Fludarabine, Alemtuzumab, and Total-Body Irradiation Followed By Donor Stem Cell Transplant and Donor White Blood Cell Infusion in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia - Full Text View

Purpose

RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) that have been treated in the laboratory after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and alemtuzumab, and removing the T cells from the donor cells before transplant, may stop this from happening.

PURPOSE: This clinical trial is studying how well giving fludarabine, alemtuzumab, and total-body irradiation together with donor stem cell transplant and donor white blood cell infusion works in treating patients with chronic phase chronic myelogenous leukemia that did not respond to previous imatinib mesylate.

Condition	Intervention
Leukemia	Drug: alemtuzumab Drug: cyclosporine Drug: fludarabine phosphate Drug: therapeutic allogeneic lymphocytes Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation Procedure: total-body irradiation

MedlinePlus related topics:

Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for:

Fludarabine Fludarabine monophosphate Cyclosporine Cyclosporin Imatinib Imatinib mesylate Alemtuzumab Campath

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label

Official Title:	Fludarabine, Campath, TBI T-Cell Deplete NMSCT With Post-Transplant T-Cell Infusions for CML Failing Imatinib Therapy With Imatinib (STI571)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Treatment-related mortality [ Designated as safety issue: No ]
Establishment of donor engraftment using partial T-cell depletion with additional T-cell infusions [ Designated as safety issue: No ]

Study Start Date:

May 2003

Detailed Description:

OBJECTIVES:

Determine the treatment-related mortality in patients with imatinib mesylate-resistant chronic phase chronic myelogenous leukemia treated with nonmyeloablative conditioning comprising fludarabine, alemtuzumab, and total-body irradiation followed by T-cell-depleted allogeneic stem cell transplantation and post-transplantation allogeneic T-cell infusion.
Determine if donor engraftment can be safely established using partial T-cell depletion with additional T-cell infusions in these patients.

OUTLINE: Patients receive alemtuzumab IV over 5-6 hours on day -8 and fludarabine IV on days -4 to -2. Patients undergo total-body irradiation followed by T-cell-depleted (CD34+ selected) allogeneic stem cell transplantation on day 0. Patients receive allogeneic T-cell infusion on days 30 and 60. Patients also receive cyclosporine twice daily beginning on day -3 and continuing until day 100 followed by a taper until day 177.

PROJECTED ACCRUAL: Not specified.

Eligibility

Ages Eligible for Study:	4 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of chronic phase chronic myelogenous leukemia
Imatinib mesylate-resistant disease

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
No fulminant liver failure, cirrhosis with portal hypertension, alcoholic hepatitis, varices, hepatic encephalopathy, or chronic viral hepatitis with bilirubin > 3 mg/dL
LVEF > 35%
DLCO > 40% and/or receiving supplemental oxygen
HIV negative

PRIOR CONCURRENT THERAPY:

No investigational drugs within the past 30 days

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00416884

Sponsors and Collaborators

Oregon Health and Science University Cancer Institute

National Cancer Institute (NCI)

Investigators


Study Chair:	Richard Maziarz, MD	Oregon Health and Science University Cancer Institute

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000449649, OHSU-TPI-02032-L, OHSU-414, OHSU-TPI-02030-L
First Received:	December 27, 2006
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00416884
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

chronic phase chronic myelogenous leukemia

childhood chronic myelogenous leukemia

relapsing chronic myelogenous leukemia

Study placed in the following topic categories:

Cyclosporine

Chronic myelogenous leukemia

Clotrimazole

Hematologic Diseases

Miconazole

Tioconazole

Myeloproliferative Disorders

Leukemia, Myeloid

Leukemia, Myeloid, Chronic-Phase

Fludarabine monophosphate

Cyclosporins

Imatinib

Leukemia

Alemtuzumab

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Fludarabine

Bone Marrow Diseases

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

Antimetabolites, Antineoplastic

Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action

Immunologic Factors

Antineoplastic Agents

Physiological Effects of Drugs

Enzyme Inhibitors

Immunosuppressive Agents

Pharmacologic Actions

Neoplasms

Antifungal Agents

Therapeutic Uses

Antirheumatic Agents

Dermatologic Agents

ClinicalTrials.gov processed this record on October 22, 2008

Sponsors and Collaborators:	Oregon Health and Science University Cancer Institute National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00416884