Lymphoma, Non-HodgkinPhase 2NCT01868035
Iodine-131 Anti-B1 Antibody Consolidation for Patients With Non-Hodgkin's Lymphoma Following First-line CHOP
A Phase 2 study testing tositumomab and iodine I-131 tositumomab in people with Lymphoma, Non-Hodgkin, run by GlaxoSmithKline.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin
- What is being tested?
- tositumomab and iodine I-131 tositumomab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- May 2000to Oct 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- brain or leptomeningeal metastases at any time since diagnosis
- active infection requiring intravenous anti-infectives
- pregnant or breastfeeding
About this study
Official title: Phase II Multicenter Study of Iodine-131 Anti-B1 Antibody Consolidation For Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma Following First-line CHOP
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.
Read the detailed description
This is a phase II, open-label, multicenter study of Iodine-131 Anti-B1 Antibody consolidation for 20 patients with diffuse large B-cell non-Hodgkin's lymphoma (NHL) achieving a partial response (PR), an unconfirmed complete response (CRu), or complete response (CR) following 6-8 cycles of first-line cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy. Although the majority of patients entered in previous Iodine-131 Anti-B1 Antibody studies had low-grade or transformed low-grade NHL, 15 patients with de novo intermediate-grade NHL have been treated. Patients will undergo two dosing phases of Iodine-131 Anti-B1 Antibody.
In the first phase, termed the "dosimetric dose," patients will receive an infusion of unlabeled Anti-B1 Antibody (450 mg) over 60 minutes followed by a 30-minute infusion (including a 10-minute flush) of Anti-B1 Antibody (35 mg) that contains 5 mCi of Iodine-131. Whole body gamma camera scans will be obtained on Day 0; Day 2, 3, or 4; and Day 6 or 7 following the dosimetric dose. Using the dosimetric data from the three imaging time points, a patient-specific dose of Iodine-131 will be calculated to deliver the desired total body dose of radiotherapy. In the second phase, termed the "therapeutic dose," patients will receive a 60-minute infusion of unlabeled Anti-B1 Antibody (450 mg) followed by a 30-minute infusion (including a 10-minute flush) of 35 mg Anti-B1 Antibody labeled with a patient-specific dose of Iodine-131 calculated to deliver a 75 cGy total body radiation dose . Patients who have platelet counts of 100,000-149,999 cells/mm3 will receive 65 cGy and patients who are obese will be dosed based upon 137% of their lean body mass. Patients will be treated with saturated solution potassium iodide (SSKI), Lugol's solution, or potassium iodide tablets starting at least 24 hours prior to the first infusion of the Iodine-131 Anti-B1 Antibody (i.e., dosimetric dose) and continuing for 14 days following the last infusion of Iodine-131 Anti-B1 Antibody (i.e., therapeutic dose).
The primary endpoint of this study is to determine the incidence of Grade IV hematologic toxicity following Iodine-131 Anti-B1 Antibody consolidation for patients with diffuse large B-cell NHL who achieved a response (PR, CRu, CR) following first-line CHOP chemotherapy. The secondary efficacy endpoints are to determine the complete response rate, duration of response, duration of complete response, progression-free survival, and time to treatment failure. The pharmacokinetic endpoint is to determine the total body residence time following the dosimetric dose. The secondary safety endpoints are to determine the incidence of adverse experiences, hematologic toxicity (e.g., nadir, time to nadir, and time to recovery), use of supportive care, percent of patients converting to human anti-murine antibody (HAMA) positivity, and survival.
- Conditions
- Lymphoma, Non-Hodgkin
- Being tested
- tositumomab and iodine I-131 tositumomab
- Keywords
- radioimmunotherapy, Iodine 131 Tositumomab
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tositumomab and iodine I-131 tositumomabDrug
Also called Bexxar
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | tositumomab and iodine I-131 tositumomab Receives: Drug: tositumomab and iodine I-131 tositumomab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
CR is defined as the complete disappearance of all detectable clinical/radiographic evidence of disease, the disappearance of all disease-related symptoms if present before therapy, and normalization of biochemical abnormalities definitely assignable to non Hodgkin's lymphoma (NHL). PR is defined as a >=50% decrease in the sum of perpendicular diameters (SPPD) of splenic and hepatic nodules determined at Baseline. SD is defined as less than a PR, but not PD, which is defined as a >=50% increase from nadir in SPPD of splenic and hepatic nodules or the appearance of any new lesion during or at the end of therapy that was >1.5 centimeters (cm) by radiographic evaluation or >1.0 cm by physical examination. RD is defined as the appearance of any new lesion or an increase of >= 50% in the size of nodules. Confirmed response requires that the same or better response be confirmed by two consecutive post-therapy response evaluations at least 4 weeks apart.
Measured: From Baseline until Week 25 and follow-up (up to 130 months)
Duration of Response and Duration of Confirmed Complete Response
Duration of response for all participants with confirmed PR, confirmed CRu, or confirmed CR is defined as the time from the first documented response to the first documented progression. CR is defined as the complete disappearance of all detectable clinical/radiographic evidence of disease, the disappearance of all disease-related symptoms if present before therapy, and the normalization of biochemical abnormalities definitely assignable to NHL. PR is defined as a >=50% decrease in the sum of the perpendicular diameters (SPPD) of splenic and hepatic nodules determined at Baseline. PD is defined as a >=50% increase from nadir in SPPD of splenic and hepatic nodules or the appearance of any new lesion during or at the end of therapy that was >1.5 centimeters (cm) by radiographic evaluation or >1.0 cm by physical examination. Confirmed response requires that the same or better response be confirmed by two consecutive post-therapy response evaluations at least 4 weeks apart.
Measured: From Baseline until Week 25 and follow-up (up to 130 months)
Progression-free Survival (PFS)
PFS is defined as the time from the start of treatment to the first documented progression or death. Duration measures were calculated using Kaplan-Meier techniques. Disease progression was based on radiographic or photographic evidence, and assessments were made by the investigator. PD is defined as a >=50% increase from nadir in SPPD of splenic and hepatic nodules or the appearance of any new lesion during or at the end of therapy that was >1.5 centimeters (cm) by radiographic evaluation or >1.0 cm by physical examination.
Measured: From Baseline until Week 25 and follow-up (up to 130 months)
Time to Treatment Failure (TTF)
TTF is defined as the time from the start of treatment to the first occurrence of treatment withdrawal, decision to seek additional therapy, study removal, disease progression, or death. Duration measures were calculated using Kaplan-Meier techniques. Disease progression was based on radiographic or photographic evidence, and assessments were made by the investigator. PD is defined as a >=50% increase from nadir in SPPD of splenic and hepatic nodules or the appearance of any new lesion during or at the end of therapy that was >1.5 centimeters (cm) by radiographic evaluation or >1.0 cm by physical examination.
Measured: From Baseline until Week 25 and follow-up (up to 130 months)
Total Body Residence Time (TBRT)
TBRT is the time at which the activity of infusion is 37% of that at time zero. Whole body images from anterior and posterior gamma camera scans were collected to assess dosimetry. The assessment of organ dosimetry required gamma camera scans from at least 4 time points. Nuclear medicine reviewers conducted a visual examination of the gamma camera scans and calculated the TBRTs. Residence time is calculated from the rate of total body clearance of iodine I-131 radioactivity during the dosimetric dose. Residence time is a measure of how long the drug resides in the body.
Measured: From Baseline until Week 25 and follow-up (up to 130 months)
Number of Participants With an Adverse Experience, Including Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily have to have a casual relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or significant worsening of a pre-existing sign or symptom, or disease temporally associated with the use of a medicinal product. An SAE is defined as any experience occurring at any dose that results in the following outcomes: death, a life-threatening adverse experience, in-patient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. See the SAE/AE module for a complete list of SAEs/AEs.
