ZAR2007: R-CHOP in Folicular Lymphoma Patients no Treated Previously. Consolidation With 90Y Ibritumomab Tiuxetan (Zevalin®) Versus Maintenance Treatment With Rituximab (MabThera®)
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ClinicalTrials.gov Identifier: NCT00662948 |
Recruitment Status :
Completed
First Posted : April 21, 2008
Last Update Posted : April 28, 2020
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After conventional induction treatment with R-CHOP (Rituximab, cyclophosphamide, adriamycin, vincristine and prednisone) the patients are randomized to:
A: Consolidation with one dose of 90Y Ibritumomab tiuxetan (Zevalin®) 0,4 mCi/Kg
B: Maintenance with 375 mg/m2 of Rituximab every 8 weeks during 24 months
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lymphoma | Drug: Rituximab Drug: Ibritumomab tiuxetan | Phase 2 |
The study will evaluate the benefit of consolidation treatment with 90Y Ibritumomab tiuxetan (Zevalin®) or maintenance with rituximab (MabThera®) in terms of progression free survival, after induction with chemotherapy and rituximab in folicular lymphoma patients no treated previously.
The other aims are, evaluate the global survival, event free survival, time until next treatment, response rate after consolidation or maintenance treatment, quality of life, security of two branches and relation cost-efectivity
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 149 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Open Study in Phase II to Evaluate Efficacy of Initial R-CHOP Combination in Folicular Lymphoma no Treated Previously. Consolidation w Ith One Dose of 90Y Ibritumomab Tiuxetan (Zevalin®) Versus Maintenance Treatment With Rituximab (MabThera®) |
Actual Study Start Date : | December 2008 |
Actual Primary Completion Date : | October 2014 |
Actual Study Completion Date : | October 30, 2017 |
Arm | Intervention/treatment |
---|---|
Experimental: A
Consolidation with one dose of 90Y Ibritumomab tiuxetan (Zevalin®) 0,4 mCi/Kg
|
Drug: Ibritumomab tiuxetan
One dose of 90Y Ibritumomab tiuxetan, 0,4 mCi/Kg |
Active Comparator: B
Maintenance with 375 mg/m2 of Rituximab every 8 weeks during 24 months
|
Drug: Rituximab
375 mg/m2 every 8 weeks during 24 months |
- Progression free survival [ Time Frame: 2 years ]
- Saffetty of two arms [ Time Frame: 2 years ]
- Quality of life [ Time Frame: 7 years ]
- Global survival [ Time Frame: 7 years ]
- Event free survival [ Time Frame: 7 years ]
- Response rate in two arms [ Time Frame: 3 years ]
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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Folicular Lymphoma CD20-positive, grade 1, 2 or 3a, confirmed in previous 4 months.
- Patients no treated previously.
- Ann Arbor Stage II, III o IV.
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Symptoms or signes wich indicate necesary treatment (GELF criteria):
- Ganglionar or extraganglionar mass
- B Symptoms
- LDH or B2-microglobuline increased
- 3 ganglionar territory afected (> 3 cm)
- Esplenomegalia
- Compresive syndrome
- Pleural/peritoneal effusion
- Secondary medular insufiency due to infiltration
- Age> 18 years and <75 years.
- ECOG < 2
- Adecuate hematological function: Hemoglobin > 8,0 g/dl (5,0 mmol/L); RAN >1,5 x 109/L; platelets > 100 x 109/L
- No pregnant women. Women and man should use an appropiate anticonceptive method during the study and one year after
- Informed consent
Exclusion Criteria:
- Transformation in high grade lymphoma
- FL grade 3b.
- Skin or gastro-intestinal primary lymphoma
- History of CNS diseases ( or CNS lymphoma)
- Previous treatment
- Regulary treatment with corticosteroids (permited < 20 mg/day prednisone or equivalent).
- Previous cancer diseases
- Major surgery in 28 days before inclusion in study.
- Creatinine > 2,0 mg/dl (197 mmol/L)
- Bilirubin > 2,0 mg/dl (34 mmol/L), AST (SGOT) > 3 x upper normal limit.
- HIV infection or active infection VHB o VHC < 4 weeks before inclusion.
- Other complicated diseases
Criteria investigador:
- Life expectancy < 6 months.
- Hipersensibility to Ibritumomab tiuxetan, rituximab, other murines proteins or any excipients.
- Treatment in other experimental study in previous 30 days
- Any medical o psicologycal condition that can modify the capacity to give the consent
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00662948
Study Chair: | Canales Miguel, Dr | Hospital La Paz | |
Study Chair: | Lopez-Guillermo Armando, Dr | Hospital Clinic of Barcelona | |
Study Chair: | Tomas Jose Francisco, Dr | MD Anderson- Madrid |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | PETHEMA Foundation |
ClinicalTrials.gov Identifier: | NCT00662948 |
Other Study ID Numbers: |
ZAR2007 |
First Posted: | April 21, 2008 Key Record Dates |
Last Update Posted: | April 28, 2020 |
Last Verified: | April 2020 |
Folicular Lymphoma Consolidation Maintenance |
Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Rituximab Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |