UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004205
Receipt number R000004947
Scientific Title Open labeled, single arm, multi centered, phase II trial to evaluate the efficacy and safety of combination therapy of rituximab and cladribine for previously untreated patients with advanced staged extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma) and nodal marginal zone B-cell lymphoma
Date of disclosure of the study information 2010/09/15
Last modified on 2012/06/28 11:04:30

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Basic information

Public title

Open labeled, single arm, multi centered, phase II trial to evaluate the efficacy and safety of combination therapy of rituximab and cladribine for previously untreated patients with advanced staged extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma) and nodal marginal zone B-cell lymphoma

Acronym

Phase II trial of combination therapy of rituximab and cladribine for previously untreated patients with advanced staged MALT lymphoma and nodal marginal zone B-cell lymphoma

Scientific Title

Open labeled, single arm, multi centered, phase II trial to evaluate the efficacy and safety of combination therapy of rituximab and cladribine for previously untreated patients with advanced staged extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma) and nodal marginal zone B-cell lymphoma

Scientific Title:Acronym

Phase II trial of combination therapy of rituximab and cladribine for previously untreated patients with advanced staged MALT lymphoma and nodal marginal zone B-cell lymphoma

Region

Japan


Condition

Condition

Malignant lymphoma, non-Hodgkin lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma) and nodal marginal zone B-cell lymphoma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of combination therapy of rituximab and cladribine for previously untreated patients with advanced staged MALT lymphoma and nodal marginal zone B-cell 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

Complete response rate
Overall response rate
Two-year overall survival rate
Time to response
Remission duration


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

Combination therapy of rituximab and cladribine

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

79 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Histologically confirmed extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue and nodal marginal zone B-cell lymphoma
2. CD20-positivity on lymphoma cells by immunohistochemical staining and/or flow cytometry.
3. Clinical stage 3 or 4 by Ann Arbor criteria.
4. At least 1 measurable lesion more than 1.5 cm in at least one dimension by computed tomography, if not any lesions defined by computed tomograghy, magnetic resonance imaging, positron emission tomograghy or endoscopy.
5. No prior chemotherapiy or immunotherapy.
6. Expected to survive for at least 3 months.
7. Performance status (ECOG) of 0 to 2
8. Age 20-79 years
9. No major organ dysfunction
(1) Neutrophil counts:more than or equal to 1200/uL
(2) Platelet counts:more than or equal to 100000/uL.
(3) Hemoglobin more than or equal to 8.0 g/dl
(4) Serum bilirubin:less than or equal to 2 x upper limit of normal (In cases with lymphomatous involvement, 5 times and less is allowed.)
(5) AST(GOT):less than or equal to 2.5 x upper limit of normal
ALT(GPT):less than or equal to 2.5 x upper limit of normal
(6) Serum creatinin:less than or equal to 1.5 x upper limit of normal
(7) SpO2:more than or equal to 90 percent
(8) No abnormalities that require treatment on ECG
10. Patient's written informed consent

Key exclusion criteria

(1) Histologically transformed lymphoma.
(2) History of glaucoma
(3) Peripheral lymphoma cells> 5000/uL
(4) Serious bacterial or viral infections.
(5) Positive for HBs antigen, HCV antibody or HIV antibody
(6) Active cancer or history of malignancies within 5 years, except for carcinoma in situ
(7) Interstitial pneumonia, pulmonary fibrosis, or severe pulmonary emphysema.
(8) Serious complications (cardiac failure, hepatic failure or renal failure)
(9) Psychological complications judged to be difficult to enroll
(10) Active disease or history of autoimmune anemia.
(11) Serious bleeding tendencies (e.g. disseminated intravascular coagulation)
(12) Patients who received granulacyte colony stimulating factor within 2 weeks before registration.
(13) Active or suggestive CNS involvement
(14) Patients who are pregnant or lactating
(15) Inadequate patients to enroll judged by investigators

Target sample size

43


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Michinori Ogura

Organization

Nagoya Daini Red Cross Hospital

Division name

Hematology and Oncology

Zip code


Address

2-9 Myoken-cho Shouwa-ku Nagoya, JAPAN

TEL

052-832-1121

Email



Public contact

Name of contact person

1st name
Middle name
Last name Michinori Ogura, Tatsuya Suzuki

Organization

Nagoya Daini Red Cross Hospital

Division name

Hematology and Oncology

Zip code


Address

2-9 Myoken-cho Shouwa-ku Nagoya, JAPAN

TEL

052-832-1121

Homepage URL


Email



Sponsor or person

Institute

Hematological Malignancy Clinical Study Group

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


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

2010 Year 09 Month 15 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

Open public recruiting

Date of protocol fixation

2010 Year 07 Month 20 Day

Date of IRB


Anticipated trial start date

2010 Year 09 Month 01 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

2010 Year 09 Month 14 Day

Last modified on

2012 Year 06 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004947


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name