NCT00438581

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2007

Completed
7 days until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
Last Updated

February 27, 2007

Status Verified

February 1, 2007

First QC Date

February 20, 2007

Last Update Submit

February 26, 2007

Conditions

Non-Hodgkin's Lymphoma

Keywords

ZevalinAutologous one Marrow TransplantNon-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Overall response rate

Secondary Outcomes (1)

  • Survival Data, adverse events, molecular response

Interventions

Yttrium 90 Ibritumomab Tiuxetan ( Zevalin )DRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University Health Center, Royal Victoria Hospital

Montreal, Quebec, H3A1A1, Canada

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

ibritumomab tiuxetan

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ahmed Galal, MD

    McGill University Health Center, Royal Victoria Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Galal, MD

CONTACT

514-934-1934galala@muhchem.mcgill.ca

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 20, 2007

First Posted

February 22, 2007

Study Start

March 1, 2007

Last Updated

February 27, 2007

Record last verified: 2007-02

Locations

CA(1)