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

Sponsors and Collaborators:	OHSU Knight Cancer Institute National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00416884

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	Biological: alemtuzumab Biological: therapeutic allogeneic lymphocytes Drug: cyclosporine Drug: fludarabine phosphate Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation Radiation: total-body irradiation

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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Radiation Therapy

Drug Information available for: Fludarabine Cyclosporine Fludarabine monophosphate Cyclosporin Campath Alemtuzumab

U.S. FDA Resources

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

OHSU Knight Cancer Institute

National Cancer Institute (NCI)

Investigators

Study Chair:

Richard Maziarz, MD

OHSU Knight Cancer Institute

More Information

Additional Information:

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

No publications provided

Study ID Numbers:	CDR0000449649, OHSU-TPI-02032-L, OHSU-414, OHSU-TPI-02030-L
Study First Received:	December 27, 2006
Last Updated:	April 4, 2009
ClinicalTrials.gov Identifier:	NCT00416884 History of Changes
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:

Antimetabolites
Anti-Infective Agents
Cyclosporine
Immunologic Factors
Hematologic Diseases
Myeloproliferative Disorders
Leukemia, Myeloid
Leukemia, Myeloid, Chronic-Phase
Fludarabine monophosphate
Immunosuppressive Agents

Cyclosporins
Imatinib
Leukemia
Antifungal Agents
Alemtuzumab
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Chronic Myelogenous Leukemia
Fludarabine
Antirheumatic Agents
Bone Marrow Diseases

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Cyclosporine
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Leukemia, Myeloid, Chronic-Phase
Cyclosporins
Leukemia
Alemtuzumab
Antifungal Agents
Therapeutic Uses

Dermatologic Agents
Neoplasms by Histologic Type
Hematologic Diseases
Myeloproliferative Disorders
Enzyme Inhibitors
Fludarabine monophosphate
Leukemia, Myeloid
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Fludarabine
Bone Marrow Diseases
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 11, 2009