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Recruitment status Terminated
Unique ID issued by UMIN UMIN000004206
Receipt No. R000004778
Scientific Title Safety and efficacy of thymoglobulin (ATG) for cord blood transplantation for hematologic malignancies
Date of disclosure of the study information 2010/09/14
Last modified on 2018/12/05

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Basic information
Public title Safety and efficacy of thymoglobulin (ATG) for cord blood transplantation for hematologic malignancies
Acronym Safety and efficacy of ATG for CBT for hematologic malignancies
Scientific Title Safety and efficacy of thymoglobulin (ATG) for cord blood transplantation for hematologic malignancies
Scientific Title:Acronym Safety and efficacy of ATG for CBT for hematologic malignancies
Region
Japan

Condition
Condition Hematologic malignancies with an indication for allogeneic hematopoietic stem cell transplantation (allo- HSCT)

Acute myeloid leukemia
Myelodysplastic syndrome
Chronic myeloid leukemia
Malignant lymphoma
Acute lymphoblastic leukemia
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the safety and efficacy of thymoglobulin (ATG) containing reduced intensity conditioning for cord blood transplantation for hematological malignancy patients with advanced age or organ dysfunction, who lack a suitable related or unrelated donor, or who require urgent allogeneic stem cell transplantation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Day 60 survival rate of patients who achieved engraftment after transplantation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 For conditioning fludarabine 30 mg/square meter for 6 days and melphalan 70mg/square meter for 2 days, and ATG 2.5mg/kg for 3 days are used.
GVHD prophylaxis consists of continuous intravenous tacrolimus (0.03mg/kg/day) given from day -1 and oral mycophenolate mofetil given at 2,250mg/day (750mg x three times) from 6h after the completion of transplantation. MMF will be discontinued at day 40 if GVHD is absent.
Graft source: HLA -A/B/DR 4/6 alleles or more matched unrelated cord blood. A minimum cell dose required is 2.5 x 10^7/kg (patient's weight)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
16 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria Patients with hematologic malignancies which are incurable by only conventional chemotherapy, and therefore has an indication for allogeneic hematopoietic stem cell transplantation.
Eligible diseases;
(a)AML
1. First CR with high risk
2. Second CR or greater
3. Relapse or failure to achieve CR after the first course of induction chemotherapy
(b)MDS
1. Patients with poor prognosis who have IPSS scores of int-2 or high
2. Transfusion dependence requiring RBC transfusion over 2 units per week or platelet transfusion over 10 units per week
(c)CML
1. Second CP or greater
2. First CP or tyrosine kinase inhibitor failure
(d)Malignant lymphoma
1. Indolent lymphoma
First relapse or greater /progression, regardless of sensitivity to prior chemotherapy
2. Agressive lymphoma
*First relapse or greater /progression
*Clinical response to prior chemotherapy : PR or CR
(e)ALL
1. CR
(2) Patients lacking a 6/6 or 5/6 HLA antigen-matched related donor
(3) Patients lacking an HLA-identical unrelated donor, or patients who require urgent transplantation due to disease status but can hardly receive transplantation from unrelated HLA-matched donor in a timely fashion
(4) ECOG performance status score:0-2
(5) Patients with no indication for myeloablative conditioning
(6) Signed informed consent

Donor eligibility criteria:
(1) CB unit preserved in the Japanese cord blood bank
(2) HLA-A, B, DR 8/8 allele match or mismatch at one or two alleles.
(3) >= 2.5 X 10^7 total nucleated cell /kg (Patient's weight)
Key exclusion criteria (1)Major organ dysfunction:
(a)Ejection fraction: <30%
(b)Pulmonary function test: %VC<30%, FEV1.0% <40%, or SaO2 <90% on room air
(c)Serum creatinine: >2.0mg/dl
(d)Liver function: total bilirubin >2.0mg/dl, AST or ALT >3 x UNL, or patients with chronic active hepatitis or liver cirrhosis
(2)Poorly controlled hypertension
(3)HIV antibody positivity
(4)Uncontrolled active infection
(5)Uncontrolled CNS invasion
(6)Pregnant, nursing or possibly pregnant woman
(7)Patients with severe mental disorder who are likely unable to participate in the study
(8)Known hypersensitivity or allergy to any of the drugs in the conditioning regimen of this transplant, or drugs used for GVHD prophylaxis
(9)Patients with positive donor-specific HLA antibodies(DSA)
(10)Patients with graft failure following allegeneic hematopoietic stem cell transplantation
(11)No indication for this study as judged by physician in charge.

Note: HBs antigen positivity and HCV antibody positivity is not excluded.
Target sample size 7

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayuki Hino
Organization Osaka City University, Graduate School of Medicine
Division name Hematology
Zip code
Address 1-4-3, Asahi-machi, Abeno-ku, Osaka, Japan. 545-8585
TEL 06-6645-3881
Email hinom@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mika Nakamae
Organization Osaka City University, Graduate School of Medicine
Division name Hematology(Clinical reserch center for hematological malignancies )
Zip code
Address 1-4-3, Asahi-machi, Abeno-ku, Osaka, Japan. 545-8585
TEL 06-6645-3881
Homepage URL
Email crc-hematology@med.osaka-cu.ac.jp

Sponsor
Institute Hematology, Osaka City University, Graduate School of Meicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2010 Year 09 Month 14 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2010 Year 09 Month 09 Day
Date of IRB
Anticipated trial start date
2011 Year 02 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 09 Month 14 Day
Last modified on
2018 Year 12 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004778

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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