A Comparative Study Of Iodine I 131 Tositumomab Therapeutic Regimen Versus Ibritumomab Tiuxetan Therapeutic Regimen

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00319332
• Date of registration: 26/04/2006
• Primary sponsor: GlaxoSmithKline
• Public title: A Comparative Study Of Iodine I 131 Tositumomab Therapeutic Regimen Versus Ibritumomab Tiuxetan Therapeutic Regimen
• Scientific title: A Multi-Center, Randomized, Phase 3 Study of Iodine I 131 Tositumomab Therapeutic Regimen Versus Ibritumomab Tiuxetan Therapeutic Regimen for Patients With Relapsed or Transformed Follicular Non-Hodgkin's Lymphoma
• Date of first enrolment: September 2005
• Target sample size: 350
• Recruitment status: Withdrawn
• URL: http://clinicaltrials.gov/show/NCT00319332
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: GSK Clinical Trials, MD
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion criteria:

- Histologically confirmed diagnosis of follicular lymphoma, Grade 1, 2, or 3, or
diffuse large cell lymphoma concurrent with or following the diagnosis of follicular
lymphoma (WHO/REAL classification).

- International Working Formulation histological equivalents of Follicular, small
cleaved; Follicular, mixed small-cleaved and large-cell; follicular large-cell; or
Transformed diffuse large cell lymphoma following or concurrent with a diagnosis of
follicular lymphoma.

- Patients diagnosed with diffuse large cell lymphoma at study enrollment must have a
historical or contemporaneous lymph node biopsy that demonstrates a diagnosis of
follicular lymphoma.

- Recurrent lymphoma after at least three qualifying therapy regimens including at
least one Rituximab-containing regimen and at least one chemotherapy regimen.

- The patient must have either not responded or responded with a duration of response
of less than 6 months to a Rituximab-containing regimen, Performance status of at
least 70% on the Karnofsky Scale and an anticipated survival of at least three
months.

- Bi-dimensionally measurable disease with at least one lesion measuring 4.0 cm2 by CT
scan.

- Absolute neutrophil count >/= 1500 cells/mm3 and platelet count >/=100,000/mm3 within
21 days prior to study enrollment.

- Blood products and/or growth factors should not be taken within 4 weeks prior to
blood draw.

- Adequate renal function (defined as serum creatinine <1.5 x upper limit of normal)
and adequate hepatic function (defined as total bilirubin <1.5x upper limit of normal
and AST <5x upper limit of normal) within 21 days prior to study enrollment.

- Human Anti-Murine Antibody (HAMA) negative within 21 days prior to study enrollment.

- Provision of informed consent as signified by a signed IRB approved consent form
prior to any study-specific procedures being implemented.

Exclusion criteria:

- Greater than 25% of the intratrabecular marrow space involved by lymphoma in bone
marrow biopsy specimens as assessed microscopically within 90 days prior to study
enrollment.

- Hypocellular bone marrow ( precursors).

- Prior myeloablative therapy.

- History of failed stem cell collection.

- Prior radiotherapy to fields encompassing more than 25% of the blood forming marrow.

- Prior chemotherapy, biologic therapy, radiation therapy or steroid therapy for NHL
within eight weeks prior to screening procedures.

- Prior radioimmunotherapy.

- Prior treatment with any non-human, particularly murine monoclonal or polyclonal
antibodies for either diagnostic or therapeutic purposes. This exclusion does not
extend to the chimeric monoclonal antibody, Rituximab.

- Prior malignancy other than lymphoma, except for adequately treated basal cell or
squamous cell skin cancer, in situ uterine cervical cancer, or other cancer for which
the patient has been disease-free for five years.

- Active infection requiring intravenous antibiotics at the time of study enrollment.

- New York Heart Association Class III or IV heart disease or other serious illness
that would preclude evaluation.

- HBsAg seropositivity.

- Known HIV infection.

- Known brain or leptomeningeal metastases.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Lymphoma, Follicular

Lymphoma, Large-Cell, Follicular

Lymphoma, Non-Hodgkin

Lymphoma, Small Cleaved-Cell, Follicular

Intervention(s)

Drug: Ibritumomab Tiuxetan

Drug: Iodine I 131 Tositumomab

Primary Outcome(s)

The primary endpoint is the proportion of subjects experiencing Grade 3/4 hematological toxicity within 120 days from completion of treatment regimen administration.

Secondary Outcome(s)

The final analysis will be carried out when 130 events (progressive disease, death or subsequent therapy) have occurred in the control arm, expected approximately 18 months after last subject last visit.

Secondary ID(s)

393229/029

CCBX001-053

Source(s) of Monetary Support

Please refer to primary and secondary sponsors