Status:
TERMINATED
Fludarabine,Cyclophosphamide and Rituximab Followed by Zevalin for Non-Follicular Indolent Lymphomas.
Lead Sponsor:
A.O. Ospedale Papa Giovanni XXIII
Collaborating Sponsors:
Regional Hospital of Bolzano
Conditions:
Lymphoma, Non-Hodgkin
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Pilot multicentre, open label study with the aim to evaluate antitumor activity in term of the sum of complete and partial response (O.R.R.) of chemotherapy (cyclophosphamide and fludarabine) and ritu...
Detailed Description
Test medication: * Yttrium-90 (90Y) ibritumomab tiuxetan 0.4 mCi/kg is delivered to patient achieving at least a partial remission (PR) after chemotherapy as a single dose for patients with baseline ...
Eligibility Criteria
Inclusion
- Patients with a lymphoma refractory to front-line chemotherapy, not including fludarabine, or in first relapse after chemotherapy not including fludarabine, not suitable for high-dose chemotherapy supported by auto or allogeneic bone marrow transplantation.
- Histologically-confirmed small lymphocytic (SLL), lymphoplasmacytic (LPL) and marginal zone (MZL) lymphomas.
- All prior chemotherapy, including corticosteroids, had to have been completed \> 4 weeks before study treatment; \< 25% of active bone marrow irradiated previously; no prior bone marrow transplantation.
- Age: 18-70 years
- ECOG- performance status: 0-2.
- No allergy to mouse proteins.
- CD20 positive B cell lymphoma.
- Ann Arbor stage III or IV disease with bidimensionally measurable disease in at least one site which has not irradiated, including any adenopathy or mass that could be measured during a physical examination or that was \> 5 cm on a computed tomographic scan (CT). In the event of splenomegaly or hepatomegaly, extension 5 cm below the costal margin was considered evidence of measurable disease. Osteoblastic bone lesions, ascites and pleural effusion are not considered measurable disease.
- Tumor involvement in the marrow\<25% before treatment with Zevalin.
- Acceptable hematologic status within one week prior study start: Hb\>9g/dL, white blood count \>3x10\^9/L, absolute neutrophil count \>1.5x10\^9/L, platelets \>100x10\^9/L.
- Written informed consent prior to any study specific screening procedures, with the understanding that the patient has the right to withdraw from that study at any time, without prejudice.
- Patients willing and able to comply with the protocol for the duration of the study.
- Patients, if sexually active, must agree to be using effective contraception for the entire treatment period and for 1 year following treatment. Women, of child-bearing potential, must have a negative pregnancy test.
Exclusion
- Histologies other than those included
- History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of cervix within the last 5 years.
- Major surgery, other than diagnostic surgery, within the last 4 weeks.
- Presence of malignant ascites or pleural effusions.
- Evidence of CNS involvement. Patients with a history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs.
- Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmias not well controlled with medication, or myocardial infarction within the last 6 months, NYHA class III or IV heart disease), abnormal liver function tests, not disease related, within 1 week prior to study start (serum bilirubin \>2 mg/dL; ALAT \>2.5 x upper normal limit; alkaline phosphatase \>2.5xupper normal limit), abnormal renal function, not disease related (serum creatinine \>2.0 mg/dL), active opportunistic infections.
- Serum positivity for HIV, HBsAg and HCV except for those with no sign of active viral replication, assessed by HCV-RNA and HBV-DNA. This latter group of patients can be enrolled in the study, but they will receive lamivudine prophylaxis and bimonthly evaluation of HbSAg, HbCAb and HBV-DNA will be provided.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00354822
Start Date
August 1 2005
End Date
August 1 2009
Last Update
September 18 2009
Active Locations (6)
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1
USC Ematologia Ospedali Riuniti di Bergamo
Bergamo, BG, Italy, 24128
2
U.O. Ematologia Ospedali Civili Brescia
Brescia, BS, Italy
3
Medicina Nucleare ed Oncologia Medica AOU Policlinico Universitario di Messina
Messina, ME, Italy, 98125
4
Istituto per la Ricerca e la Cura del Cancro IRCC
Candiolo, TO, Italy, 10060