Fludara (Oral) Phase II Study for Indolent Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00688883
Recruitment Status : Completed
First Posted : June 3, 2008
Last Update Posted : December 4, 2013
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

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

Condition or disease Intervention/treatment Phase
Lymphoma Drug: Fludarabine Phosphate (Fludara) Phase 2

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  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2003
Actual Primary Completion Date : August 2004
Actual Study Completion Date : August 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

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 Name: BAY86-4864

Primary Outcome Measures :
  1. Best overall response rate; Antitumor effect [ Time Frame: 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 :
  1. CR rate [ Time Frame: after last observation of last treatment cycle ]
  2. Time to treatment failure [ Time Frame: after last observation of last treatment cycle ]
  3. Overall survival [ Time Frame: after last observation of last treatment cycle ]
  4. Adverse events collection [ Time Frame: after last observation of last treatment cycle ]

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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00688883

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

Additional Information:
Responsible Party: Genzyme, a Sanofi Company Identifier: NCT00688883     History of Changes
Other Study ID Numbers: 305621
First Posted: June 3, 2008    Key Record Dates
Last Update Posted: December 4, 2013
Last Verified: December 2013

Keywords provided by Sanofi ( Genzyme, a Sanofi Company ):
Purine analog
Indolent lymphoma

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Fludarabine phosphate
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents