NCT00336206

Brief Summary

The aim of the study is to evaluate if the treatment with Alemtuzumab (after I or II line chemotherapy) administered for 6 weeks followed by 4 months maintenance treatment compared to a control group can reduce disease activity/residual disease and thereby delay the reoccurrence of the CLL disease.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2006

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 13, 2006

Completed
18 days until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

July 25, 2006

Status Verified

June 1, 2006

First QC Date

June 12, 2006

Last Update Submit

July 21, 2006

Conditions

B-Cell Chronic Lymphocytic Leukemia

Keywords

Low dose AlemtuzumabChronic lymphocytic leukemiaB-Cell

Outcome Measures

Primary Outcomes (1)

  • To determine the Time to Treatment Failure (TTF)

Secondary Outcomes (6)

  • To evaluate Complete Remission (CR) rate.

  • To evaluate Partial Response (PR) rate.

  • Minimal Residual Disease (MRD) evaluated with flow-cytometry ("MRD flow panel") in patients with CR

  • To determine Overall Response Rate (ORR).

  • To evaluate duration of response.

  • +1 more secondary outcomes

Interventions

AlemtuzumabDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • B-CLL diagnosis taken consideration of NCI criteria.
  • In case of CR: positive MRD status
  • At least achieving a PR to the last line of antitumor therapy given and than at least PR is still present after a follow-up of 3-6 months after the last antitumor course (wash-out period)
  • Age \>18 years and \< 75 years.
  • WHO performance status 0-II.
  • ANC ≥1.0 x 109/L
  • Platelet count ≥50 x 109/L
  • Negative pregnancy test in fertile females
  • Anticipated life expectancy ≥ 12 months
  • Signed informed consent
  • Fertile men or women of childbearing potential using adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile)

You may not qualify if:

  • Elapsed time of less than 3 months or more than 6 months since last dose of previous antitumor therapy
  • Previous Alemtuzumab administration.
  • Contraindication for Alemtuzumab
  • More than 2 previous treatment regimens
  • SD or PD on last antitumor therapy
  • Persistent CLL symptoms in clinical need of further antitumor therapy
  • History of severe pneumocytis carinii infection (PCP)
  • HIV positive
  • Active hepatitis or a history of prior viral hepatitis B or hepatitis C, or positive hepatitis B serologies without prior immunization
  • Active viral, fungal or bacterial infection.
  • Active autoimmune hemolytic anemia or active autoimmune thrombocytopenia.
  • Severe concurrent diseases or mental disorders.
  • Significant renal dysfunction ( serum creatinine ≥150 µmol/l or creatinine clearance \< 30 ml/min)
  • Significant hepatic dysfunction (total bilirubin or transaminases \>2 times ULN)
  • Pregnancy or lactation.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Alemtuzumab

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Jorgen Kristensen, MD PhD

    Department of Oncology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorgen Kristensen, MD PhD

CONTACT

971 3 7677444jkr@emirates.net.ae

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 12, 2006

First Posted

June 13, 2006

Study Start

July 1, 2006

Study Completion

October 1, 2009

Last Updated

July 25, 2006

Record last verified: 2006-06