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Efficacy and Safety of Treatment With a Single Dose of 90Y-ibritumomab Tiuxetan in Patients With Low Tumor Burden Untreated or Indolent NHL

Primary Purpose

Lymphoma

Status

Withdrawn

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

90Y-ibritumomab tiuxetan (Zevalin)

About this trial

This is an interventional treatment trial for Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

histologically confirmed indolent lymphoma including:
- follicular grade 1 or 2
- small lymphocytic
- marginal zone (nodal)
- marginal zone (splenic)
- mucosa associated lymphoid tissue (MALT)
no evidence of transformation
Stage III or IV disease
No prior therapy
involvement by less than 25% of bone marrow on assessment of trephine biopsy
absolute lymphocyte count ≤ x 109/L
platelets ≥ 150 x 109/L
hemoglobin ≥ 100g/L
absolute neutrophil count ≥ 1.5 x 109/L
at least one bidimensionally measurable lesion at least 2cm by CT scanning

Exclusion Criteria:

any other anticancer treatment for NHL
prior radiation therapy
prior myeloablative therapy (bone marrow or peripheral blood stem cell transplant)
no other malignancy within the past 10 years except adequately treated non-melanoma skin tumors or carcinoma in situ of the cervix
presence of central nervous system lymphoma
patients known to be HIV positive
patients with known seropositivity for Hepatitis C virus, Hepatitis B virus or other active infection uncontrolled by treatment
patients with abnormal liver function: total bilirubin > 1.5X ULN or ALT > 2.5X ULN
patients with abnormal renal function: serum creatinine > 2.5X ULN
known hypersensitivity to murine antibodies or proteins
immunotherapy during the preceding 6 months (including monoclonal antibodies, interleukins, interferon)

Sites / Locations

Cross Cancer Institute

Outcomes

Primary Outcome Measures

Response

Secondary Outcome Measures

Progression free survival

Full Information

NCT ID

NCT00414089

First Posted

December 19, 2006

Last Updated

February 12, 2016

Sponsor

AHS Cancer Control Alberta

1. Study Identification

Unique Protocol Identification Number

NCT00414089

Brief Title

Efficacy and Safety of Treatment With a Single Dose of 90Y-ibritumomab Tiuxetan in Patients With Low Tumor Burden Untreated or Indolent NHL

Official Title

Efficacy and Safety of Treatment With a Single Dose of 90Y-ibritumomab Tiuxetan in Patients With Previously Untreated Low Tumor Burden Indolent Non-Hodgkin's Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

July 2007

Overall Recruitment Status

Withdrawn

Why Stopped

Funding will not be provided for the drug

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

AHS Cancer Control Alberta

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to see how well Zevalin works in the treatment of low grade indolent B-cell lymphoma when given to patients who have not had any previous treatment for their lymphoma and who otherwise would be followed on a "watch & wait" policy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

90Y-ibritumomab tiuxetan (Zevalin)

Primary Outcome Measure Information:

Title

Response

Secondary Outcome Measure Information:

Title

Progression free survival

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: histologically confirmed indolent lymphoma including: follicular grade 1 or 2 small lymphocytic marginal zone (nodal) marginal zone (splenic) mucosa associated lymphoid tissue (MALT) no evidence of transformation Stage III or IV disease No prior therapy involvement by less than 25% of bone marrow on assessment of trephine biopsy absolute lymphocyte count ≤ x 109/L platelets ≥ 150 x 109/L hemoglobin ≥ 100g/L absolute neutrophil count ≥ 1.5 x 109/L at least one bidimensionally measurable lesion at least 2cm by CT scanning Exclusion Criteria: any other anticancer treatment for NHL prior radiation therapy prior myeloablative therapy (bone marrow or peripheral blood stem cell transplant) no other malignancy within the past 10 years except adequately treated non-melanoma skin tumors or carcinoma in situ of the cervix presence of central nervous system lymphoma patients known to be HIV positive patients with known seropositivity for Hepatitis C virus, Hepatitis B virus or other active infection uncontrolled by treatment patients with abnormal liver function: total bilirubin > 1.5X ULN or ALT > 2.5X ULN patients with abnormal renal function: serum creatinine > 2.5X ULN known hypersensitivity to murine antibodies or proteins immunotherapy during the preceding 6 months (including monoclonal antibodies, interleukins, interferon)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrew Belch, MD

Organizational Affiliation

AHS Cancer Control Alberta

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cross Cancer Institute

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1X2

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of Treatment With a Single Dose of 90Y-ibritumomab Tiuxetan in Patients With Low Tumor Burden Untreated or Indolent NHL

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