NCT00493467

Brief Summary

The goal of this clinical research study is to find out if giving (Rituxan) rituximab with 90Y (ibritumomab tiuxetan) (90 Y Zevalin®) may be effective in treating low-grade lymphoma. The safety of this combination treatment will also be studied.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for phase_2 lymphoma

Timeline
Completed

Started Jun 2006

Longer than P75 for phase_2 lymphoma

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2007

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
5.4 years until next milestone

Results Posted

Study results publicly available

September 1, 2020

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2022

Completed
Last Updated

September 15, 2022

Status Verified

August 1, 2022

Enrollment Period

8.8 years

First QC Date

June 27, 2007

Results QC Date

April 20, 2016

Last Update Submit

August 30, 2022

Conditions

Lymphoma

Keywords

Non-Hodgkin's LymphomaLymphomaIndolent LymphomasIbritumomab TiuxetanZevalin

Outcome Measures

Primary Outcomes (1)

  • Overall Response Rate (ORR)

    ORR defined as the percentage of number of complete response (CR), complete response unconfirmed (CRu) or partial response (PR) in patients treated using International Working Group (IWG) revised response criteria for Malignant Lymphoma. ORR to therapy is evaluated after three months using radiographic and clinical parameters to assess response. CR: Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms. CRu: A residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of the greatest diameters (SPD). Individual nodes that were previously confluent must have regressed by more than 75% in their SPD compared to the original mass and indeterminate bone marrow. PR: ≥ 50% decrease in SPD of the six largest dominant nodes or nodal masses. No increase in the size of other nodes, liver or spleen and no new sites of disease.

    Up to 5 years; Evaluation at 3-month intervals during Year 1, then every 6 months to Year 4. The median follow-up was 56 months for censored observations.

Secondary Outcomes (1)

  • Progression Free Survival (PFS) Rate at 3 Years

    Evaluation at 3-month intervals during the first year and then every 6 months until year 3

Study Arms (1)

Zevalin

EXPERIMENTAL

Ibritumomab Tiuxetan (Zevalin) + Rituximab

Drug: Ibritumomab Tiuxetan (Zevalin)Drug: Rituximab

Interventions

Ibritumomab Tiuxetan (Zevalin)DRUG

111In Zevalin (5 mCi of \^111In, 1.6 mg of Ibritumomab Tiuxetan) Intravenously Over 10 minutes on Day 1. 90Y Zevalin 0.3 or 0.4 mCi/kg Intravenously Over 10 minutes on Day 8.

Also known as: Ibritumomab, Zevalin, IDEC-Y2B8
Zevalin
RituximabDRUG

250 mg/m\^2 Intravenously Over 4-6 Hours On Days 1 and 8.

Also known as: Rituxan
Zevalin

Eligibility Criteria

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

You may qualify if:

  • New diagnosis of low-grade indolent lymphomas Stage I-II. Patients with multiple skin lesions will be eligible provided that the skin is the only site of involvement.
  • Histology includes Indolent cluster of differentiation antigen 20 (CD20)+ lymphomas including: Follicular lymphoma, Extranodal marginal lymphoma of MALT type, Nodal Marginal zone B-cell lymphoma (+/- monocytoid cells), and Splenic marginal B-cell lymphoma (+/- villous lymphocytes).
  • Signed Informed Consent.
  • Age \>/= 18 years.
  • Pre-study Zubrod performance status of 0, 1, or 2.
  • Acceptable hematologic status within two weeks prior to patient registration, including: absolute neutrophil count (\[segmented neutrophils + bands\] x total WBC) \>/= 1, 500/mm\^3, total lymphocyte count \</= 5,000/mm\^3 and platelet counts \>/= 100,000/mm\^3.
  • Female patients who are not pregnant or lactating.
  • Men and women of reproductive potential who are following accepted birth control methods (as determined by the treating physician, however abstinence is not an acceptable method).
  • Patients determined to have \< 25% bone marrow involvement with lymphoma within six weeks of registration (define measurement of a bone marrow aspirate or biopsy).
  • Patient should have at least one lesion measuring \>/= 1.5 cm in a single dimension. Measurable cutaneous lesions are allowed.

You may not qualify if:

  • Presence of central nervous system (CNS) lymphoma.
  • Patients with HIV or AIDS-related lymphoma.
  • Patients with pleural effusion.
  • Patients with abnormal liver function: total bilirubin \> 2.0 mg/dL.
  • Patients with abnormal renal function: serum creatinine \> 2.0 mg/dL.
  • Patients who have received prior external beam radiation therapy to \> 25% of active bone marrow (involved field or regional).
  • Impaired bone marrow reserve as indicated by \< 15% bone marrow cellularity
  • Serious nonmalignant disease or infection which, in the opinion of the investigator and/or the sponsor, would compromise other protocol objectives.
  • Major surgery, other than diagnostic surgery, within four weeks.
  • Evidence of transformation in the latest biopsy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

LymphomaLymphoma, Non-Hodgkin

Interventions

ibritumomab tiuxetanRituximab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Felipe Samaniego, MD/Associate Professor, Lymphoma/Myeloma
Organization
University of Texas (UT) MD Anderson Cancer Center
fsamaniego@mdanderson.org
713-563-1509

Study Officials

  • Felipe Samaniego, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2007

First Posted

June 28, 2007

Study Start

June 1, 2006

Primary Completion

April 1, 2015

Study Completion

August 11, 2022

Last Updated

September 15, 2022

Results First Posted

September 1, 2020

Record last verified: 2022-08

Locations

US(1)