Allogeneic Stem Cell Transplantation for Myelofibrosis - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00475020

Purpose

Primary Objective

To assess the safety of fludarabine and busulfan as a preparative regimen for allogeneic stem cell transplantation in patients with myelofibrosis as determined by non-relapse mortality.

Secondary Objective

To evaluate efficacy of this therapy as determined by:

Engraftment
Complete clinical/hematological remission
Progression free survival
Overall survival

Condition	Intervention	Phase
Myelofibrosis	Drug: Busulfan Drug: Fludarabine Drug: Thymoglobulin (ATG)	Phase II

MedlinePlus related topics: Spleen Diseases

Drug Information available for: Busulfan Fludarabine Fludarabine monophosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Allogeneic Stem Cell Transplantation for Myelofibrosis Using Reduced Intensity Busulfan and Fludarabine Conditioning

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To learn if using a combination of fludarabine, busulfan, and antithymocyte globulin (ATG) can help to control myelofibrosis in patients receiving a bone marrow or blood stem cell transplant. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate efficacy of this therapy as determined by: engraftment, complete clinical/hematological remission, progression free survival, and overall survival. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	January 2006
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Fludarabine + Busulfan + Thymoglobulin	Drug: Busulfan Test dose = 32 mg/m^2 IV x 1 day; 100 mg/m^2 IV daily over 3 hours x 4 days Drug: Fludarabine 40 mg/m^2 IV daily over 1 hour x 4 days Drug: Thymoglobulin (ATG) 2.5 mg/kg IV over 6 hours x 3 days if there is an unrelated or a mismatched donor

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Eligibility

Ages Eligible for Study:	up to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with idiopathic myelofibrosis or myelofibrosis secondary to polycythemia vera or essential thrombocythemia
Patients 70 years or younger
Patients must have an HLA matched or at least a 9/10 antigen (A, B, C, DQ, or DR) matched related or unrelated donor
Patients must have a Zubrod PS 2 or less
Creatinine < 1.6 mg/dl
Ejection fraction >/= 40%, unless cleared by cardiology
Serum direct bilirubin < 2 mg/dl (unless due to Gilbert's syndrome), SGPT </= 4 x normal values
FEV1, FVC, or DLCO >/= 40% of expected
Negative Beta HCG test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization

Exclusion Criteria:

Uncontrolled life-threatening infections
HIV positive
Patients with active viral hepatitis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00475020

Contacts

Contact: Uday Popat, MD

713-745-3055

Locations

United States, Texas
U.T. M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Uday Popat, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Uday Popat, MD

U.T.M.D. Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Uday Popat, MD/Associate Professor )
Study ID Numbers:	2005-0726
Study First Received:	May 15, 2007
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00475020 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Idiopathic Myelofibrosis
Myelofibrosis
Essential Thrombocythemia
Polycythemia Vera
Busulfan

Antithymocyte Globulin
ATG
Fludarabine
Thymoglobulin

Study placed in the following topic categories:

Antimetabolites
Polycythemia
Polycythemia Vera
Myelofibrosis
Immunologic Factors
Hematologic Diseases
Myeloproliferative Disorders
Fludarabine monophosphate
Immunosuppressive Agents
Antilymphocyte Serum
Myeloid Metaplasia

Lymphatic Diseases
Busulfan
Metaplasia
Thrombocytosis
Thrombocythemia, Hemorrhagic
Hemorrhagic Thrombocythemia
Essential Thrombocytosis
Antineoplastic Agents, Alkylating
Fludarabine
Bone Marrow Diseases
Alkylating Agents

Additional relevant MeSH terms:

Antimetabolites
Myelofibrosis
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Hematologic Diseases
Physiological Effects of Drugs
Myeloproliferative Disorders
Fludarabine monophosphate
Immunosuppressive Agents
Pharmacologic Actions

Myeloid Metaplasia
Antilymphocyte Serum
Lymphatic Diseases
Therapeutic Uses
Busulfan
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Fludarabine
Bone Marrow Diseases
Alkylating Agents
Splenic Diseases

ClinicalTrials.gov processed this record on May 07, 2009