Measured: From Baseline until Week 25 and follow-up (up to 130 months)
Time to Recovery From the Indicated Hematology Toxicities
Hematology toxicities included ANC (calculated), WBC count, platelet count, and hemoglobin. Time to recovery to Baseline grade for participants with Grade 0 toxicity at Baseline was defined as the time from the date of the last administration of study drug to the first post-nadir date with Grade 0 toxicity, with no other Grade 1-4 toxicities recorded during the next week. For participants with a Grade 1-4 toxicity at Baseline, time to recovery was defined as the time from the last administration of study drug to the first post-nadir date with a Baseline grade or better, with no other higher grade toxicities recorded during the next week. For participants with a nadir grade less than or equal to the Baseline grade, the time to recovery to the Baseline grade equaled the time to nadir.
Measured: From Baseline until Week 25 and follow-up (up to 130 months)
Nadir for the Indicated Hematology Toxicities
Hematology toxicities included ANC (calculated), hemoglobin, platelet count, WBC count. Nadir is defined as lowest counts that the cells reach after chemotherapy.
Measured: From Baseline until Week 25 and follow-up (up to 130 months)
Time to Nadir for the Indicated Hematology Toxicities
Hematology toxicities included ANC (calculated), WBC count, platelet count, and hemoglobin. Nadir is defined as the lowest counts (for ANC, WBC, and platelet counts)/concentration (for hemoglobin) that the cells reach after chemotherapy. Time to nadir is defined as the time from Baseline to the lowest value recorded up to 120 days following the therapeutic dose.
Measured: From Baseline until Week 25 and follow-up (up to 130 months)
Number of Participants Needing Supportive Care at Week 7 and Week 13
During the administration of unlabeled Anti-B1 antibody and Iodine-131 Anti-B1 antibody, emergency support for anaphylaxis, including epinephrine, diphenhydramine, hydrocortisone, a laryngoscope, and an endotracheal tube, was readily available. The use of steroids were discouraged unless other measures were ineffective.
Measured: Week 7 and Week 13
Number of Participants Converting to Human Anti-Murine (Mouse) Antibody (HAMA) Positivity at Any Follow-up Visit From HAMA Negativity at Baseline
The number of participants who developed human anti-murine (mouse) anibodies (HAMA) after treatment was measured.
Measured: Baseline; any follow-up visit (up to 72 months)
Overall Survival
Overall survival (time to death) is defined from the start of treatment to the date of death from any cause.
Measured: From Baseline until Week 25 and follow-up (up to 130 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startMay 2000
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01868035
- Sponsor's protocol ID
- 393229/007
- Status last verified
- Nov 2016
- First submitted
- 30 May 2013
- Last updated
- 9 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
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.
PubMed 26832194
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Multicenter Study of Iodine-131 Anti-B1 Antibody Consolidation For Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma Following First-line CHOP
- ClinicalTrials.gov ID
- NCT01868035
- Acronym / sponsor ID
- 393229/007
- Conditions
- Lymphoma, Non-Hodgkin
- Keywords
- radioimmunotherapy, Iodine 131 Tositumomab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- May 2000
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 4 Jun 2013 (estimated)
- Results
- Posted 12 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a phase II, open-label, multicenter study of Iodine-131 Anti-B1 Antibody consolidation for 20 patients with diffuse large B-cell non-Hodgkin's lymphoma (NHL) achieving a partial response (PR), an unconfirmed complete response (CRu), or complete response (CR) following 6-8 cycles of first-line cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy. Although the majority of patients entered in previous Iodine-131 Anti-B1 Antibody studies had low-grade or transformed low-grade NHL, 15 patients with de novo intermediate-grade NHL have been treated. Patients will undergo two dosing phases of Iodine-131 Anti-B1 Antibody.
