Clinical Trials Directory

Trials / Terminated

TerminatedNCT01678443

Monoclonal Antibody Therapy Before Stem Cell Transplant in Treating Patients With Relapsed or Refractory Lymphoid Malignancies

A Phase I Study Evaluating Escalating Doses of 90Y-BC8-DOTA (Anti-CD45) Antibody Followed by Autologous Stem Cell Transplantation for Relapsed or Refractory Lymphoid Malignancies

Status
Terminated
Phase
Phase 1
Study type
Interventional
Enrollment
2 (actual)
Sponsor
Fred Hutchinson Cancer Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase I trial studies the side effects and best dose of monoclonal antibody therapy before stem cell transplant in treating patients with relapsed or refractory lymphoid malignancies. Radiolabeled monoclonal antibodies, such as yttrium-90 anti-CD45 monoclonal antibody BC8, can find cancer cells and carry cancer-killing substances to them without harming normal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving radiolabeled monoclonal antibody before a stem cell transplant may be an effective treatment for relapsed or refractory lymphoid malignancies.

Detailed description

PRIMARY OBJECTIVES: I. To estimate the maximally tolerated dose (MTD) of 90Y-BC8-DOTA (anti-cluster of differentiation \[CD\]45) (yttrium-90 anti-CD45 monoclonal antibody BC8) that can be delivered prior to autologous stem cell transplantation for patients with relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL), T-cell NHL (T-NHL), and Hodgkin lymphoma (HL). SECONDARY OBJECTIVES: I. To optimize the protein dose (antibody \[Ab\]) to deliver a favorable biodistribution in the majority of patients. II. To describe the impact of rituximab concentrations, B-cell depletion, and disease burden on CD20 and CD45 targeting. III. To describe response rates and remission durations in relapsed B-NHL, T-NHL, and HL following administration of myeloablative doses of 90Y-BC8-DOTA prior to autologous stem cell transplant (ASCT). IV. To assess the correlation of lymphoma biomarkers with outcomes. OUTLINE: This is a dose-escalation study of yttrium-90 anti-CD45 monoclonal antibody BC8. Patients receive indium-111 anti-CD45 monoclonal antibody BC8 intravenously (IV) on day -28 and (if necessary) day -21 to evaluate the antibody's biodistribution. Patients then receive yttrium-90 anti-CD45 monoclonal antibody BC8 IV on day -14. Patients then undergo autologous peripheral blood stem cell transplantation on day 0. After completion of study treatment, patients are followed up at 3, 6, and 12 months and then annually thereafter.

Conditions

Interventions

TypeNameDescription
BIOLOGICALindium In 111 anti-CD45 monoclonal antibody BC8Given IV
RADIATIONyttrium Y 90 anti-CD45 monoclonal antibody BC8Given IV
PROCEDUREperipheral blood stem cell transplantationUndergo autologous peripheral blood stem cell transplant

Timeline

Start date
1999-09-01
Primary completion
2013-09-21
Completion
2018-09-27
First posted
2012-09-05
Last updated
2021-04-02
Results posted
2017-11-09

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01678443. Inclusion in this directory is not an endorsement.