MDACC Study Summary 2005-0726

Study Summary
No. 2005-0726:.......Blood And Marrow Transplantation; Hematologic Disorder; Leukemia......Uday Popat......Stem Cell Transplantation and Cellular Therapy

Study Summary Title



Study Summary Number:	2005-0726

Study Title:	Allogeneic stem cell transplantation for myelofibrosis using reduced intensity busulfan and fludarabine conditioning.

Physician

New Patient Referral



Name:	Uday Popat	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Stem Cell Transplantation and Cellular Therapy	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-3055 Contact us about clinical trials

General Information



Disease Group:	Blood And Marrow Transplantation Hematologic Disorder Leukemia	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Patients are followed continuously at MDACC until 100 days post transplant then q 3 mo for one year and q 6 months for second year after transplant and annually thereafter

Treatment Agents:	Busulfan Fludarabine Thymoglobulin	Home Care:	None

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	Four weeks


Description/ Intervention:	The goal of this clinical research study is 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. The safety of these drugs will also be studied.

Study Objectives / Outcomes

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:

1.1 Engraftment
1.2 Complete clinical/hematological remission
1.3 Progression free survival
1.4 Overall survival

Study Status Information



Study Activation / Registration Date:	01/04/2006

IRB Review and Approval Date:	12/07/2005

Study Type:	Therapeutic

Recruitment Status:	Open

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patients with Idiopathic Myelofibrosis or Myelofibrosis secondary to Polycythemia Vera or Essential Thrombocythemia or Myelodysplastic syndrome with or without fibrosis.

2) Patients 75 years or younger

3) Patients must have an HLA matched or at least a 9/10 antigen (A, B, C, DQ or DR) matched related or unrelated donor.

4) Patients must have a Zubrod PS 2 or less.

5) Creatinine < 1.6 mg/dl

6) Ejection fraction >/= 40%, unless cleared by cardiology

7) Serum direct bilirubin < 2 mg/dl (unless due to Gilbert's syndrome), SGPT </= 4 x normal values

8) FEV1, FVC, or DLCO >/= 40% of expected.

9) 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:

1) Uncontrolled life-threatening infections

2) HIV positive

3) Patients with Active viral hepatitis

Links

Registration Number: NCT00475020
Study Information on Clinical Trials Registry (clinicaltrials.gov)