Rituximab Combined With Chemotherapy in Burkitt`s Lymphoma

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

Burkimab:Study Multicenter of Optimization of the Treatment of LLA-B and the Burkitt's Lymphoma in Adult Patients (From 15 Years Old)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00388193
• Other study ID #: 2005-001067-64
• Status: Completed
• Phase: Phase 2
• First received: October 13, 2006
• Last updated: October 27, 2014
• Start date: August 2006
• Est. completion date: December 2013

Study information

• Verified date: February 2013
• Source: PETHEMA Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical trial is to prove the efficacy of the following new regimen treatment:

• Administration of anti-CD20 (Rituximab) combined with chemotherapy.

• Combined treatment with high doses of methotrexate and high doses of cytarabine with conventional cytostatics (block C)

• Prophylactic administration of G-CSF after all chemotherapy cycles

• local irradiation after 6 cycle if CNS was affected or if there are residual tumour

Description:

Clinical Trial with a pharmaceutical speciality in new conditions to use.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• Patients diagnosed with mature LLA-B cell (LLA-L3)

• Patients diagnosed with Burkitt´s and Burkitt´s Like Lymphoma

• Patients 15 years old or up

• Written Informed Consent signed

Exclusion Criteria:

• Serious complications related with LAL3/LB or Secondary illness:

Serious complications, uncontrollable, for example, sepsis, pneumonia with hypoxia, shock, haemorrhage at diagnosis.

• Renal failure unconditional for the Lymphoma/Leukemia

• Heart failure or serious liver.

• Pulmonary obstructive disease or serious restrictive that not allow to treat the patient with intensive chemotherapy.

• Secondary Lymphoma after chemotherapy or previous radiotherapy or second malignant tumour.

• Known hypersensitivity to any foreign protein.

• Previous treatment with cytostatics of the LLA-B or Burkitt´s Lymphoma (exception:

administration on short time of glucocorticoids = 7 days, one administration of vincristine or cyclophosphamide, one cycle of CHOP, urgent administration of the another cytostatics).

• With another malignant tumour in the last 5 year.

• Women in fertile age must give positive in the pregnancy test or nursing mother.

• Mental disability or emotional or psychiatric significant disorder were the patient can't understand nor cooperate with treatment.

• Patients is enrolled in another clinical research study.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Burkitt Lymphoma
• Burkitt's Lymphoma
• Leukemia, Lymphoid
• Lymphoma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• RITUXIMAB
375 mg/m2/d day 1

Locations

Country	Name	City	State
Spain	Hospital General de Alicante	Alicante
Spain	Hospital "Santa Creu i Sant Pau"	Barcelona
Spain	Hospital Clínico y Provincial de Barcelona	Barcelona
Spain	Complejo Hospitalario de Cáceres	Cáceres
Spain	Hospital general de Jerez de la Frontera	Jerez de la Frontera
Spain	Hospital Juan Canalejo	La Coruña
Spain	Hospital Clínico San Carlos de Madrid	Madrid
Spain	Hospital Doce de Octubre	Madrid
Spain	Hospital Carlos Haya	Málaga
Spain	Hospital Universitario Morales Meseguer, Murcia	Murcia
Spain	Hospital Son Dureta	Palma de Mallorca
Spain	Hospital Clínico Universitario de Salamanca	Salamanca
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Spain	Hospital La Fe	Valencia
Spain	Hospital Txagorritxu	Vitoria

Sponsors (1)

Lead Sponsor	Collaborator
PETHEMA Foundation

Country where clinical trial is conducted

Spain, 

References & Publications (8)

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. — View Citation

Hoelzer D, Ludwig WD, Thiel E, Gassmann W, Löffler H, Fonatsch C, Rieder H, Heil G, Heinze B, Arnold R, Hossfeld D, Büchner 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, Gökbuget N, Völkers B, Messerer D, Uberla K. Improved outcome in adult B-cell acute lymphoblastic leukemia. Blood. 1996 Jan 15;87(2):495-508. — View Citation

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. Review. — View Citation

Mounier N, Briere J, Gisselbrecht C, Emile JF, Lederlin P, Sebban C, Berger F, Bosly A, Morel P, Tilly H, Bouabdallah R, Reyes F, Gaulard P, Coiffier B. Rituximab plus CHOP (R-CHOP) overcomes bcl-2--associated resistance to chemotherapy in elderly patients with diffuse large B-cell lymphoma (DLBCL). Blood. 2003 Jun 1;101(11):4279-84. Epub 2003 Feb 6. — View Citation

Oriol A, Ribera JM, Esteve J, Sanz MA, Brunet S, Garcia-Boyero R, Fernández-Abellán P, Martí JM, Abella E, Sánchez-Delgado M, Peñarrubia 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. — View Citation

Reiter A, Schrappe M, Tiemann M, Ludwig WD, Yakisan E, Zimmermann M, Mann G, Chott A, Ebell W, Klingebiel T, Graf N, Kremens B, Müller-Weihrich S, Plüss 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-Münster Group Trial NHL-BFM 90. Blood. 1999 Nov 15;94(10):3294-306. — View Citation

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. — View Citation

Zinzani PL, Martelli M, Magagnoli M, Pescarmona E, Scaramucci L, Palombi F, Bendandi M, Martelli MP, Ascani S, Orcioni GF, Pileri SA, Mandelli F, Tura S. Treatment and clinical management of primary mediastinal large B-cell lymphoma with sclerosis: MACOP-B regimen and mediastinal radiotherapy monitored by (67)Gallium scan in 50 patients. Blood. 1999 Nov 15;94(10):3289-93. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determinate the efficacy of the administration of anti-CD20 (RITUXIMAB) combined with chemotherapy.		1 year	No
Secondary	Combined treatment with high doses of methotrexate and high doses of cytarabine with conventional cytostatics (block C)		1 year	Yes
Secondary	Prophylactic administration of G-CSF after all chemotherapy cycles		1 year	Yes
Secondary	local irradiation after 6 cycle if CNS was affected or if there are residual tumour		1 year	No

External Links

•   Pethema Foundation web
•   Spanish association of Haematology