Zevalin Plus BuCyE High-dose Therapy in B-cell Non-Hodgkin's Lymphoma

NCT ID: NCT00336843

Last Updated: 2016-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2010-05-31

Brief Summary

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.

Detailed Description

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

Conditions

Non-Hodgkin's Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Zevalin-BuCyE

histologically confirmed, relapsed or refractory CD20 positive B-cell NHL including diffuse large B-cell, follicular, mantle cell, and Burkitt lymphomas.

Group Type: EXPERIMENTAL

Zevalin-BuCyE

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility 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

• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Schering-Plough

INDUSTRY

Sponsor Role: collaborator

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Cheolwon Suh

ASCT team

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cheolwon Suh, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan Medical Center, Departement of Internal Medicine, Division of Oncology

Seoul, , South Korea

Countries

South Korea

References

Kang BW, Kim WS, Kim C, Jang G, Lee SS, Choi YH, Lee DH, Kim SW, Kim S, Ryu JS, Huh J, Lee JS, Suh C. Yttrium-90-ibritumomab tiuxetan in combination with intravenous busulfan, cyclophosphamide, and etoposide followed by autologous stem cell transplantation in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma. Invest New Drugs. 2010 Aug;28(4):516-22. doi: 10.1007/s10637-009-9283-z. Epub 2009 Jun 23.

Reference Type: RESULT

PMID: 19547918 (View on PubMed)

Other Identifiers

AMC 2005-276

Identifier Type: -

Identifier Source: org_study_id