Clinical trial NCT00438581: Study Combining Zevalin With High-Dose Chemotherapy Prior to Autologous StemCell Transplant in Patients With Relapsed, Refractory, or Transformed Non-Hodgkin's Lymphoma
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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-Hodgkin's Lymphoma
Keywords: Zevalin
Autologous one Marrow Transplant
Non-Hodgkin's Lymphoma
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: McGill University Health Centre/Research Institute of the McGill University Health Centre
First posted: 2007-02-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Overall response rate
Secondary outcomes:
measure: Survival Data, adverse events, molecular response
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Center, Royal Victoria Hospital
state: Quebec
Study officials:
affiliation: McGill University Health Center, Royal Victoria Hospital
name: Ahmed Galal, MD
role: PRINCIPAL_INVESTIGATOR
References: