Phase II Study of Myeloablative Double Unit Umbilical Cord Blood Transplantation in Adult Patients

Hematologic Malignancy Clinical Trial

Official title:

Prospective Multicenter Phase II Study of Myeloablative Double Unit Umbilical Cord Blood Transplantation in Adult Patients With Hematologic Malignancies

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02385955
• Other study ID #: KSBMT200809
• Status: Not yet recruiting
• Phase: Phase 2
• First received: January 20, 2015
• Last updated: March 10, 2015
• Start date: April 2015
• Est. completion date: April 2019

Study information

• Verified date: March 2015
• Source: Seoul National University Hospital
• Contact: Sung-Soo Yoon, MD, PhD
• Phone: +82-2-2072-3079
• Email: ssysmc[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 39
• Est. completion date: April 2019
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

• Patients who have suitable cord blood units for dUCBT

• Patients with ECOG performance status 0-1

• Patients with adequate organ function: lung, kidney, liver, heart, etc.

• Informed consent

Exclusion Criteria:

• Patients who can receive hematopoietic stem cell transplantation from HLA-matched sibling or unrelated donors

• Patients who have anti-HLA antibodies

• Patients with any evidence of central nervous system (CNS) involvement of disease

• Patients with uncontrolled diabetes

• Patients with uncontrolled hypertension

• Patients with any evidence of active infection

• Positive for human immunodeficiency virus (HIV)

• 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.)

• Women who are pregnant or breastfeeding

• Patients with previous history of allogeneic stem cell transplantation

• Patients with major psychotic disorder or drug/alcohol abuser

• Inappropriate patients according to the investigators' opinion

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hematologic Malignancy
• Neoplasms

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	The Korean Society of Blood and Marrow Transplantation

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		2 years	No
Secondary	Progression-free survival		2 years	No
Secondary	Time to relapse or progression		2 years	No
Secondary	Time to engraftment		2 years	Yes
Secondary	Acute graft-versus-host disease		2 years	Yes
Secondary	Chronic graft-versus-host disease		2 years	Yes
Secondary	Non-relapse mortality		2 years	Yes
Secondary	Other transplant-related serious adverse events		2 years	Yes