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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00688883

Enrollment

Registered

2008-06-03

Start date

2003-02-28

Completion date

2004-08-31

Last updated

2013-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

Keywords

Fludarabine, Purine analog, Indolent lymphoma

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.

Interventions

DRUGFludarabine 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 74 Years

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

Design outcomes

Primary

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

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026