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Fludara (Oral) Phase II Study for Indolent Lymphoma

NCT ID: NCT00688883

Last Updated: 2013-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2004-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Lymphoma

Keywords

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Fludarabine Purine analog Indolent lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Fludarabine Phosphate (Fludara)

Intervention Type 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.

Interventions

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Fludarabine Phosphate (Fludara)

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.

Intervention Type DRUG

Other Intervention Names

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BAY86-4864

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Genzyme, a Sanofi Company

Locations

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Nagoya, Aichi-ken, Japan

Site Status

Nagoya, Aichi-ken, Japan

Site Status

Kashiwa-shi, Chiba, Japan

Site Status

Fukuoka, Fukuoka, Japan

Site Status

Fukuoka, Fukuoka, Japan

Site Status

Sapporo, Hokkaido, Japan

Site Status

Akashi-shi, Hyōgo, Japan

Site Status

Kagoshima, Kagoshima-ken, Japan

Site Status

Isehara-shi, Kanagawa, Japan

Site Status

Kyoto, Kyoto, Japan

Site Status

Sendai, Miyagi, Japan

Site Status

Nagasaki, Nagasaki, Japan

Site Status

Okayama, Okayama-ken, Japan

Site Status

Moriguchi-shi, Osaka, Japan

Site Status

Hamamatsu, Shizuoka, Japan

Site Status

Chuo-ku, Tokyo, Japan

Site Status

Shinjuku-ku, Tokyo, Japan

Site Status

Countries

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Japan

Other Identifiers

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91101

Identifier Type: -

Identifier Source: secondary_id

305621

Identifier Type: -

Identifier Source: org_study_id