Fludara (Oral) Phase II Study for Indolent Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00688883
First received: May 30, 2008
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Lymphoma
Drug: Fludarabine Phosphate (Fludara)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CR rate [ Time Frame: after last observation of last treatment cycle ] [ Designated as safety issue: No ]
  • Time to treatment failure [ Time Frame: after last observation of last treatment cycle ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: after last observation of last treatment cycle ] [ Designated as safety issue: No ]
  • Adverse events collection [ Time Frame: after last observation of last treatment cycle ] [ Designated as safety issue: Yes ]

Enrollment: 52
Study Start Date: February 2003
Study Completion Date: August 2004
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00688883

Locations
Japan
Nagoya-shi, Aichi, Japan, 464-8681
Nagoya-shi, Aichi, Japan, 466-8560
Kashiwa-shi, Chiba, Japan, 277-8577
Fukuoka-shi, Fukuoka, Japan, 812-8582
Fukuoka-shi, Fukuoka, Japan, 812-0033
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
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00688883     History of Changes
Other Study ID Numbers: 305621, 91101
Study First Received: May 30, 2008
Last Updated: December 2, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Sanofi:
Fludarabine
Purine analog
Indolent lymphoma

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

ClinicalTrials.gov processed this record on October 30, 2014