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 - Tabular View

Tracking Information

First Received Date ^ICMJE

October 3, 2003

Last Updated Date

February 6, 2009

Start Date ^ICMJE

December 2001

Estimated Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00069992 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label

Condition ^ICMJE

Chronic Myeloproliferative Disorders
Leukemia
Myelodysplastic Syndromes

Intervention ^ICMJE

Biological: alemtuzumab
Drug: fludarabine phosphate
Procedure: allogeneic bone marrow transplantation
Procedure: peripheral blood stem cell transplantation
Radiation: radiation therapy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Estimated Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 69 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00069992

Responsible Party

Study ID Numbers ^ICMJE

CDR0000328132, BCM-H-10857

Study Sponsor ^ICMJE

Baylor College of Medicine

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

George Carrum, MD

Baylor College of Medicine

Information Provided By

National Cancer Institute (NCI)

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP