NCT01657955

Brief Summary

The purpose of this study is to determine whether bendamustine is effective in the treatment of initial treatment of Chronic Lymphocytic Leukemia (CLL).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2011

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

August 6, 2012

Status Verified

August 1, 2012

Enrollment Period

2.8 years

First QC Date

August 2, 2012

Last Update Submit

August 3, 2012

Conditions

Chronic Lymphocytic LeukemiaLeukemiaNeoplasms

Outcome Measures

Primary Outcomes (1)

  • Overall response rate (ORR)

    24 months

Secondary Outcomes (3)

  • Progress free survival(PFS)

    24 months

  • Duration of Response (DR)

    24 months

  • Overall Survival(OS)

    24 months

Study Arms (2)

Bendamustine Hydrochloride Injection

EXPERIMENTAL

d1-d2,i.v.gtt, 100mg/m2/d, 28 days per cycle, at most 6 cycles.

Drug: Bendamustine Hydrochloride Injection

Chlorambucil

ACTIVE COMPARATOR

d1-d2, d15-d16, p.o., 0.4mg/kg/day, 28 days per cycle, at most 6 cycles(if WBC≥4×109 /L at d12-d14 ); d1-d2, p.o., 0.4mg/kg/day, 28 days per cycle, at most 6 cycles(if WBC\<4×109 /L at d12-d14 );

Drug: Chlorambucil

Interventions

Bendamustine Hydrochloride InjectionDRUG
Bendamustine Hydrochloride Injection
ChlorambucilDRUG
Also known as: Leukeran
Chlorambucil

Eligibility Criteria

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

You may qualify if:

  • Patients must have a diagnosis of CLL;
  • No prior or no standard treatment for CLL;
  • Binet stage B, C or symptomatic stage A;
  • Needs treatment to control diseases;
  • (Eastern Cooperative Oncology Group)ECOG performance status ≤ 2
  • Life expectancy ≥3 months
  • Written informed consent

You may not qualify if:

  • Patients were diagnosed with or treated for malignant tumors other than CLL (including active central nervous system lymphoma) within one year prior to entering the study
  • Transformation to Richter's syndrome, or prolymphocytic leukemia(PLL)
  • Autoimmune hemolytic anemia requiring glucocorticoid therapy
  • Autoimmune thrombocytopenia requiring glucocorticoid therapy
  • Alanine aminotransferase(ALT)\>3 times upper limits of normal value, Aspartate aminotransferase(AST)\>3 times upper limits of normal value, Total bilirubin(TBIL)\>2 times upper limits of normal value, serum creatinine\>1.5 times upper limits of normal value;
  • Other serious Concomitant diseases which affect participation of this study(uncontrolled diabetes, gastric ulcer, cardiac and pulmonary diseases, at active phases of autoimmune diseases;
  • Serious or uncontrolled infections;
  • Central nervous system dysfunction with clinical symptoms;
  • Patients received major surgery within 30 days prior to study entry;
  • Pregnant or lactating women
  • Allergic to study drug or mannitol
  • Participation in any other clinical trials within 3 months prior to study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hematologic hospital of Chinese academy of medical sciences

Tianjin, China

RECRUITING

Related Links

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-CellLeukemiaNeoplasms

Interventions

Bendamustine HydrochlorideChlorambucil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Lu G Qiu, M.D.

    Hematologic Hospital of Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lu G Qiu, M.D.

CONTACT

+86-02223909172

Jian J Yu, Master

CONTACT

+86-15336402751yujj@lanjin.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2012

First Posted

August 6, 2012

Study Start

January 1, 2011

Primary Completion

October 1, 2013

Study Completion

December 1, 2013

Last Updated

August 6, 2012

Record last verified: 2012-08

Locations

CN(1)