NCT00143065

Brief Summary

This purpose of this study is to assess the toxicity and the rate of complete and overall response using fludarabine, rituximab, and alemtuzumab to treat patients with B-chronic lymphocytic leukemia or small lymphocytic leukemia who have received previous treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2005

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

February 8, 2017

Status Verified

February 1, 2017

Enrollment Period

1.5 years

First QC Date

August 31, 2005

Last Update Submit

February 6, 2017

Conditions

Lymphoma, Small LymphocyticLymphocytic Leukemia, Chronic

Keywords

Antigens, CD5Antigens, CD19Antigens, CD20

Outcome Measures

Primary Outcomes (1)

  • Assess the rate of complete (CR) and overall response (ORR) using fludarabine, rituximab, and alemtuzumab

    2005-present

Secondary Outcomes (1)

  • Assess toxicity of this regimen.

    2005-present

Interventions

FludarabineDRUG

25 mg/m2/day for 5 days every 28 days (Week 2,6,10,14, 18,and 22) will be administered by IV over 10-30 minutes. (Fludarabine should be given AFTER rituximab on all days on which both drugs will be administered.)

Also known as: Fludara
RituximabDRUG

Day 1, week 2 of cycle 1 rituximab 100 mg will be administered by IV, without dose escalation, over 4 hours (rate: 25 mg/hr). Day 3, week 2 of cycle 1 rituximab 375 mg/m2 will be administered by IV. Rituximab can be administered at 50 mg/hr. If hypersensitivity or infusion related events do not occur, the infusion rate will be escalated in 50 mg/hr increments every 30 minutes to a maximum of 400 mg/hr. * On Day 5, week 2 of cycle 1 rituximab 375 mg/m2 will be administered by IV. Rituximab can be administered at 100 mg/hr. If hypersensitivity or infusion related events do not occur, the infusion rate will be escalated in 100 mg/hr increments every 30 minutes to a maximum of 400 mg/hr. * Rituximab 375 mg/m2 will be repeated on Day 1 of Week 6, 10, 14, 18, and 22. During these treatments, acetaminophen and diphenhydramine prophylactic treatment is left to the discretion of the treating physician.

Also known as: Rituxan
AlemtuzumabDRUG

The dose of alemtuzumab will be escalated during Week 1 of therapy. On Day 1 of Week 1, a dose of 3 mg should be administered IV over 2-hours. If this dose is well tolerated(grade 2 or less infusion or skin related toxicity), then the dose on Day 2 can be increased to 10 mg IV over 2 hours. If this dose is well tolerated, then the dose on Day 3 will be increased to 30 mg IV over 2-hours, and if tolerated, then day 5 and all subsequent alemtuzumab doses will be 30 mg. Vital signs (blood pressure, pulse, respiration rate,temperature, and O2 saturation) and skin assessment should be assessed at baseline, 1-hour, and 1-hour post administration during week 1 and 2. Following successful escalation to 30 mg of alemtuzumab, all subsequent doses of alemtuzumab will be 30 mg administered on the second day of fludarabine therapy (week 2,6,10,14,18,and 22).

Also known as: Campath

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must have B-CLL/SLL
  • active disease
  • \>=1 prior systemic therapy
  • ECOG PS 0-2.

You may not qualify if:

  • Pregnant or nursing women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Links

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

fludarabinefludarabine phosphateRituximabAlemtuzumab

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsAntibodies, Monoclonal, Humanized

Study Officials

  • John C. Byrd, M.D.

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 31, 2005

First Posted

September 2, 2005

Study Start

August 1, 2005

Primary Completion

February 1, 2007

Study Completion

July 1, 2009

Last Updated

February 8, 2017

Record last verified: 2017-02

Locations

US(1)