Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Objectives

Primary

1. 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

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

Entry 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

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

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

Expected Enrollment

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

Outcomes

Nonrelapse mortality at 100 days
Graft-vs-host disease (GVHD) at 100 days

Progression-free survival
Survival
Relapse
Complete remission
Acute and chronic GVHD
Toxicity
Hematopoietic engraftment

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.

Trial Contact Information

Trial Lead Organizations

Dan L. Duncan Cancer Center at Baylor College of Medicine

George Carrum, MD, Protocol chair		Ph: 713-441-1450

Registry Information
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
Trial Start Date		2001-12-04
Trial Completion Date		2007-11-14 (estimated)
Registered in ClinicalTrials.gov		NCT00069992
Date Submitted to PDQ		2003-08-06
Information Last Verified		2008-03-30

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