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Study Summary
No. 2008-0363:.......Blood And Marrow Transplantation; Leukemia; Lymphoma; Pediatrics......Laura L. Worth......Pediatrics
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Study Summary Title
Study Summary
Number:
2008-0363
Study Title:Thiotepa-Clofarabine-Busulfan with Allogeneic and Haploidentical Stem Cell Transplant for High Risk Malignancies
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Physician New Patient Referral
Name:Laura L. WorthPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:PediatricsReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-6620
Contact us about clinical trials
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General Information
Disease Group:Blood And Marrow Transplantation
Leukemia
Lymphoma
Pediatrics
Supported By:N/A
Phase of Study:Phase IIReturn
Visit:
Upon discharge patients may be required to return daily until Day +100, then 3
months, 6 months, and 12 months post-transplant or at other time points if
clinically indicated.
Treatment
Agents:
Busulfan
Clofarabine
Cyclophosphamide
MESNA
Thiotepa
Home Care:N/A
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
Approximately 30 days
Description/
Intervention:
The goal of this clinical research study is to learn if thiotepa, busulfan, and
clofarabine, when given before an allogeneic (bone marrow , blood, or cord
blood cells) or halpoidentical (bone marrow) stem cell transplantation can help
to control cancers of the bone marrow and lymph node system. The safety of this
treatment will also be studied.
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Study Objectives / Outcomes
Primary objective is to determine the safety and efficacy of a pre-transplant conditioning regimen consisting of thiotepa, busulfan, and clofarabine followed by allogeneic hematopoietic stem cell transplant for high risk malignancies.

Secondary objectives are to evaluate the engraftment, toxicity, relapse rate, rate and severity of graft-vs-host disease, disease-free and overall survival.
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Study Status Information
Study Activation / Registration Date:
IRB Review and Approval Date:11/12/2008
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Open
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) Diagnosed with one of the following diseases:

2) Acute myelogenous leukemia (AML) in induction failure, relapse, past first remission, or CR1 considered at risk for relapse

3) Myelodysplastic syndromes with International Prognostic Scoring System score (IPSS score) >/= 2 or myelodysplasia that has not responded to chemotherapy

4) Biphenotypic leukemia

5) Acute lymphocytic leukemia with induction failure, first complete remission with high risk cytogenetics (e.g. Philadelphia positive chromosome, t(4:11) Remission requiring more than 2 chemotherapy to achieve remission, or any stage beyond CR1

6) Chronic Myelogenous Leukemia (CML): second chronic phase, accelerated phase or blast crises with less than 10% blasts in the bone marrow, or CR1 and resistance to Gleevec or other tyrosine kinase inhibitors

7) Non-Hodgkin's Lymphoma - induction failures, second or third complete remission, or relapse (including relapse post autologous hematopoietic stem cell transplant)

8) Hodgkin's disease - induction failure, second or later complete remission, or relapse (including relapse post autologous hematopoietic stem cell transplant).

9) Chronic Lymphocytic Leukemia that has failed induction therapy or Rai Stages 2-4

10) Related or unrelated donor which is HLA-matched or mismatched in 1 HLA A, B, C, DR, or DQ locus is acceptable (i.e. >/= 9/10 matched related or unrelated donor, matched with molecular high-resolution technique per current std. for BMT program). Cord blood units must match patient at 4, 5, or 6/6 HLA class 1 serological & II molecular antigens with a min. of 2 x 10e7 TNC/kg recipient weight in the pre-thawed fraction. For patient lacking a matched related or unrelated donor or acceptable cord blood unit(s), a related haploidentical donor (</= 7/8 allele matched at A, B, C, DR loci) may be used.

11) Age </= 60 years.

12) Lansky performance score >/= 50% for patients </= 16 years of age, or Zubrod performance status score of 0-2 for patients > 16 years of age.

13) Cardiac function - left ventricular ejection fraction >/= 40%.

14) Pulmonary function - diffusion capacity of at least 50% predicted. Children unable to perform pulmonary function tests (e.g. less than 7 years old) pulse oximetry of >/= 92% on room air.

15) Serum creatinine < 1.6 mg/dL or creatinine clearance >/= 50 ml/min.

16) SGPT </= 200 IU/mL, serum bilirubin < 1.5 x normal.

17) Written informed consent and assent as is age appropriate.

18) No active infection.

Exclusion Criteria:1) Pregnancy in women of child bearing potential (pregnancy test performed within 2 weeks of study entry).

2) HIV positive (highly immunosupressive treatment)

3) Active CNS leukemia

4) Chronic or active Hepatitis B or Hepatitis C. If questions about liver health discuss with PI and strongly consider liver biopsy.

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Links
Registration Number: NCT00857389
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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