NCT00336843

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2005

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 14, 2006

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

February 17, 2016

Status Verified

February 1, 2016

Enrollment Period

3.3 years

First QC Date

June 13, 2006

Last Update Submit

February 13, 2016

Conditions

Non-Hodgkin's Lymphoma

Keywords

ZevalinB-cell non-Hodgkin's lymphomaautologous stem cell transplantationBuCyE regimen

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Overall survival

    from stem cell infusion to death of any cause or last follow-up

  • Toxicity of the treatment combination

    any toxicity due to study treatment during study period

Study Arms (1)

Zevalin-BuCyE

EXPERIMENTAL

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

Drug: Zevalin-BuCyE

Interventions

Zevalin-BuCyEDRUG

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

Zevalin-BuCyE

Eligibility Criteria

AgeUp to 64 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seoul, 138-736, South Korea

Location

Related 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 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.

    PMID: 19547918RESULT

MeSH Terms

Conditions

Lymphoma, Non-HodgkinLymphoma, B-Cell

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Cheolwon Suh, MD, PhD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASCT team

Study Record Dates

First Submitted

June 13, 2006

First Posted

June 14, 2006

Study Start

November 1, 2005

Primary Completion

February 1, 2009

Study Completion

May 1, 2010

Last Updated

February 17, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)