NCT00009984

Brief Summary

This randomized phase II trial is studying thalidomide and fludarabine to see how well they work compared to thalidomide alone in treating patients with hematologic cancer that has not responded to previous treatment with fludarabine. Thalidomide may stop the growth of hematologic cancer by stopping blood flow to the cancer. Combining thalidomide with fludarabine may increase the effectiveness of chemotherapy by making cancer cells more sensitive to the drug. It is not yet known whether thalidomide is more effective with or without fludarabine for hematologic cancer.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

February 2, 2001

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 1, 2002

Completed
11 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Last Updated

June 6, 2013

Status Verified

June 1, 2013

Enrollment Period

4.7 years

First QC Date

February 2, 2001

Last Update Submit

June 5, 2013

Conditions

Recurrent Small Lymphocytic LymphomaRefractory Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (2)

  • Toxicities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0

    Up to 5 years

  • Incidence of complete and partial remission

    Up to 5 years

Study Arms (2)

Arm I (thalidomide)

EXPERIMENTAL

Patients receive oral thalidomide once daily in the absence of disease progression or unacceptable toxicity.

Drug: thalidomide

Arm II (thalidomide, fludarabine phosphate)

EXPERIMENTAL

Patients receive thalidomide as in arm I and fludarabine IV over 30 minutes on days 1-5. Treatment with fludarabine repeats every 28 days for 6 courses. Once fludarabine is completed, patients continue to receive thalidomide alone as in arm I.

Drug: fludarabine phosphateDrug: thalidomide

Interventions

fludarabine phosphateDRUG

Given IV

Also known as: 2-F-ara-AMP, Beneflur, Fludara
Arm II (thalidomide, fludarabine phosphate)
thalidomideDRUG

Given orally

Also known as: Kevadon, Synovir, THAL, Thalomid
Arm I (thalidomide)Arm II (thalidomide, fludarabine phosphate)

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of one of the following:
  • Confirmed chronic lymphocytic leukemia (CLL), meeting the following criteria:
  • Peripheral blood lymphocytosis greater than 5,000/mm\^3
  • Co-expression of the CD5, CD19, CD20, and CD23 surface antigens
  • Clonal kappa and lambda light chain expression
  • Dim surface immunoglobulin expression
  • Small lymphocytic lymphoma
  • Relapsed or refractory disease
  • Must have received at least 1 prior regimen containing fludarabine
  • Meets one of the following criteria:
  • Recurrence of lymphocytosis greater than 5,000/mm\^3 or an increase in lymph node volume greater than 50% after achieving complete (CR) or partial response (PR)
  • Never achieved a CR or PR after receiving at least 2 courses of fludarabine IV for 5 days at a dose of 25 mg/m\^2/day
  • No other lymphoproliferative diseases or diseases due to transformation of CLL (e.g., prolymphocytic leukemia or Richter's syndrome)
  • No known CNS disease
  • Performance status - Karnofsky 60-100%
  • +24 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467-2490, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

fludarabine phosphateThalidomide

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

  • Richard Furman

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2001

First Posted

January 27, 2003

Study Start

March 1, 2002

Primary Completion

November 1, 2006

Last Updated

June 6, 2013

Record last verified: 2013-06

Locations

US(1)