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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)

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ClinicalTrials.gov Identifier: NCT00438581
Recruitment Status : Unknown
Verified February 2007 by McGill University.
Recruitment status was:  Not yet recruiting
First Posted : February 22, 2007
Last Update Posted : February 27, 2007
Sponsor:
Collaborator:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Drug: Yttrium 90 Ibritumomab Tiuxetan ( Zevalin ) Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Overall response rate

Secondary Outcome Measures :
  1. Survival Data, adverse events, molecular response

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00438581


Contacts
Contact: Ahmed Galal, MD 514-934-1934 ext 31558 galala@muhchem.mcgill.ca

Locations
Canada, Quebec
McGill University Health Center, Royal Victoria Hospital Not yet recruiting
Montreal, Quebec, Canada, H3A1A1
Contact: Ahmed Galal, MD    514-934-1934 ext 31558    galala@muhchem.mcgill.ca   
Principal Investigator: Ahmed Galal, MD         
Sponsors and Collaborators
McGill University
McGill University Health Center
Investigators
Principal Investigator: Ahmed Galal, MD McGill University Health Center, Royal Victoria Hospital
More Information

ClinicalTrials.gov Identifier: NCT00438581     History of Changes
Other Study ID Numbers: BMA-05-017-ZEV
First Posted: February 22, 2007    Key Record Dates
Last Update Posted: February 27, 2007
Last Verified: February 2007

Keywords provided by McGill University:
Zevalin
Autologous one Marrow Transplant
Non-Hodgkin's Lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs