Fludara (Oral) Phase II Study for Indolent Lymphoma
This study has been completed.
Sponsor:
Genzyme
Information provided by (Responsible Party):
Genzyme
ClinicalTrials.gov Identifier:
NCT00688883
First received: May 30, 2008
Last updated: March 4, 2013
Last verified: March 2013
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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 Genzyme:
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
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
Investigators
| Study Director: | Medical Monitor | Genzyme |
More Information
Additional Information:
No publications provided
| Responsible Party: | Genzyme |
| ClinicalTrials.gov Identifier: | NCT00688883 History of Changes |
| Other Study ID Numbers: | 305621, 91101 |
| Study First Received: | May 30, 2008 |
| Last Updated: | March 4, 2013 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Keywords provided by Genzyme:
|
Fludarabine Purine analog Indolent lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Fludarabine Fludarabine monophosphate Vidarabine Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 16, 2013