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CompletedNCT00388193Updated Oct 28, 2014

Rituximab Combined With Chemotherapy in Burkitt's Lymphoma

A Phase 2 interventional study of RITUXIMAB in Acute Lymphoblastic Leukemia and Burkitt's Lymphoma, sponsored by PETHEMA Foundation. Completed at 15 sites in Spain. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2014-10-28.

Sponsored by PETHEMA Foundation · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
15 Years and older
Sex
All
01

Study 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
Read the detailed description

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

02

Conditions studied

  • Acute Lymphoblastic Leukemia
  • Burkitt's Lymphoma

Keywords

  • ALL (L3)
  • BURKITT's LYMPHOMA
  • RITUXIMAB
03

In context

Burkitt Lymphoma

392 studies on the registry are indexed under Burkitt Lymphoma; 114 are open to participants now.

This study's planned enrollment of 20 is below the median of 41 across 354 interventional studies indexed under Burkitt Lymphoma.

Browse Burkitt Lymphoma studies →

Lead sponsor

PETHEMA Foundation is the lead sponsor of 104 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    1

    Drug: RITUXIMAB

Interventions

  • DrugRITUXIMAB

    375 mg/m2/d day 1

06

What researchers measure

Primary outcomes

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

    Time frame: 1 year

Secondary outcomes

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

    Time frame: 1 year

  2. Prophylactic administration of G-CSF after all chemotherapy cycles

    Time frame: 1 year

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

    Time frame: 1 year

07

Study locations

15 sites
  • 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 Universitario Morales Meseguer, Murcia
    Murcia, Spain
  • Hospital Carlos Haya
    Málaga, 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, Spain
08

References and documents

Publications

  • 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 ↗
  • 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. PubMed 12576316 ↗
  • 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 ↗
  • 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. PubMed 10552937 ↗
  • 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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00388193
Lead sponsor
PETHEMA Foundation
Responsible party
Sponsor
First posted
Oct 16, 2006
Start date
Aug 2006
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Oct 28, 2014

Study contacts

Ribera Josep Mª, Dr
study chair · Germans Trias i Pujol Hospital
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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