Fludara (Oral) Phase II Study for Indolent Lymphoma | NCT00688883

Studies
Fludara (Oral) Phase II Study for Indolent Lymphoma

NCT00688883

Sponsor

Genzyme, a Sanofi Company

Status

Completed

Last Update Posted

Dec 4, 2013Estimated

Enrollment

52Actual

Phase

Phase 2

Conditions

Lymphoma

Interventions

Fludarabine Phosphate (Fludara)

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
91101

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2003

Primary Completion Date

Aug 2004Actual

Completion Date

Aug 2004Actual

First Submitted Date

May 30, 2008

First Submission Date that Met QC Criteria

Jun 2, 2008

First Posted Date

Jun 3, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2013

Last Update Posted Date

Dec 4, 2013Estimated

Description Module

Brief Summary

To assess the antitumor effect and safety of Fludara in patients with indolent lymphoma.

Detailed Description

As of 29 May 2009, the clinical trial sponsor is Genzyme Corporation. NOTE: This study was originally posted by sponsor Schering AG, Germany, which was subsequently renamed to Bayer Schering Pharma AG, Germany.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental		Drug: Fludarabine Phosphate (Fludara)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fludarabine Phosphate (Fludara)	Drug	Patients received Fludarabine Phosphate orally for 5 consecutive days, followed by a 23-day observation period. Setting this as 1 treatment cycle, 6 cycles will be given.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Best overall response rate; Antitumor effect		at screening and re-evaluation, at 4th week or at the time of discontinuation of treatment cycles 1, 3 and 6, and at 12th week after last observation of last treatment cycle

Secondary Outcomes

Measure	Description	Time Frame
CR rate		after last observation of last treatment cycle
Time to treatment failure		after last observation of last treatment cycle
Overall survival

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with histologically or cytologically confirmed indolent lymphoma (including mantle cell lymphoma)
Patients with measurable lesions (major axis > 1.5 cm by CT)
Patients who failed to have PR to previous chemotherapies or antibody therapies. Patients with subsequent relapse after a previously attained CR or with subsequent recurrence after a previously attained PR
Patients who have not received chemotherapies, antibody therapies or radiotherapies for more than 4 weeks (more than 3 months in the case of the antibody therapies)
Patients who have PS Grade 0 to 2 in the criteria of ECOG
Patients with adequately maintained organ functions

Exclusion Criteria:

Patients with infectious disease, serious complications, serious gastrointestinal symptoms, serious bleeding tendency (DIC), CNS metastases, fever more than 38 degrees Celsius, interstitial pneumonia or pulmonary fibrosis, active other malignancies, AIHA or the history of allergies to similar purine analogs
Patients who are positive for HBs antigen, HCV antibody or HIV antibody
Patients who received G-CSF or blood transfusion within 1 week before the screening test
Patients who had ever received previous therapy with fludarabine phosphate injection (Fludara), pentostatin (Coforin), cladribine (Leustatin) or SH T 586
Patients who are pregnant, of childbearing potential, lactating, or who do not agree to practice contraception

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

74 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Nagoya	Aichi-ken	464-8681	Japan

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases