Last updated: 11/07/2018 14:19:57

Retreatment of Patients with Non-Hodgkin's Lymphoma Who Have Previously Responded to Iodine-131 Anti B1 Antibody

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GSK study ID
393229/010
See study documents
Clinicaltrials.gov ID
NCT00938041
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Retreatment Study of Patients with Non-Hodgkin's Lymphoma Who Have Previously Responded to Iodine-131 Anti B1 Antibody
Trial description: This multicenter study will determine the response rate, the complete response rate, duration of response, time to progression, time-to-treatment failure, safety, and survival following treatment with Iodine-131 Anti-B1 Antibody for the retreatment of patients with non-Hodgkin's lymphoma who previously responded with a duration of response of at least 3 months to Iodine-131 Anti-B1 Antibody therapy. Patients will undergo two phases of study. In the first phase, patients will receive a dosimetric dose of unlabeled Anti-B1 Antibody (450 mg) followed by Anti-B1 Antibody (35 mg) which has been radiolabeled with 5 mCi of Iodine-131. Whole body gamma camera scans will be obtained after the dosimetric dose and data from three imaging time points will be used to calculate a patient-specific dose to deliver the desired total body dose of radiotherapy. In the second phase, patients will receive the therapeutic dose of unlabeled Anti-B1 Antibody (450 mg) followed by 35 mg of Anti-B1 Antibody labeled with the patient-specific dose to deliver the desired whole body dose of radiation. Patients will be treated with thyroid blocking medication at least 24 hours prior to the first infusion and continuing for 14 days following the last infusion.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Number of participants with complete response and confirmed complete response

Timeframe: Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)

Duration of response for all confirmed responders (CR + CCR + PR)

Timeframe: Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)

Progression-free survival

Timeframe: Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)

Time to treatment failure

Timeframe: Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)

Overall survival

Timeframe: Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)

Number of participants with any Serious Adverse Event (SAE) and Adverse Event (AE)

Timeframe: Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)

Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: Tositumomab and Iodine I 131 Tositumomab
    • Enrollment:
    32
    Primary completion date:
    2003-01-05
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Kaminski MS, Estes J, Regan D, et al. Retreatment with Bexxar (tositumomab and iodine I 131 tositumomab) for patients with low-grade or transformed low-grade non-Hodgkin’s lymphoma (NHL). Proc Am Soc Clin Oncol 2001;20(pt 1):285a. Abstract 1139.
    Kaminski MS, Knox SJ, Radford J, et al. Retreatment with tositumomab and iodine I 131 tositumomab (the Bexxar therapeutic regimen) in patients with non-Hodgkin’s lymphoma with a previous response to the Bexxar therapeutic regimen. Blood 2003;102(suppl, pt 1): 407a. Abstract 1478
    Kaminski MS, Radford JA, Gregory SA, et al. Retreatment with I 131 tositumomab in patients with non-Hodgkin’s lymphoma who had previously responded to I 131 tositumomab. J Clin Oncol. 2005:23:1-9.
    Wahl RL, Leonard JP, Kaminski MS, Goldsmith SJ. Can patients with non-Hodgkin’s lymphoma who have been treated with and responded to the Bexxar therapeutic regimen (tositumomab and iodine I 131 tositumomab) be retreated. J Nucl Med. 2004;45 (suppl):143. Abstract 401.
    Re-Treatment With I-131 Tositumomab in Patients With Non-Hodgkin’s Lymphoma Who Had Previously Responded to I-131 Tositumomab. J Clin Oncol. 2005;23(31):7985-7993.
    Medical condition
    Lymphoma, Non-Hodgkin
    Product
    tositumomab
    Collaborators
    Not applicable
    Study date(s)
    April 1998 to June 2013
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Patients with histologically confirmed initial diagnosis of non-Hodgkin's B-cell lymphoma
    • Patients must have previously responded with a duration of response of at least 3 months to Iodine-131 Anti-B1 Antibody therapy
    • Patients with more than 25% bone marrow involvement
    • Patients who have received cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment within 4 weeks prior to study entry or who exhibit persistent clinical evidence of toxicity. The use of systemic steroids much be discontinued at least 1 week prior to study entry.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Patients with histologically confirmed initial diagnosis of non-Hodgkin's B-cell lymphoma
    • Patients must have previously responded with a duration of response of at least 3 months to Iodine-131 Anti-B1 Antibody therapy
    • Patients must have evidence that their tumor tissue had CD20 expression
    • Patients must have performance status of at least 60% on the Karnofsky scale and an anticipated survival of at least 3 months
    • Patients must have absolute granulocyte count (ANC) greater than 1,500 cells/mm3 and platelet count greater than 100,000 cells/mm3 within 14 days of study entry without support of hematopoietic cytokines or transfusion of blood products
    • Patients must have adequate renal (serum creatine less than 1.5 x upper limit of normal) and hepatic function (total bilirubin less than 1.5 x upper limit of normal and hepatic transaminases, AST and ALT, less than 5 x upper limit of normal) within 14 days of study entry
    • Patients must have bi-dimensionally measurable disease with a least one lesion greater than or equal to 2 cm x 2 cm by CT scan
    • Patients must be at least 18 years of age
    • Patients must give written informed consent and sign an Institutional Review Board/Ethics Committee- approved informed consent form prior to study entry
    Exclusion criteria:
    • Patients with more than 25% bone marrow involvement
    • Patients who have received cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment within 4 weeks prior to study entry or who exhibit persistent clinical evidence of toxicity. The use of systemic steroids much be discontinued at least 1 week prior to study entry.
    • Patients with active obstructive hydronephoresis
    • Patients with evidence of active infection requiring IV antibiotics at time of study entry
    • Patients with New York Heart Association class III or IV heart disease or other serious illness that would preclude evaluation
    • Patients with prior malignancy other than lymphoma, except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for 5 years
    • Patients with known HIV infection
    • Patients with known brain or leptomeningeal metasteses
    • Patients who are pregnant or nursing

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2003-01-05
    Actual study completion date
    2013-30-06

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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