XCancer

Safety Study to Evaluate Induction and Consolidation Treatment in Patients With Mantle Cell Lymphoma (LCM-04-02)

Description:

Mantle Cell Lymphoma (MCL) is a malignancy with a poor response to treatment and with a median survival of 2- 4 years since diagnosis. Although histology is similar to that of an indolent lymphoma, MCL is currently considered an aggressive tumour. Few prospective therapeutic trials have been reported in MCL, and results are difficult to interpret due to treatment heterogeneity. It is known that standard chemotherapy for other clinically aggressive lymphomas yields poor results. Recently, better results have been communicated with intense induction chemotherapy treatments or consolidating the response with high dose chemotherapy with stem cell support. Keeping in mind these considerations, we will use and intensive induction treatment with Hyper-CVAD/MTX-AraC associated with anti-CD20 in order to increase the overall response rate followed by consolidation treatment with Ibritumomab -tiuxetan (Zevalin) with the aim of eradicate the minimal residual disease, responsible of relapse.

Sponsor:

Cancer Targeted Technology

Phase:

Phase 2

Contacts:

Reyes Arranz, MD, PhD (PRINCIPAL_INVESTIGATOR)

Government Study Link:

NCT00505232 - Click here to see study on

ClinicalTrials.gov

Ibritumomab tiuxetan

Isotope(s):
Target(s):
  • cd20
Ligand Class: Antibodies
Linker: tiuxetan
Inclusion
  • Age between 18 and 70 years old
  • Adequate organ (hepatic, cardiac and renal) and marrow function: Hb\> 10g/dl, neutrophil counts\> 1500/ µl, platelet\> 100000/ µl. Creatinine \< 2,5xULN, bilirubin, AST or ALT\<2,5xULN.
  • Cardiac ejection fraction \>50%
  • * All histologic MCL subtypes (WHO classification)
  • Performance status 0 to 2 (ECOG)
Exclusion
  • Previous chemotherapy or radiotherapy treatment.
  • HIV, HBV or HCV positive serology.
  • * Ann Arbor stages I or II without B symptoms or bulky disease (\>10 cm).
  • Uncontrolled current illness: Hepatic, renal, cardiovascular, neurological or metabolic illness.
  • Symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia.