Iodine I 131 Monoclonal Antibody BC8 Before Autologous Stem Cell Transplant in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma or Non-Hodgkin Lymphoma
|ClinicalTrials.gov Identifier: NCT00860171|
Recruitment Status : Active, not recruiting
First Posted : March 12, 2009
Results First Posted : October 12, 2017
Last Update Posted : December 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Recurrent B-Cell Non-Hodgkin Lymphoma Recurrent Hodgkin Lymphoma Recurrent T-Cell Non-Hodgkin Lymphoma Refractory B-Cell Non-Hodgkin Lymphoma Refractory Hodgkin Lymphoma Refractory T-Cell Non-Hodgkin Lymphoma||Procedure: Autologous Hematopoietic Stem Cell Transplantation Radiation: Iodine I 131 Monoclonal Antibody BC8 Other: Laboratory Biomarker Analysis||Phase 1|
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 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 autologous stem cell transplantation (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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||A single site, open label clinical trial.|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||March 2015|
Experimental: Treatment (iodine I 131 monoclonal antibody B, 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.
Procedure: Autologous Hematopoietic Stem Cell Transplantation
Autologous stem cells given via central catheter
Other Name: Autologous Stem Cell Transplantation
Radiation: Iodine I 131 Monoclonal Antibody BC8
Other: Laboratory Biomarker Analysis
- Maximum Tolerated Dose (MTD) of I-131-BC8 That Can be Delivered Prior to Transplant [ Time Frame: Within 30 days post-transplant ]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).
- I-131 Activity Administered [ Time Frame: At time of I-131 therapy ]
- Adverse Events [ Time Frame: Up to 6 years ]Descriptive statistics will be calculated. DLT will be defined by the Bearman Scale that is designed to address the specific toxicities associated with transplantation.
- Overall Survival [ Time Frame: Up to 6 years ]
- Progression-free Survival [ Time Frame: Up to 6 years ]Kaplan-Meier estimates will be calculated.
- Relapse Rate [ Time Frame: Up to 6 years ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00860171
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Ajay Gopal||Fred Hutch/University of Washington Cancer Consortium|