Trial Outcomes & Findings for Fludarabine, Cyclophosphamide, and Rituximab in Treating Patients Who Have Chronic Lymphocytic Leukemia (NCT NCT00003659)

Results Overview

Response was determined as indicated in the protocol. The categories are: complete response, nodular partial response, partial response and failure. The major criteria for determination of response to therapy in patients with CLL include physical examination and examination of the peripheral blood and bone marrow. The laboratory and radiographic studies which were abnormal pre-study, will be repeated to document the degree of maximal response.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

39 participants

Primary outcome timeframe

3 years

Results posted on

2017-10-24

Participant Flow

Protocol Open to Accrual 09/08/1998 Protocol Closed to Accrual 06/14/2005 Primary Completion Date 05/12/2009 Recruitment Location is the medical clinic

Participant milestones

Participant milestones
Measure	Intermediate or High Risk Chronic Lymphocytic Leukemia This is a single-arm open-label pilot study designed to assess the antileukemic activity of a regimen containing sequential administration of fludarabine, high-dose cyclophosphamide, and rituximab.
Overall Study STARTED	39
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Intermediate or High Risk Chronic Lymphocytic Leukemia This is a single-arm open-label pilot study designed to assess the antileukemic activity of a regimen containing sequential administration of fludarabine, high-dose cyclophosphamide, and rituximab.
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Fludarabine, Cyclophosphamide, and Rituximab in Treating Patients Who Have Chronic Lymphocytic Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intermediate or High Risk Chronic Lymphocytic Leukemia n=39 Participants This is a single-arm open-label pilot study designed to assess the antileukemic activity of a regimen containing sequential administration of fludarabine, high-dose cyclophosphamide, and rituximab.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants
Age, Continuous	57.7 years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants
Region of Enrollment United States	39 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years

Population: There were 36 assessable patients as described in the protocol

Response was determined as indicated in the protocol. The categories are: complete response, nodular partial response, partial response and failure. The major criteria for determination of response to therapy in patients with CLL include physical examination and examination of the peripheral blood and bone marrow. The laboratory and radiographic studies which were abnormal pre-study, will be repeated to document the degree of maximal response.

Outcome measures

Outcome measures
Measure	Intermediate or High Risk Chronic Lymphocytic Leukemia n=36 Participants This is a single-arm open-label pilot study designed to assess the antileukemic activity of a regimen containing sequential administration of fludarabine, high-dose cyclophosphamide, and rituximab.
Overall Response Rate Complete Response	22 participants
Overall Response Rate Nodular Partial Response	2 participants
Overall Response Rate Partial Response	8 participants
Overall Response Rate Failure	4 participants

SECONDARY outcome

Timeframe: 3 years

Population: All assessable patients as indicated in the protocol

The flow cytometric response and the molecular polymerase chain reaction (PCR) response was captured as indicated in the protocol. Immunophenotypic analysis of bone marrow and/ or peripheral blood demonstrate a normal k:λ ratio and a normal number of CD5/CD19 (or CD5/CD20) dual staining cells (\<5% of the lymphocyte gate).

Outcome measures

Outcome measures
Measure	Intermediate or High Risk Chronic Lymphocytic Leukemia n=36 Participants This is a single-arm open-label pilot study designed to assess the antileukemic activity of a regimen containing sequential administration of fludarabine, high-dose cyclophosphamide, and rituximab.
Utilize Flow Cytometry and Polymerase Chain Reaction as Sensitive Measures of Minimal Residual Disease Flow cytometric complete response	20 participants
Utilize Flow Cytometry and Polymerase Chain Reaction as Sensitive Measures of Minimal Residual Disease Molencular (PCR) complete response	12 participants

SECONDARY outcome

Timeframe: up to 5 years

Population: All assessable patients as indicated in the protocol.

The 5 year survival rate. The survival of patients with this disease is dependent on the stage of disease. Two useful staging systems are: Three-stage Rai System Clinical Feature and the Binet System.

Outcome measures

Outcome measures
Measure	Intermediate or High Risk Chronic Lymphocytic Leukemia n=36 Participants This is a single-arm open-label pilot study designed to assess the antileukemic activity of a regimen containing sequential administration of fludarabine, high-dose cyclophosphamide, and rituximab.
Overall Survival Status	26 participants

Adverse Events

Intermediate or High Risk Chronic Lymphocytic Leukemia

Serious events: 10 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Intermediate or High Risk Chronic Lymphocytic Leukemia n=36 participants at risk This is a single-arm open-label pilot study designed to assess the antileukemic activity of a regimen containing sequential administration of fludarabine, high-dose cyclophosphamide, and rituximab.
Blood and lymphatic system disorders Anemia	16.7% 6/36
Respiratory, thoracic and mediastinal disorders Pulmonary, other Pneumonia	5.6% 2/36
Infections and infestations Infection with grade 3/4 neut	13.9% 5/36

Other adverse events

Other adverse events
Measure	Intermediate or High Risk Chronic Lymphocytic Leukemia n=36 participants at risk This is a single-arm open-label pilot study designed to assess the antileukemic activity of a regimen containing sequential administration of fludarabine, high-dose cyclophosphamide, and rituximab.
Blood and lymphatic system disorders Neutropenia	88.9% 32/36
Blood and lymphatic system disorders Thrombocytopenia	77.8% 28/36

Additional Information

Dr. David Scheinberg

Memorial-Sloan Kettering Cancer Center

Phone: 646-888-2190

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place