Last updated: 11/04/2018 05:52:39
Study of Untreated or Transformed Follicular Non-Hodgkin's Lymphoma with Fission-Derived Iodine I 131 Tositumomab
GSK study ID
CCBX001-048
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Multi-Center Study to Examine the Pharmacokinetics, Whole Body and Organ Dosimetry, and Biodistribution of Fission-Derived Iodine I 131 Tositumomab for Patients with Previously Untreated or Relapsed Follicular or Transformed Follicular Non-Hodgkin's Lymphoma
Trial description: The purpose of this study is to assess the blood pharmacokinetics in patients with previously untreated or relapsed follicular or transformed follicular non-Hodgkin's lymphoma who have received a dosimetric dose of fission-derived iodine I 131 tositumomab.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
12
Primary completion date:
2007-30-04
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Non-Hodgkin's Lymphoma
Product
tositumomab
Collaborators
None
Study date(s)
April 2003 to April 2007
Type
Interventional
Phase
1/2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- At least 18 years of age
- Histologically confirmed diagnosis of follicular lymphoma, Grade 1, 2, or 3, or diffuse large cell lymphoma (WHO/REAL classification).
- Greater than 25% of the intratrabecular marrow space involved by lymphoma in bone marrow biopsy specimens as assessed microscopically within 90 days of study enrollment. Bilateral posterior iliac crest core biopsies are required if the core obtained on a unilateral biopsy is less than 2 cm.
- Prior chemotherapy, biologic therapy, steroids, or radiation therapy as treatment for their NHL within 28 days prior to study enrollment.
Inclusion and exclusion criteria
Inclusion criteria:
- At least 18 years of age
- Histologically confirmed diagnosis of follicular lymphoma, Grade 1, 2, or 3, or diffuse large cell lymphoma (WHO/REAL classification). Follicular, small cleaved; Follicular, mixed small cleaved and large cell; Follicular large cell lymphoma Transformed diffuse large cell lymphoma following or concurrent with a diagnosis of follicular lymphoma.
- Stage III or IV disease at the time of study entry.
- Previously untreated or recurrent lymphoma after no more than four prior qualifying therapy regimens.
- Performance status of at least 70% on the Karnofsky Performance Scale and an anticipated survival of at least three months.
- Bi-dimensionally measurable disease with at least one lesion measuring greater than or equal to 2.0 cm x 2.0 cm (=4.0 cm2)by CT scan.
- Absolute B lymphocyte count (as determined by CD 19 reactivity)of 30 to 350 cell/mm3 within 21 days prior to study enrollment.
- ANC greater than or equal to 1500 cells/mm3; absolute lymphocyte count within normal limits; and platelet count greater than or equal to 150,000/mm3 within 21 days prior to study enrollment. Blood products and/or growth factors should not have been taken within 4 weeks prior to blood draw.
- Adequate renal function (defined as serum creatinine < 1.5 x ULN) and hepatic function (defined as total bilirubin < 1.5 x ULN and AST < 5 x ULN) within 21 days of study enrollment.
- Human Anti-Murine Antibody (HAMA) negative within 21 days prior to study enrollment.
- 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 of study enrollment. Bilateral posterior iliac crest core biopsies are required if the core obtained on a unilateral biopsy is less than 2 cm.
- Prior chemotherapy, biologic therapy, steroids, or radiation therapy as treatment for their NHL within 28 days prior to study enrollment.
- Prior Rituximab therapy within 120 days prior to study enrollment.
- Prior radioimmunotherapy.
- Prior splenectomy.
- Splenomegaly defined as spleen mass greater than 700 grams.
- Bulky disease as defined as any unidimensional measurement of lymphomatous mass exceeding 7 cm.
- Prior malignancy other than lymphoma, except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which the patient has a generally accepted risk of recurrence less than 20%.
- Central nervous system involvement by lymphoma.
- Evidence of active infection requiring IV antibiotics at the time of study enrollment.
- Known HIV infection.
- New York Heart Association class III or IV heart disease or other serious illness that would preclude evaluation.
- Active obstructive hydronephrosis.
- Evidence of clinically significant ascites or pleural effusion observed on screening physical exam or baseline CAT xcan.
- Prior myeloablative therapy.
- History of failed stem cell collection.
- Pregnant or nursing patients. Patients of childbearing potential must undergo a serum pregnancy test within 7 days of study enrollment and radiolabeled antibody is not to be administered until a negative result is obtained. Males and females of childbearing age, must agree to use effective contraception for six months following the radioimmunotherapy.
Trial location(s)
Location
Hospital of the University of Pennsylvania
Philadelphia, PA, United States, 19104
Status
Recruiting
Location
University of Michigan Medical Center
Ann Arbor, MI, United States, 48109-0936
Status
Will Be Recruiting
Location
University of Nebraska Medical Center
Omaha, NE, United States, 68198-7680
Status
Will Be Recruiting
Location
Duke University Medical Center
Durham, North Carolina, United States, 27710
Status
Recruiting
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Study complete
Actual primary completion date
2007-30-04
Actual study completion date
2007-30-04
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
Additional information
Not applicable
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