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Rituximab Combined With Chemotherapy in Burkitt's Lymphoma

Primary Purpose

Acute Lymphoblastic Leukemia, Burkitt's Lymphoma

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
RITUXIMAB
Sponsored by
PETHEMA Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lymphoblastic Leukemia focused on measuring ALL (L3), BURKITT's LYMPHOMA, RITUXIMAB

Eligibility Criteria

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

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.

Sites / Locations

  • Hospital General de Alicante
  • Hospital "Santa Creu i Sant Pau"
  • Hospital Clínico y Provincial de Barcelona
  • Complejo Hospitalario de Cáceres
  • Hospital general de Jerez de la Frontera
  • Hospital Juan Canalejo
  • Hospital Clínico San Carlos de Madrid
  • Hospital Doce de Octubre
  • Hospital Universitario Morales Meseguer, Murcia
  • Hospital Carlos Haya
  • Hospital Son Dureta
  • Hospital Clínico Universitario de Salamanca
  • Hospital Universitario Virgen del Rocío
  • Hospital La Fe
  • Hospital Txagorritxu

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Determinate the efficacy of the administration of anti-CD20 (RITUXIMAB) combined with chemotherapy.

Secondary Outcome Measures

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

Full Information

First Posted
October 13, 2006
Last Updated
October 27, 2014
Sponsor
PETHEMA Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00388193
Brief Title
Rituximab Combined With Chemotherapy in Burkitt's Lymphoma
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PETHEMA Foundation

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia, Burkitt's Lymphoma
Keywords
ALL (L3), BURKITT's LYMPHOMA, RITUXIMAB

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
RITUXIMAB
Intervention Description
375 mg/m2/d day 1
Primary Outcome Measure Information:
Title
Determinate the efficacy of the administration of anti-CD20 (RITUXIMAB) combined with chemotherapy.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Combined treatment with high doses of methotrexate and high doses of cytarabine with conventional cytostatics (block C)
Time Frame
1 year
Title
Prophylactic administration of G-CSF after all chemotherapy cycles
Time Frame
1 year
Title
local irradiation after 6 cycle if CNS was affected or if there are residual tumour
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ribera Josep Mª, Dr
Organizational Affiliation
Germans Trias i Pujol Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital General de Alicante
City
Alicante
Country
Spain
Facility Name
Hospital "Santa Creu i Sant Pau"
City
Barcelona
Country
Spain
Facility Name
Hospital Clínico y Provincial de Barcelona
City
Barcelona
Country
Spain
Facility Name
Complejo Hospitalario de Cáceres
City
Cáceres
Country
Spain
Facility Name
Hospital general de Jerez de la Frontera
City
Jerez de la Frontera
Country
Spain
Facility Name
Hospital Juan Canalejo
City
La Coruña
Country
Spain
Facility Name
Hospital Clínico San Carlos de Madrid
City
Madrid
Country
Spain
Facility Name
Hospital Doce de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Morales Meseguer, Murcia
City
Murcia
Country
Spain
Facility Name
Hospital Carlos Haya
City
Málaga
Country
Spain
Facility Name
Hospital Son Dureta
City
Palma de Mallorca
Country
Spain
Facility Name
Hospital Clínico Universitario de Salamanca
City
Salamanca
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
Country
Spain
Facility Name
Hospital La Fe
City
Valencia
Country
Spain
Facility Name
Hospital Txagorritxu
City
Vitoria
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
8555471
Citation
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Results Reference
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PubMed Identifier
10552938
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, 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.
Results Reference
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PubMed Identifier
10561310
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. doi: 10.1200/JCO.1999.17.8.2461.
Results Reference
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PubMed Identifier
9578060
Citation
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.
Results Reference
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PubMed Identifier
12576316
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. doi: 10.1182/blood-2002-11-3442. Epub 2003 Feb 6.
Results Reference
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PubMed Identifier
11600602
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. doi: 10.1200/JCO.2001.19.20.4014.
Results Reference
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PubMed Identifier
10552937
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.
Results Reference
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PubMed Identifier
12681972
Citation
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.
Results Reference
background
Links:
URL
http://www.aehh.org
Description
Spanish association of Haematology

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Rituximab Combined With Chemotherapy in Burkitt's Lymphoma

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