UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023548
Receipt number R000027122
Scientific Title Hematopoietic stem cell transplantation from HLA fully mismatched family members for post-transplant relapse/rejection (phase I/II trial)
Date of disclosure of the study information 2016/08/09
Last modified on 2017/02/01 21:00:06

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Basic information

Public title

Hematopoietic stem cell transplantation from HLA fully mismatched family members for post-transplant relapse/rejection (phase I/II trial)

Acronym

HLA fully mismatched hematopietic stem cell transplantation

Scientific Title

Hematopoietic stem cell transplantation from HLA fully mismatched family members for post-transplant relapse/rejection (phase I/II trial)

Scientific Title:Acronym

HLA fully mismatched hematopietic stem cell transplantation

Region

Japan


Condition

Condition

hematologic malignancies relapesd/rejected after allogeneic stem cell transplantation

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety and efficacy of stem cell transplantation from HLA fully mismatched family members for hematologic malignancies relapsed or rejected after allogeneic transplantation

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase I,II


Assessment

Primary outcomes

Rate of donor cell engraftment (defined as Neutrophil >500/microL with >90% of donor origin) on day 35

Key secondary outcomes

a) Incidence and severity of chronic GVHD
b) transplantion-associated complications, including TMA
c) survival rate
d) relapse rate
e) other adverse effects (CTCAE)

within three months


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

The basic structure of the preconditioning regimen consists of fludarabine (FLU) at 30 mg/m2/day for 6 days (days -9 and -4), melphalan (MEL) at 70 mg/ m2/day for 2 days (days -3 and -2), and rabbit anti-thymocyte globulin (ATG, Thymoglobulin, Sanofi) at 1.25 mg/kg/day for 2 days (days -2 and -1). To ensure engraftment, 3 Gy of total body irradiation (TBI) was added. For active diseases, high-dose cytarabine (CA) at 2 g/m2/day for 4 days (days -9 and -6) was added for the purpose of tumor reduction. To prevent anaphylaxis caused by ATG, methylprednisolone (mPSL) was administered at 2 mg/kg on days -2 and -1. GVHD prophylaxis consists of the continuous infusion of TAC with a target concentration of 10-12 ng/mL started from day -3, 1 mg/kg/day of mPSL started after day 0, and 15 mg/kg/day of MMF started from day 3 (Table 1). Peripheral blood stem cells (PBSC) were used as a stem cell source, which were infused without being frozen. G-CSF was administered from day 3 to the day of engraftment.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with hematologic malignancies relapsed or rejected after allogeneic stem cell transplantation who fulfill the following (patient and donor),
[patient]
1) Written informed consent
2) no expectancy of cure with standard therapies including DLI
[donor]
1) healthy spouse who desires to become the donor
2) no available or suitable donor in unrelate bank, cord blood bank, haploidentical relatives (confirmed by the conference)

Key exclusion criteria

1) Cre > 2.0 mg/dl
2) EF < 40%
3) T-Bil > 2.0 mg/dl
4) AST and/or ALT > 200 U/L
5) SpO2 < 90% (room air)
6) PS (ECOG score) 3-4
Patients with data due to original disease are not excluded.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroyasu Ogawa

Organization

Hyogo College of Medicine

Division name

Division of Hematology, Department of Internal Medicine

Zip code


Address

1-1, Mukogawa-cho, Nishinomiya city, Hyogo

TEL

+81-798-45-6886

Email

haplo@hyo-med.a.cjp


Public contact

Name of contact person

1st name
Middle name
Last name Kazuhiro Ikegame

Organization

Hyogo College of Medicine

Division name

Division of Hematology, Department of Internal Medicine

Zip code


Address

1-1, Mukogawa-cho, Nishinomiya city, Hyogo

TEL

+81-798-45-6886

Homepage URL


Email

kame@hyo-med.ac.jp


Sponsor or person

Institute

Hyogo College of Medicine

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

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

2016 Year 08 Month 09 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

Enrolling by invitation

Date of protocol fixation

2016 Year 08 Month 08 Day

Date of IRB


Anticipated trial start date

2016 Year 08 Month 09 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

2016 Year 08 Month 08 Day

Last modified on

2017 Year 02 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027122


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name