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B-cell Chronic Lymphocytic LeukemiaPhase 2CLL004NCT01982175

Phase II Clinical Trial of Alemtuzumab to Treat B-cell Chronic Lymphocytic Leukemia

A Phase 2 study testing Alemtuzumab in people with B-cell Chronic Lymphocytic Leukemia, run by Shanghai Zhangjiang Biotechnology Limited Company at 1 site in China.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

This is a phase II, prospective, multicenter, open-label study to evaluate the efficacy and safety of Alemtuzumab in patients with relapse and refractory B-cell chronic lymphocytic leukemia. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
B-cell Chronic Lymphocytic Leukemia
What is being tested?
Alemtuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteChina
Study dates
Jul 2011to Jun 2022
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • An established diagnosis of B-cell chronic lymphocytic leukemia(B-CLL)
  • Meet criteria of relapsed or refractory CLL
  • Presence of one or more measurable lesions
  • ECOG Score 0-1
  • Life expectancy > 3 months
  • Female patients with childbearing potential must have a negative serum pregnancy test, male and female patients must agree to use an effective contraceptive method while on study treatment, and for a minimum 1 year following study therapy.

Who cannot join

  • Less than 2 weeks from prior anti-cancer therapy.
  • Allergic to the antibody or any component of the investigational product.
  • Other severe, concurrent diseases, including mental disorders, serious cardiac functional capacity (Class III or IV), uncontrolled diabetes.
  • Use of investigational agents rather than Alemtuzumab.
  • Active systematic infection or major organ malfunction requiring treatment.
  • Serum total bilirubin greater than or equal to 1.5 times upper limits of normal; or Serum alanine aminotransferase (ALT) and/or serum aspartate aminotransferase (AST) greater than or equal to 2.5 times upper limits of normal ( no liver metastases); or ALT and/or AST greater than or equal to 5 times upper limits of normal (liver metastases).
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  • Blood urea nitrogen(BUN) greater than or equal to 1.5 times upper limits of normal or Serum creatinine greater than or equal to 1.5 times upper limits of normal.
  • White blood cell(WBC) count< 3.5×109/L or Absolute neutrophil count(ANC)<1.5×109/L or platelet count<75×109/L or Hemoglobin<80g/L.
  • Human immunodeficiency virus (HIV) positive.
  • Active hepatitis or a history of prior viral hepatitis B or C, or positive hepatitis B serologies without prior immunization.
  • Pregnant or nursing women.
  • Known central nervous system(CNS) metastases with B-CLL.
  • Active secondary malignancy.
  • cytomegalovirus(CMV) positive or immunodeficiency disease or after stem cell transplantation.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University Cancer Hospital

    Beijing, Beijing Municipality

Other trials in China

About this study

Official title: A Multi-center, Open, Prospective, Phase II Study of Recombinant Humanized Anti-CD52 Monoclonal Antibody Injection in Patients With Relapse and Refractory B-cell Chronic Lymphocytic Leukemia

This is a phase II, prospective, multicenter, open-label study to evaluate the efficacy and safety of Alemtuzumab in patients with relapse and refractory B-cell chronic lymphocytic leukemia.

Being tested
Alemtuzumab
Keywords
Alemtuzumab, B-cell chronic lymphocytic leukemia, CD52
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.

  • AlemtuzumabBiological

    Also called Recombinant Humanized Anti-CD52 Mab

    Escalation Phase: Initial Doses of Alemtuzumab 3mg/day by intravenous(IV) infusion until tolerated, then Alemtuzumab 10mg/day IV infusion until tolerated, then Alemtuzumab 30mg IV infusion until tolerated.

    Escalation to 30mg/day should be accomplished in 3~7 days.

    Stable dose Phase: Once 30mg/day infusion of Alemtuzumab was tolerated, then continue 3 times per week. The total duration of Alemtuzumab therapy including escalation and stable dose phase is 12 weeks.

    More than 30mg daily or 90mg weekly dose is prohibited

    --------------------------------------------------------------------------------

Study groups in NCT01982175
Study groupRoleWhat they receive
AlemtuzumabExperimentalPatients receive Alemtuzumab escalated from initial dose of 3mg/day then 10mg/day and up to 30mg/day by intravenous infusion(if tolerated). when stable dose of 30mg/day is tolerated, Alemtuzumab is administrated at 30mg by IV infusion 3 times per week for up to 12 weeks (including escalation and stable dose period). After completion of 12 weeks treatment, or discontinuation of treatment within 12 weeks due to disease progression, patients will be visited every 3 months up to 1 year from enrollment or to death, whichever occurs first.
Receives: Biological: Alemtuzumab

What is being measured

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

  1. Objective Response Rate(ORR)

    Objective Response Rate was defined as the proportion of patients who have CR, PR during the study as evaluated according to National Comprehensive Cancer Network(NCCN) guideline 2010 response criteria. Response categories include Complete Response(CR) and Partial Response(PR).

    ORR=CR+PR

    Measured: up to 1 year

Secondary outcomes (5)

  1. Progression-Free Survival

    Progression-Free Survival was defined as the time from randomization to disease progression (PD) or death due to any cause, whichever comes first.

    Measured: up to 1 year

  2. Disease Control Rate(DCR)

    Patients were evaluated according to National Comprehensive Cancer Network(NCCN) guideline 2010 response criteria. The best response observed during the study is summarized. Response categories include Complete Response(CR), Partial Response(PR) and Stable Disease(SD).

    DCR=CR+PR+SD

    Measured: up to 1 year

  3. Duration of Response(DOR)

    Duration of response was analyzed for patients who achieved a complete release(CR) or partial release(PR) and was defined as the time from the first date of documented response to the date of disease progression or death due to any cause.

    Measured: up to 1 year

  4. Overall Survival

    Overall Survival was defined as the duration from randomization to death due to any cause.

    Measured: up to 1 year

  5. Summary of patients with Adverse Events(AEs)

    Analysis of patients with adverse experiences according to CTCAE Version 4.

    Measured: up to 1 year

Timeline

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

  1. First posted13 Nov 2013 (estimated)
  2. Study startJul 2011
  3. Primary completionFeb 2021
  4. Study completionJun 2022 (estimated)

Why it stopped: recruiting difficulties

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
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01982175
Sponsor's protocol ID
CMAB004
Acronym
CLL004
Status last verified
Jun 2022
First submitted
5 Nov 2013
Last updated
21 Jun 2022
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Alemtuzumab in people with B-cell Chronic Lymphocytic Leukemia, run by Shanghai Zhangjiang Biotechnology Limited Company at 1 site in China.

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 6 inclusion and 14 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: paused, as of the sponsor's last update on 21 Jun 2022. 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 China. 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?

Results are not available in the source record.

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?

Objective Response Rate(ORR) (time frame: up to 1 year). 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 NCT01982175.

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 21 Jun 2022.

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