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Study Summary
No. 2005-0508:.......Leukemia......Richard E. Champlin......Stem Cell Transplantation and Cellular Therapy
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Study Summary Title
Study Summary
Number:
2005-0508
Study Title:Alloreactive NK Cells with Busulfan, Fludarabine and Thymoglobulin for Allogeneic Stem Cell Transplantation for AML and MDS.
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Physician New Patient Referral
Name:Richard E. ChamplinPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Stem Cell Transplantation and Cellular TherapyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-8750
Contact us about clinical trials
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General Information
Disease Group:LeukemiaSupported By:N/A
Phase of Study:Phase IReturn
Visit:
varies from daily immediately post discharge to annually
Treatment
Agents:
Antithymocyte Globulin
Busulfan
Fludarabine
Home Care:none
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
about 28 days
Description/
Intervention:
The goal of this clinical research study is to find out if giving "alloreactive
natural killer (NK) cells" will help the result of a stem cell transplant for
patients with AML and MDS. The safety of this treatment will also be studied.
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Study Objectives / Outcomes
The primary objectives are the following:
To assess the safety of infusing alloreactive NK cells from a haploidentical relative and to determine the maximum tolerated dose of these cells given in combination with busulfan, fludarabine, Thymoglobulin and allogeneic transplantation from a separate HLA identical donor for treatment of AML/MDS.

To determine the rate of engraftment, graft-vs-host disease (GVHD), immune reconstitution and survival after infusion of alloreactive haploidentical NK cells effects.
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Study Status Information
Study Activation / Registration Date:05/05/2006
IRB Review and Approval Date:10/19/2005
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Open
Projected Accrual:48
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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 age </= 70 years with one of of the following: Acute myeloid leukemia past first remission, in first or subsequent relapse, in second or greater remission or primary induction failure; Myelodysplastic syndromes with intermediate or high risk IPSS score; CML which has progressed to accelerated phase or blast crisis despite imatinib treatment

2) Patients must have an HLA matched related or unrelated donor willing to donate for allogeneic peripheral blood progenitor cell transplantation.

3) Patients must have a haploidentical relative who is predicted to be alloreactive based upon the presence of the relevant KIR genes and incompatibility with the recipient for HLA C and Bw antigens.

4) Zubrod performance status </= 2.

5) Left ventricular ejection fraction >/= 45%. No uncontrolled arrhythmias or uncontrolled symptomatic cardiac disease.

6) No symptomatic pulmonary disease. FEV1, FVC and DLCO >/= 50% of expected, corrected for hemoglobin.

7) Serum creatinine </= 1.8mg%.

8) SGPT </= 200 IU/ml unless related to patients malignancy.

9) Bilirubin </= 1.5 mg/dl (unless Gilbert's syndrome).No evidence of chronic active hepatitis or cirrhosis. If positive hepatitis serology, discuss with Study Chairman and consider liver biopsy.

10) Patient or patient's legal representative, parent(s) or guardian able to sign informed consent.

11) No known allergy to mouse proteins or monoclonal antibodies

Exclusion Criteria:1) Uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy. The Protocol PI is the final arbiter of eligibility.

2) Pleural/pericardial effusion or ascites estimated to be >1L.

3) HIV-positive.

4) Pregnancy: Positive Beta HCG test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.

5) Known allergy to mouse proteins.

6) Patient has received other systemic chemotherapeutic drugs (including Mylotarg) within 21 days prior to trial enrollment. (Hydroxyurea or low dose ara-c < 20 mg/m2/d is permitted if indicated to control induction refractory disease, and IT chemotherapy is allowed if indicated as maintenance treatment for previously diagnosed LMD, that has been in remission for at least 3 months prior to enrollment on this study).

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Links
Registration Number: NCT00402558
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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