Trial Outcomes & Findings for Phase II Study of Fludarabine and Mitoxantrone, Followed by GM-CSF(Granulocyte-macrophage Colony-stimulating Factor) and Rituximab (NCT NCT00208975)

NCT ID: NCT00208975

Last Updated: 2012-06-28

Results Overview

Complete Response (CR): Disappearance of all clinical evidence of active tumor for a minimum of eight weeks and absence of any symptoms related to the tumor. Partial Response (PR):50% decrease in the sum of the product diameters of all lesions that persist for at least four weeks. No lesion can increase in size and no new lesion can appear during this period. Stable disease (SD):A tumor that is neither growing nor shrinking.No new tumors have developed

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

15 participants

Primary outcome timeframe

6 months

Results posted on

2012-06-28

Participant Flow

Participant milestones

Participant milestones
Measure	Fludarabine and Cyclophosphamide With Sequential Administratio Patients will receive fludarabine and cyclophosphamide with sequential administration of GM-CSF on days 6 and 7 and rituximab on day 8.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase II Study of Fludarabine and Mitoxantrone, Followed by GM-CSF(Granulocyte-macrophage Colony-stimulating Factor) and Rituximab

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fludarabine and Cyclophosphamide With Sequential Administratio n=15 Participants Patients will receive fludarabine and cyclophosphamide with sequential administration of GM-CSF on days 6 and 7 and rituximab on day 8.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age Continuous	62 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants
Diagnosis Type Low Grade Non Hodgkin's Lymphoma(NHL)	7 Participants n=5 Participants
Diagnosis Type Chronic Lymphocytic Leukemia (CLL)	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Chronic Lymphocytic Leukemia n=8 Participants Chronic Lymphocytic Leukemia (CLL) is a condition characterized by an accumulation of abnormal lymphocytes in the blood and the bone marrow. These lymphocytes do not perform their functions as normal ones would and interfere with the production of other blood cells necessary for the normal functioning of the blood, leading to a host of complications like deficiency of the immune system, coagulation problems, swollen lymph nodes, and many other conditions. Fludarabine-based combination provide effective treatment for patients with low-grade NHL and CLL with high complete response rates that are improved with the addition of Rituximab.	Non Hodgkin Lymphoma n=7 Participants Non-Hodgkin's lymphoma, also called non-Hodgkin lymphoma, is cancer that originates in your lymphatic system, the disease-fighting network spread throughout your body. In non-Hodgkin's lymphoma, tumors develop from lymphocytes - a type of white blood cell. Fludarabine-based combination provide effective treatment for patients with low-grade NHL and CLL with high complete response rates that are improved with the addition of Rituximab.
Number of Patients's Who Had Complete Response and Partial Response to the Treatment of Fludarabine and Cyclophosphamide Followed by GM-CSF and Rituximab. Complete Response	4 participants	5 participants
Number of Patients's Who Had Complete Response and Partial Response to the Treatment of Fludarabine and Cyclophosphamide Followed by GM-CSF and Rituximab. Partial Response	2 participants	2 participants
Number of Patients's Who Had Complete Response and Partial Response to the Treatment of Fludarabine and Cyclophosphamide Followed by GM-CSF and Rituximab. Stable Disease	1 participants	0 participants

Adverse Events

Fludarabine and Cyclophosphamide With Sequential Administratio

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Fludarabine and Cyclophosphamide With Sequential Administratio n=15 participants at risk Patients will receive fludarabine and cyclophosphamide with sequential administration of GM-CSF on days 6 and 7 and rituximab on day 8.
Blood and lymphatic system disorders Neutropenia	66.7% 10/15
Blood and lymphatic system disorders Thrombocytopenia	46.7% 7/15
Blood and lymphatic system disorders Anemia	60.0% 9/15
Gastrointestinal disorders Nausea	60.0% 9/15
General disorders Fatigue	46.7% 7/15
Gastrointestinal disorders Vomiting	20.0% 3/15
Musculoskeletal and connective tissue disorders Arthritis	13.3% 2/15
Gastrointestinal disorders Diarrhea	6.7% 1/15
General disorders Fever	20.0% 3/15
General disorders Night Sweats	26.7% 4/15
Renal and urinary disorders Hyperkalemia	6.7% 1/15
General disorders Pain	80.0% 12/15
Gastrointestinal disorders Constipation	33.3% 5/15
Skin and subcutaneous tissue disorders Infusion reaction	26.7% 4/15
Blood and lymphatic system disorders Hypoprotinemia	6.7% 1/15
General disorders Weight Loss	13.3% 2/15
General disorders Loss of Appetite	26.7% 4/15
General disorders Anxiety	13.3% 2/15
Gastrointestinal disorders Muscositis	20.0% 3/15
Renal and urinary disorders Polyuria	13.3% 2/15
Endocrine disorders Hyperglycemia	26.7% 4/15
General disorders Malaise	13.3% 2/15
Musculoskeletal and connective tissue disorders Myalgia	13.3% 2/15

Additional Information

Dr. Christopher Flowers

Emory University

Phone: 404-778-3942

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place