Back to resultsSafety and Efficacy Study of Iodine-131 Anti-B1 Antibody Plus CHOP For Untreated Mantle Cell Lymphoma
Primary Purpose
Lymphoma, Mantle-Cell
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Tositumomab and Iodine I 131 Tositumomab followed by CHOP
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, Mantle-Cell focused on measuring Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP), Tositumomab, Tositumomab and Iodine I-131 tostumomab, Bexxar, Iodine-131 Anti-B1 Antibody, Mantle Cell, radioimmunotherapy
Eligibility Criteria
Inclusion Criteria:
- Patients must have a confirmed initial diagnosis of mantle cell non-Hodgkin's lymphoma by histology according to the WHO classification .
- Patients must have Ann Arbor bulky stage II, stage III, or stage IV disease at diagnosis. Bulky stage II disease is defined as a mediastinal mass greater than one-third of the maximum chest diameter, or any other mass greater than or equal to 10 cm in maximum diameter.
- Patients must have less than an average of 25% of the intratrabecular marrow space involved by NHL in bilateral bone marrow biopsy specimens as assessed microscopically at study entry. A unilateral bone marrow biopsy demonstrating <10% involvement with NHL is also adequate.
- Patients must have evidence that their tumor tissue expresses the CD20 antigen. Immunoperoxidase stains of paraffin-embedded tissue showing positive reactivity with L26 antibody or immunoperoxidase stains of frozen tissue showing positive reactivity with Anti-B1 Antibody (Coulter Clone) or similar commercially available CD20 antibody or evidence of CD20 positivity by flow cytometry are acceptable evidence of CD20 positivity. This must be performed within 42 days of study entry.
- Patients must have a performance status of at least 60% on the Karnofsky Performance Scale and an anticipated survival of at least 3 months.
- Patients must have an ANC greater than or equal to 1500 cells/mm3 and a platelet count greater than or equal to 100,000 cells/mm3 within 14 days of study enrollment. These blood counts must be sustained without support of hematopoietic cytokines or transfusion of blood products.
- Patients must have adequate renal function (defined as serum creatinine <1.5 times the upper limit of normal) and hepatic function (defined as total bilirubin <1.5 times the upper limit of normal and AST <5 times the upper limit of normal) within 14 days of study enrollment.
- Patients must have bi-dimensionally measurable disease. At least one lesion must be greater than or equal to 2.0 x 2.0 cm by computerized tomography scan.
- Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.
- Patients must have a cardiac left ventricular ejection fraction of greater than or equal to 50% by ventriculography or echocardiogram.
Exclusion Criteria:
- Patients who have received prior chemotherapy, biologic therapy, steroids, or radiation therapy as treatment for their MCL
- Patients with active obstructive hydronephrosis
- Patients with serious illness that would preclude evaluation
- Patients with prior malignancy other than lymphoma, except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for 5 years
- Patients with known HIV infection
- Patients who are HAMA positive
- Patients with known brain or leptomeningeal metastases.
- Patients who are pregnant or breastfeeding. Males and females must agree to use a contraceptive method while on study and for 6 months after receiving Iodine-131 Anti-B1 Antibody.
- Patients with active infection requiring IV anti-infectives at the time of study enrollment.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tositumomab and Iodine I 131 Tositumomab followed by CHOP
Arm Description
Tositumomab and Iodine I 131 Tositumomab followed by CHOP
Outcomes
Primary Outcome Measures
Number of Participants With the Indicated Unconfirmed Response (Complete Response, Complete Response Unconfirmed, and Partial Response)
Participants with response include those with complete response (CR: complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms), complete response unconfirmed (CRu: CR, with one of the following: residual lymph node mass >1.5 centimeters [cm] that has regressed by more than 75% in the sum of the product of the diameters or indeterminate bone marrow), or partial response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).
