UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004681
Receipt number R000005573
Scientific Title Multicenter clinical trial of reduced-intensity conditioning regimen for unrelated bone marrow transplantation with fludarabine, iv busulfan, and low-dose ATG-F
Date of disclosure of the study information 2010/12/08
Last modified on 2010/12/08 07:44:19

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Basic information

Public title

Multicenter clinical trial of reduced-intensity conditioning regimen for unrelated bone marrow transplantation with fludarabine, iv busulfan, and low-dose ATG-F

Acronym

U-RIST ATG protocol

Scientific Title

Multicenter clinical trial of reduced-intensity conditioning regimen for unrelated bone marrow transplantation with fludarabine, iv busulfan, and low-dose ATG-F

Scientific Title:Acronym

U-RIST ATG protocol

Region

Japan


Condition

Condition

Hematologic malignancy

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To test feasibility and efficacy of reduced-intensity conditioning regimen for unrelated bone marrow transplantation with fludarabine, iv busulfan, and low-dose ATG-F.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Day 100 survival with donor cell engraftment

Key secondary outcomes

1-year OS and PFS
1-year non-relapse mortality
Primary and secondary graft failure
Time to neutrophil engraftment and complete chimerism
Acute and chronic GVHD
Regimen-related toxicity (CTCAE ver 3.0)
Relapse or progression
Bacterial, fungal, and viral infection
Immune reconstitution


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

(1) Fludarabine, 30 mg/m2/day, div, on days -8 to -3
(2) Busulfan, 3.2 mg/kg/day div, divided into 4 doses, on days -6 and -5
(3) Anti-T-lymphocyte immunoglobulin (ATG-Fresenius), 5 mg/kg/day div, on day -2

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

65 years-old >=

Gender

Male and Female

Key inclusion criteria

(1) Hematologic malignancy
(a) Acute myeloid leukemia
High risk CR1
CR2 or later CR
Relapse or primary refractory*
*who do not require chemotherapy for 1 month

(b) Myelodysplastic syndrome
IPSS intermediate-2 or high
Require blood transfusion of 10 units/week platelet or 2 units/week red blood cell
*Patients who have not received standard chemotherapy are ineligible.

(c) Chronic myeloid leukemia
CP2 or later CP
CP1 with gleevec failure
*Patients who have not received standard chemotherapy are ineligible.

(d) Malignant lymphoma
1. Indolent lymphoma including chronic lymphocytic leukemia
*First or later relapse/progression.
2. Aggressive lymphoma or Hodgkin lymphoma
*First or later relapse/progression with sensitivity to prior chemotherapy.

(2) No available HLA 6/6 matched or 5/6 matched related donor.

(3) Available HLA 8/8, 7/8, or 6/8 allele-matched unrelated donor

(4) Age at transplantation: between 16 years and 65 years

(5) ECOG performance status: 0 or 1

(6) Ineligible for myeloablative conditioning due to (A) older age (50 years or older), (B) organ dysfunction as mentioned below, or (C) a history of high-dose chemotherapy or total-body irradiation followed by autologous hematopoietic stem cell transplantation within 6 months.
(a) EF 40%-50%
(b) %VC 30%-40%, FEV1.0% 40%-50%, or PaO2 60-80 mmHg or SO2 90-95% on room air
(c) Serum Cr 1.5-2.0 mg/dl or above
(d) Serum bilirubin 1.5-2.0 mg/dl or ALT(GPT) 2-3xUNL

(7) Obtained informed consent from patients

(8) Expected to live at least 3 months after transplantation

Key exclusion criteria

(1) Patients with organ dysfunction as defined below are excluded.
(a) EF <40%
(b) %VC <30%, FEV1.0% <40%, or PaO2 <50 mmHg or SO2 <90% on room air
(c) Serum Cr 2.0 mg/dl or above
(d) Serum bilirubin >2.0 mg/dl, ALT(GPT) >3xUNL, chronic active hepatitis, or liver cirrhosis.

(2) Uncontrollable hypertension

(3) Positive anti-HIV antibody

(4) Uncontrollable active infection

(5) Uncontrollable CNS disease

(6) During pregnancy or breast-feeding

(7) Patients with severe psychiatric problems

(8) Allergy to drugs for conditioning and GVHD prophylaxis

(9) Patients who are considered as ineligible by attending physicians

Target sample size

27


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Fukuda, Takahiro

Organization

National Cancer Center Hospital

Division name

Hematopoietic Stem Cell Transplantation Division

Zip code


Address

5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045 Japan

TEL

03-3542-2511

Email



Public contact

Name of contact person

1st name
Middle name
Last name Fukuda, Takahiro

Organization

National Cancer Center Hospital

Division name

Hematopoietic Stem Cell Transplantation Division

Zip code


Address

5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045 Japan

TEL

03-3542-2511

Homepage URL


Email



Sponsor or person

Institute

National Cancer Center Hospital

Institute

Department

Personal name



Funding Source

Organization

Grants from the Japanese Ministry of Health, Labor and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


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

国立がん研究センター中央病院(東京都)
東京慈恵会医科大学附属病院(東京都)
横浜市立大学附属病院(神奈川県)
国立病院機構熊本医療センター(熊本県)
大阪市立大学医学部附属病院(大阪府)
三重大学医学部附属病院(三重県)
信州大学医学部附属病院(長野県)
国際医療センター戸山病院(東京都)
東京都立駒込病院(東京都)
金沢大学附属病院(石川県)
和歌山県立医科大学(和歌山県)


Other administrative information

Date of disclosure of the study information

2010 Year 12 Month 08 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

Open public recruiting

Date of protocol fixation

2008 Year 03 Month 18 Day

Date of IRB


Anticipated trial start date

2009 Year 01 Month 01 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 12 Month 08 Day

Last modified on

2010 Year 12 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005573


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name