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Study Summary
No. 2006-0200:.......Advanced Cancers; Blood And Marrow Transplantation......Richard E. Champlin......Stem Cell Transplantation and Cellular Therapy
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Study Summary Title
Study Summary
Number:
2006-0200
Study Title:Busulfan-Fludarabine-Clofarabine with allogeneic stem cell transplantation for advanced refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome and advanced, Gleevec refractory Chronic Myeloid Leukemia. A Randomized Phase II Study.
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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:Advanced Cancers
Blood And Marrow Transplantation
Supported By:N/A
Phase of Study:Phase IIReturn
Visit:
up to daily for the first 100 days, every 3 months for one year, yearly
thereafter x 5 years
Treatment
Agents:
Antithymocyte Globulin
Busulfan
Clofarabine
Fludarabine
Home Care:none
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
28 days
Description/
Intervention:
Unavailable
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Study Objectives / Outcomes
1.1 The primary endpoint is to determine the efficacy and optimal dose levels of clofarabine and fludarabine in combination with busulfan for treatment of high risk patients with AML, MDS and CML.

1.2 Secondary endpoints include describing engraftment, toxicity, relapse rate, long-term overall and disease-free survival.
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Study Status Information
Study Activation / Registration Date:09/25/2006
IRB Review and Approval Date:08/16/2006
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Terminated
Projected Accrual:N/A
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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) Diagnosis or 1) Acute myeloid leukemia past first remission, in first or subsequent relapse, or induction failures, 2) Myelodysplastic syndromes with intermediate or high risk International Prognostic Scoring System score (IPSS scores) (16), and having failed previous chemotherapy, or 3) Chronic Myeloid Leukemia, Philadelphia-chromosome positive and having failed / being resistant to therapy based on Gleevec or other tyrosine kinase inhibitors.

2) Patient has not been administered intensive systemic chemotherapeutic drugs within 21 days prior to trial enrollment (BMT Day –9). Gleevec, alternative tyrosine kinase inhibitors, other nonmyelosuppressive agents, low dose cytarabine, hydroxyurea is permitted if indicated to control the leukemia. All tyrosine inhibitor- or other non-myelosuppressive agents have to be terminated at least one week prior to admission for this treatment.

3) No uncontrolled infection. Protocol PI will be final arbiter if there is uncertainty regarding whether a previous infection is resolved on appropriate antibiotics therapy.

4) age </= 60

5) A related or unrelated donor who is HLA-matched or mismatched in 1 HLA, A, B, C, DR or DQ locus is acceptable (i.e. at least a 9/10 matched related or unrelated donor, matched with molecular high-resolution technique per current standard for the BMT program).

6) ZUBROD performance status <2

7) Life expectancy is not severely limited by concomitant illness.

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

9) FEV1, FVC and DLCO >/= 50% of expected corrected for hemoglobin. In patients </= 7 years pulmonary function will be assessed per pediatric BMT routine

10) Serum creatinine </= 1.5 mg%.

11) SGPT </= 200 IU/ml, serum bilirubin and alkaline phosphatase within accepted laboratory standard normal limits or considered not clinically significant. No evidence of chronic active hepatitis or cirrhosis. If positive hepatitis serology, discuss with Study Chairman and perform liver biopsy pror to determining study eligibility.

12) Female patient is not pregnant (negative B-HCG pregnancy test in all women of child-bearing-potential in accordance with departmental routine).

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

Exclusion Criteria:1) Effusion or ascites estimated to be >1L prior to drainage.

2) HIV-positive.

3) Hepatitis C or HBsAg positive

4) Prior stem cell transplant after a myeloablative conditioning program (such as busulfan-based using a total dose of >/= 12 mg/kg given by mouth or >/= 10 mg/kg IV, or a total-body irradiation-based program.

5) Active or prior CNS leukemia

6) Biphenotypic acute leukemia.

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Links
Registration Number: NCT00469014
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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