Secondary Outcome Measures
Number of Participants With the Indicated Confirmed Response (Confirmed Complete Response, Complete Response Unconfirmed, and Partial Response)
A confirmed response is defined as a response that was confirmed by two separate response evaluations occurring at least 4 weeks apart. Participants with a confirmed response include those with complete response (CR: complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms), complete response unconfirmed (CRu: CR, with one of the following: residual lymph node mass >1.5 cm that has regressed by more than 75% in the sum of the product of the diameters or indeterminate bone marrow), or partial response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions). The individual rows for confirmed CR, confirmed CRu, and confirmed PR represent confirmation of the same response. For example, a confirmed CR indicates that a CR was followed by another CR at least 4 weeks later.
Duration of Response for All Confirmed Responders (CR + CRu + PR)
Complete response (CR) is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms. Complete response unconfirmed (CRu) is defined as CR, with one of the following: residual lymph node mass >1.5 cm that has regressed by more than 75% in the sum of the product of the diameters or indeterminate bone marrow. Partial response (PR) is defined as a >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions. For participants with CR, CRu, or PR, duration of response is defined as the time from the first documented response to the first documented progression.
Duration of Response for All Unconfirmed Responders (CR + CRu + PR)
Complete response (CR) is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms. Complete response unconfirmed is defined as CR, with one of the following: residual lymph node mass >1.5 cm that has regressed by more than 75% in the sum of the product of the diameters or indeterminate bone marrow. Partial response (PR) is defind as a >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions. Duration of response is defined as the time from the first documented response to the first documented progression.
Duration of Response for Unconfirmed Complete Responders
Complete response is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms. Duration of response is defined as the time from the first documented response to the first documented progression.
Duration of Response for Confirmed Complete Responders
Complete response is the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms. A confirmed response is defined as a response that was confirmed by two separate response evaluations occurring at least 4 weeks apart. Duration of response is defined as the time from the first documented response to the first documented progression.
Progression-free Survival
Progression-free survival is defined as the time from the start of treatment (i.e., the dosimetric dose) to the first documented disease progression or death. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must have been greater than 2 centimeters (cm) in diameter by radiographic evaluation or greater than 1 cm in diameter by physical examination.
Time to Treatment Failure
Time to treatment failure is defined as the time from the date of the dosimetric dose to the first occurrence of treatment withdrawal, decision to seek additional therapy, study removal, disease progression, alternative therapy, or death.
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAEs are defined as those events that were fatal or immediately life-threatening, and those events that resulted in hospitalization; prolonged an existing hospitalization; resulted in disability; or was a congenital anomaly. Refer to the general AE/SAE module for a complete list of all AEs and SAEs.
Mean Nadir Value for Absolute Neutrophil Count (ANC)
Nadir is defined as the lowest laboratory value recorded following the administration of study medication. ANC is a measure of the number of neutrophil granulocytes present in the blood. Neutrophils are a type of white blood cell that fights infection.
Mean Nadir Value for Hemoglobin
Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Hemoglobin is the iron-containing oxygen-transport metalloprotein in the red blood cells.
Mean Nadir Values for Platelets and White Blood Cell (WBC) Count
Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Platelets and WBCs are types of blood cells.
Time to Nadir for the Indicated Hematology Parameters
Hematology parameters include ANC (calculated), hemoglobin, platelet count, and WBC count. Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Time to nadir is defined as the time from Baseline to the time the lowest value recorded following the therapeutic dose.
Time to Recovery From the Indicated Hematology Parameters
Hematology parameters include ANC (calculated), hemoglobin, platelet count, and WBC count. Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Time to recovery to Baseline for the indicated hematologic parameters is defined as the time required for recovery from nadir values to Baseline values.
Number of Participants Negative for Human Anti-Murine (Mouse) Antibody (HAMA) at Screening Who Converted to HAMA Positivity or Remained Negative During the Course of the Study
The number of participants who developed human anti-murine (mouse) anibodies (HAMA) after treatment was measured. Conversion to HAMA positivity is relative to Screening (participants were evaluable for HAMA analysis if they were HAMA negative at Screening).
