UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004892
Receipt No. R000005828
Scientific Title Rituximab, Ifosfamide, Dexamethasone, Etoposide, and Ara-C (R-IDEA) for Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Date of disclosure of the study information 2011/01/20
Last modified on 2016/01/18

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Rituximab, Ifosfamide, Dexamethasone, Etoposide, and Ara-C (R-IDEA) for Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Acronym R-IDEA for relapsed/refractory DLBCL
Scientific Title Rituximab, Ifosfamide, Dexamethasone, Etoposide, and Ara-C (R-IDEA) for Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Scientific Title:Acronym R-IDEA for relapsed/refractory DLBCL
Region
Japan

Condition
Condition Diffuse large B-cell lymphoma
Classification by specialty
Hematology and clinical oncology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the efficacy and safety of induction therapy R-IDEA after 3 cycles adjusted to successful mobilization of stem cells in patients with previously treated diffuse large B-cell lymphoma.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Mobilization-adjusted overall response rate (MARR) after 3 cycles of R-IDEA
Key secondary outcomes progression-free survival, overall survival, response rate

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 Chemotherapy (3 or 4 cycles of R-IDEA) and High dose chemotherapy with autologous stem cell transplantation support
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
18 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria - Patients with relapsed or refractory histologically-proven CD20-positive diffuse large B-cell lymphoma.
Aged 18 to 65 years
- ECOG performance status 0 to 2.
- Previously treated with chemotherapy regimen containing anthracyclines.
- Eligible for autologous stem cell transplantation.
- Existence of measurable disease.
- Signed written informed consent.
Key exclusion criteria - CD20-negative diffuse large cell lymphoma
- Central nervous system involvement by lymphoma.
- Prior transplantation.
- Contra-indication to any drug contained in the chemotherapy regimens.
- Uncontrollable active infection.
- Complication; uncontrollable hypertension or DM, liver cirrhosis, interstitial pneumonia, pulmonary fibrosis.
- Documented infection with HIV, hepatitis B virus and Hepatitis C virus.
- Pregnant women
- Psychiatric illness or social situation that would preclude study compliance.
- A patient who was judged as inappropriate for the trial
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eisei KONDO, M.D., Ph.D.
Organization Okayama University Hospital
Division name Department of Hematology and Oncology
Zip code
Address 2-5-1 Shikata-cho, Kita-ku,Okayama 700-8558, JAPAN
TEL 086-235-7227
Email eisei-k@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eisei KONDO, M.D., Ph.D.
Organization Okayama University Hospital
Division name Department of Hematology and Oncology
Zip code
Address 2-5-1 Shikata-cho, Kita-ku,Okayama 700-8558, JAPAN
TEL 086-235-7227
Homepage URL http://westjhog.umin.jp/10saihatsubiman.html
Email eisei-k@md.okayama-u.ac.jp

Sponsor
Institute West JHOG / ALTSG
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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
2011 Year 01 Month 20 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications http://oncologypro.esmo.org/Meeting-Resources/ESMO-2014/Haematological-Malignancies/Interim-analysis
Number of participants that the trial has enrolled
Results
20 pts were enrolled (median age 59.5, range 42-65; M:F ratio 11:9). 17 pts were enrolled after first relapse and three were primary refactory. 5 pts relapsed within 1 year from initial diagnosis. The most frequent grade 3/4 adverse events were neutropenia (55/56 cycles), thrombocytopenia (46/56 cycles), anemia (24/56 cycles), and febrile neutropenia (26/56 cycles). No other grade 5 adverse event occurred. After completion of R-IDEA, 7 pts (35%) achieved CR, 5 (25%) PR, one had SD, and 7 had PD. The median CD34+ count was 2.64 million/kg (range: 0.17-43.7). 3 pts failed to mobilize >2 million of CD34+ cells/kg, for a MARR of 45% (9/20). No patient of primary refractory or relapsed within 1 year after initial diagnosis and 9 pts relapsed >1 year from diagnosis achieved mobilization adjusted response (p = 0.001). The nine pts proceeded to HDT/ASCT.
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
2010 Year 10 Month 22 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 01 Day
Last follow-up date
2016 Year 01 Month 31 Day
Date of closure to data entry
2016 Year 01 Month 31 Day
Date trial data considered complete
2016 Year 01 Month 31 Day
Date analysis concluded
2016 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2011 Year 01 Month 18 Day
Last modified on
2016 Year 01 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005828

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.