Pooled Unrelated Donor Umbilical Cord Blood Transplant For Hematologic Malignancy Needing Allogeneic Stem Cell Transplant Without Related HLA-Match
NCT01500161 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1
Last updated 2013-11-25
Summary
The purpose of this study is to evaluate the multi-lineage hematopoietic chimerism for unrelated umbilical cord blood (UCB) grafts pooled from two to three cord blood units. Also to evaluate the toxicity, and antitumor responses of pooled unrelated UCB transplants.
Conditions
- Acute Myelogenous Leukemia
- Acute Lymphocytic Leukemia
- Chronic Lymphocytic Leukemia
- Chronic Myelogenous Leukemia
- Hodgkins Disease
- Non-Hodgkins Lymphoma
- Aplastic Anemia
- Multiple Myeloma
- Myelodysplastic Syndrome
Interventions
- DRUG
-
Busulfan
Busulfan 3.2 mg/kg/day intravenously on days -7, -6, -5 and -4(for non-NHL patients patients who get Clofarabine regimen)
- DRUG
-
Clofarabine
Clofarabine intravenously 40 mg/m2/day on days -7, -6, -5, -4 and -3(for non-NHL patients patients who get Busulfan regimen)
- DRUG
-
Fludarabine 30 mg/kg/day intravenously on days -7, -6, -5, -4 and -3 (for non-NHL patients who receive Melphalan containing regimen)
- DRUG
-
Melphalan
Melphalan intravenously 140 mg/m2/day on day -3 (only for non-NHL patients who receive Fludarabine OR for all NHL regimens)
- DRUG
-
Carmustine
BCNU(Carmustine)300 mg/m2 intravenously on day -7 (for NHL patients only)
- DRUG
-
Etoposide
Etoposide 300 mg/m2/day intravenously on days -6, -5, -4 and -3 (for NHL patients only)
- DRUG
-
ARA-C(Cytarabine) 100 mg/m2/day on days -6, -5, -4 and -3 (for NHL patients only)
Sponsors & Collaborators
-
Texas Oncology Cancer Center
lead INDUSTRY
Principal Investigators
-
Seah Lim, MD · Texas Oncology - Amarillo,TX
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-11-30
- Primary Completion
- 2013-11-30
- Completion
- 2013-11-30
Countries
- United States
Study Locations
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