Low-Dose Total-Body Irradiation, Fludarabine, and Alemtuzumab Followed By Allogeneic Stem Cell Transplant in Treating Patients With Myeloproliferative Disorder, Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Chronic Myelogenous Leukemia - Full Text View

Sponsor:	Baylor College of Medicine
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00069992

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 abnormal 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).Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving a monoclonal antibody, alemtuzumab, before transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well giving low-dose total-body irradiation together with fludarabine and alemtuzumab followed by a donor stem cell transplant works in treating patients with myeloproliferative disorder, myelodysplastic syndrome, acute myeloid leukemia, or chronic myelogenous leukemia.

Condition	Intervention	Phase
Chronic Myeloproliferative Disorders Leukemia Myelodysplastic Syndromes	Biological: alemtuzumab Drug: fludarabine phosphate Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Safety And Efficacy of Sub-Myeloablative Allogeneic Stem Cell Transplantation For Patients With Myeloproliferative Disorder (MPD), Myelodysplastic Syndrome (MDS), Acute Myelogenous Leukemia (AML) or Chronic Myelogenous Leukemia

Resource links provided by NLM:

MedlinePlus related topics: Bone Marrow Transplantation Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: Fludarabine Fludarabine monophosphate Campath Alemtuzumab

U.S. FDA Resources

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

Primary Outcome Measures:

Nonrelapse mortality at 100 days [ Designated as safety issue: No ]
Graft-vs-host disease (GVHD) at 100 days [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression-free survival [ Designated as safety issue: No ]
Survival [ Designated as safety issue: No ]
Relapse [ Designated as safety issue: No ]
Complete remission [ Designated as safety issue: No ]
Acute and chronic GVHD [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]
Hematopoietic engraftment [ Designated as safety issue: No ]

Estimated Enrollment:	44
Study Start Date:	December 2001
Estimated Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Determine the safety and feasibility of a submyeloablative conditioning regimen comprising low-dose total body irradiation, fludarabine, and alemtuzumab in patients receiving allogeneic stem cell infusion for myeloproliferative disorders, myelodysplastic syndromes, acute myeloid leukemia or chronic myelogenous leukemia as defined by non-relapse mortality and graft rejection at day 100 after transplantation.

Secondary

Determine complete remission at day 100 in patients treated with this regimen.
Determine 1-year disease-free survival in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Conditioning: Patients undergo low-dose total body irradiation on day -6. Patients receive fludarabine IV over 30 minutes and alemtuzumab IV over 2 hours on days -5 to -2.
Transplantation: Allogeneic stem cells are infused on day 0. Patients are followed monthly for 1 year, then every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	up to 69 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of 1 of the following:
- Myelodysplastic syndromes with International Prognostic Scoring System score greater than 0
- One of the following myeloproliferative disorders:
  - Primary myelofibrosis with Lile score of 1 or 2
  - Polycythemia vera (PV) or essential thrombocythemia transformed to acute myeloid leukemia or myelofibrosis and PV "spent phase"
- Acute myeloid leukemia
- Chronic myelogenous leukemia
Available 5/6 or 6/6 related or unrelated (molecular typing for DRB1) healthy donor
No active CNS disease from hematologic disorder

PATIENT CHARACTERISTICS:

Age

Under 70

Performance status

Zubrod 0-2

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

No active hepatitis
No cirrhosis
Bilirubin no greater than 3 times normal
SGOT and SGPT no greater than 3 times normal

Renal

No dependence on hemodialysis

Cardiovascular

No unstable angina
No uncompensated congestive heart failure
No unstable cerebral vascular disease
No hemorrhagic stroke within the past 6 months

Pulmonary

No severe chronic pulmonary disease requiring oxygen

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 3 months after study participation
HIV negative
No concurrent uncontrolled infection
No concurrent solid organ malignancy not in remission, except stage 0 or A prostate cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00069992

Locations

United States, Texas
Dan L. Duncan Cancer Center at Baylor College of Medicine
Houston, Texas, United States, 77030
Methodist Hospital
Houston, Texas, United States, 77030
Texas Children's Hospital
Houston, Texas, United States, 77030

Sponsors and Collaborators

Baylor College of Medicine

Investigators

Study Chair:

George Carrum, MD

Baylor College of Medicine

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:	CDR0000328132, BCM-H-10857
Study First Received:	October 3, 2003
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00069992 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

polycythemia vera
essential thrombocythemia
de novo myelodysplastic syndromes
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes
chronic idiopathic myelofibrosis
chronic myelogenous leukemia

adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
childhood myelodysplastic syndromes

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Vidarabine
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Precancerous Conditions
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Leukemia, Myeloid, Acute
Leukemia
Preleukemia
Pathologic Processes
Therapeutic Uses
Syndrome

Alemtuzumab
Neoplasms by Histologic Type
Disease
Hematologic Diseases
Myelodysplastic Syndromes
Myeloproliferative Disorders
Leukemia, Myeloid
Fludarabine monophosphate
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Fludarabine
Bone Marrow Diseases

ClinicalTrials.gov processed this record on November 27, 2009