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Study Summary
No. 2006-0075:.......Blood And Marrow Transplantation; Leukemia; Lymphoma; Pediatrics......Laura L. Worth......Pediatrics
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Study Summary Title
Study Summary
Number:
2006-0075
Study Title:Infusion of Expanded Cord Blood T cells following Cord Blood Transplantation
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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 IReturn
Visit:
After the first 100 days (+/-3 days), every 3 months (+/-1 week) during the
first year, and then annually (+/-1 week) while the subject is on the study.
Patients will be considered on study for up to 5 yrs. unless a criterion for
removal is met.
Treatment
Agents:
Etoposide
Expanded Cord Blood T Cells
Filgrastim
Fludarabine
Melphalan
Mycophenolate Mofetil
Rituximab
Tacrolimus
Thiotepa
Thymoglobulin
Total Body Irradiation
Home Care:If needed, parental nutrition, antibiotic, IV fluids and antiemetics may be
given at home.
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
Initial phase of treatment: 30 - 50 days in the inpatient unit.

Patients will be followed out patient after discharge. Readmission may be
necessary
Patients are expected to remain in Houston for 4 - 6 months.
Description/
Intervention:
The goal of this clinical research study is to learn if treating umbilical cord
blood with growth factors before a transplant can help to improve the body's
ability to accept the cord blood transplants.
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Study Objectives / Outcomes
Primary Objectives:
To evaluate the safety and feasibility of infusion of cord blood T cells, expanded ex vivo prior to infusion, following cord blood transplant in patients with hematological malignancies requiring high dose chemotherapy.

Secondary Objectives:
1. To determine the effect of infusion of ex vivo expanded cord blood T cells on the rate of infection following transplantation.

2. To determine the effect of infusion of ex vivo expanded cord blood T cells on the immune reconstitution of patients following transplantation

3. To evaluate the rate and severity of graft-versus-host disease after infusion of ex vivo expanded cord blood T cells.

4. Determine the disease-free survival, graft failure rate, relapse incidence after infusion of ex vivo expanded cord blood T cells.
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Study Status Information
Study Activation / Registration Date:09/02/2009
IRB Review and Approval Date:06/24/2008
Study Type:Phase I
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) Patient must have one of the following hematologic malignancies: a) AML, b) ALL, c) CML, d) NHL, e) HD, or f) CLL. (Select from Criteria #2 through #7)

2) Acute Myelogenous Leukemia (AML), Myelodysplastic Syndrome (MDS; Myelodyplastic syndromes with International Prognostic Scoring System score >2 or myelodysplasia that has not responded to chemotherapy): induction failure, high-risk for relapse 1st remission (with high-risk cytogenetics or FLT3 mutation), 2nd or 3rd complete remission, or 2nd relapse with less than 10% blasts in the bone marrow and/or peripheral blood.

3) Acute Lymphoblastic Leukemia (ALL): induction failure, 1st complete remission with Philadelphia chromosome or translocation, 2nd or 3rd complete remission, or 2nd relapse with less than 10% blasts in the bone marrow and/or peripheral blood.

4) Chronic Myelogenous Leukemia (CML) second chronic phase, accelerated phase or blast crisis with less than 10% blasts in the bone marrow and/or peripheral blood and failure of at least one tyrosine kinase inhibitor.

5) Non-Hodgkin's Lymphoma (NHL): Induction failures, second or third complete remission, or relapse (including relapse post autologous hematopoietic stem cell transplant).

6) Hodgkin's Disease (HD): Induction failures, second or third complete remission, or relapse (including relapse post autologous hematopoietic stem cell transplant).

7) Chronic Lymphocytic Leukemia (CLL): Failure of one multi-agent regimen including fludarabine or other nucleoside analog

8) Patient's Age Criteria: Age >/= 6 months and </= 55 years

9) Performance score of < 3 (Zubrod score).

10) Adequate major organ system function as demonstrated by: (SEE CRITERIA #11 through #14)

11) Left ventricular ejection function of >/= 50%.

12) Pulmonary function test demonstrating a diffusion capacity of at least 50% predicted. If unable to perform pulmonary function test (most children <6 years of age), pulse oximetry >/= 92% on room air.

13) Creatinine </= 1.6 mg/dL in adults and </=2 times upper limit of normal in pediatric patients.

14) SGPT/bilirubin </= 3.0 x normal.

15) Signed informed consent.

16) Negative Beta HCG or urine test in females of childbearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization and willing to use an effective contraceptive measure while on the study.

17) Cord Blood Requirements: Unrelated CB will be used as a source of hematopoietic support if a 5/6 or 6/6 related or 6/6 unrelated bone marrow donor is not available, or if the tempo of the patient's disease dictates it is not in the patient's best interest to wait for an unrelated marrow donor to be procured. The back up cord blood unit must match at 4 of 6 HLA.

18) An unrelated donor, second cord blood transplant, or autologous stem cells harvested prior to high-dose chemotherapy will be used in the event of graft failure. Based on the health status of the patient, autologous harvest may or may not occur. To be determined by the treating physician. The cord blood unit will be identified prior to enrollment in this study.

Exclusion Criteria:1) HIV positive (due to the extreme immunosuppressive nature of allogeneic stem cell transplant)

2) Patient with active (untreated) CNS disease

3) Availability of an appropriate, willing, HLA-matched related marrow donor

4) Active invasive infections.

5) Pregnant or breast-feeding

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Links
Registration Number: NCT00972101
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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