CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
Carmustine +8 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/NCT03019640
NCT03019640Phase 2Completed

Immunotherapy With Ex Vivo-Expanded Cord Blood-Derived NK Cells Combined With Rituximab High-Dose Chemotherapy and Autologous Stem Cell Transplant for B-Cell Non-Hodgkin's Lymphoma

M.D. Anderson Cancer Center·interventional·Posted Jan 12, 2017·Updated Feb 16, 2023

In Brief

A Phase 2 clinical trial evaluating Autologous Hematopoietic Stem Cell Transplantation, Carmustine, and 7 other interventions for Mantle Cell Lymphoma and 6 related conditions. Completed, enrolled 22 participants across 1 site.

Detailed Summary

This phase II trial studies the side effects of cord blood-derived expanded allogeneic natural killer cells (umbilical cord blood natural killer \[NK\] cells), rituximab, high-dose chemotherapy, and stem cell transplant in treating patients with B-cell non-Hodgkin's lymphoma that has come back (recurrent) or that does not respond to treatment (refractory). Immune system cells, such as cord blood-derived expanded allogeneic natural killer cells, are made by the body to attack foreign or cancerous cells. Immunotherapy with rituximab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carmustine, cytarabine, etoposide, lenalidomide, melphalan, and rituximab, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. A stem cell transplant using stem cells from the patient or a donor may be able to replace blood-forming cells that were destroyed by chemotherapy used to kill cancer cells. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells. Giving cord blood-derived expanded allogeneic natural killer cells, rituximab, high-dose chemotherapy, and stem cell transplant may work better in treating patients with recurrent or refractory B-cell non-Hodgkin's lymphoma.

Study Details

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 12, 2017
Enrollment StartOct 10, 2017
Primary CompletionAug 16, 2021
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 9.5 years ago

Interventions

Autologous Hematopoietic Stem Cell Transplantationprocedure

Undergo stem cell transplant

Carmustinedrug

Given IV

Cord Blood-derived Expanded Allogeneic Natural Killer Cellsbiological

Given IV

Cytarabinedrug

Given IV

Etoposidedrug

Given IV

Filgrastimbiological

Given SC

Lenalidomidedrug

Given PO

Melphalandrug

Given IV

Rituximabbiological

Given IV