Number of Participants With an Adverse Event of Cytopenia
The effects of iodine I-131 tositumomab on the growth and function of hematopoietic progenitor cells was measured as the number of participants who had cytopenia. An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Overall Survival
Overall survival is defined as the time from the start of treatment to the date of death from any cause.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00992992
Brief Title
Safety and Efficacy Study of Iodine-131 Anti-B1 Antibody Plus CHOP For Untreated Mantle Cell Lymphoma
Official Title
Phase II Study Of Iodine-131 Anti-B1 Antibody Plus CHOP For Patients With Previously Untreated Mantle Cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
June 28, 2001 (Actual)
Primary Completion Date
June 30, 2013 (Actual)
Study Completion Date
June 30, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
The primary efficacy endpoint of this study is to determine the duration of response of the sequential administration of Iodine-131 Anti-B1 Antibody followed by six cycles of CHOP for patients with previously untreated Mantle Cell Lymphoma (MCL). The secondary efficacy endpoints for this study are to determine the response rate, confirmed response rate, complete response rate, confirmed complete response rate, duration of response for confirmed responders, duration of response for complete responders, duration of response for confirmed complete responders, progression-free survival, time to treatment failure, and the predictive value of detection of minimal residual disease by molecular techniques on response duration. The pharmacokinetic endpoint is to determine the total body residence time of Iodine-131 Anti-B1 Antibody following the dosimetric dose. The 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, the effects of Iodine-131 Anti-B1 Antibody on the growth and function of hematopoietic progenitor cells, and survival of patients with previously untreated MCL treated with Iodine-131 Anti-B1 Antibody followed by six cycles of CHOP.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Mantle-Cell
Keywords
Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP), Tositumomab, Tositumomab and Iodine I-131 tostumomab, Bexxar, Iodine-131 Anti-B1 Antibody, Mantle Cell, radioimmunotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tositumomab and Iodine I 131 Tositumomab followed by CHOP
Arm Type
Experimental
Arm Description
Tositumomab and Iodine I 131 Tositumomab followed by CHOP
Intervention Type
Biological
Intervention Name(s)
Tositumomab and Iodine I 131 Tositumomab followed by CHOP
Intervention Description
Patients will receive an infusion of unlabeled Tositumomab (450 mg) followed by an infusion of Tositumomab (35 mg) containing 5 mCi of Iodine-131 (dosimetric dose). 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. Patients will then receive an infusion of unlabeled Tositumomab (450 mg) followed by an infusion of 35 mg Tositumomab containing a patient-specific dose of Iodine-131 calculated to deliver a 75 cGy total body radiation dose (therapeutic dose). Patients who have platelet counts of 100,000-149,000 cells/mm3 will receive 65 cGy; obese patients will be dosed based upon 137% of their lean body mass. Patients will be treated with a thyroid blocking agent 24 hours prior to the dosimetric dose and continuing for 14 days following the therapeutic dose. Approximately 13 weeks following the therapeutic dose, CHOP will be administered every 21 days for a total of 6 cycles.
Primary Outcome Measure Information:
Title
Number of Participants With the Indicated Unconfirmed Response (Complete Response, Complete Response Unconfirmed, and Partial Response)
Description
Participants with response include those with complete response (CR: complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms), complete response unconfirmed (CRu: CR, with one of the following: residual lymph node mass >1.5 centimeters [cm] that has regressed by more than 75% in the sum of the product of the diameters or indeterminate bone marrow), or partial response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).
Time Frame
Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)
Secondary Outcome Measure Information:
Title
Number of Participants With the Indicated Confirmed Response (Confirmed Complete Response, Complete Response Unconfirmed, and Partial Response)
Description
A confirmed response is defined as a response that was confirmed by two separate response evaluations occurring at least 4 weeks apart. Participants with a confirmed response include those with complete response (CR: complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms), complete response unconfirmed (CRu: CR, with one of the following: residual lymph node mass >1.5 cm that has regressed by more than 75% in the sum of the product of the diameters or indeterminate bone marrow), or partial response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions). The individual rows for confirmed CR, confirmed CRu, and confirmed PR represent confirmation of the same response. For example, a confirmed CR indicates that a CR was followed by another CR at least 4 weeks later.
