Induction Treatment With Anti-CD20 Plus Hyper-CVAD and Methotrexate/Cytarabine Followed by Consolidation Treatment With Y90 Ibritumomab-Tiuxetan in Patients With Mantle Cell Lymphoma
18 Years
70 Years
Both
Mantle Cell Lymphoma
Trial Information
Induction Treatment With Anti-CD20 Plus Hyper-CVAD and Methotrexate/Cytarabine Followed by Consolidation Treatment With Y90 Ibritumomab-Tiuxetan in Patients With Mantle Cell Lymphoma
Study Design:
- The Patients will receive 6 cycles of induction chemotherapy as follows:
Anti-CD20/Hyper -CVAD chemotherapy will be alternated with anti-CD20 +MTX/Ara-C
chemotherapy. After 4 cycles (2 x2), response will be evaluated. If response (complete
or partial) is observed, 2 additional cycles will be administrated. If less than a
partial response is observed, the patient will be out of the study.
- Consolidation treatment will be a single dose of Y90Ibritumomab -Tiuxetan (Zevalin)
will be administered after 12 weeks after completion of induction chemotherapy. The
initial dose of Zevalin will be 0.3 mCi/kg, to be further escalated to 0.4 mCi/Kg if
unacceptable toxicity does not occur.
Inclusion Criteria:
- All histologic MCL subtypes (WHO classification)
- Age between 18 and 70 years old
- Performance status 0 to 2 (ECOG)
- Cardiac ejection fraction >50%
- 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.
- For Y90-ibritumomab tiuxetan administration: Bone Marrow Infiltration by lymphoma
cells < than 25% ; platelet count >100,000/µl and neutrophil counts >1500/µl
- Informed consent should be obtained
Exclusion Criteria:
- Ann Arbor stages I or II without B symptoms or bulky disease (>10 cm).
- Previous chemotherapy or radiotherapy treatment.
- Uncontrolled current illness: Hepatic, renal, cardiovascular, neurological or
metabolic illness.
- Symptomatic congestive heart failure, unstable angina pectoris, clinically
significant cardiac arrhythmia.
- HIV, HBV or HCV positive serology.
- Limitation of the patient´s ability to comply with the treatment or follow-up
protocol.
- Men and women with reproductive potential who are not using effective contraceptive
methods during and at least 12 months after the end of the study
- Acute or chronic active infection.
- Known hypersensitivity to some of the drugs or other related compounds
- No informed consent obtained
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Treatment safety
Outcome Description:
Safety of the treatment, recording the adverse events throughout the treatment.
Outcome Time Frame:
36 months
Safety Issue:
Yes
Principal Investigator
Reyes Arranz, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Hospital La Princesa
Authority:
Spain: Spanish Agency of Medicines
Study ID:
GELTAMO-LCM-04-02
NCT ID:
NCT00505232
Start Date:
January 2006
Completion Date:
May 2011
Related Keywords:
- Mantle Cell Lymphoma
- Y-90 Ibritumomab tiuxetan
- Rituximab
- Hyper-CVAD
- Mantle Cell Lymphoma Patients
- Zevalin(R)
- Lymphoma
- Lymphoma, Mantle-Cell
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