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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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by McGill University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
McGill University Health Center
Information provided by:
McGill University
ClinicalTrials.gov Identifier:
NCT00438581
First received: February 20, 2007
Last updated: February 26, 2007
Last verified: February 2007
  Purpose

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 Intervention Phase
Non-Hodgkin's Lymphoma
Drug: Yttrium 90 Ibritumomab Tiuxetan ( Zevalin )
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by McGill University:

Primary Outcome Measures:
  • Overall response rate

Secondary Outcome Measures:
  • Survival Data, adverse events, molecular response

Estimated Enrollment: 40
Study Start Date: March 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00438581     History of Changes
Other Study ID Numbers: BMA-05-017-ZEV
Study First Received: February 20, 2007
Last Updated: February 26, 2007
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on November 20, 2014