Time Frame
Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)
Title
Duration of Response for All Confirmed Responders (CR + CRu + PR)
Description
Complete response (CR) is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms. Complete response unconfirmed (CRu) is defined as CR, with one of the following: residual lymph node mass >1.5 cm that has regressed by more than 75% in the sum of the product of the diameters or indeterminate bone marrow. Partial response (PR) is defined as a >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions. For participants with CR, CRu, or PR, duration of response is defined as the time from the first documented response to the first documented progression.
Time Frame
Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)
Title
Duration of Response for All Unconfirmed Responders (CR + CRu + PR)
Description
Complete response (CR) is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms. Complete response unconfirmed is defined as CR, with one of the following: residual lymph node mass >1.5 cm that has regressed by more than 75% in the sum of the product of the diameters or indeterminate bone marrow. Partial response (PR) is defind as a >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions. Duration of response is defined as the time from the first documented response to the first documented progression.
Time Frame
Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)
Title
Duration of Response for Unconfirmed Complete Responders
Description
Complete response is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms. Duration of response is defined as the time from the first documented response to the first documented progression.
Time Frame
Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)
Title
Duration of Response for Confirmed Complete Responders
Description
Complete response is the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms. A confirmed response is defined as a response that was confirmed by two separate response evaluations occurring at least 4 weeks apart. Duration of response is defined as the time from the first documented response to the first documented progression.
Time Frame
Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)
Title
Progression-free Survival
Description
Progression-free survival is defined as the time from the start of treatment (i.e., the dosimetric dose) to the first documented disease progression or death. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must have been greater than 2 centimeters (cm) in diameter by radiographic evaluation or greater than 1 cm in diameter by physical examination.
Time Frame
Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)
Title
Time to Treatment Failure
Description
Time to treatment failure is defined as the time from the date of the dosimetric dose to the first occurrence of treatment withdrawal, decision to seek additional therapy, study removal, disease progression, alternative therapy, or death.
Time Frame
Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)
Title
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
Description
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAEs are defined as those events that were fatal or immediately life-threatening, and those events that resulted in hospitalization; prolonged an existing hospitalization; resulted in disability; or was a congenital anomaly. Refer to the general AE/SAE module for a complete list of all AEs and SAEs.
Time Frame
Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)
Title
Mean Nadir Value for Absolute Neutrophil Count (ANC)
Description
Nadir is defined as the lowest laboratory value recorded following the administration of study medication. ANC is a measure of the number of neutrophil granulocytes present in the blood. Neutrophils are a type of white blood cell that fights infection.
Time Frame
Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)
Title
Mean Nadir Value for Hemoglobin
Description
Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Hemoglobin is the iron-containing oxygen-transport metalloprotein in the red blood cells.
Time Frame
Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)
Title
Mean Nadir Values for Platelets and White Blood Cell (WBC) Count
Description
Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Platelets and WBCs are types of blood cells.
Time Frame
Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)
Title
Time to Nadir for the Indicated Hematology Parameters
Description
Hematology parameters include ANC (calculated), hemoglobin, platelet count, and WBC count. Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Time to nadir is defined as the time from Baseline to the time the lowest value recorded following the therapeutic dose.
Time Frame
Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)
Title
Time to Recovery From the Indicated Hematology Parameters
Description
Hematology parameters include ANC (calculated), hemoglobin, platelet count, and WBC count. Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Time to recovery to Baseline for the indicated hematologic parameters is defined as the time required for recovery from nadir values to Baseline values.
Time Frame
Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)
Title
Number of Participants Negative for Human Anti-Murine (Mouse) Antibody (HAMA) at Screening Who Converted to HAMA Positivity or Remained Negative During the Course of the Study
Description
The number of participants who developed human anti-murine (mouse) anibodies (HAMA) after treatment was measured. Conversion to HAMA positivity is relative to Screening (participants were evaluable for HAMA analysis if they were HAMA negative at Screening).
