CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Carmustine +7 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01921387
NCT01921387Phase 2Completed

A Phase I/II Study Evaluating Escalating Doses of 90Y-BC8-DOTA (Anti-CD45) Antibody Followed by BEAM Chemotherapy and Autologous Stem Cell Transplantation for High-Risk Lymphoid Malignancies

Fred Hutchinson Cancer Center·interventional·Posted Aug 13, 2013·Updated Aug 4, 2020

In Brief

A Phase 2 clinical trial evaluating Autologous Hematopoietic Stem Cell Transplantation, Carmustine, and 6 other interventions for Recurrent B-Cell Non-Hodgkin Lymphoma and 7 related conditions. Completed, enrolled 20 participants across 1 site.

Detailed Summary

This phase I/II trial studies the side effects and the best dose of radiolabeled monoclonal antibody when given together with combination chemotherapy before stem cell transplant and to see how well it works in treating patients with high-risk lymphoid malignancies. Radiolabeled monoclonal antibodies, such as yttrium Y 90 anti-CD45 monoclonal antibody BC8, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Giving chemotherapy before a stem transplant stops the growth of cancer cells by stopping them from dividing or killing them. Stem cells collected from the patient's blood are then returned to the patient to replace the blood-forming cells that were destroyed by the radiolabeled monoclonal antibody and chemotherapy.

Study Details

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 13, 2013
Enrollment StartOct 9, 2013
Primary CompletionJul 26, 2017
Study CompletionJul 26, 2020
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 12.9 years ago

Interventions

Autologous Hematopoietic Stem Cell Transplantationprocedure

Undergo autologous PBSC transplant

Carmustinedrug

Given IV

Cytarabinedrug

Given IV

Etoposidedrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Melphalandrug

Given IV

Peripheral Blood Stem Cell Transplantationprocedure

Undergo autologous PBSC transplant

Yttrium Y 90 Anti-CD45 Monoclonal Antibody BC8radiation

Given IV