UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013940
Receipt number R000016251
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)
Date of disclosure of the study information 2014/05/13
Last modified on 2018/11/15 09:24:55

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Basic information

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

Condition

Relapsed or refractory aggressive non Hodgkin lymphomas (NHL)

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

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


Assessment

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.


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

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



Eligibility

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


Research contact person

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


Public contact

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


Sponsor or person

Institute

Department of Hematology
Toranomon Hospital

Institute

Department

Personal name



Funding Source

Organization

Department of Hematology
Toranomon Hospital

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

虎の門病院(東京都)、虎の門病院分院(神奈川県)


Other administrative information

Date of disclosure of the study information

2014 Year 05 Month 13 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

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

Other related information



Management 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name