack of influence of human immunodeficiency virus infection status in the response to therapy and survival of adult patients with mature B-cell lymphoma or leukemia. Results of the PETHEMA-LAL3/97 study. Haematologica. 2003 Apr;88(4):445-53.

    PubMed 12681972

  • Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, Coiffier B, Fisher RI, Hagenbeek A, Zucca E, Rosen ST, Stroobants S, Lister TA, Hoppe RT, Dreyling M, Tobinai K, Vose JM, Connors JM, Federico M, Diehl V; International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86. doi: 10.1200/JCO.2006.09.2403. Epub 2007 Jan 22.

    PubMed 17242396

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rituximab, Methotrexate and Dexamethasone in people with Mature B-Cell Leukemia Burkitt Type and Burkitt Lymphoma (BL), run by PETHEMA Foundation at 29 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Carmen López-Carrero (carmen@fundacionpethema.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Throughout the study period. Approximately 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05049473, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2021.

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