UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004206
Receipt number 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 11:23:00

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Hematology, Osaka City University, Graduate School of Meicine

Institute

Department

Personal name



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

Value
https://center6.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