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Fludara (Oral) Phase II Study for Indolent Lymphoma

Information source: Sanofi
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lymphoma

Intervention: Fludarabine Phosphate (Fludara) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Genzyme, a Sanofi Company

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Genzyme, a Sanofi Company

Summary

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

Clinical Details

Official title: A Multicenter, Open Study to Assess the Antitumor Effect and Safety of Oral Fludarabine Phosphate (Fludara (SH T 586): 40 mg/m2/Day) Administered in 3 - 6 Treatment Cycles (1 Treatment Cycle: 5-consecutive Day Dosing, Followed by a Observation Period of 23 Days) in Patients With Indolent Lymphoma

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Best overall response rate; Antitumor effect

Secondary outcome:

CR rate

Time to treatment failure

Overall survival

Adverse events collection

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.

Eligibility

Minimum age: 20 Years. Maximum age: 74 Years. Gender(s): Both.

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

Locations and Contacts

Nagoya-shi, Aichi 464-8681, Japan

Nagoya-shi, Aichi 466-8560, Japan

Kashiwa-shi, Chiba 277-8577, Japan

Fukuoka-shi, Fukuoka 812-0033, Japan

Fukuoka-shi, Fukuoka 812-8582, Japan

Sapporo-shi, Hokkaido 003-0006, Japan

Akashi-shi, Hyogo 673-8558, Japan

Kagoshima-shi, Kagoshima 890-0064, Japan

Isehara-shi, Kanagawa 259-1193, Japan

Kyoto-shi, Kyoto 602-0841, Japan

Sendai-shi, Miyagi 980-0872, Japan

Nagasaki-shi, Nagasaki 852-8523, Japan

Okayama-shi, Okayama 700-8558, Japan

Moriguchi-shi, Osaka 570-8540, Japan

Hamamatsu-shi, Shizuoka 431-3192, Japan

Chuo-ku, Tokyo 104-0045, Japan

Shinjuku-ku, Tokyo 160-8582, Japan

Additional Information

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Starting date: February 2003
Last updated: December 2, 2013

Page last updated: August 20, 2015

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