UMIN-CTR Clinical Trial

Public title

Allogeneic stem cell transplantation for relapsed/refractory aggressive lymphoma with conditioning regimen consisted of fludarabine, iv busulfan, and melphalan (single center prospective trial)

Acronym

Allogeneic stem cell transplantation for relapsed/refractory aggressive lymphoma with fludarabine, iv busulfan, and melphalan.

Scientific Title

Allogeneic stem cell transplantation for relapsed/refractory aggressive lymphoma with conditioning regimen consisted of fludarabine, iv busulfan, and melphalan (single center prospective trial)

Scientific Title:Acronym

Allogeneic stem cell transplantation for relapsed/refractory aggressive lymphoma with fludarabine, iv busulfan, and melphalan.

Region

Japan

Condition

Relapsed or refractory aggressive non Hodgkin lymphomas (NHL)

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To assess safety and efficacy of allogeneic stem cell transplantation with conditioning regimen consisted of fludarabine 180 mg/m2, iv busulfan 12.8 mg/kg, and melphalan 80 mg/kg in patients with relapsed or refractory aggressive NHL.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase I

Primary outcomes

Survival rate with engraftment on day 60 after transplantation

Key secondary outcomes

Survival rate with engraftment on day 100.
Grade>=3 AEs from start of conditioning to day 100 after transplantation.
Non relapse mortality at day 100, 12 months after transplantation.
Relapse rate at day 100, 12 months after transplantation.
Event free survival rate at 12 months after transplantation.
Overall survival at 12 months after transplantation.
Rate of infectious disease at 12 months after transplantation.
Rate and severity of acute or chronic graft-versus-host disease at 12 months after transplantation.

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

Allogeneic stem cell transplantation with conditioning regimen consisted of fludarabine 180 mg/m2, iv busulfan 12.8 mg/kg, and melphalan 80 mg/kg.

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

20

years-old

<=

Age-upper limit

65

years-old

>=

Gender

Male and Female

Key inclusion criteria

Candidates for allogeneic stem cell transplantation who fulfill each criteria.
1) ECOG performance status: 0-2, no severe organ dysfunction.
2) Relapse or refractory aggressive NHL (progressive disease during first-line chemotherapy, early relapse (<12 mo) after first-line chemotherapy, less than PR with salvage chemotherapy, relapse after high dose chemotherapy associated with autologous hematopoietic stem cell transplantation, mobilization failure)
3) >=stable disease with recent salvage chemotherapy.
4) Donor availability: HLA A/B/DR 6-locus matched related/unrelated bone marrow, related peripheral blood, cord blood >=2x10^7/kg with disparity <=2 antigens.

Key exclusion criteria

Positive for anti-HIV antibody
Active double cancer
Severe mental conditions
Active infectious disease
Known hypersensitivity to drugs to be used in the protocol.
Not appropriate for enrollment as judged by the investigator.

Target sample size

12

Name of lead principal investigator

1st name
Middle name
Last name	Koji Izutsu

Organization

Toranomon Hospital

Division name

Department of Hematology

Zip code

Address

Toranomon 2-2-2, Minato-ku, Tokyo 105-8470, Japan

TEL

03-3588-1111

Email

izutsu-tky@umin.ac.jp

Name of contact person

1st name
Middle name
Last name	Koji Izutsu

Organization

Toranomon Hospital

Division name

Department of Hematology

Zip code

Address

Toranomon 2-2-2, Minato-ku, Tokyo 105-8470, Japan

TEL

03-3588-1111

Homepage URL

Email

izutsu-tky@umin.ac.jp

Institute

Department of Hematology
Toranomon Hospital

Institute

Department

Personal name

Organization

Department of Hematology
Toranomon Hospital

Organization

Division

Category of Funding Organization

Self funding

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

虎の門病院（東京都）、虎の門病院分院（神奈川県）

Date of disclosure of the study information

2014

Year

05

Month

13

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

Completed

Date of protocol fixation

2014

Year

02

Month

19

Day

Date of IRB

Anticipated trial start date

2014

Year

02

Month

19

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

05

Month

13

Day

Last modified on

2018

Year

11

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016251