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Study Combining Zevalin With High-Dose Chemotherapy Prior to Autologous StemCell Transplant in Patients With Relapsed, Refractory, or Transformed Non-Hodgkin's Lymphoma (Zevalin)

Primary Purpose

Non-Hodgkin's Lymphoma

Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Yttrium 90 Ibritumomab Tiuxetan ( Zevalin )
Sponsored by
McGill University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring Zevalin, Autologous one Marrow Transplant, Non-Hodgkin's Lymphoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age >=18 to <=70 years

  2. Relapsed or refractory Stage III or IV, grade 1,2, or 3 Follicular Lymphoma or transformed follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, Waldenstrom's macroglobulinemia, or diffuse large B-Cell lymphoma as defined by the WHO and:

    • Expressing the CD 20 antigen
    • ECOG performance 0-2
    • Written informed consent
  3. Prior collection of at least 2.5x10^6 CD34-positive peripheral blood stem cells/kg.

Exclusion Criteria:

  1. Abnormal renal function (Creatinine >2.5x upper limit of normal (ULN)
  2. Abnormal hepatic function (Bilirubin >2xULN, ALT/AST >3x ULN)
  3. Cardiac ejection fraction <40%
  4. Severe defects in pulmonary function tests (DLCO<70% predicted, FEV1, FVC<60% predicted) or receiving continuous oxygen
  5. A history of human anti-mouse antibodies (HAMA) or known type 1 hypersensitivity or anaphylactic proteins to any component of the Zevalin therapy.
  6. Female patients who are pregnant or breast feeding, and adults of reproductive potential who are not employing an effective method of birth control during study treatment
  7. Prior radiotherapy to >25% of the bone marrow or >20 Gy to critical organ (lung, liver, kidney, spinal cord).
  8. CNS lymphoma
  9. Ongoing infection
  10. Prior treatment with radioimmunotherapy

Sites / Locations

  • McGill University Health Center, Royal Victoria Hospital

Outcomes

Primary Outcome Measures

Overall response rate

Secondary Outcome Measures

Survival Data, adverse events, molecular response

Full Information

First Posted
February 20, 2007
Last Updated
February 26, 2007
Sponsor
McGill University
Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
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1. Study Identification

Unique Protocol Identification Number
NCT00438581
Brief Title
Study Combining Zevalin With High-Dose Chemotherapy Prior to Autologous StemCell Transplant in Patients With Relapsed, Refractory, or Transformed Non-Hodgkin's Lymphoma
Acronym
Zevalin
Official Title
Phase II Non-Randomized Study Combining Yttrium 90 Ibritumomab Tiuxetan (Zevalin) With High-Dose Chemotherapy Prior to Autologous Stem Cell Transplantation in Patients With Relapsed, Refractory, or Transformed Non-Hodgkin's Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2007
Overall Recruitment Status
Unknown status
Study Start Date
March 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
McGill University
Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre

4. Oversight

5. Study Description

Brief Summary
This aim of this study to evaluate the safety and efficacy of combining a single course of Yttrium 90 Ibritumomab Tiuxetan, a radiolabeled monoclonal antibody ( Zevalin ), with high-dose BEAM chemotherapy and autologous peripheral stem cell transplantation in patients with relapsed, refractory, or transformed Non-Hodgkin's lymphoma.
Detailed Description
Relapse rates after chemotherapy for relapsed, refractory or transformed Non-Hodgkin's lymphoma (NHL)remain very high. NHL is a radiosensitive tumor. We hypothesize that targeted radioimmunotherapy combined with high-dose chemotherapy may increase response and survival rates in a safe and reliable manner.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma
Keywords
Zevalin, Autologous one Marrow Transplant, Non-Hodgkin's Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Yttrium 90 Ibritumomab Tiuxetan ( Zevalin )
Primary Outcome Measure Information:
Title
Overall response rate
Secondary Outcome Measure Information:
Title
Survival Data, adverse events, molecular response

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age >=18 to <=70 years Relapsed or refractory Stage III or IV, grade 1,2, or 3 Follicular Lymphoma or transformed follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, Waldenstrom's macroglobulinemia, or diffuse large B-Cell lymphoma as defined by the WHO and: Expressing the CD 20 antigen ECOG performance 0-2 Written informed consent Prior collection of at least 2.5x10^6 CD34-positive peripheral blood stem cells/kg. Exclusion Criteria: Abnormal renal function (Creatinine >2.5x upper limit of normal (ULN) Abnormal hepatic function (Bilirubin >2xULN, ALT/AST >3x ULN) Cardiac ejection fraction <40% Severe defects in pulmonary function tests (DLCO<70% predicted, FEV1, FVC<60% predicted) or receiving continuous oxygen A history of human anti-mouse antibodies (HAMA) or known type 1 hypersensitivity or anaphylactic proteins to any component of the Zevalin therapy. Female patients who are pregnant or breast feeding, and adults of reproductive potential who are not employing an effective method of birth control during study treatment Prior radiotherapy to >25% of the bone marrow or >20 Gy to critical organ (lung, liver, kidney, spinal cord). CNS lymphoma Ongoing infection Prior treatment with radioimmunotherapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Galal, MD
Phone
514-934-1934
Ext
31558
Email
galala@muhchem.mcgill.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Galal, MD
Organizational Affiliation
McGill University Health Center, Royal Victoria Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
McGill University Health Center, Royal Victoria Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A1A1
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Galal, MD
Phone
514-934-1934
Ext
31558
Email
galala@muhchem.mcgill.ca
First Name & Middle Initial & Last Name & Degree
Ahmed Galal, MD

12. IPD Sharing Statement

Learn more about this trial

Study Combining Zevalin With High-Dose Chemotherapy Prior to Autologous StemCell Transplant in Patients With Relapsed, Refractory, or Transformed Non-Hodgkin's Lymphoma

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