NCT00003620

Brief Summary

Phase II trial to study the effectiveness of flavopiridol in treating patients who have chronic lymphocytic leukemia that has not responded to treatment with fludarabine. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die

Trial Health

80
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 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

June 1, 1999

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.9 years until next milestone

First Posted

Study publicly available on registry

September 25, 2003

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Last Updated

January 17, 2013

Status Verified

January 1, 2013

Enrollment Period

7 years

First QC Date

November 1, 1999

Last Update Submit

January 16, 2013

Conditions

B-cell Chronic Lymphocytic LeukemiaRefractory Chronic Lymphocytic LeukemiaStage I Chronic Lymphocytic LeukemiaStage II Chronic Lymphocytic LeukemiaStage III Chronic Lymphocytic LeukemiaStage IV Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

  • Complete + partial response rate

    The CR + PR rate will be estimated with a 95% confidence interval, and the success of the study will be judged with the two-stage design given above.

    Up to 5 years

Secondary Outcomes (3)

  • Toxicity profile of flavopiridol

    Up to 5 years

  • Progression-free survival

    From onstudy date to the date of progression or death, assessed up to 5 years

  • Overall survival

    From onstudy date to the date of death, assessed up to 5 years

Study Arms (1)

Treatment (flavopiridol)

EXPERIMENTAL

Patients registered before 9/15/2000 receive flavopiridol IV continuously on days 1-3. Treatment repeats every 14 days for a total of 12 courses in the absence of disease progression or unacceptable toxicity. Patients registered after 9/15/2000 receive flavopiridol IV over 1 hour daily on days 1-3. Treatment repeats every 3 weeks for a total of 8 courses in the absence of disease progression or unacceptable toxicity.

Drug: alvocidibOther: laboratory biomarker analysis

Interventions

alvocidibDRUG

Given IV

Also known as: FLAVO, flavopiridol, HMR 1275, L-868275
Treatment (flavopiridol)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (flavopiridol)

Eligibility Criteria

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

You may qualify if:

  • Histologically diagnosed intermediate risk (stage I or II) or high risk (stage III or IV) refractory B-cell chronic lymphocytic leukemia
  • Intermediate risk group must have evidence of active disease as shown by at least one of the following:
  • Massive or progressive splenomegaly and/or lymphadenopathy
  • Weight loss of greater than 10% in the last 6 months
  • CALGB grade 2-4 fatigue
  • Fevers greater than 100.5 degree Fahrenheit OR night sweats for greater than2 weeks without evidence of infection
  • Progressive lymphocytosis with an increase greater than 50% over a 2 month period or an anticipated doubling time of less than 6 months
  • Refractory to fludarabine treatment OR relapsed within 6 months of fludarabine
  • Lymphocytosis greater than 5000/mm3 at some time during disease
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • Creatinine no greater than 1.5 times ULN
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No more than 1 prior nonradiolabeled antibody treatment (e.g., Campath-1H or rituximab)
  • At least 1, but no more than 3, prior chemotherapy regimens
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer and Leukemia Group B

Chicago, Illinois, 60606, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

alvocidib

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

Study Officials

  • John Byrd

    Cancer and Leukemia Group B

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

September 25, 2003

Study Start

June 1, 1999

Primary Completion

June 1, 2006

Last Updated

January 17, 2013

Record last verified: 2013-01

Locations

US(1)