UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012122 |
|---|---|
| Receipt number | R000014173 |
| Scientific Title | Phase I/II study of bendamustine, fludarabine and cyclophosphamide conditioning for allogeneic stem cell transplantation in refractory follicular lymphoma (KSGCT1301 / FL benda) |
| Date of disclosure of the study information | 2013/11/01 |
| Last modified on | 2023/06/08 19:59:14 |
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Basic information
Public title
Phase I/II study of bendamustine, fludarabine and cyclophosphamide conditioning for allogeneic stem cell transplantation in refractory follicular lymphoma
(KSGCT1301 / FL benda)
Acronym
KSGCT1301 / FL benda
Scientific Title
Phase I/II study of bendamustine, fludarabine and cyclophosphamide conditioning for allogeneic stem cell transplantation in refractory follicular lymphoma
(KSGCT1301 / FL benda)
Scientific Title:Acronym
KSGCT1301 / FL benda
Region
| Japan |
Condition
Condition
follicular lymphoma(FL)
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze efficacy and safety of bendamustine, fludarabine and cyclophosphamide conditioning regimen in refractory follicular lymphoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Phase I study: Incidence of dose-limiting toxicity
Phase II study: Overall survival at 1 year
Key secondary outcomes
(1) Engraftment at 30 days
(2) Incidence of grade 3-4 toxicity at 30 days
(3) Response rate
(4) Progression free survival at 1 year
(5) Non-relapse mortality at 1 year
(6) Incidence of infection
(7) Incidence of acute GVHD, chronic GHVD
(8) Influence of cardiac function
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A standard 3+3 trail is designed. Three patients are enrolled on the first bendamustine dose level. Dose limiting toxicity (DLT) is defined as any grade 3 or 4 non-hematologic toxicity (except alopecia, nausea and vomiting, mucositis, and fatigue) that does not resolve to grade 2 by day 30. If no DLT is observed in any of the three patients or in one of the six patients, the dose is escalated to the next level. If two or more patients experience DLT, the maximum tolerated dose (MTD) is exceeded, and three additional patients are to be treated at the next lower dose. If none of the three patients or one of the six patients experiences DLT at the lower dose, this dose defines MTD. If two or more patients experiences DLT, three additional patients are to be treated at the next lower dose. If no DLT is observed in any of the three patients or in one of the six patients at the lower dose, this dose defines MTD.
The first bendamustine dose is 80mg/m2.
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)Patient must be diagnosed follicular lymphoma, and age must be equal and over 16 years or less than 66 years.
(2)Patient must have relapsed, primary refractorylymphoma.
(3)Patient may have chemoresistant refractory disease.
(4)Patient should not receive chemotherapy except rituximab within 4 weeks before transplantation.
(5)Patiens should not have pathologically transformed disease.
(6)Patients must have HLA identical sibling donor, HLA one antigen mismatched sibling donor, HLA identical unrelated donor or HLA DRB1 allele one mismatched unrelated donor.
(7)Patients must have an Eastern Cooperative Oncology Group performance status of 0 or 1.
(8)
1)Saturation of oxygen >= 94%
2)DLCO >= 50%
3)Serum creatinine <= 1.5mg/dl
4)Total bilirubin <= 1.5mg/dl
5)AST, ALT, r-GTP <= 3 times upper limit of normal
6)No evidence of active cardiac disease
7)Left ventricular ejection fraction >= 55%
(9)All patients must be informed of the investigational nature of the study and have given written consent.
Key exclusion criteria
(1) Patients should not have controllable disease by chemotherapy
(2) Uncontrolled diabetes mellitus
(3) Uncontrolled hypertension
(4) Active infection
(5) Positive for TPHA, HBs Ag, HBe Ag, or HCV Ab
(6) Positive for HIV Ab
(7) Patients should be expected that they survive over 100 days after transplantation.
(8) Patients should not have other active malignant diseases.
(9) Pregnant or nursing women
(10) Mental disorder
(11) Previous allogeneic transplantation
(12) Other inappropriate symptoms
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichiro Okamoto |
Organization
Kanto Study Group for Cell Therapy
(KSGCT)
Division name
Chairman
Zip code
Address
Tokyo
TEL
03-6225-2040
ksgctdc@ksgct.net
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shingo Yano |
Organization
Kanto Study Group for Cell Therapy
Division name
Trial Office
Zip code
Address
Tokyo
TEL
03-6225-2040
Homepage URL
yano@jikei.ac.jp
Sponsor or person
Institute
Kanto Study Group for Cell Therapy
(KSGCT)
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2013 | Year | 11 | Month | 01 | 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
| 2013 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 11 | Day |
Anticipated trial start date
| 2013 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 25 | Day |
Last modified on
| 2023 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014173
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