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

Non-Hodgkin's Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00336843
• Other study ID #: AMC 2005-276
• Status: Completed
• Phase: Phase 2
• First received: June 13, 2006
• Last updated: February 13, 2016
• Start date: November 2005
• Est. completion date: May 2010

Study information

• Verified date: February 2016
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 2010
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 64 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center, Departement of Internal Medicine, Division of Oncology	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	Schering-Plough

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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 transplantatio — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-free survival	Three year event-free survival rate would be reported.	the time from stem cell infusion to failure or death from any cause	No
Secondary	Overall survival	Three year overall survival would be reported.	from stem cell infusion to death of any cause or last follow-up	No
Secondary	Toxicity of the treatment combination	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.	any toxicity due to study treatment during study period	Yes