UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003867
Receipt number R000004653
Scientific Title Phase 1 study of fludarabine combined with rituximab followed by Zevalin for patients with relapsed or refractory indolent B cell lymphoma
Date of disclosure of the study information 2010/07/05
Last modified on 2014/07/04 13:03:35

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Basic information

Public title

Phase 1 study of fludarabine combined with rituximab followed by Zevalin for patients with relapsed or refractory indolent B cell lymphoma

Acronym

Fludarabine combined with rituximab followed by Zevalin for patients with relapsed or refractory indolent B cell lymphoma

Scientific Title

Phase 1 study of fludarabine combined with rituximab followed by Zevalin for patients with relapsed or refractory indolent B cell lymphoma

Scientific Title:Acronym

Fludarabine combined with rituximab followed by Zevalin for patients with relapsed or refractory indolent B cell lymphoma

Region

Japan


Condition

Condition

Indolent B cell lymphoma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety and efficacy of fludarabine conbined with riutximab followed by Zevalin therapy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase I


Assessment

Primary outcomes

Periods from the initiation of Zevalin therapy to the time of bone marrow recovery, neutrophil count is more than 1000/mm3 and pletlet count is more than 50000/mm3.

Key secondary outcomes



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

As dose limiting toxicity, delayed bone marrow recovery is selected.
Delayed bone marrow recovery is defined that neutrophil count less than 1000/ mm3 or platelet count less than 50000/mm3 after 12 weeks of Zevalin therapy.
In FR therapy, rituximab at 375 mg/m2 is administered on day 1 of each treatment cycle along with oral dosing of fludarabine phosphate tablets once daily from day 1 through 5 every 28 days.

In level 1, treated with two courses of FR therapy followed by Zevalin therapy.
In level 2, treated with three courses of FR therapy followed by Zevalin therapy.

Evaluate three patients at level 1.
1) If zero of three have DLT, then go to level 2.
2) If one of three have DLT, then evaluate an additional three patients at level 1.
a)If one of six have DLT, then go to level 2.
b)If two of six have DLT, then level 1 is recommended.
c) If at least three of six have DLT, discontinue this trial.
3) If at least two of three have DLT, then discontinue this trial.

Evaluate six patients at level 2.
1) If two or less of six have DLT, level 2 is recommended.
2)If at least three of six have DLT, level 1 is recommended.

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

(a)Have had diagnosis of indolent B cell lymphoma
(b)Relapsed or refractory patients
(c)The number of previous chemotherapy regimens is two or less
(d)After rituximab more than 12 weeks
(e)After previous chemotherapy more than 4 weeks
(f)CD20 positive by flowcytometry or immunohistochemistory
(g)Aged 20 - 79
(h)PS 0 - 2
(i)Without CNS involvement
(j)Have measurable lesions(diameter more than 1.5cm)
(k)Have adequate organs functions
(l)Gave written informed consent
(m)Expectet survival period more than three manths
(n)Not pregnant or lactating
(o)Consent to contraception

Key exclusion criteria

(a)History of hematopoietic stem cell transplantation
(b)History of whole pelvic or whole abdomen radiation
(c)Received G-CSF or erythropoietin or transfusion less than one week before registration
(d)Taken an operation less than four weeks before registration
(e)History of Zevalin therapy
(f)History of the treatment of purin analogs
(g)Have active systemic infections
(h)Have a serious complication(cardiac dysfunction, hepatic failure, or renal failure)
(i)Have a serious digestive organ symptom
(j)Have a serious bleeding tendency
(k) Positive for HBs antigen, HCV antibody, or HIV antibody.
(l)Have an interstitial pneumonia or fibrosis
(m)Active cancers
(n)Have or history of autoimmune hemolytic anemia
(o)Have aglucoma
(p) Otherwise judged by investigator to be unsuitable

Target sample size

12


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hideo Harigae

Organization

Tohoku University Graduate School of Medicine

Division name

Hematology & Rheumatology

Zip code


Address

1-1 Seryou-machi, Aoba-ku Sendai

TEL

022-717-7165

Email

kishizaw@med.tohoku.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kenichi Ishizawa

Organization

Tohoku University Graduate School of Medicine

Division name

Hematology & Rheumatology

Zip code


Address

1-1 Seryou-machi, Aoba-ku Sendai

TEL

022-717-7165

Homepage URL


Email

kishizaw@med.tohoku.ac.jp


Sponsor or person

Institute

Tohoku Hematology Form

Institute

Department

Personal name



Funding Source

Organization

Tohoku Hematology Form

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

2010 Year 07 Month 05 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

2009 Year 10 Month 01 Day

Date of IRB


Anticipated trial start date

2010 Year 01 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2014 Year 07 Month 01 Day


Other

Other related information



Management information

Registered date

2010 Year 07 Month 04 Day

Last modified on

2014 Year 07 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004653


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name