Alemtuzumab, Fludarabine Phosphate, and Low-Dose Total Body Irradiation Before Donor Stem Cell Transplantation in Treating Patients With Hematological Malignancies

ClinicalTrials.gov ID: NCT00040846

Public ClinicalTrials.gov record NCT00040846. 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.

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Official title

Campath® [Alemtuzumab] Dose Escalation, Low-Dose TBI and Fludarabine Followed by HLA Class I Mismatched Donor Stem Cell Transplantation for Patients With Hematologic Malignancies - A Multi-Center Trial

Brief summary

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

This phase II trial studies the side effects and the best dose of alemtuzumab when given together with fludarabine phosphate and low-dose total body irradiation (TBI) and how well it works before donor stem cell transplant in treating patients with hematological malignancies. Giving chemotherapy and low-dose TBI before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. Also, monoclonal antibodies, such as alemtuzumab, can find cancer cells and either kill them or deliver 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. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine (CSP) and mycophenolate mofetil (MMF) after transplant may stop this from happening.

Study identification

NCT ID: NCT00040846
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: Fred Hutchinson Cancer Center; Other
Enrollment: 60 participants

Conditions and interventions

Conditions

Interventions

alemtuzumab Biological
fludarabine phosphate Drug
total-body irradiation Radiation
allogeneic hematopoietic stem cell transplantation Procedure
peripheral blood stem cell transplantation Procedure
mycophenolate mofetil Drug
cyclosporine Drug

Biological · Drug · Radiation + 1 more

Eligibility (public fields only)

Age range: Up to 74 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: Oct 31, 2001
Primary completion: Nov 30, 2009
Completion: Nov 30, 2009
Last update posted: Jan 28, 2020

2001 – 2009

United States locations

U.S. sites: 6
U.S. states: 4
U.S. cities: 4

Facility	City	State	ZIP	Site status
Presbyterian - Saint Lukes Medical Center - Health One	Denver	Colorado	80218	—
Huntsman Cancer Institute/University of Utah	Salt Lake City	Utah	84112	—
LDS Hospital	Salt Lake City	Utah	84143	—
VA Puget Sound Health Care System	Seattle	Washington	98101	—
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium	Seattle	Washington	98109	—
Froedtert Memorial Lutheran Hospital, Medical College of Wisconsin	Milwaukee	Wisconsin	53226	—

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

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00040846, 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 28, 2020 · Synced Sep 18, 2026

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