Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Antineoplastic Agents

All Drugs and Chemicals

Fludarabine

Fludarabine phosphate

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

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.

Fludarabine Phosphate (Fludara)

Medical Monitor

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

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.

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

Genzyme, a Sanofi Company

Lymphoma, Non-Hodgkin

Antirheumatic Agents

Rituximab

Antineoplastic Agents, Immunological

Injection of rituximab on Day 1 along with 5-consecutive day oral dosing of fludarabine phosphate from Day 1 to Day 5, followed by an observation period from Day 6 to Day 28 as 1 treatment cycle, 6 cycles will be given. As for patients who has been observed with partial response (PR) or better antitumor effect, any treatment shall not be provided in principle until the status comes to progressive disease (PD)

Injection of rituximab on Day 1, followed by an observation period from Day 6 to Day 28 as 1 treatment cycle, 6 cycles will be given. As for patients who has been observed with partial response (PR) or better antitumor effect, any treatment shall not be provided in principle until the status comes to progressive disease (PD)

The purpose of this study is to assess the antitumor effect and safety of fludarabine phosphate tablet in combination with rituximab in patient with indolent lymphoma.

Efficacy and Safety Study of SH T 586 in Combination With Rituximab to Treat Low-Grade NHL

A Multicenter Study to Assess the Antitumor Effect and Safety of Fludarabine Phosphate Tablet (SH T 586) in Combination With Rituximab Administered in 6 Treatment Cycles (1 Treatment Cycle: Rituximab 375 mg/m2 iv on Day 1 Along With 5-Consecutive Day Oral Dosing of SH T 586 40 mg/m2/Day From Day 1 to Day 5, Followed by an Observation Period of 23 Days) in Patients With Indolent Lymphoma

Symptoms and General Pathology

Leukemia

Leukemia, Lymphoid

Anemia

Thrombocytopenia

Leukemia, Lymphocytic, Chronic, B-Cell

Hematologic Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Blood Platelet Disorders

Cytopenia

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

6 cycles (1 cycle: 5 treatment days every 28 days)

The purpose of this study is to confirm the efficacy and safety of fludarabine phosphate administered with dose increasing in 6 cycles (1 cycle: 5 treatment days every 28 days) in untreated chronic lymphocytic leukemia (CLL) patients with anemia and/or thrombocytopenia.

A Study to Confirm the Efficacy and Safety of Fludarabine Phosphate Administered in Untreated Chronic Lymphocytic Leukemia Patients With Anemia and/or Thrombocytopenia

A Multicenter Study to Confirm the Efficacy and Safety of Fludara i.v. (Fludarabine Phosphate, SH L 573), Administered in 6 Treatment Cycles (1 Treatment Cycle: 5-consecutive Day Dosing, Followed by an Observation Period of 23 Days) in Untreated Chronic Lymphocytic Leukemia Patients With Anemia and/or Thrombocytopenia

Analgesics

Mitoxantrone

All patients will receive fludarabine phosphate orally for 3 consecutive days per cycle and mitoxantrone on day 1. Each patient will receive up to six treatment cycles. Treatment cycles will be given at 4 weeks intervals.

The purpose of the study is to demonstrate that oral fludarabine phosphate is comparable to i.v. formulation used in combination with mitoxantrone in terms of efficacy, safety and risk/benefit profile

Efficacy and Safety Study of Oral Fludarabine Phosphate in Combination With Mitoxantrone as First Line Treatment in Follicular NHL

A Phase II Study to Evaluate the Efficacy and Safety of Oral Fludarabine Phosphate in Combination With Mitoxantrone as First Line Treatment in Follicular NHL

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Fludara (Oral) Phase II Study for Indolent Lymphoma	NCT00688883	Lymphoma	Fludarabine Pho...	20 Years - 74 Years	Sanofi
Efficacy and Safety Study of SH T 586 in Combination With Rituximab to Treat Low-Grade NHL	NCT00311129	Lymphoma, Low-G...	Fludarabine Pho... Rituximab	20 Years - 74 Years	Sanofi
A Study to Confirm the Efficacy and Safety of Fludarabine Phosphate Administered in Untreated Chronic Lymphocytic Leukemia Patients With Anemia and/or Thrombocytopenia	NCT00220311	Leukemia, Lymph...	Fludarabine Pho...	15 Years - 80 Years	Sanofi
Efficacy and Safety Study of Oral Fludarabine Phosphate in Combination With Mitoxantrone as First Line Treatment in Follicular NHL	NCT00185445	Non Hodgkin Lym...	Fludarabine Pho...	18 Years -	Sanofi
Efficacy and Safety Study of SH T 586 in Combination With Rituximab to Treat Low-Grade NHL	NCT00311129	Lymphoma, Low-G...	Fludarabine Pho... Rituximab	20 Years - 74 Years	Sanofi

Spots Global Cancer Trial Database for fludarabine phosphate (fludara)