UMIN-CTR Clinical Trial

Public title

Single agent graft-versus-host disease prophylaxis with post-transplant cyclophosphamide for stem cell transplantation: a phase II study (SAP-P2)

Acronym

Single agent GVHD prophylaxis with PTCY for SCT: a phase II study (SAP-P2)

Scientific Title

Single agent graft-versus-host disease prophylaxis with post-transplant cyclophosphamide for stem cell transplantation: a phase II study (SAP-P2)

Scientific Title:Acronym

Single agent GVHD prophylaxis with PTCY for SCT: a phase II study (SAP-P2)

Region

Japan

Condition

Acute leukemia

Classification by specialty

Hematology and clinical oncology

Pediatrics

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

To assess the efficacy and safety of post-transplant cyclophosphamide as a single agent for prevention of graft-versus-host disease in stem cell transplantation from HLA-matched donor or one-antigen mismatched related donor.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Incidence of graft-versus-host disease at day 100

Key secondary outcomes

1. Engraftment probability at day 30
2. Non-relapse mortality at day 100
3. Incidence of infectious disease at week 8
4. Reconstruction of immune status
5. Time from transplantation to onset of chronic GVHD
6. Time from transplantation to relapse
7. Time from transplantation to death

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Conditioning regime without cyclophosphamide
Stem cell transplantation at day 0
Cyclophosphamide 50mg/kg at days 3, 4

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

Age-lower limit

0

years-old

<=

Age-upper limit

20

years-old

>

Gender

Male and Female

Key inclusion criteria

1) Diagnosed as acute leukemia (acute lymphoblastic leukemia/acute myeloblastic leukemia), or lymphoma
2) First or second remission, and planned to have stem cell transplantation
3) Donor for transplantation is one of the follows;
a. HLA 6/6 (A, B, DR) matched related donor
b. HLA 5/6 (A, B, DR) matched related donor
c. HLA 6/6 (A, B, DR) matched unrelated donor
4) Age at transplantation <20 years
5) ECOG Performance status: 0-2
6) Sufficient organ function, as follows;
a. T-Bil <= 1.5 mg/dl
b. Serum creatinine <= 0.8 mg/dl (age <5y), <= 1.2 mg/dl (age 5-9y), <= 1.5 mg/dl (10y or older)
c. Ejection fraction 45% or better, and QTfc <0.45 sec
7) Obtained informed consent from a guardian of the patient

Key exclusion criteria

1. Prior allogeneic stem cell transplantation
2. Effusion with grade 2 or worse at CTCAE ver 4.0
3. Uncontrolled infection
4. Severe psychological disorders
5. Pregnant or suspected pregnancy
6. Not eligible for this study at the discretion of the investigator.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Motohiro Kato

Organization

National Center for Child Health and Development

Division name

Children's Cancer Center

Zip code

Address

2-10-1, Okura, Setagaya, Tokyo

TEL

03-3416-1811

Email

kato-mt@ncchd.go.jp

Name of contact person

1st name
Middle name
Last name	Motohiro Kato

Organization

National Center for Child Health and Development

Division name

Children's Cancer Center

Zip code

Address

2-10-1, Okura, Setagaya, Tokyo

TEL

03-3416-1811

Homepage URL

Email

kato-mt@ncchd.go.jp

Institute

National Center for Child Health and Development

Institute

Department

Personal name

Organization

National Center for Child Health and Development

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

03

Month

07

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2016

Year

03

Month

01

Day

Date of IRB

Anticipated trial start date

2016

Year

03

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

03

Month

07

Day

Last modified on

2016

Year

03

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024602