UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004892 |
|---|---|
| Receipt number | 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 14:02:48 |
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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
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
eisei-k@md.okayama-u.ac.jp
Sponsor or person
Institute
West JHOG / ALTSG
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005828
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| Registered date | File name |
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