In the first phase, termed the "dosimetric dose," patients will receive an infusion of unlabeled Anti-B1 Antibody (450 mg) over 60 minutes followed by a 30-minute infusion (including a 10-minute flush) of Anti-B1 Antibody (35 mg) that contains 5 mCi of Iodine-131. Whole body gamma camera scans will be obtained on Day 0; Day 2, 3, or 4; and Day 6 or 7 following the dosimetric dose. Using the dosimetric data from the three imaging time points, a patient-specific dose of Iodine-131 will be calculated to deliver the desired total body dose of radiotherapy. In the second phase, termed the "therapeutic dose," patients will receive a 60-minute infusion of unlabeled Anti-B1 Antibody (450 mg) followed by a 30-minute infusion (including a 10-minute flush) of 35 mg Anti-B1 Antibody labeled with a patient-specific dose of Iodine-131 calculated to deliver a 75 cGy total body radiation dose . Patients who have platelet counts of 100,000-149,999 cells/mm3 will receive 65 cGy and patients who are obese will be dosed based upon 137% of their lean body mass. Patients will be treated with saturated solution potassium iodide (SSKI), Lugol's solution, or potassium iodide tablets starting at least 24 hours prior to the first infusion of the Iodine-131 Anti-B1 Antibody (i.e., dosimetric dose) and continuing for 14 days following the last infusion of Iodine-131 Anti-B1 Antibody (i.e., therapeutic dose).
The primary endpoint of this study is to determine the incidence of Grade IV hematologic toxicity following Iodine-131 Anti-B1 Antibody consolidation for patients with diffuse large B-cell NHL who achieved a response (PR, CRu, CR) following first-line CHOP chemotherapy. The secondary efficacy endpoints are to determine the complete response rate, duration of response, duration of complete response, progression-free survival, and time to treatment failure. The pharmacokinetic endpoint is to determine the total body residence time following the dosimetric dose. The secondary safety endpoints are to determine the incidence of adverse experiences, hematologic toxicity (e.g., nadir, time to nadir, and time to recovery), use of supportive care, percent of patients converting to human anti-murine antibody (HAMA) positivity, and survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: tositumomab and iodine I-131 tositumomabtositumomab and iodine I-131 tositumomab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tositumomab and iodine I-131 tositumomabAlso: BexxarSubjects 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. | Drug | Single Arm |
Primary outcome
Number of Participants With the Indicated Grade 4 Hematology Toxicities Following Iodine-131 Anti-B1 Antibody
Time frame: From Baseline until Week 25 and follow-up (up to 130 months)
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.
12 secondary outcomes
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)
Time frame: From Baseline until Week 25 and follow-up (up to 130 months)
Duration of Response and Duration of Confirmed Complete Response
Time frame: From Baseline until Week 25 and follow-up (up to 130 months)
Progression-free Survival (PFS)
Time frame: From Baseline until Week 25 and follow-up (up to 130 months)
Time to Treatment Failure (TTF)
Time frame: From Baseline until Week 25 and follow-up (up to 130 months)
Total Body Residence Time (TBRT)
Time frame: From Baseline until Week 25 and follow-up (up to 130 months)
Number of Participants With an Adverse Experience, Including Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From Baseline until Week 25 and follow-up (up to 130 months)
Time to Recovery From the Indicated Hematology Toxicities
Time frame: From Baseline until Week 25 and follow-up (up to 130 months)
Nadir for the Indicated Hematology Toxicities
Time frame: From Baseline until Week 25 and follow-up (up to 130 months)
Time to Nadir for the Indicated Hematology Toxicities
Time frame: From Baseline until Week 25 and follow-up (up to 130 months)
Number of Participants Needing Supportive Care at Week 7 and Week 13
Time frame: Week 7 and Week 13
Number of Participants Converting to Human Anti-Murine (Mouse) Antibody (HAMA) Positivity at Any Follow-up Visit From HAMA Negativity at Baseline
Time frame: Baseline; any follow-up visit (up to 72 months)
Overall Survival
Time frame: From Baseline until Week 25 and follow-up (up to 130 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26832194Leonard 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.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tositumomab and iodine I-131 tositumomab in people with Lymphoma, Non-Hodgkin, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With the Indicated Grade 4 Hematology Toxicities Following Iodine-131 Anti-B1 Antibody (time frame: From Baseline until Week 25 and follow-up (up to 130 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01868035, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2017.