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LeukemiaPhase 2NCT00858117

A Phase II Trial of Alemtuzumab and Rituximab in Patients With Previously Untreated CLL

A Phase 2 study testing Alemtuzumab and Rituximab in people with Leukemia, run by Northwestern University 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

RATIONALE: Monoclonal antibodies, such as alemtuzumab and rituximab, 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 and Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
26 Sep 2005to 24 Jan 2013
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

DISEASE CHARACTERISTICS:

  • Diagnosis of B-cell chronic lymphocytic leukemia (CLL)*, as defined by the following criteria:
  • Peripheral blood absolute lymphocyte count > 5,000/mm³
  • Small- to moderate-size lymphocytes with < 55% prolymphocytes, atypical lymphocytes, or lymphoblasts
  • Phenotypically characterized B-CLL expressing CD20 and CD52, as defined by the following:
  • Predominant population of cells share B-cell antigens with CD-5 in the absence of other pan-T-cell markers (e.g., CD-3, CD-2)
  • B-cell expresses either lambda or kappa light chains
  • Surface immunoglobulin with low-cell surface density expression NOTE: *Presence of splenomegaly, hepatomegaly, or lymphadenopathy are not required for the diagnosis of CLL
  • Requires therapy, as indicated by ≥ 1 of the following criteria:
  • Unintentional weight loss > 10% within the past 6 months
  • Extreme fatigue (i.e., ECOG performance status 2)
  • Fevers > 100.5°F for 2 weeks without evidence of infection
  • Night sweats without evidence of infection
  • Evidence of progressive marrow failure as manifested by the development of or worsening of anemia (hemoglobin < 10 g/dL) and/or thrombocytopenia (platelet count < 100,000/mm³)
  • Massive (i.e., > 6 cm below left costal margin) or progressive splenomegaly
  • Massive nodes/clusters (> 5 cm), progressive symptomatic adenopathy, or adenopathy resulting in end-organ damage
  • Progressive lymphocytosis with an increase of > 50% over 2 months or an anticipated doubling time < 6 months
  • Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease is not sufficient for eligibility

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • ANC ≥ 1,000/mm³*
  • Platelet count ≥ 50,000/mm³*
  • Hemoglobin ≥ 10 g/dL*
  • Serum creatinine ≤ 2.0 mg/dL OR creatinine clearance > 40 mL/min
  • Bilirubin < 2 mg/dL
  • AST and ALT ≤ 2 times normal (unless secondary to tumor infiltration/lymphadenopathy)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after completion of study treatment
  • No active autoimmune anemia or thrombocytopenia
  • No active infection requiring oral or intravenous antibiotics
  • No second malignancy, other than basal cell carcinoma of the skin or in situ carcinoma of the cervix, unless curatively treated ≥ 2 years ago NOTE: *If cytopenias are due to degree of bone marrow involvement, patient may be eligible at the discretion of the principal investigator.

PRIOR CONCURRENT THERAPY:

  • Prior corticosteroid therapy allowed
  • No prior cytotoxic therapy (other than corticosteroids)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Northwestern University, Northwestern Medical Faculty Foundation

    Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: A Phase II Trial of Alemtuzumab (Campath-1H) and Rituximab (Rituxan) in Patients With Previously Untreated CLL

RATIONALE: Monoclonal antibodies, such as alemtuzumab and rituximab, 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. Giving alemtuzumab together with rituximab may kill more cancer cells.

PURPOSE: This phase II trial is studying the side effects of giving alemtuzumab together with rituximab and to see how well it works in treating patients with previously untreated B-cell chronic lymphocytic leukemia.

Read the detailed description

OBJECTIVES:

  • To determine the response rate in patients with previously untreated B-cell chronic lymphocytic leukemia treated with alemtuzumab and rituximab.
  • To evaluate the toxicity of alemtuzumab and rituximab in these patients.

OUTLINE: Patients receive alemtuzumab subcutaneously on days 1, 3, and 5 in weeks 1-18 and rituximab IV on day 1 in weeks 3, 5, 7, 9, 11, 13, 15, and 17 in the absence of disease progression or unacceptable toxicity.

Peripheral blood and bone marrow samples are collected periodically for laboratory biomarker studies. Samples are analyzed for surface markers (e.g., CD3, CD4, CD8, CD10, CD19, CD20, CD25, CD38, CD52, Zap-70) and IgVH by PCR, flow cytometry, and FISH. Samples are also analyzed for alemtuzumab and anti-alemtuzumab antibody levels by flow cytometry.

After completion of study treatment, patients are followed periodically for 5 years.

