A Phase 1 interventional study of 131Iodine-Anti-B1 Radioimmunotherapy and BEAM in Lymphoma, sponsored by University of Nebraska. Completed at 1 site in United States. Open to participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-10-10.
Sponsored by University of Nebraska · Phase 1, Interventional, and Treatment
The purpose of this study is to assess the safety of 131I-anti-B1 Radioimmunotherapy when combined with high-dose BEAM or BEAC chemotherapy and hematopoietic stem cell transplantation. The study will also compare the difference in response rates and time to treatment failure between historical control patients receiving high-dose BEAM or BEAC chemotherapy with autologous hematopoietic stem cell transplant and patients receiving radioimmunotherapy and high-dose BEAM or BEAC chemotherapy with autologous hematopoietic stem cell transplant. Patients will receive escalating doses of radioimmunotherapy with anti-B1 radiolabeled with 131Iodine, high-dose carmustine, etoposide, cytarabine and Melphalan (BEAM) chemotherapy, and autologous hematopoietic stem cell transplant.
Thirty patients will be enrolled in this study. There will be two administrations of 131I-anti-B1 given to patients, the "dosimetric dose" and the "radioimmunotherapy dose". The dosimetric dose will consist of an infusion of unlabeled Anti-B1 (450 mg) immediately followed by an infusion of Anti-B1 (35 mg) which has been trace labeled with 5mCi of 131I-anti-B1. The total whole body dosimetry dose is then calculated over an approximated one-week time interval from the radioactive clearance data obtained by the Whole Body anterior and posterior gamma camera scans. Based upon dosimetric data calculations specific for each individual patient, a radioimmunotherapy dose will be given consisting of an infusion of unlabeled Anti-B1 (450 mg)immediately followed by an infusion of 35 mg Anti-B1 including a patient specific dose of 131Iodine-Anti-B1. Calculations will be made such that in a dose escation study, whole body radiation doses of 30, 45, 60, and 75cGy will result from the administration of the therapeutic activity of 131I-anti-B1. The amount of the unlabeled Anti-B1 administered is not calculated on a body surface area basis, but is given to provide an excess of Anti-B1 independent of tumor burden, splenic uptake, or other causes.
5,623 studies on the registry are indexed under Lymphoma; 823 are open to participants now.
This study's enrollment of 34 is below the median of 40 across 4,534 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →University of Nebraska is the lead sponsor of 495 studies on the registry; 68 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 52 (63%) have results posted.
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Exclusion Criteria:
BEAM + 131Iodine-Anti-B1 radioimmunotherapy and autologous HSCT
Radiation: 131Iodine-Anti-B1 Radioimmunotherapy · Drug: BEAM
Dosimetric dose of 450 mg unlabeled Anti-B1 followed by 35 mg Anti-B1 which has been trace labeled with 5mCi of 131I-Anti-B1.
Carmustine (B) also known as BCNU Etoposide (E) Cytarabine (A) also known as Ara-C and cytosine arabinoside Melphalan (M) also known as alkeran
Also known as: Carmustine, Etoposide, Cytarabine, and Melphalan
Safety of 131I-anti-B1 radioimmunotherapy when combined with high-dose BEAM or BEAC chemotherapy & HSCT
Safety of 131I-anti-B1 radioimmunotherapy when combined with high-dose BEAM or BEAC chemotherapy \& HSCT. Calculations will be made such that in a dose escation study, whole body radiation doses of 30, 45, 60, and 75cGy will result from the administration of the therapeutic activity of 131I-anti-B1.
Time frame: During treatment
Comparing high-dose BEAM or BEAC chemo. with autologous HSCT and radioimmunotherapy and high-dose BEAM or BEAC chemo. with autologous HSCT
Difference in response rates/time to treatment failure between historical control patients receiving high-dose BEAM or BEAC chemo. with autologous HSCT and pateints receiving radioimmunotherapy and high-dose BEAM or BEAC chemo. with autologous HSCT
Time frame: time of registration to time of treatment discontinuation
Ran from Mar 1996 to primary completion in Nov 2014, 223 months.
Of 276 non-industry phase 1 interventional studies under Lymphoma, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 76. This study's 223 months is above that.
Counting every sponsor, half of 537 studies reached it within 47 months; a quarter within 30 and three quarters within 70.
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This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: BEAM regimen