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B-cell Chronic Lymphocytic LeukemiaPhase 2NCT00006226

Thalidomide in Treating Patients With Relapsed Chronic Lymphocytic Leukemia

A Phase 2 study testing thalidomide 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 thalidomide in treating patients who have relapsed chronic lymphocytic leukemia. Thalidomide may stop the growth of chronic lymphocytic leukemia by stopping blood flow to the tumor. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
thalidomide and laboratory biomarker analysis
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
1 siteUnited States
Study dates
Sep 2000to Dec 2007
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

  • Diagnosis of chronic lymphocytic leukemia (CLL) evidenced by monoclonal population of mature CD5+, CD19+, CD23+, and B cells
  • Relapsed after prior treatment for CLL
  • Active disease with 1 or more of the following characteristics:
  • At least 10% weight loss within the past 6 months
  • Fever greater than 100.5 degrees F for at least 2 weeks without evidence of infection
  • Night sweats without evidence of infection
Show all 34Show fewer
  • Evidence of progressive marrow failure with anemia (hemoglobin less than 11 g/dL) and/or thrombocytopenia (platelet count less than 100,000/mm^3) (i.e., any stage III or IV disease)
  • Autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroid therapy
  • Massive or progressive splenomegaly (i.e., greater than 6 cm below the left costal margin or more than 50% increase over 2 months)
  • Progressive lymphadenopathy (i.e., more than 50% increase over 2 months)
  • Progressive lymphocytosis (not due to corticosteroids) with an increase of more than 50% over a 2-month period or an anticipated doubling time of less than 6 months
  • Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease are not considered evidence of active disease
  • Measurable disease
  • Absolute lymphocyte count greater than 5,000/mm^3
  • No bulky lymph node disease greater than 10 cm in at least 1 dimension except splenomegaly
  • Performance status - ECOG 0-2
  • Absolute neutrophil count at least 500/mm^3
  • Platelet count at least 20,000/mm^3 (in absence of sargramostim [GM-CSF])
  • Hemoglobin at least 8 g/dL
  • Bilirubin no greater than 2.5 times upper limit of normal (ULN)
  • AST no greater than 2.5 times ULN
  • Creatinine no greater than 1.5 mg/dL
  • Creatinine clearance at least 60 mL/min
  • No other active malignancy
  • No peripheral neuropathy (sensory) grade 2 or greater
  • No active infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use 1 highly effective method of contraception AND 1 additional effective method of contraception for at least 4 weeks before, during, and for 4 weeks after study completion
  • No prior allogeneic bone marrow transplantation
  • At least 10 days since prior filgrastim (G-CSF) or GM-CSF
  • No more than 3 prior chemotherapy regimens
  • At least 30 days since prior chemotherapy
  • No concurrent corticosteroids except for adrenal insufficiency

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • North Central Cancer Treatment Group

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: A Phase II Trial of Thalidomide in Patients With Relapsed Chronic Lymphocytic Leukemia

Phase II trial to study the effectiveness of thalidomide in treating patients who have relapsed chronic lymphocytic leukemia. Thalidomide may stop the growth of chronic lymphocytic leukemia by stopping blood flow to the tumor.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine whether thalidomide can induce objective responses in relapsed B-CLL patients.

II. To determine the toxicity of thalidomide in this patient population. III. To document if alterations in vascular growth factors and/or bone marrow angiogenesis patterns correlate with thalidomide related clinical responses.

OUTLINE:

Patients receive oral thalidomide daily for 4 weeks. Courses repeat every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 5 years.

Being tested
thalidomide, 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.

  • thalidomideDrug

    Given PO

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00006226
Study groupRoleWhat they receive
Treatment (thalidomide)ExperimentalPatients receive oral thalidomide daily for 4 weeks. Courses repeat every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.
Receives: Drug: thalidomide; Other: laboratory biomarker analysis

What is being measured

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

  1. Confirmed response, noted as the objective status of CR, nPR, or PR on 2 consecutive evaluations at least 4 weeks apart

    Ninety percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.

    Measured: Up to 5 years

Secondary outcomes (5)

  1. Overall survival

    The Kaplan-Meier method will be used.

    Measured: Up to 5 years

  2. Progression-free survival

    The Kaplan-Meier method will be used.

    Measured: Up to 5 years

  3. Time to progression

    The Kaplan-Meier method will be used.

    Measured: Up to 5 years

  4. Duration of response

    Measured: Up to 5 years

  5. Maximum grade of each type of toxicity

    Frequency tables will be reviewed.

    Measured: 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 posted27 Jan 2003 (estimated)
  2. Study startSep 2000
  3. Primary completionDec 2007

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
41 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00006226
Sponsor's protocol ID
NCI-2012-01852
Other IDs
NCI-2012-01852, NCCTG-N9986, CDR0000068148, N9986, N9986, U10CA025224
Status last verified
Oct 2013
First submitted
11 Sep 2000
Last updated
8 Oct 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing thalidomide 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 34 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 8 Oct 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?

Confirmed response, noted as the objective status of CR, nPR, or PR on 2 consecutive evaluations at least 4 weeks apart (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 NCT00006226.

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 8 Oct 2013.

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