Conditions
Leukemia
Being tested
Alemtuzumab, Rituximab
Keywords
B-cell chronic lymphocytic leukemia, stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, stage III 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

    Also called Campath-1H

    Alemtuzumab administered subcutaneously 30mg per day, 3 days per week for 18 weeks

  • RituximabBiological

    Also called Rituxan

    Rituximab administered intravenously at 375mg/m2 every 2 weeks for 18 weeks

Study groups in NCT00858117
Study groupRoleWhat they receive
Alemtuzumab and RituximabExperimentalAdministration of Alemtuzumab combined with Rituximab to test the feasibility of combining these two monoclonal antibodies as a first line therapy in patients with B-cell chronic lymphocytic leukemia.
Receives: Biological: Alemtuzumab; Biological: Rituximab

What is being measured

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

  1. Number of Patients Treated With Alemtuzumab and Rituximab Combination With a Response (CR or PR) Assessed by NCI-WG 1996 Criteria With Lymph-adenopathy and Organomegaly Measured During Physical Examination

    Response rate (complete remission(CR) + partial remission(PR)) will be, assessed by NCI-WG 1996 criteria with lymphadenopathy and organomegaly measured during physical examination.

    CR=Absence of lymphadenopathy and constitutional symptoms, Normal CBC (leukocytes ≥ 1500/μl, Platelets >100,000/μl, Hemoglobin > 11.0 gm/dl), peripheral blood lymphocytes ≤ 4,000/μl.The marrow sample must be at least normocellular with < 30% of nucleated cells being lymphocytes.

    PR=absence of constitutional symptoms, ≥ 50% decrease in peripheral blood lymphocyte count from the pretreatment baseline value, ≥ 50% reduction in lymphadenopathy, ≥ 50% reduction in size of liver and/or spleen and one of the following:

    polymorphonuclear leukocytes ≥ 1,500/μl or 50% improvement over baseline platelets > 100,000/μl or 50% improvement over baseline or hemoglobin > 11.0 gm/dl or 50% improvement over baseline without transfusions

    Measured: At week 9, and post-18 weeks then every 3 months for a year and up every 6 months for up to 2 years

  2. Number of Patients Treated With Alemtuzumab and Rituximab Combination With Response (CR or PR) Assessed by NCI-WG 1996 Criteria With Measurements of the Lymph Nodes and Spleen Size by CT Scans

    Response rate (complete remission(CR) + partial response(PR)) will be assessed by NCI-WG 1996 criteria with measurements of the lymph nodes and spleen size by CT scans. Best response at any timepoint is captured below.

    CR= absence of significant lymphadenopathy (e.g. lymph nodes > 1.5 cm in their greatest transverse diameter) and no hepatomegaly or splenomegaly.

    PR=reduction in lymphadenopathy as defined by the following: (a) a decrease in lymph node size by 50% or more either in the sum products of up to six lymph nodes, or in the largest diameter of the enlarged lymph node(s) detected prior to therapy; (b) no increase in any lymph node, and no new enlarged lymph node; in small lymph nodes (< 2cm), an increase of less than 25% was not considered to be significant and a reduction in the noted pretreatment enlargement of the spleen or liver by 50% or more.

    Measured: At week 9, and post-18 weeks then every 3 months for a year and up every 6 months for up to 2 years

Secondary outcomes (1)

  1. Toxicity of the Study Medications, Alemtuzumab and Rituximab

    Toxicity data will be collected at visits during 18 weeks of treatment and include adverse events considered at least possibly related to either study drugs (Alemtuzumab and Rituximab) and graded 3-5 using CTCAE 3.0.

    In general grading is as follows:

    Grade 1=mild Grade 2=moderate Grade 3=severe Grade 4=life threatening Grade 5=death Reported below are the number of patients who experienced each event

    Measured: During treatment, 18 weeks

Timeline

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

  1. First posted9 Mar 2009 (estimated)
  2. Study start26 Sep 2005
  3. Primary completion17 Mar 2010
  4. Study completion24 Jan 2013

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
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00858117
Sponsor's protocol ID
NU 04H6
Other IDs
NU 04H6, STU00004494
Status last verified
Oct 2020
First submitted
6 Mar 2009
Last updated
6 Nov 2020
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Alemtuzumab and Rituximab in people with Leukemia, run by Northwestern University 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?

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 6 Nov 2020. 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?

Yes. Results are posted in the registry (first posted 19 Oct 2020). 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?

Number of Patients Treated With Alemtuzumab and Rituximab Combination With a Response (CR or PR) Assessed by NCI-WG 1996 Criteria With Lymph-adenopathy and Organomegaly Measured During Physical Examination (time frame: At week 9, and post-18 weeks then every 3 months for a year and up every 6 months for up to 2 years). 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 NCT00858117.

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 6 Nov 2020.

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