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NCT01022021 · ClinicalTrials.gov registry record · Early Phase 1
Peripheral Blood Stem Cell (PBSC) Mobilization in Patients With Relapsed Lymphoma Treated With Bendamustine
A Early Phase 1 study, sponsored by University of Kansas Medical Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 17
- Enrollment target
NCT01022021 is a Early Phase 1 study that has completed, run by University of Kansas Medical Center. The registered enrollment target is 17 participants.
The verdict
NCT01022021, a Early Phase 1 study, has completed, sponsored by University of Kansas Medical Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
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 P
Interventions
- DRUG Rituximab
- DRUG Bendamustine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2010-01 |
| Est. Completion | 2015-08 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01022021
The ClinicalTrials.gov registry entry for NCT01022021 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Kansas Medical Center, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Rituximab is the first listed.
NCT01022021 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01022021 about?
NCT01022021 is a clinical study titled "Peripheral Blood Stem Cell (PBSC) Mobilization in Patients With Relapsed Lymphoma Treated With Bendamustine". 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 form...
What is the current status of trial NCT01022021?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 17 participants. The study started on 2010-01. Estimated completion is 2015-08.
What interventions are being tested in trial NCT01022021?
The interventions under investigation include: Rituximab (DRUG), Bendamustine (DRUG).
Who is sponsoring clinical trial NCT01022021?
This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.
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