- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00476047
Tositumomab and Iodine I 131 Tositumomab in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma in First Remission
A Study of 131I-Tositumomab (Bexxar®) Consolidation in Patients With B-Cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma in First Remission
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To estimate the progression-free survival at 2 years following administration of 131I-tositumomab (tositumomab and iodine I 131 tositumomab) in patients with CLL/SLL who achieve a complete remission (CR) or partial remission (PR) with prior therapy.
II. To improve the response rate by administering 131I-tositumomab to patients who have achieved a PR not a CR after any prior therapy.
III. To eliminate residual disease (documented by flow cytometry or polymerase chain reaction [PCR]) using 131I-tositumomab in patients who have achieved a CR after any prior therapy.
SECONDARY OBJECTIVES:
I. To evaluate the toxicities of 131I-tositumomab in 1st remission patients with previously treated CLL/SLL.
OUTLINE:
Patients receive tositumomab and iodine I 131 tositumomab intravenously (IV) over 90 minutes on day 0 and then again 7-14 days later over 30-60 minutes.
After completion of study treatment, patients are followed up weekly for 3 months, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98109
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with a diagnosis of cluster of differentiation (CD)20+ CLL/SLL; prior to the first treatment patients with CLL must have been either Rai stage III/IV disease or Rai stage I/II with evidence of disease activity as defined by the National Cancer Institute (NCI) 1996 guidelines, and patients with SLL must have been Stage III or IV per Ann Arbor staging system
- Patient has received prior therapy and is in 1st remission with a partial or complete response to treatment
- Patients must have no more than 25% of the intratrabecular marrow space involved by leukemia in bone marrow biopsy specimens as assessed microscopically after completion of treatment; bilateral posterior iliac crest core biopsies are required if the percentage of intratrabecular space involved exceeds 10% on a unilateral biopsy; the mean of bilateral biopsies must be no more than 25%
- Patient must have consented to participate in the study and signed and dated an appropriate institutional review board (IRB)-approved consent form that conforms to federal and institutional guidelines
- Patient must have a Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 (0 = fully active, able to carry on all pre-disease performance without restriction; 1 = restricted in physically strenuous activity but ambulatory and ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2 = ambulatory and capable of all self-care but unable to carry out any work activities and is up and about more than 50% of waking hours)
- Patient must have an anticipated survival of at least 3 months
- Granulocytes >= 1,500/uL within 14 days of planned dosimetric infusion
- Platelets >= 100,000/uL within 14 days of planned dosimetric infusion
- White blood count =< 20,000/mm^3
- Serum creatinine < 2 times upper limit of normal
- Total bilirubin < 2 times upper limit of normal
- Aspartate aminotransferase (AST) < 5 times upper limit of normal
- Males and females must agree to use a contraceptive method from enrollment to 6 months after receiving I-131 labeled tositumomab
Exclusion Criteria:
- Patients who have received prior radiolabeled antibody
- Patients with active hemolysis
- Patients must not require sustained transfusion support of blood products
- Patients in 2nd remission or beyond
- Patients who have undergone treatment with either stem cell or bone marrow transplant
- Patients with active obstructive hydronephrosis
- Patients with evidence of any significant systemic illness, active hepatitis B infection or other active infection at the 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 known human immunodeficiency virus (HIV) infection
- Patients who are pregnant or nursing
- Patients with prior malignancy other than CLL/SLL, except for adequately treated skin cancer (basal cell or squamous cell carcinoma), in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years unless approved by the principal investigator (PI)
- Patients with active brain or leptomeningeal involvement by malignancy
- Patients who have, in the opinion of the investigator, other medical, social, or psychosocial factors that may negatively impact compliance or their safety by participation in this study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (monoclonal antibody therapy)
Patients receive tositumomab and iodine I 131 tositumomab IV over 90 minutes on day 0 and then again 7-14 days later over 30-60 minutes.
|
Give IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Probability of Progression-free Survival (PFS)
Time Frame: 36 months
|
Progression free survival (PFS) is defined as the interval between the first treatment day to the first sign of disease progression.
This outcome measures the percentage of participants with PFS at 36 months.
|
36 months
|
Improved Response Rate After Treatment With 131I-tositumomab for Patients Who Had Evidence of CLL at the End of Initial Chemotherapy
Time Frame: 3 months after 131I-tositumomab consolidation
|
Response rates determined using National Cancer Institute (NCI) working group guidelines plus computed tomography (CT) scan criteria.
