Tositumomab and Iodine I 131 Tositumomab in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma in First Remission

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00476047
First received: May 17, 2007
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

This phase II trial studies how well tositumomab and iodine I 131 tositumomab works in treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in first remission. Monoclonal antibodies, such as tositumomab and iodine I 131 tositumomab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer cancer-killing substances to them


Condition Intervention Phase
B-cell Chronic Lymphocytic Leukemia
Recurrent Small Lymphocytic Lymphoma
Refractory Chronic Lymphocytic Leukemia
Radiation: tositumomab and iodine I 131 tositumomab
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of 131I-Tositumomab (Bexxar®) Consolidation in Patients With B-Cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma in First Remission

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • Probability of PFS [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Change in residual disease [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Assessed by CD5, CD19, Kappa, Lambda, and CD20 levels by flow cytometry, PCR, and fluorescence in situ hybridization (FISH) in blood or bone marrow samples.

  • Change in residual disease [ Time Frame: Over 2 years ] [ Designated as safety issue: No ]
    Assessed by CD5, CD19, Kappa, Lambda, and CD20 levels by flow cytometry, PCR, and FISH in blood or bone marrow samples.

  • Change in residual disease [ Time Frame: Over 3 years ] [ Designated as safety issue: No ]
    Assessed by CD5, CD19, Kappa, Lambda, and CD20 levels by flow cytometry, PCR, and FISH in blood or bone marrow samples.

  • Change in residual disease [ Time Frame: Annually for up to approximately 5 ] [ Designated as safety issue: No ]
    Assessed by CD5, CD19, Kappa, Lambda, and CD20 levels by flow cytometry, PCR, and FISH in blood or bone marrow samples.


Secondary Outcome Measures:
  • Rate of grade 4 hematologic toxicity as defined by National Institutes of Health (NIH) Common Toxicity Criteria (CTC) v 3.0 [ Time Frame: Up to 3 months post-treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: February 2007
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Radiation: tositumomab and iodine I 131 tositumomab
Give IV
Other Names:
  • Bexxar
  • Bexxar therapeutic regimen
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To estimate the progression-free survival (PFS) at 2 years following administration of 131I-tositumomab (tositumomab and iodine I 131 tositumomab) in patients with CLL/SLL who achieve a complete response (CR) or partial response (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00476047

Locations
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Principal Investigator: John Pagel Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

No publications provided

Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00476047     History of Changes
Other Study ID Numbers: PSOC 2301, NCI-2011-01311
Study First Received: May 17, 2007
Last Updated: March 3, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Iodine-131 anti-B1 antibody
Antibodies, Monoclonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014