Tositumomab And Iodine I 131-Tositumomab In Patients With Relapsed Indolent Non-Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00240565
First received: October 14, 2005
Last updated: August 9, 2012
Last verified: August 2012
  Purpose

This study will further characterize the activity of Tositumomab and Iodine I 131-Tositumomab in patients with relapsed indolent non-Hodgkin's Lymphoma who have progressed following treatment with rituximab.


Condition Intervention Phase
Lymphoma, Non-Hodgkin
Drug: Tositumomab 450 mg
Drug: Tositumomab 35 mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Arm, Open-label, Multicentre, Phase II Study of Tositumomab and Iodine 131-Tositumomab in Subjects With Indolent Non-Hodgkin's Lymphoma Who Have Previously Received Rituximab.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Response Rate [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
    Responders are defined as participants with Complete Response (CR: disappearance of all clinical and radiological evidence of lymphoma), Clinical Complete Response (CCR: all criteria met for CR, except there is a residual nodal mass >15 millimeters), or Partial Response (PR: 50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions with no new lesions). Response is based on objective evaluation, using the guidelines developed by The International Workshop to Standardize Response Criteria, independent of the investigator's evaluation.


Secondary Outcome Measures:
  • Complete response rate (CR) [ Time Frame: From the start of treatment (Study Day 0, Baseline) until long-term follow-up (every 6 months until 5 years from the time of study entry) ] [ Designated as safety issue: No ]
    Investigator-assessed confirmed CR is defined as the disappearance of all clinical and radiological evidence of lymphoma. Response is based on objective evaluation, using the guidelines developed by The International Workshop to Standardize Response Criteria, independent of the investigator's evaluation.

  • Duration of response [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Duration of response is defined as the time from the first documented response to the first documented disease progression. Response is based on objective evaluation, using the guidelines developed by The International Workshop to Standardize Response Criteria, independent of the investigator's evaluation. Disease progression is defined as a 50% increase in the sum of the products of the two perpendicular diameters of all measurable lesions, or the appearance of new lesions.

  • Progression-free survival (PFS) [ Time Frame: 5 years or until death ] [ Designated as safety issue: No ]
    PFS is defined as the time interval between the date of the DD to the first date at which progressive disease (PD) or death is observed. PD is defined as a 50% increase in the sum of the products of two perpendicular diameters of all measurable lesions, or the appearance of new lesions. Participants with no evidence of PD were censored to the last date of contact; and those who died for any reason in the absense of PD were classified as having experienced PD on the date of death. For non-responders, duration of PFS was recorded as 0. Participants were censored if they withdrew without PD.

  • Adverse events [ Time Frame: 5 years or until death ] [ Designated as safety issue: No ]
    An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that, at any dose results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly in a child from a parent who was exposed to treatment; or is an SAE based on medical or scientific judgement of the investigator.

  • Quality of Life [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
    Qualty of Life will be asessed utilizing several scales and questionnaires: FACT-G questionnaire was designed to measure multidimensional quality of life (QOL) in participants with cancer. FACT-LymThe FACT-Lym subscale questionnaire is a cancer-specific questionnaire designed to measure multidimensional QOL in participants with lymphoma.

  • Resource Utilization Assessment [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
    The Resource Utilization Assessment questionnaires are used to assess the resource utilization of the participant and impacted associates (e.g., family members, caregivers) as well as costs involved to treat participants receiving TST and I 131 TST. As an assessment of general health, participants were asked to rate their activity level on average in the last 7 days on an 11-point scale: 0= exhausted in bed all day; 10=normal activity level.

  • Duration of Overall Survival [ Time Frame: 5 years or until death ] [ Designated as safety issue: No ]
    Survival time is defined as the number of weeks from the first study medication administration to the date of death. In the absence of confirmation of death, survival time was censored to the last date the participant was known be alive. If the participant was alive at the time of analysis, then the survival time was censored at the date of last contact.


Enrollment: 93
Study Start Date: April 2004
Study Completion Date: September 2011
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Participants underwent two phases of treatment: an initial DD, followed by a therapeutic dose. The one-day DD comprised a 1 hr IV infusion of 450 mg unlabeled TST, followed by a 20 min IV infusion of 35 mg TST labeled with 185 MBq (5.0 mCi) of I 131. After 7 to 14 days, the one-day therapeutic dose comprised a second 1 hr IV infusion of 450 mg unlabeled TST, followed by a 20 min IV infusion of 35 mg TST labeled with I 131 with an administered activity (MBq or mCi) determined from the dosimetry calculation.
Drug: Tositumomab 450 mg
Unlabeled TST
Drug: Tositumomab 35 mg
TST labeled with 185 megaBecqueral (mbq) of iodine 131

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients must have evidence of persistent or progressive follicular grade, 1, 2 or 3 or marginal zone B-cell non-Hodgkin's lymphoma.
  • Must have received at least two prior courses of systemic treatment including at least one treatment of rituximab (lymphoma must not have progressed during their most recent systemic chemotherapy treatment).
  • Must have evidence that their lymphoma expresses CD20 antigen and have adequate renal and hepatic function.

Exclusion criteria:

  • Received chemotherapy, radiation therapy, immunosuppressants or cytokine treatment within 4 weeks prior to study entry.
  • Have active obstructive hydronephrosis.
  • Had prior autologous hematopoietic stem cell transplant or any allogenic stem cell transplant.
  • Have active infection requiring IV antibiotics.
  • Have brain or leptomeningeal metastasis.
  • Had previous allergic reaction to iodine, previously received radioimmunotherapy or are currently receiving approved or experimental anti-cancer drugs.
  • Patients who are pregnant or breast feeding, have known HIV infection, or are Human anti-murine antibody (HAMA) positive.
  • Other criteria will be evaluated at the screening visit.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00240565

Locations
Canada, Alberta
GSK Investigational Site
Calgary, Alberta, Canada, T2N 4N2
GSK Investigational Site
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Nova Scotia
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
GSK Investigational Site
Hamilton, Ontario, Canada, L8V 5C2
GSK Investigational Site
Ottawa, Ontario, Canada, K1H 8L6
GSK Investigational Site
Toronto, Ontario, Canada, M5G 2M9
GSK Investigational Site
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
GSK Investigational Site
Montreal, Quebec, Canada, H2L 4M1
GSK Investigational Site
Montreal, Quebec, Canada, H4J 1C5
Canada
GSK Investigational Site
Quebec, Canada, G1R 2J6
GSK Investigational Site
Quebec, Canada, G1S 4L8
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00240565     History of Changes
Other Study ID Numbers: 393229/032
Study First Received: October 14, 2005
Last Updated: August 9, 2012
Health Authority: Canada: Health Canada

Keywords provided by GlaxoSmithKline:
BEXXAR
non-Hodgkin's Lymphoma
tositumomab
I-131

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Iodine
Iodine-131 anti-B1 antibody
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 19, 2014