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

Phase 2

• Conditions: Non-Hodgkin's Lymphoma

• Registration Number: NCT00438581
• Lead Sponsor: McGill University

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.

Study Timeline

• Status Verified: 2007-02
• Study First Submitted: 2007-02-20
• Study First Submitted QC: 2007-02-20
• Study First Posted: 2007-02-22
• Last Update Submitted: 2007-02-26
• Last Update Posted: 2007-02-27
• Study Start: 2007-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Overall response rate

Secondary Outcome Measures

Name	Time	Method
Survival Data, adverse events, molecular response

Trial Locations

Locations (1)

McGill University Health Center, Royal Victoria Hospital; 🇨🇦 Montreal, Quebec, Canada