Participants were assessed for response after initial chemotherapy and again 3 months after 131I-tositumomab treatment.Only patients who had less than a complete response (CR) after initial chemotherapy were assessed for improved response after 131I-tositumomab.
|
3 months after 131I-tositumomab consolidation
|
Minimal Residual Disease (MRD) by Flow Cytometry or Polymerase Chain Reaction (PCR) in Patients Who Had a Complete Remission (CR) After Any Prior Therapy
Time Frame: 3 months after 131I-tositumomab consolidation
|
3 months after 131I-tositumomab consolidation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate Toxicities of 131I-tositumomab
Time Frame: 48 months (median)
|
Adverse events following treatment of 131I-tositumomab
|
48 months (median)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mazyar Shadman, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PSOC 2301 (Other Identifier: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium)
- P30CA015704 (U.S. NIH Grant/Contract)
- NCI-2011-01311 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stage III Small Lymphocytic Lymphoma
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedChronic Lymphocytic Leukemia | Stage III Small Lymphocytic Lymphoma | Stage IV Small Lymphocytic Lymphoma | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic Leukemia | Stage I Small Lymphocytic Lymphoma | Stage III Chronic Lymphocytic Leukemia | Stage IV Chronic Lymphocytic Leukemia and other conditionsUnited States
-
Mayo ClinicNational Cancer Institute (NCI)CompletedChronic Lymphocytic Leukemia | Stage III Small Lymphocytic Lymphoma | Stage IV Small Lymphocytic Lymphoma | Stage 0 Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic Leukemia | Stage I Small Lymphocytic Lymphoma | Stage III Chronic Lymphocytic Leukemia and other conditionsUnited States
-
Ohio State University Comprehensive Cancer CenterMorphoSys AGActive, not recruitingRecurrent Small Lymphocytic Lymphoma | Prolymphocytic Leukemia | Refractory Chronic Lymphocytic Leukemia | Stage III Small Lymphocytic Lymphoma | Stage IV Small Lymphocytic Lymphoma | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic Leukemia | Contiguous Stage II Small Lymphocytic... and other conditionsUnited States
-
National Cancer Institute (NCI)TerminatedChronic Lymphocytic Leukemia | Recurrent Small Lymphocytic Lymphoma | Prolymphocytic Leukemia | Refractory Chronic Lymphocytic Leukemia | Stage III Small Lymphocytic Lymphoma | Stage IV Small Lymphocytic Lymphoma | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic Leukemia | Stage... and other conditionsUnited States
-
National Cancer Institute (NCI)TerminatedB-cell Chronic Lymphocytic Leukemia | Stage III Small Lymphocytic Lymphoma | Stage IV Small Lymphocytic Lymphoma | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic Leukemia | Contiguous Stage II Small Lymphocytic Lymphoma | Noncontiguous Stage II Small Lymphocytic Lymphoma | Stage... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedStage III Grade 1 Follicular Lymphoma | Stage III Grade 2 Follicular Lymphoma | Stage III Grade 3 Follicular Lymphoma | Stage III Small Lymphocytic Lymphoma | Stage IV Grade 1 Follicular Lymphoma | Stage IV Grade 2 Follicular Lymphoma | Stage IV Grade 3 Follicular Lymphoma | Stage IV Small Lymphocytic...United States
-
Case Comprehensive Cancer CenterCephalonTerminatedRecurrent Small Lymphocytic Lymphoma | Refractory Chronic Lymphocytic Leukemia | Stage III Small Lymphocytic Lymphoma | Stage IV Small Lymphocytic Lymphoma | Stage III Chronic Lymphocytic Leukemia | Stage IV Chronic Lymphocytic LeukemiaUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Small Lymphocytic Lymphoma | Refractory Chronic Lymphocytic Leukemia | Stage III Small Lymphocytic Lymphoma | Stage IV Small Lymphocytic Lymphoma | Noncontiguous Stage II Small Lymphocytic LymphomaUnited States
-
University of ChicagoNational Cancer Institute (NCI)Active, not recruitingExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Nodal Marginal Zone B-cell Lymphoma | Splenic Marginal Zone Lymphoma | Waldenström Macroglobulinemia | Cutaneous B-cell Non-Hodgkin Lymphoma | Intraocular Lymphoma | Small Intestine Lymphoma | Testicular Lymphoma | B-cell... and other conditionsUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)CompletedExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Nodal Marginal Zone B-cell Lymphoma | Recurrent Grade 1 Follicular Lymphoma | Recurrent Grade 2 Follicular Lymphoma | Recurrent Grade 3 Follicular Lymphoma | Recurrent Marginal Zone Lymphoma | Splenic Marginal Zone... and other conditionsUnited States
Clinical Trials on Tositumomab and Iodine I 131 Tositumomab
-
GlaxoSmithKlineCompleted
-
GlaxoSmithKlineCompleted
-
GlaxoSmithKlineCompleted
-
GlaxoSmithKlineCompleted
-
University of Michigan Rogel Cancer CenterGlaxoSmithKlineActive, not recruitingMultiple MyelomaUnited States
-
University of NebraskaNational Cancer Institute (NCI); Coulter Pharmaceutical, Inc.Terminated
-
GlaxoSmithKlineCompletedNon-Hodgkin's LymphomaUnited States
-
GlaxoSmithKlineWithdrawnLymphoma, Follicular | Lymphoma, Non-Hodgkin | Lymphoma, Small Cleaved-Cell, Follicular | Lymphoma, Large-Cell, FollicularUnited States
-
GlaxoSmithKlineCompletedLymphoma, Non-HodgkinUnited States, France, United Kingdom
-
GlaxoSmithKlineCompleted