NCT00388193

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2006

Longer than P75 for phase_2

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 16, 2006

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

October 28, 2014

Status Verified

February 1, 2013

Enrollment Period

7.3 years

First QC Date

October 13, 2006

Last Update Submit

October 27, 2014

Conditions

Acute Lymphoblastic LeukemiaBurkitt's Lymphoma

Keywords

ALL (L3)BURKITT's LYMPHOMARITUXIMAB

Outcome Measures

Primary Outcomes (1)

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

    1 year

Secondary Outcomes (3)

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

    1 year

  • Prophylactic administration of G-CSF after all chemotherapy cycles

    1 year

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

    1 year

Study Arms (1)

1

EXPERIMENTAL
Drug: RITUXIMAB

Interventions

RITUXIMABDRUG

375 mg/m2/d day 1

1

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Hospital General de Alicante

Alicante, Alicante, Spain

Location

Hospital "Santa Creu i Sant Pau"

Barcelona, Barcelona, Spain

Location

Hospital Clínico y Provincial de Barcelona

Barcelona, Barcelona, Spain

Location

Hospital Juan Canalejo

A Coruña, La Coruña, Spain

Location

Hospital Clínico San Carlos de Madrid

Madrid, Madrid, Spain

Location

Hospital Doce de Octubre

Madrid, Madrid, Spain

Location

Hospital Universitario Morales Meseguer, Murcia

Murcia, Murcia, Spain

Location

Hospital Carlos Haya

Málaga, Málaga, Spain

Location

Hospital Son Dureta

Palma de Mallorca, Palma de Mallorca, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, Sevilla, Spain

Location

Hospital La Fe

Valencia, Valencia, Spain

Location

Complejo Hospitalario de Cáceres

Cáceres, Spain

Location

Hospital general de Jerez de la Frontera

Jerez de la Frontera, Spain

Location

Hospital Clínico Universitario de Salamanca

Salamanca, Spain

Location

Hospital Txagorritxu

Vitoria-Gasteiz, Spain

Location

Related Publications (8)

  • 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.

    PMID: 8555471BACKGROUND

  • 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.

    PMID: 10552938BACKGROUND

  • 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.

    PMID: 10561310BACKGROUND

  • 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.

    PMID: 9578060BACKGROUND

  • 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.

    PMID: 12576316BACKGROUND

  • 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.

    PMID: 11600602BACKGROUND

  • 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.

    PMID: 10552937BACKGROUND

  • 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.

    PMID: 12681972BACKGROUND

Related Links

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaBurkitt Lymphoma

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinLymphoma

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Ribera Josep Mª, Dr

    Germans Trias i Pujol Hospital

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

October 13, 2006

First Posted

October 16, 2006

Study Start

August 1, 2006

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

October 28, 2014

Record last verified: 2013-02

Locations

ES(15)