Fludara (Oral) Phase II Study for Indolent Lymphoma

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

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

Study Overview

• Status: Completed
• Conditions: Lymphoma
• Intervention / Treatment: Drug: Fludarabine Phosphate (Fludara)

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Aichi
    • Nagoya-shi, Aichi, Japan, 464-8681
    • Nagoya-shi, Aichi, Japan, 466-8560
  • Chiba
    • Kashiwa-shi, Chiba, Japan, 277-8577
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan, 812-0033
    • Fukuoka-shi, Fukuoka, Japan, 812-8582
  • Hokkaido
    • Sapporo-shi, Hokkaido, Japan, 003-0006
  • Hyogo
    • Akashi-shi, Hyogo, Japan, 673-8558
  • Kagoshima
    • Kagoshima-shi, Kagoshima, Japan, 890-0064
  • Kanagawa
    • Isehara-shi, Kanagawa, Japan, 259-1193
  • Kyoto
    • Kyoto-shi, Kyoto, Japan, 602-0841
  • Miyagi
    • Sendai-shi, Miyagi, Japan, 980-0872
  • Nagasaki
    • Nagasaki-shi, Nagasaki, Japan, 852-8523
  • Okayama
    • Okayama-shi, Okayama, Japan, 700-8558
  • Osaka
    • Moriguchi-shi, Osaka, Japan, 570-8540
  • Shizuoka
    • Hamamatsu-shi, Shizuoka, Japan, 431-3192
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0045
    • Shinjuku-ku, Tokyo, Japan, 160-8582

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1	Drug: 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.; Other Names: BAY86-4864

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	Time Frame
CR rate	after last observation of last treatment cycle
Time to treatment failure	after last observation of last treatment cycle
Overall survival	after last observation of last treatment cycle
Adverse events collection	after last observation of last treatment cycle

Collaborators and Investigators

• Sponsor: Genzyme, a Sanofi Company

Study record dates

Study Major Dates

• Study Start: February 1, 2003
• Primary Completion (Actual): August 1, 2004
• Study Completion (Actual): August 1, 2004

Study Registration Dates

• First Submitted: May 30, 2008
• First Submitted That Met QC Criteria: June 2, 2008
• First Posted (Estimate): June 3, 2008

Study Record Updates

• Last Update Posted (Estimate): December 4, 2013
• Last Update Submitted That Met QC Criteria: December 2, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Fludarabine; Purine analog; Indolent lymphoma
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Fludarabine; Fludarabine phosphate
• Other Study ID Numbers: 305621; 91101