NCT00015821

Brief Summary

Phase II trial to study the effectiveness of thalidomide in treating patients who have myelofibrosis. Thalidomide may stop the growth of myelofibrosis by stopping blood flow to the cancer cells.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
43

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

May 1, 2000

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 6, 2001

Completed
2 years until next milestone

First Posted

Study publicly available on registry

May 23, 2003

Completed
4.5 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

7.6 years

First QC Date

May 6, 2001

Last Update Submit

October 7, 2013

Conditions

Primary Myelofibrosis

Outcome Measures

Primary Outcomes (1)

  • Confirmed Response, i.e., an objective status of complete or partial response, recorded on 2 consecutive evaluations at least 4 weeks apart.

    The proportion of successes will be estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients) and 95% confidence intervals calculated using the Duffy-Santner algorithm for multi-stage designs.

    Up to 5 years

Secondary Outcomes (3)

  • Survival

    Number of days from registration date to the date of death or last follow-up, assessed up to 5 years

  • Time to progression

    Number of days from registration date to the date of disease progression or last follow-up, assessed up to 5 years

  • Response duration

    Number of days from the first date that objective status = complete or partial response was recorded to the date of disease progression or date of death, whichever comes first, assessed up to 5 years

Study Arms (1)

Treatment (thalidomide)

EXPERIMENTAL

Patients receive oral thalidomide once daily for 1 year in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive 1 additional year of therapy.

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:

  • Histologically confirmed myelofibrosis with myeloid metaplasia
  • Agnogenic myeloid metaplasia
  • Post-polycythemic myeloid metaplasia
  • Post-thrombocythemic myeloid metaplasia
  • No metastatic carcinoma, lymphoma, myelodysplasia, hairy cell leukemia, mast cell disease, acute leukemia (including M7), or acute myelofibrosis
  • No chromosomal translocation t(9;22) or bcr/abl gene rearrangement
  • Presence of reticulin fibrosis in bone marrow and leukoerythroblastosis and dacrocytosis in peripheral blood
  • Presence of anemia (hemoglobin less than 10 g/dL), palpable splenomegaly, or hepatomegaly
  • Performance status - ECOG 0-2
  • Absolute neutrophil count greater than 750/mm\^3
  • Platelet count less than 400,000/mm\^3
  • WBC less than 50,000/mm\^3
  • Bilirubin no greater than 2 mg/dL (if total bilirubin elevated, direct bilirubin must be normal)
  • AST no greater than 3 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 3 times ULN
  • +12 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

Primary Myelofibrosis

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Myeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Michelle Elliott

    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

May 6, 2001

First Posted

May 23, 2003

Study Start

May 1, 2000

Primary Completion

December 1, 2007

Last Updated

October 8, 2013

Record last verified: 2013-10

Locations

US(1)