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Fludara (Oral) Phase II Study for Indolent Lymphoma

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Fludarabine Phosphate (Fludara)
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring Fludarabine, Purine analog, Indolent lymphoma

Eligibility Criteria

20 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

Best overall response rate; Antitumor effect

Secondary Outcome Measures

CR rate
Time to treatment failure
Overall survival
Adverse events collection

Full Information

First Posted
May 30, 2008
Last Updated
December 2, 2013
Sponsor
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00688883
Brief Title
Fludara (Oral) Phase II Study for Indolent Lymphoma
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 Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
August 2004 (Actual)
Study Completion Date
August 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genzyme, a Sanofi Company

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
Fludarabine, Purine analog, Indolent lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Fludarabine Phosphate (Fludara)
Other Intervention Name(s)
BAY86-4864
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
CR rate
Time Frame
after last observation of last treatment cycle
Title
Time to treatment failure
Time Frame
after last observation of last treatment cycle
Title
Overall survival
Time Frame
after last observation of last treatment cycle
Title
Adverse events collection
Time Frame
after last observation of last treatment cycle

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Genzyme, a Sanofi Company
Official's Role
Study Director
Facility Information:
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
466-8560
Country
Japan
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
812-0033
Country
Japan
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
003-0006
Country
Japan
City
Akashi-shi
State/Province
Hyogo
ZIP/Postal Code
673-8558
Country
Japan
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
890-0064
Country
Japan
City
Isehara-shi
State/Province
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
602-0841
Country
Japan
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
980-0872
Country
Japan
City
Nagasaki-shi
State/Province
Nagasaki
ZIP/Postal Code
852-8523
Country
Japan
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
700-8558
Country
Japan
City
Moriguchi-shi
State/Province
Osaka
ZIP/Postal Code
570-8540
Country
Japan
City
Hamamatsu-shi
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan

12. IPD Sharing Statement

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Fludara (Oral) Phase II Study for Indolent Lymphoma

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