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.
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
- Conditions the study is for
- B-cell Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia
- 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
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:
- 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 group | Role | What they receive |
|---|---|---|
| Treatment (thalidomide) | Experimental | 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. Receives: Drug: thalidomide; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Overall survival
The Kaplan-Meier method will be used.
Measured: Up to 5 years
Progression-free survival
The Kaplan-Meier method will be used.
Measured: Up to 5 years
Time to progression
The Kaplan-Meier method will be used.
Measured: Up to 5 years
Duration of response
Measured: Up to 5 years
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.
- First posted27 Jan 2003 (estimated)
- Study startSep 2000
- Primary completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Neil Kay, Principal investigator, North Central Cancer Treatment Group
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Thalidomide in Patients With Relapsed Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT00006226
- Acronym / sponsor ID
- NCI-2012-01852
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Sep 2000
- Primary completion
- Dec 2007 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (thalidomide) | Experimental | Drug: thalidomide, Other: laboratory biomarker analysisPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (34 listed)
- 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:
- Measurable disease
- No bulky lymph node disease greater than 10 cm in at least 1 dimension except splenomegaly
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thalidomideGiven PO | Drug | Treatment (thalidomide) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (thalidomide) |
Primary outcome
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
Ninety percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
5 secondary outcomes
Overall survival
Time frame: Up to 5 years
Progression-free survival
Time frame: Up to 5 years
Time to progression
Time frame: Up to 5 years
Duration of response
Time frame: Up to 5 years
Maximum grade of each type of toxicity
Time frame: Up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil Kay principal investigator
North Central Cancer Treatment Group
1 site in 1 country: see every site and its status.
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?
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; AzTrials last refreshed its copy on 6 Nov 2026.