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LeukemiaPhase 2NCT00458523

Alemtuzumab in Treating Patients With B-Cell Chronic Lymphocytic Leukemia in Partial Remission or Complete Remission

A Phase 2 study testing alemtuzumab, fluorescence in situ hybridization and mutation analysis in people with Leukemia, run by Leeds Cancer Centre at St. James's University Hospital at 2 sites in United Kingdom.

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

RATIONALE: Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia
What is being tested?
alemtuzumab, fluorescence in situ hybridization and mutation analysis
How many people
54 participants
Where
2 sitesUnited Kingdom
Study dates
Dec 2006to Feb 2008
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

DISEASE CHARACTERISTICS:

  • Diagnosis of B-cell chronic lymphocytic leukemia (B-CLL) meeting the following criterion:
  • Confirmed by characteristic immunophenotype on peripheral blood flow cytometry
  • In complete or partial remission after prior therapy for B-CLL
  • No treatment failure after receiving prior alemtuzumab therapy
  • Minimal residual disease (MRD) status meeting 1 of the following criteria:
  • Detectable B-CLL MRD (i.e., MRD-positive) as shown by peripheral blood or bone marrow involvement
  • Undetectable B-CLL MRD (i.e., MRD-negative remission)
  • Lymph nodes < 2 cm in maximum diameter
  • No persisting severe pancytopenia due to prior therapy rather than disease, as defined by the following criteria:
  • Neutrophil count < 5,000/mm^3
  • Platelet count < 50,000/mm^3
  • No clinically progressive disease (i.e., peripheral blood B-cell count ≥ 5,000/mm³)
  • No mantle cell lymphoma
  • No CNS involvement with B-CLL

PATIENT CHARACTERISTICS:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after completion of study therapy
  • Creatinine < 2 times upper limit of normal (ULN)*
  • Bilirubin < 2 times ULN*
  • No known HIV positivity
  • No concurrent active infection
  • No history of anaphylaxis after exposure to rat or mouse-derived, complementary-determining region-grafted humanized monoclonal antibodies
  • No other concurrent severe diseases or mental disorders
  • No concurrent active secondary malignancy NOTE: *Unless secondary to direct infiltration of the liver by B-CLL or hemolysis

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior allogeneic stem cell transplantation
  • Any other prior therapy allowed
  • At least 6 months since completion of last therapy for B-CLL
  • More than 6 weeks since prior investigational agents
  • No other concurrent cytotoxic agents

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

  • Kent and Canterbury Hospital

    Canterbury, England, CT1 3NG

  • Leeds General Infirmary

    Leeds, England, LS1 3EX

Other trials in United Kingdom

About this study

Official title: Eradication of Minimal Residual Disease (MRD) in Patients With Chronic Lymphocytic Leukaemia (CLL) With Alemtuzumab: A Phase II Study

RATIONALE: Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them.

PURPOSE: This phase II trial is studying the side effects and how well alemtuzumab works in treating patients with B-cell chronic lymphocytic leukemia in partial remission or complete remission.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the rate of achieving minimum residual disease (MRD) negativity after treatment with alemtuzumab in patients with B-cell chronic lymphocytic leukemia (B-CLL) who have low levels of MRD after conventional therapy or who relapse at an MRD level after a prior MRD-negative remission.
  • Determine the safety of alemtuzumab in patients treated in the MRD-positive setting.

Secondary

  • Determine the clinical response in patients treated with this drug.
  • Determine the time to MRD relapse in patients treated with this drug.
  • Determine the overall survival of patients treated with this drug.
  • Determine the effect of this drug when administered as consolidation/maintenance therapy on CD52 expression on CLL cells.
  • Determine the safety and efficacy of repeated drug dosing required to achieve sustained MRD negativity in these patients.

OUTLINE: This is a multicenter study.

  • Observation: Patients with minimal residual disease (MRD)-negative status are observed every 4 weeks for 12 weeks and then every 12 weeks thereafter. If they become MRD-positive, then they are eligible for treatment.
  • Treatment: Patients with MRD-positive status receive alemtuzumab subcutaneously or IV over 2 hours three times weekly for up to 12 weeks in the absence of disease progression or unacceptable toxicity. After completion of 6 weeks of study therapy, patients are evaluated for response. Patients who remain MRD-positive and are responding to study therapy receive an additional 6 weeks of treatment. Patients who remain MRD-positive and show no significant improvement in the level of leukemic cells detected in their peripheral blood or bone marrow are removed from the study. Patients achieving MRD-negative remission are removed from study therapy and monitored for disease recurrence at an MRD level. If MRD-level relapse is confirmed in these patients, they may be retreated with alemtuzumab provided their initial response to therapy lasted for at least 6 months.

Patients undergo collection of peripheral blood and bone marrow periodically during study for assessment of MRD by MRD flow cytometry, fluorescent in situ hybridization (FISH) analysis, somatic mutation analysis, and B-cell selection.

After completion of study therapy, patients are followed periodically.

PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.

Conditions
Leukemia
Being tested
alemtuzumab, fluorescence in situ hybridization, mutation analysis, flow cytometry
Keywords
B-cell chronic lymphocytic leukemia, stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage 0 chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia
Medical subject headings
Leukemia, Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

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

  • alemtuzumabBiological

  • fluorescence in situ hybridizationGenetic

  • mutation analysisGenetic

  • flow cytometryOther

What is being measured

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

  1. Rate of undetectable minimal residual disease (MRD) after completion of alemtuzumab therapy

  2. Rate of unacceptable toxicities

Secondary outcomes (8)

  1. Rate of overall response (complete or partial response)

  2. Time to MRD relapse

  3. Overall survival

  4. Expression of CD52 on chronic lymphocytic leukemia cells

  5. Rate of re-achievement of MRD negativity after completion of alemtuzumab therapy

  6. Incidence of successful retreatment

  7. Toxicity from repeated therapy

  8. Length of interval between required treatments

Timeline

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

  1. First posted11 Apr 2007 (estimated)
  2. Study startDec 2006
  3. Study completionFeb 2008

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
Masking
None (open label)
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00458523
Sponsor's protocol ID
LCC-CTRU-CLL207
Other IDs
CDR0000538115, SPRI-LCC-CTRU-CLL207, ISRCTN23153249, EU-20715, EUDRACT-2006-000053-22
Status last verified
Apr 2007
First submitted
9 Apr 2007
Last updated
12 Aug 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing alemtuzumab, fluorescence in situ hybridization and mutation analysis in people with Leukemia, run by Leeds Cancer Centre at St. James's University Hospital at 2 sites in United Kingdom.

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

Who may be eligible to take part?

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 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. 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?

Rate of undetectable minimal residual disease (MRD) after completion of alemtuzumab therapy. The study lists 2 primary outcomes in all. 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 NCT00458523.

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 12 Aug 2013.

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