NCT00006226

Brief Summary

Phase II trial to study the effectiveness of thalidomide in treating patients who have relapsed chronic lymphocytic leukemia. Thalidomide may stop the growth of chronic lymphocytic leukemia by stopping blood flow to the tumor.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2000

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2000

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Last Updated

October 8, 2013

Status Verified

October 1, 2013

Enrollment Period

7.3 years

First QC Date

September 11, 2000

Last Update Submit

October 7, 2013

Conditions

B-cell Chronic Lymphocytic LeukemiaRefractory Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

  • Confirmed response, noted as the objective status of CR, nPR, or PR on 2 consecutive evaluations at least 4 weeks apart

    Ninety percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.

    Up to 5 years

Secondary Outcomes (5)

  • Overall survival

    Up to 5 years

  • Progression-free survival

    Up to 5 years

  • Time to progression

    Up to 5 years

  • Duration of response

    Up to 5 years

  • Maximum grade of each type of toxicity

    Up to 5 years

Study Arms (1)

Treatment (thalidomide)

EXPERIMENTAL

Patients receive oral thalidomide daily for 4 weeks. Courses repeat every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.

Drug: thalidomideOther: laboratory biomarker analysis

Interventions

thalidomideDRUG

Given PO

Treatment (thalidomide)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (thalidomide)

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of chronic lymphocytic leukemia (CLL) evidenced by monoclonal population of mature CD5+, CD19+, CD23+, and B cells
  • Relapsed after prior treatment for CLL
  • Active disease with 1 or more of the following characteristics:
  • At least 10% weight loss within the past 6 months
  • Fever greater than 100.5 degrees F for at least 2 weeks without evidence of infection
  • Night sweats without evidence of infection
  • Evidence of progressive marrow failure with anemia (hemoglobin less than 11 g/dL) and/or thrombocytopenia (platelet count less than 100,000/mm\^3) (i.e., any stage III or IV disease)
  • Autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroid therapy
  • Massive or progressive splenomegaly (i.e., greater than 6 cm below the left costal margin or more than 50% increase over 2 months)
  • Progressive lymphadenopathy (i.e., more than 50% increase over 2 months)
  • Progressive lymphocytosis (not due to corticosteroids) with an increase of more than 50% over a 2-month period or an anticipated doubling time of less than 6 months
  • Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease are not considered evidence of active disease
  • Measurable disease
  • Absolute lymphocyte count greater than 5,000/mm\^3
  • No bulky lymph node disease greater than 10 cm in at least 1 dimension except splenomegaly
  • +19 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Central Cancer Treatment Group

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Thalidomide

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)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Neil Kay

    North Central Cancer Treatment Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2000

First Posted

January 27, 2003

Study Start

September 1, 2000

Primary Completion

December 1, 2007

Last Updated

October 8, 2013

Record last verified: 2013-10

Locations

US(1)