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Phase II Study of Submyeloablative Conditioning Regimen Comprising Low-Dose Total Body Irradiation, Fludarabine, and Alemtuzumab Followed By Allogeneic Stem Cell Transplantation in Patients With Myeloproliferative Disorder, Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Chronic Myelogenous Leukemia

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

Phase Type Status Age Sponsor Protocol IDs
Phase II Treatment Closed Under 70 Other BCM-H-10857
NCT00069992

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.

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

Primary Outcome(s)

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

Secondary Outcome(s)

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

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.