Time Frame
Screening; at Week 7, Week 13, then every 6 months until disease progression or death (up to 143 months)
Title
Number of Participants With an Adverse Event of Cytopenia
Description
The effects of iodine I-131 tositumomab on the growth and function of hematopoietic progenitor cells was measured as the number of participants who had cytopenia. An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time Frame
Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)
Title
Overall Survival
Description
Overall survival is defined as the time from the start of treatment to the date of death from any cause.
Time Frame
Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must have a confirmed initial diagnosis of mantle cell non-Hodgkin's lymphoma by histology according to the WHO classification .
Patients must have Ann Arbor bulky stage II, stage III, or stage IV disease at diagnosis. Bulky stage II disease is defined as a mediastinal mass greater than one-third of the maximum chest diameter, or any other mass greater than or equal to 10 cm in maximum diameter.
Patients must have less than an average of 25% of the intratrabecular marrow space involved by NHL in bilateral bone marrow biopsy specimens as assessed microscopically at study entry. A unilateral bone marrow biopsy demonstrating <10% involvement with NHL is also adequate.
Patients must have evidence that their tumor tissue expresses the CD20 antigen. Immunoperoxidase stains of paraffin-embedded tissue showing positive reactivity with L26 antibody or immunoperoxidase stains of frozen tissue showing positive reactivity with Anti-B1 Antibody (Coulter Clone) or similar commercially available CD20 antibody or evidence of CD20 positivity by flow cytometry are acceptable evidence of CD20 positivity. This must be performed within 42 days of study entry.
Patients must have a performance status of at least 60% on the Karnofsky Performance Scale and an anticipated survival of at least 3 months.
Patients must have an ANC greater than or equal to 1500 cells/mm3 and a platelet count greater than or equal to 100,000 cells/mm3 within 14 days of study enrollment. These blood counts must be sustained without support of hematopoietic cytokines or transfusion of blood products.
Patients must have adequate renal function (defined as serum creatinine <1.5 times the upper limit of normal) and hepatic function (defined as total bilirubin <1.5 times the upper limit of normal and AST <5 times the upper limit of normal) within 14 days of study enrollment.
Patients must have bi-dimensionally measurable disease. At least one lesion must be greater than or equal to 2.0 x 2.0 cm by computerized tomography scan.
Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.
Patients must have a cardiac left ventricular ejection fraction of greater than or equal to 50% by ventriculography or echocardiogram.
Exclusion Criteria:
Patients who have received prior chemotherapy, biologic therapy, steroids, or radiation therapy as treatment for their MCL
Patients with active obstructive hydronephrosis
Patients with serious illness that would preclude evaluation
Patients with prior malignancy other than lymphoma, except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for 5 years
Patients with known HIV infection
Patients who are HAMA positive
Patients with known brain or leptomeningeal metastases.
Patients who are pregnant or breastfeeding. Males and females must agree to use a contraceptive method while on study and for 6 months after receiving Iodine-131 Anti-B1 Antibody.
Patients with active infection requiring IV anti-infectives at the time of study enrollment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study will be made available via the Clinical Study Data Request site.
IPD Sharing Time Frame
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD Sharing URL
https://clinicalstudydatarequest.com/Posting.aspx?ID=20064
Citations:
PubMed Identifier
32800518
Citation
Zelenetz AD, Popplewell LL, Noy A, Horner TJ, Lin TS, Donnelly G, Sgouros G, Rijo I, Divgi CR. Phase 2 Study of Iodine-131 Tositumomab Plus Chemotherapy in Patients With Previously Untreated Mantle-Cell Lymphoma. Clin Lymphoma Myeloma Leuk. 2020 Nov;20(11):749-756.e1. doi: 10.1016/j.clml.2019.04.010. Epub 2019 Apr 29.
Results Reference
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Safety and Efficacy Study of Iodine-131 Anti-B1 Antibody Plus CHOP For Untreated Mantle Cell Lymphoma
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