Phase II Study of Myeloablative Double Unit Umbilical Cord Blood Transplantation in Adult Patients
Study Details
Study Description
Brief Summary
This study aimed to evaluate the efficacy and safety of myeloablative double unit umbilical cord blood transplantation (dUCBT) in adult patients with hematologic malignancies. Two myeloablative conditioning regimens will be used in this study: (1) total body irradation (TBI), cyclophosphamide, and cytarabine, or (2) thiotepa, busulfan, and fludarabine.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Myeloablative dUCBT Myeloablative conditioning with (1) TBI, cyclophosphamide, and cytarabine, or (2) thiotepa, busulfan, and fludarabine, followed by double unit umbilical cord blood transplant |
Procedure: Myeloablative double unit cord blood transplantation
Two myeloablative conditioning regimens will be used in this study: (1) total body irradation (TBI, 12Gy), followed by cyclophosphamide (60 mg/kg/day on day -3 and -2) and cytarabine (3 g/m2 every 12 hours on day -5 and -4), or (2) thiotepa (5 mg/kg/day on day -7 and -6), busulfan (3.2 mg/kg/day on day -5, -4, and -3), and fludarabine (50 mg/m2/day on day -5, -4, and -3).
|
Outcome Measures
Primary Outcome Measures
- Overall survival [2 years]
Secondary Outcome Measures
- Progression-free survival [2 years]
- Time to relapse or progression [2 years]
- Time to engraftment [2 years]
- Acute graft-versus-host disease [2 years]
- Chronic graft-versus-host disease [2 years]
- Non-relapse mortality [2 years]
- Other transplant-related serious adverse events [2 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with hematologic malignancies requiring hematopoietic stem cell transplantation: (1) high risk acute myeloid leukemia in remission, (2) high risk acute lymphoblastic leukemia in remission, or (3) IPSS intermediate-2, high, or transfusion-dependent myelodysplastic syndrome
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Patients who have suitable cord blood units for dUCBT
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Patients with ECOG performance status 0-1
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Patients with adequate organ function: lung, kidney, liver, heart, etc.
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Informed consent
Exclusion Criteria:
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Patients who can receive hematopoietic stem cell transplantation from HLA-matched sibling or unrelated donors
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Patients who have anti-HLA antibodies
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Patients with any evidence of central nervous system (CNS) involvement of disease
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Patients with uncontrolled diabetes
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Patients with uncontrolled hypertension
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Patients with any evidence of active infection
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Positive for human immunodeficiency virus (HIV)
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Previous history of other malignancy within 5 years (Basal cell carcinoma of skin, cervical carcinoma in situ, and differentiated thyroid carcinoma with curative resection are permitted.)
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Women who are pregnant or breastfeeding
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Patients with previous history of allogeneic stem cell transplantation
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Patients with major psychotic disorder or drug/alcohol abuser
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Inappropriate patients according to the investigators' opinion
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Seoul National University Hospital
- The Korean Society of Blood and Marrow Transplantation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Mori T, Tanaka M, Kobayashi T, Ohashi K, Fujisawa S, Yokota A, Fujita H, Nakaseko C, Sakura T, Nannya Y, Takahashi S, Kanamori H, Kanda Y, Sakamaki H, Okamoto S; Kanto Study Group for Cell Therapy. Prospective multicenter study of single-unit cord blood transplantation with myeloablative conditioning for adult patients with high-risk hematologic malignancies. Biol Blood Marrow Transplant. 2013 Mar;19(3):486-91. doi: 10.1016/j.bbmt.2012.12.007. Epub 2012 Dec 16.
- Ruggeri A, Sanz G, Bittencourt H, Sanz J, Rambaldi A, Volt F, Yakoub-Agha I, Ribera JM, Mannone L, Sierra J, Mohty M, Solano C, Nabhan S, Arcese W, Gluckman E, Labopin M, Rocha V; Eurocord and Acute Leukemia Working Party of European Blood and Marrow Transplant Group. Comparison of outcomes after single or double cord blood transplantation in adults with acute leukemia using different types of myeloablative conditioning regimen, a retrospective study on behalf of Eurocord and the Acute Leukemia Working Party of EBMT. Leukemia. 2014 Apr;28(4):779-86. doi: 10.1038/leu.2013.259. Epub 2013 Sep 5.
- Sanz J, Boluda JC, Martín C, González M, Ferrá C, Serrano D, de Heredia CD, Barrenetxea C, Martinez AM, Solano C, Sanz MA, Sanz GF; Grupo Español de Trasplante Hematopoyético y Terapia Celular (GETH). Single-unit umbilical cord blood transplantation from unrelated donors in patients with hematological malignancy using busulfan, thiotepa, fludarabine and ATG as myeloablative conditioning regimen. Bone Marrow Transplant. 2012 Oct;47(10):1287-93. doi: 10.1038/bmt.2012.13. Epub 2012 Feb 13.
- Takahashi S, Ooi J, Tomonari A, Konuma T, Tsukada N, Oiwa-Monna M, Fukuno K, Uchiyama M, Takasugi K, Iseki T, Tojo A, Yamaguchi T, Asano S. Comparative single-institute analysis of cord blood transplantation from unrelated donors with bone marrow or peripheral blood stem-cell transplants from related donors in adult patients with hematologic malignancies after myeloablative conditioning regimen. Blood. 2007 Feb 1;109(3):1322-30. Epub 2006 Oct 12.
- KSBMT200809