Zevalin Plus BuCyE High-dose Therapy in B-cell Non-Hodgkin's Lymphoma
This study has been completed.
Sponsor:
Asan Medical Center
Collaborator:
Schering-Plough
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00336843
First received: June 13, 2006
Last updated: February 7, 2011
Last verified: November 2008
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Purpose
In order to improve the clinical result of high-dose chemotherapy and autologous stem cell transplantation for B-cell non-Hodgkin's lymphoma, Zevalin will be added to the conditioning regimen. Investigators expect this radioimmunotherapy of Zevalin plus busulfan, cyclophosphamide and etoposide regimen will improve survival of relapsed or poor-risk B-cell non-Hodgkin's lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Hodgkin's Lymphoma |
Drug: Zevalin-BuCyE |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Combining 90Y-ibritumomab Tiuxetan With High-dose Chemotherapy of BuCyE and Autologous Stem Cell Transplantation in Patients With B-cell Non-Hodgkin's Lymphoma - an Open-labeled Phase II Study |
Resource links provided by NLM:
MedlinePlus related topics:
Lymphoma
Drug Information available for:
Ibritumomab tiuxetan
U.S. FDA Resources
Further study details as provided by Asan Medical Center:
Primary Outcome Measures:
- Event-free survival [ Time Frame: the time from stem cell infusion to failure or death from any cause ] [ Designated as safety issue: No ]Three year event-free survival rate would be reported.
Secondary Outcome Measures:
- Overall survival [ Time Frame: from stem cell infusion to death of any cause or last follow-up ] [ Designated as safety issue: No ]Three year overall survival would be reported.
- Toxicity of the treatment combination [ Time Frame: any toxicity due to study treatment during study period ] [ Designated as safety issue: Yes ]Adverse events would be assessed and graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE), version 3.0. And the frequency of each grade would be reported as case number and proportion.
| Enrollment: | 19 |
| Study Start Date: | November 2005 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: Zevalin-BuCyE
rituximab (IV, 250 mg/m2 on days −21 and −14) single dose of 90Y-ibritumomab (IV, 0.4 mCi/kg on day −14) Busulfan (IV, 0.8 mg/kg every 6 h from day −7 to day −5) Cyclophosphamide (IV, 50 mg/kg on days −3 and −2) Etoposide (IV, 200 mg/m2 every 12 h on days −5 and −4) Autologous stem cells infusion on day 0
Other Name: Zevalin-BuCyE
Title: Combining 90Y-Ibritumomab tiuxetan (Zevalin) with high-dose chemotherapy of BuCyE and autologous stem cell transplantation in patients with relapsed, refractory, or high-risk B-cell non-Hodgkin's lymphoma - an open-labeled phase II study.
Study design: Prospective, multicenter, open-labeled, phase II trial.
Study objectives:
- Primary: event-free survival time following autologous stem cell transplantation with 90Y-Ibritumomab tiuxetan and BuCyE high-dose chemotherapy in patients with relapsed, refractory, or high-risk B-cell non-Hodgkin's lymphoma
- Secondary: overall survival response rate toxicity of the treatment combination
Treatment:
Z-BuCyE Regimen
- Day 21: rituximab, 250 mg/m2, I.V.
- Day 14: rituximab, 250 mg/m2, I.V. 90Y-Ibritumomab tiuxetan, 0.4 mCi/kg, I.V.
- Day 7, 6, 5: busulfan 3.2 mg/kg I.V.
- Day 5, 4: etoposide 200 mg/m2 I.V. every 12 hours
- Day 3, 2: Cytoxan 50 mg/kg I.V.
- Day 0: autologous stem cell infusion
Eligibility| Ages Eligible for Study: | up to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically confirmed B-cell NHL in chemotherapy-sensitive relapse, in partial response to 1st line chemotherapy, or in complete response after 1st line chemotherapy with high IPI score at diagnosis
- Age < 65 years old
- WHO performance status (PS) of 0-2
- ANC > 1,500/mm3, platelet > 100,000/mm3
- Cr < 2.0 mg% or Ccr > 50 mL/min
- Transaminase < 3X upper normal value
- Bilirubin < 2 mg/dL
- Life expectancy of at least 3 months
- Written informed consent
- Optimal harvest of autologous stem cells (CD34+ cells > 5 million/kg plus 2 million/kg for back-up)
Exclusion Criteria:
- Prior hematopoietic stem cell transplantation
- Prior RIT
- Prior external radiation to > 25% of active bone marrow
- CNS involvement of non-Hodgkin's lymphoma
- Serious comorbid diseases
- HIV or HTLV-1 associated malignancy
- History of other malignant disease in the previous 5 years, except squamous cell or basal cell carcinoma of skin or stage I uterine cervical carcinoma or cervical carcinoma in situ
- Known hypersensitivity to murine antibodies/proteins
- Pregnant or breast feeding female patients, adults without effective contraception up to 12 months after RIT
- Persistent toxic side effects from prior therapy
- Prior biologic or immunotherapy less than 4 weeks prior to entry on this study
- Investigational drugs less than 4 weeks prior to entry on this study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00336843
Locations
| Korea, Republic of | |
| Asan Medical Center, Departement of Internal Medicine, Division of Oncology | |
| Seoul, Korea, Republic of, 138-736 | |
Sponsors and Collaborators
Asan Medical Center
Schering-Plough
Investigators
| Principal Investigator: | Cheolwon Suh, MD, PhD | Asan Medical Center |
More Information
Publications:
| Responsible Party: | Chairman, IRB, Asan Medical Center |
| ClinicalTrials.gov Identifier: | NCT00336843 History of Changes |
| Other Study ID Numbers: | AMC 2005-276 |
| Study First Received: | June 13, 2006 |
| Last Updated: | February 7, 2011 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Asan Medical Center:
|
Zevalin B-cell non-Hodgkin's lymphoma autologous stem cell transplantation BuCyE regimen |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013