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B-cell Chronic Lymphocytic LeukemiaPhase 2NCT00003620

Flavopiridol in Treating Patients With Chronic Lymphocytic Leukemia

A Phase 2 study testing alvocidib and laboratory biomarker analysis in people with B-cell Chronic Lymphocytic Leukemia and Refractory Chronic Lymphocytic Leukemia, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
alvocidib and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteUnited States
Study dates
Jun 1999to Jun 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 21Show fewer
  • 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
  • At least 1 prior chemotherapy regimen comprising fludarabine
  • No other concurrent chemotherapy
  • No concurrent chronic use of oral corticosteroids
  • No concurrent hormone therapy except for non-disease related conditions
  • No concurrent dexamethasone or other corticosteroid-based antiemetics
  • No concurrent palliative radiotherapy

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cancer and Leukemia Group B

    Chicago, Illinois, 60606

Other trials in United States

About this study

Official title: A PHASE II STUDY OF FLAVOPIRIDOL (NSC # 649890) IN PATIENTS WITH PREVIOUSLY TREATED BCELL CHRONIC LYMPHOCYTIC LEUKEMIA

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

Read the detailed description

OBJECTIVES: Determine the complete and partial response rate to flavopiridol in patients with fludarabine-refractory chronic lymphocytic leukemia.

Assess the toxicity profile of this treatment in these patients. Examine progression-free survival and overall survival following this treatment in these patients.

Determine the effects of flavopiridol on normal T-cell subsets and immunoglobulin levels in these patients.

OUTLINE: This is an open label, multicenter study.

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.

Patients are followed every 3 months for the first year and then every 6 months for 5 years.

Being tested
alvocidib, laboratory biomarker analysis
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • alvocidibDrug

    Also called FLAVO, flavopiridol, HMR 1275, L-868275

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00003620
Study groupRoleWhat they receive
Treatment (flavopiridol)ExperimentalPatients 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.
Receives: Drug: alvocidib; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 5 years

Secondary outcomes (3)

  1. Toxicity profile of flavopiridol

    Toxicities will be tabulated by type and grade

    Measured: Up to 5 years

  2. Progression-free survival

    Will be estimated using the Kaplan-Meier method.

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

  3. Overall survival

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2003 (estimated)
  2. Study startJun 1999
  3. Primary completionJun 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003620
Sponsor's protocol ID
NCI-2012-02280
Other IDs
CALGB-19805, U10CA031946, CDR0000066699
Status last verified
Jan 2013
First submitted
1 Nov 1999
Last updated
17 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing alvocidib and laboratory biomarker analysis in people with B-cell Chronic Lymphocytic Leukemia and Refractory Chronic Lymphocytic Leukemia, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete + partial response rate (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00003620.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2013.

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