Iodine I 131 Monoclonal Antibody BC8 Before Autologous Stem Cell Transplant in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma or Non-Hodgkin Lymphoma
Adult Nasal Type Extranodal NK/T-cell Lymphoma
Anaplastic Large Cell Lymphoma
Angioimmunoblastic T-cell Lymphoma
B-cell Adult Acute Lymphoblastic Leukemia
B-cell Chronic Lymphocytic Leukemia
Cutaneous B-cell Non-Hodgkin Lymphoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Hepatosplenic T-cell Lymphoma
Nodal Marginal Zone B-cell Lymphoma
Peripheral T-cell Lymphoma
Recurrent Adult Acute Lymphoblastic Leukemia
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma
Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Adult Grade III Lymphomatoid Granulomatosis
Recurrent Adult Hodgkin Lymphoma
Recurrent Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Adult T-cell Leukemia/Lymphoma
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Marginal Zone Lymphoma
Recurrent Mycosis Fungoides/Sezary Syndrome
Recurrent Small Lymphocytic Lymphoma
Refractory Chronic Lymphocytic Leukemia
Refractory Hairy Cell Leukemia
Small Intestine Lymphoma
Splenic Marginal Zone Lymphoma
T-cell Adult Acute Lymphoblastic Leukemia
T-cell Large Granular Lymphocyte Leukemia
Radiation: iodine I 131 monoclonal antibody BC8
Procedure: autologous hematopoietic stem cell transplantation
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Study Evaluating Escalating Doses of 131I-BC8 (Anti-CD45) Antibody Followed by Autologous Stem Cell Transplantation for Relapsed or Refractory Lymphoid Malignancies|
- Estimation of the maximum tolerated dose (MTD) of I-131-BC8 that can be delivered prior to transplant [ Time Frame: Within 30 days post-transplant ] [ Designated as safety issue: Yes ]Dose escalation/de-escalation will be conducted by the "two-stage" approach introduced by Storer. Escalation will continue until a dose-limiting toxicity (DLT) occurs. A DLT will be defined as a therapy-related grade III or IV Bearman (transplant) toxicity. The MTD is estimated to be the dose that is associated with a toxicity rate of 25% (Bearman grade 3-4).
- Overall survival [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]Kaplan-Meier estimates will be calculated.
- Progression-free survival [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]Kaplan-Meier estimates will be calculated.
- Relapse rate [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]Summarized using cumulative incidence estimates combining all patients and will be utilized as a rough guide to the potential benefits and toxicities of this therapy, but no formal statistical comparisons with regard to efficacy will be made because of the phase I nature of this trial.
- Incidence of adverse events/toxicity graded using the National Cancer Institute Common Terminology Criteria for Adverse Events [ Time Frame: Up to 6 years ] [ Designated as safety issue: Yes ]Descriptive statistics will be calculated. DLT will be defined by the Bearman Scale that is designed to address the specific toxicities associated with transplantation.
|Study Start Date:||February 2009|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
Experimental: Treatment (monoclonal antibody, autologous HCT)
Patients receive a dosimetric dose of iodine I 131 monoclonal antibody BC8 IV on day -20 and a therapeutic dose on day -11. Before day -20, patients may also receive up to 2 additional dosimetric doses of iodine I 131 monoclonal antibody BC8 IV approximately 1-2 weeks apart. Patients then undergo autologous stem cell transplantation on day 0.
Radiation: iodine I 131 monoclonal antibody BC8
Other Names:Procedure: autologous hematopoietic stem cell transplantation
Autologous stem cells given via central catheterOther: laboratory biomarker analysis
I. To estimate the maximally tolerated dose of 131I-BC8 (anti-cluster of differentiation [CD]45) (iodine I 131 monoclonal antibody BC8) that can be delivered prior to autologous stem cell transplantation (ASCT) for patients with relapsed/refractory B-non-Hodgkin lymphoma (NHL), T-NHL, or Hodgkin lymphoma (HL).
I. To optimize the protein dose (antibody [Ab]) to deliver a favorable biodistribution in the majority of patients.
II. To assess the radiation dose delivered to tumor sites and normal organs by the above therapy.
III. To evaluate the dose-response relationship of radiation-dose to tumor and clinical response.
IV. To estimate the overall and progression-free survival of the above regimen in such patients.
V. To evaluate the toxicity and tolerability of the above therapy.
VI. To evaluate the feasibility of delivering high-dose 131I-BC8 and ASCT to B-Cell NHL, T-NHL, and HL patients.
VII. To evaluate the ability to reduce infusion reactions via unlabeled BC8 preinfusion.
OUTLINE: This is a dose-escalation study of iodine I 131 monoclonal antibody BC8.
Patients receive a dosimetric dose of iodine I 131 monoclonal antibody BC8 intravenously (IV) on day -20 and a therapeutic dose on day -11. Before day -20, patients may also receive up to 2 additional dosimetric doses of iodine I 131 monoclonal antibody BC8 IV approximately 1-2 weeks apart. Patients then undergo autologous stem cell transplantation on day 0.
After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months and then annually thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00860171
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Ajay K. Gopal 206-288-2037 email@example.com|
|Principal Investigator: Ajay K. Gopal|
|Principal Investigator:||Ajay Gopal||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|