Iodine-131 Anti-B1 Antibody Consolidation for Patients With Non-Hodgkin's Lymphoma Following First-line CHOP

NCT01868035 | Completed Phase 2 Results DMC

• 1 other identifier: 393229/007
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multicenter study for the long-term follow-up of surviving patients who are expected to complete or who have completed at least two years of follow-up after treatment with Iodine I 131 Tositumomab (BEXXAR) on studies CP-97-011, CP-98-025, CP-99-032, or CP-99-036. All patients will be assessed for survival and disease status, including subsequent therapy for Diffuse Large B-cell Non-Hodgkin's Lymphoma (NHL), and for long-term safety. Additionally laboratory evaluations consisting of a thyroid stimulating hormone (TSH) level and a complete blood cell (CBC) count with a differential and platelet count will be obtained annually. Additionally, patients who remain in long-term response following Iodine I 131 Tositumomab treatment will be followed for response and progression.

Conditions

Lymphoma, Non-Hodgkin

Keywords

radioimmunotherapy; Iodine 131 Tositumomab

Outcome Measures

Primary Outcomes (1)

• Number of Participants With the Indicated Grade 4 Hematology Toxicities Following Iodine-131 Anti-B1 Antibody

  Hematology parameter grades were summarized according to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 2.0. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; Grade 5, death. Data are presented for those participants who experienced Grade 4 toxicities. Grade 4 hematological toxicities included absolute neutrophil count (ANC) (calculated) \<1000 cells/millimeters cubed (mm\^3), white blood cells (WBC) \<2000 cells/mm\^3, platelets \<50000 cells/mm\^3, and hemoglobin \< 8.0 grams/deciliter.

  From Baseline until Week 25 and follow-up (up to 130 months)

Secondary Outcomes (12)

• Number of Participants (Par.) With Confirmed (Con.) Complete Response (CR) Confirmed, Confirmed Complete Response Unconfirmed (CRu), Confirmed Partial Response (PR), Relapse Disease (RD), and Progressive Disease (PD)

  From Baseline until Week 25 and follow-up (up to 130 months)

• Duration of Response and Duration of Confirmed Complete Response

  From Baseline until Week 25 and follow-up (up to 130 months)

• Progression-free Survival (PFS)

  From Baseline until Week 25 and follow-up (up to 130 months)

• Time to Treatment Failure (TTF)

  From Baseline until Week 25 and follow-up (up to 130 months)

• Total Body Residence Time (TBRT)

  From Baseline until Week 25 and follow-up (up to 130 months)

Study Arms (1)

Single Arm

EXPERIMENTAL

tositumomab and iodine I-131 tositumomab

Drug: tositumomab and iodine I-131 tositumomab

Interventions

tositumomab and iodine I-131 tositumomab DRUG

Subjects received the following treatments of TST/I-131 TST by intravenous (IV) infusion: Dosimetric Dose: 450 mg of TST infused over 1 hour immediately followed by 35 mg of TST labeled with 5 milliCuries (mCi) of I 131 infused over 30 minutes. Therapeutic Dose: 7 to 14 days after the dosimetric dose, 450 mg of TST infused over 60 minutes, immediately followed by 35 mg of TST labeled with the subject-specific mCi activity of I 131 needed to deliver a total body dose of 75 centiGrays (cGy), infused over 30 minutes for subjects with a platelet count of 150,000/mm3. Subjects with platelet counts of 100,000 to 149,999/mm3 received 65 cGy, and obese subjects were dosed based upon 137% of their calculated lean body mass.

Also known as: Bexxar

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male or female subjects age 18 to 80 years, inclusive, with any International Prognostic Index score; treated with 6 or more cycles of first-line CHOP chemotherapy and achieved a PR, CRu, or CR
• de novo diffuse large B-cell NHL according to the REAL classification; Ann Arbor stage III, stage IV, or bulky stage II disease (any mass ≥10 cm in diameter)
• less than an average of 25% of the intratrabecular marrow space involved by NHL in bilateral bone marrow biopsy specimens or \<10% involvement with NHL from unilateral bone marrow biopsy; tumor tissue expressing the CD20 antigen
• ≥60% performance status on the Karnofsky Performance Scale and an anticipated survival of at least 3 months
• absolute neutrophil count (ANC) ≥1500 cells/mm3 and platelet count ≥100,000/mm3
• adequate renal function (serum creatinine \<1.5 × upper limit of normal \[ULN\]) and hepatic function (total bilirubin ≤2.0 × ULN and aspartate aminotransferase \<5 × ULN)

You may not qualify if:

• prior radiation, prior biological therapy, or prior chemotherapy other than first-line CHOP
• active bilateral obstructive hydronephrosis
• New York Heart Association class III or IV heart disease or other serious illness
• prior malignancy other than lymphoma (except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which they had been disease-free for \>5 years)
• human immunodeficiency virus infection
• HAMA positive
• brain or leptomeningeal metastases at any time since diagnosis
• active infection requiring intravenous anti-infectives
• pregnant or breastfeeding

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related Publications (1)

• Leonard JP, Gregory SA, Smith H, Horner TJ, Williams VC, Giampietro P, Lin TS. CHOP Chemotherapy Followed by Tositumomab and Iodine-131 Tositumomab for Previously Untreated Diffuse Large B-cell Lymphoma. Clin Lymphoma Myeloma Leuk. 2016 Apr;16(4):191-6. doi: 10.1016/j.clml.2015.12.011. Epub 2016 Jan 4.

  PMID: 26832194 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

tositumomab I-131

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2013
• First Posted: June 4, 2013
• Study Start: May 1, 2000
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: January 9, 2017
• Results First Posted: September 12, 2013

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share