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Leukemia, Lymphocytic, Chronic, B-CellPhase 2ECO-1NCT00206726

Alemtuzumab/Fludarabine for Relapsed/Refractory B-cell Chronic Lymphocytic Leukemia (B-CLL)

A Phase 2 study testing Alemtuzumab plus Fludarabine in people with Leukemia, Lymphocytic, Chronic, B-Cell, run by Genzyme, a Sanofi Company at 27 sites 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

This is a multi-center, Phase II, open label trial evaluating the efficacy and safety of alemtuzumab and fludarabine in the treatment of B-cell chronic lymphocytic leukemia (B-CLL) patients who have received at least one prior therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia, Lymphocytic, Chronic, B-Cell
What is being tested?
Alemtuzumab plus Fludarabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
27 sitesUnited States
Study dates
May 2005to Apr 2008
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Patient must have confirmed B-CLL.
  • Patients must have received at least one prior therapy and must require treatment for active disease

Who cannot join

  • Treatment with any anti-cancer agents (chemotherapies, monoclonal antibodies, etc) within 4 weeks of start of study.
  • History of significant allergic reaction to antibody therapies that required discontinuation of antibody therapy
  • History of human immunodeficiency virus (HIV) positivity.
  • Active infection requiring treatment
  • Pregnancy or lactation
  • Other severe, concurrent diseases or mental disorders
  • Central nervous system involvement of chronic lymphocytic leukemia (CLL)

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

United States27 sites

  • Study site

    Albany, New York, 12208-3473

  • Study site

    Atlanta, Georgia, 30322

  • Study site

    Aurora, Illinois, 60504

  • Study site

    Berkeley, California, 94704

  • Study site

    Birmingham, Alabama, 35223

  • Study site

    Boston, Massachusetts, 02115

  • Study site

    Burbank, California, 91595

  • Study site

    Chicago, Illinois, 60637

  • Study site

    Clinton, Maryland, 20735

  • Study site

    Concord, California, 94520

  • Study site

    Jackson, Michigan, 39202

  • Study site

    Johnson City, Tennessee, 37604

  • Study site

    Lakeland, Florida, 33805

  • Study site

    Lawton, Oklahoma, 73505

  • Study site

    Lebanon, New Hampshire, 03756-0001

  • Study site

    Metairie, Louisiana, 70006

  • Study site

    Milwaukee, Wisconsin, 53226-3596

  • Study site

    Minneapolis, Minnesota, 55417

  • Study site

    New Brunswick, New Jersey, 08903-2681

  • Study site

    Northport, New York, 11768

  • Study site

    Pittsburgh, Pennsylvania, 15224

  • Study site

    Portland, Oregon, 97239

  • Study site

    Reno, Nevada, 89520

  • Study site

    Springfield, Illinois, 62703

  • Study site

    Stanford, California, 94305-5118

  • Study site

    Tacoma, Washington, 98431-5000

  • Study site

    Washington D.C., District of Columbia, 20422

Other trials in United States

About this study

Official title: Phase II Study Using Alemtuzumab Combined With Fludarabine for the Treatment of Relapsed/Refractory B-cell Chronic Lymphocytic Leukemia (B-CLL)

This is a multi-center, Phase II, open label trial evaluating the efficacy and safety of alemtuzumab and fludarabine in the treatment of B-cell chronic lymphocytic leukemia (B-CLL) patients who have received at least one prior therapy.

Treatments will be administered on a 28-day cycle for 4-6 cycles, with an evaluation during Cycle 4 to permit re-staging. Alemtuzumab and fludarabine will be administered on Days 1-5 of each cycle. Patients will be assessed for response at the time of re-staging at Cycle 4 and at the end of Cycle 6. At the time of the re-staging, patients achieving a Partial Remission (PR) or Stable Disease (SD) will be given an additional 2 cycles of treatment and patients demonstrating presumptive signs of a Complete Remission (CR) will receive no further treatment but will be followed for response.

Read the detailed description

As of April, 2011 Bayer transferred this record to Genzyme. Genzyme is now the sponsor of this trial. NOTE: This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.

Being tested
Alemtuzumab plus Fludarabine
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.

  • Alemtuzumab plus FludarabineDrug

    Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days

Study groups in NCT00206726
Study groupRoleWhat they receive
Alemtuzumab plus FludarabineExperimentalAlemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days.
Receives: Drug: Alemtuzumab plus Fludarabine

What is being measured

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

  1. Complete Response (CR)

    Participants evaluated for therapeutic clinical response according to National Cancer Institute (NCI) response criteria, 28 days after 4 or 6 treatment cycles. Response confirmation involved bone marrow biopsy and aspirate performed 2 months after final treatment. CR requires for at least 2 months: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count (CBC); confirmed by bone marrow aspirate and biopsy 2 months later with lymphocytes <30% of nucleated cells and procedure repeated in 4 weeks if hypocellular.

    Measured: 28 days after last cycle with confirmation 2 months later

Secondary outcomes (5)

  1. Overall Response (OR)

    Participant had either complete response (CR) or partial response (PR) at 28 days after last treatment cycle (date of OR) and at Months 2 follow-up. PR requires for at least 2 months: 50% decrease from Baseline in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence or absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100000/μL platelets, >11.0 g/dL hemoglobin, or 50% improvement from Baseline for these parameters without transfusions, nodular CR or persistent anemia/thrombocytopenia unrelated to disease.

    Measured: 28 days after last cycle with confirmation 2 months later

  2. Overall Survival (OS)

    Percentage of participants alive 1 year after the first dose date, described as Kaplan-Meier estimate at 1 year

    Measured: 1 year after start of treatment

  3. Progression-free Survival (PFS)

    Percentage of participants who survived progression-free at 1 year, described as Kaplan-Meier estimate at 1 year

    Measured: 1 year after start of treatment

  4. Percentage of Participants With Overall Response at Different Observation Times

    Participant had either complete response (CR) or partial response (PR) at different observation times (after 90 days; after 180 days; after 270 days). PR requires for at least 2 months: 50% decrease from Baseline in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence or absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100000/μL platelets, >11.0 g/dL hemoglobin, or 50% improvement from Baseline for these parameters without transfusions, nodular CR or persistent anemia/thrombocytopenia unrelated to disease.

    Measured: from first date of confirmed response until relapse, or death, or study data cutoff date, whichever is earlier

  5. Number of Participants With Minimal Residual Disease (MRD)

    Presence of MRD was assessed by laboratory testing of molecular responses in blood and bone marrow samples.

    Measured: When CR is confirmed

Timeline

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

  1. First posted21 Sep 2005 (estimated)
  2. Study startMay 2005
  3. Primary completionApr 2008
  4. Study completionApr 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
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00206726
Sponsor's protocol ID
13603
Other IDs
305825
Acronym
ECO-1
Status last verified
Jul 2016
First submitted
19 Sep 2005
Last updated
29 Aug 2016

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Alemtuzumab plus Fludarabine in people with Leukemia, Lymphocytic, Chronic, B-Cell, run by Genzyme, a Sanofi Company at 27 sites 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 2 inclusion and 7 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 29 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites 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?

Yes. Results are posted in the registry (first posted 13 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Response (CR) (time frame: 28 days after last cycle with confirmation 2 months later). 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 NCT00206726.

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 29 Aug 2016.

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