UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011661 |
|---|---|
| Receipt number | R000013635 |
| Scientific Title | Phase II study of the addition of rituximab to dmCODOX-M/IVAC therapy for AIDS-related burkitt lymphoma |
| Date of disclosure of the study information | 2013/09/06 |
| Last modified on | 2013/09/05 20:23:04 |
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Basic information
Public title
Phase II study of the addition of rituximab to dmCODOX-M/IVAC therapy for AIDS-related burkitt lymphoma
Acronym
ABL-R trial
Scientific Title
Phase II study of the addition of rituximab to dmCODOX-M/IVAC therapy for AIDS-related burkitt lymphoma
Scientific Title:Acronym
ABL-R trial
Region
| Japan |
Condition
Condition
AIDS-related burkitt lymphoma
Classification by specialty
| Hematology and clinical oncology | Infectious disease |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of R-dmCODOX-M/IVAC for previously untreated patients with AIDS-related burkitt lymphoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Two-year progression-free survival
Key secondary outcomes
Two-year overall survival, complete response rate, overall response rate, adversed effect, incidence of opportunistic disease, treatment-related mortality
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
the addition of rituximab to dmCODOX-M/IVAC therapy
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
1. HIV infection positive
2. Previously untreated patients with histologically confirmed Burkitt lymphoma
3. Presence of mesurable lesions by computed tomography or Magnetic Resonance Imaging
4. Age 20-65 years
5. Performance status (ECOG) of 0 to 2, or PS 3 by burkitt lymphoma
6. No major organ dysfunction
(1) White cell counts: more than or equal to 2000/uL or, neutrophil counts:more than or equal to 1200/uL , and platelet counts:more than or equal to 50000/uL.
(2) AST(GOT):less than or equal to 100IU/U, ALT(GPT):less than or equal to 100IU/U, and serum bilirubin:less than or equal to 2.0 mg/dl
(3) Serum creatinin:less than 1.5mg/dl
(4) a left ventricular ejection fraction by echocardiography at least 50%
(5) SpO2:more than or equal to 90 percent
7. Informed consented patients
Key exclusion criteria
1. Pregnant or possible pregnant women
2. Other active malignancies except for Kaposi sarcoma
3. Severe complication
Uncontrollable angina pectoris, myocardial infarction, or heart failure
Uncontrollable active infection
Uncontrollable diabetes
Interstitial pneumonia or pulmonary fibrosis by chest-Xay
Uncontrollable opportunistic disease of central nervous system
Uncontrollable pleural effusion, ascites or fluid retention in third space
Severe psychosis
4. Judged for inappropriate with other reasons
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirokazu Nagai |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Clinical Research Center
Zip code
Address
4-1-1, Sannomaru,Naka-Ku, Nagoya, Japan
TEL
052-951-1111
nagaih@nnh.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuki Kojima |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Clinical Research Center
Zip code
Address
4-1-1, Sannomaru,Naka-Ku, Nagoya, Japan
TEL
052-951-1111
Homepage URL
yukik@nnh.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Nagoya Medical Center
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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 | 09 | Month | 06 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 07 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 10 | 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
| 2013 | Year | 09 | Month | 05 | Day |
Last modified on
| 2013 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013635
