NCT00688883

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P50-P75 for phase_2 lymphoma

Timeline
Completed

Started Feb 2003

Shorter than P25 for phase_2 lymphoma

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 3, 2008

Completed
Last Updated

December 4, 2013

Status Verified

December 1, 2013

Enrollment Period

1.5 years

First QC Date

May 30, 2008

Last Update Submit

December 2, 2013

Conditions

Lymphoma

Keywords

FludarabinePurine analogIndolent lymphoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: Fludarabine Phosphate (Fludara)

Interventions

Fludarabine Phosphate (Fludara)DRUG

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.

Also known as: BAY86-4864
Arm 1

Eligibility Criteria

Age20 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Unknown Facility

Nagoya, Aichi-ken, 464-8681, Japan

Location

Unknown Facility

Nagoya, Aichi-ken, 466-8560, Japan

Location

Unknown Facility

Kashiwa-shi, Chiba, 277-8577, Japan

Location

Unknown Facility

Fukuoka, Fukuoka, 812-0033, Japan

Location

Unknown Facility

Fukuoka, Fukuoka, 812-8582, Japan

Location

Unknown Facility

Sapporo, Hokkaido, 003-0006, Japan

Location

Unknown Facility

Akashi-shi, Hyōgo, 673-8558, Japan

Location

Unknown Facility

Kagoshima, Kagoshima-ken, 890-0064, Japan

Location

Unknown Facility

Isehara-shi, Kanagawa, 259-1193, Japan

Location

Unknown Facility

Kyoto, Kyoto, 602-0841, Japan

Location

Unknown Facility

Sendai, Miyagi, 980-0872, Japan

Location

Unknown Facility

Nagasaki, Nagasaki, 852-8523, Japan

Location

Unknown Facility

Okayama, Okayama-ken, 700-8558, Japan

Location

Unknown Facility

Moriguchi-shi, Osaka, 570-8540, Japan

Location

Unknown Facility

Hamamatsu, Shizuoka, 431-3192, Japan

Location

Unknown Facility

Chuo-ku, Tokyo, 104-0045, Japan

Location

Unknown Facility

Shinjuku-ku, Tokyo, 160-8582, Japan

Location

MeSH Terms

Conditions

Lymphoma

Interventions

fludarabine phosphate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Medical Monitor

    Genzyme, a Sanofi Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2008

First Posted

June 3, 2008

Study Start

February 1, 2003

Primary Completion

August 1, 2004

Study Completion

August 1, 2004

Last Updated

December 4, 2013

Record last verified: 2013-12

Locations

JP(17)