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Completed Early Phase 1 Interventional

Peripheral Blood Stem Cell (PBSC) Mobilization in Patients With Relapsed Lymphoma Treated With Bendamustine

ClinicalTrials.gov ID: NCT01022021

Public ClinicalTrials.gov record NCT01022021. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 3:15 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Adequacy of Peripheral Blood Stem Cell Mobilization in Patients With Relapsed Lymphoma Treated With Bendamustine: A Pilot Project and a Proof of Concept Study

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Patients with certain types of cancer require treatment with very high doses of chemotherapy. A side effect of high chemotherapy doses is damage to the bone marrow where our blood and immune system cells are produced. Stem cells (or progenitor cells) are the source of all blood cells. They are formed in the bone marrow (the spongy cavity in the center of large bones). The stem cells receive signals that direct them to become red cells, white cells or platelets. This happens before they are released into the blood stream. Stem cells circulating in the blood stream can be collected through a process called "apheresis" or "stem cell collection". The cells are then processed and frozen to preserve them. After chemotherapy has been given the stem cells are thawed and given back intravenously (IV: into the vein), like a blood transfusion. The stem cells in the collection will find their way back into the bone marrow space and, after a few days, will start to produce the blood and immune cells as they normally would. Having your own stem cells collected and returned to you later is called an "autologous transplant." Non-Hodgkin's lymphoma is a disease in which malignant cancer cells form in the lymph system. Autologous stem cell transplantation is the standard of care for a chemo-sensitive relapse in patients with large cell lymphoma that has spread. Bendamustine works by blocking the growth of cancer cells. It is used for the management of chronic lymphocytic leukemia and follicular lymphoma. Bendamustine in addition to rituximab (BR) is used in several trials in patients with lymphoma with encouraging results. Adequate peripheral blood stem cell (PBSC) collection is a pre-requisite for high dose therapy followed by cell transplantation in patients with relapsed lymphoma. Exposure to previous multiple chemotherapy and radiation treatment may lead to poor mobilization of PBSC. It is not known whether pre-treatment with bendamustine will adversely affect the process of PBSC mobilization and harvest. On the other hand, it is assumed that high dose alkylating agents like cyclophosphamide may actually help in breaking the bond between stem cells and the stromal cells in the marrow cavity and hence may lead to a better mobilization of PBSC.

Study identification

NCT ID
NCT01022021
Recruitment status
Completed
Study type
Interventional
Phase
Early Phase 1
Enrollment
17 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 70 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 2010 (Type not available)
Primary completion
Apr 2014 (Actual)
Completion
Aug 2015 (Actual)
Last update posted
Jan 10, 2017

2010 – 2015

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
University of Kansas Medical Center Kansas City Kansas 66205 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01022021, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 10, 2017 · Synced Oct 21, 2026

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Open the official record

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