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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
This study is ongoing, but not recruiting participants.
First Received: October 3, 2003   Last Updated: February 6, 2009   History of Changes
Sponsored by: 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 Radiation Therapy
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

Study placed in the following topic categories:
Antimetabolites
Polycythemia
Immunologic Factors
Precancerous Conditions
Leukemia, Myeloid, Acute
Leukemia
Preleukemia
Acute Myelocytic Leukemia
Acute Myeloid Leukemia, Adult
Alemtuzumab
Chronic Myeloproliferative Disorders
Thrombocytosis
Neoplasm Metastasis
Thrombocythemia, Hemorrhagic
Hemorrhagic Thrombocythemia
 Congenital Abnormalities
Polycythemia Vera
Myelofibrosis
Hematologic Diseases
Myelodysplastic Syndromes
Myeloproliferative Disorders
Leukemia, Myeloid
Fludarabine monophosphate
Immunosuppressive Agents
Myeloid Metaplasia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Essential Thrombocytosis
Fludarabine
Chronic Myelogenous Leukemia
Bone Marrow Diseases

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Precancerous Conditions
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
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
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Fludarabine
Bone Marrow Diseases

ClinicalTrials.gov processed this record on July 02, 2009



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