NCT00493181

Brief Summary

The goal of this clinical research study is to find out if IL-11 (NeumegaTM) may increase the platelet count in patients with Chronic myeloid leukemia (CML) who develop low platelet counts while receiving therapy with imatinib mesylate (Gleevec, STI571), or other tyrosine kinase inhibitors such as AMN107, dasatinib, or SK1606. Primary Objective: 1\. To determine efficacy of low-dose interleukin-11, (IL-11, oprelvekin, NeumegaTM) in improving the thrombocytopenia associate with imatinib or other tyrosine kinase inhibitor therapy in patients with CML. Secondary Objective: 1\. To determine the safety of low-dose IL-11 in patients with CML and thrombocytopenia associated with imatinib or other tyrosine kinase inhibitors

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for phase_2 leukemia

Timeline
Completed

Started Oct 2005

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

October 1, 2005

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2007

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
4 months until next milestone

Results Posted

Study results publicly available

May 4, 2011

Completed
Last Updated

February 20, 2012

Status Verified

February 1, 2012

Enrollment Period

5.3 years

First QC Date

June 26, 2007

Results QC Date

April 1, 2011

Last Update Submit

February 17, 2012

Conditions

LeukemiaChronic Myelogenous LeukemiaChronic Myeloid Leukemia

Keywords

oprelvekintyrosine kinase inhibitorChronic Myelogenous LeukemiaLeukemiaCMLThrombocytopeniaImatinibIL-11Interleukin 11Neumega

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Complete Response

    Number of participants with platelet response of 'Complete Response' (CR) defined as a sustained (\>/= 3 months) platelet count \>/= 60 x 10\^9/L while continuing tyrosine kinase inhibitor (TKI) therapy or sustained (\>/= 3 months) re-escalation of TKI dose to the pre-thrombocytopenia level without recurrence of thrombocytopenia.

    Weekly platelet count till stabilized with on-going review while receiving treatment (study total 2 years)

Study Arms (1)

Interleukin-11

EXPERIMENTAL

Starting dose 10 mcg/kg subcutaneously 3 times a week

Drug: Interleukin-11 (IL-11 or Neumega)

Interventions

Interleukin-11 (IL-11 or Neumega)DRUG

10 mcg/kg under the skin (usually of the arms, legs or abdomen) three times weekly. If the treatment is well tolerated but there is not enough of a platelet improvement, the dose and frequency of injections may be increased.

Also known as: IL-11, Neumega
Interleukin-11

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • CML patients in chronic or accelerated phase receiving treatment with imatinib mesylate (Gleevec), or other tyrosine kinase inhibitors such as AMN107, dasatinib, or SK1606.
  • Grade \>/= 3 thrombocytopenia (platelets \<50 \* 10(9)/L) after the first 4 weeks of therapy with the tyrosine kinase inhibitor. Thrombocytopenia must be either recurrent (i.e., second or greater episode of grade \>/= 3 thrombocytopenia) or having required dose reductions of the tyrosine kinase inhibitor.
  • Signed informed consent.
  • Expected to have therapy with imatinib continued for \> 3 months.

You may not qualify if:

  • Known allergies to E. coli.
  • New York Heart Association (NYHA) class III or IV.
  • Patient has known hypersensitivity to Neumega or any component of Neumega.
  • Thrombocytopenia that is considered to be unrelated to treatment with imatinib.
  • Stem cell transplantation within 60 days.
  • History of atrial arrhythmias
  • Pregnancy
  • Papilledema

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

LeukemiaLeukemia, Myelogenous, Chronic, BCR-ABL PositiveThrombocytopenia

Interventions

Interleukin-11oprelvekin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBlood Platelet DisordersCytopenia

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Results Point of Contact

Title
Jorge Cortes M.D./Professor
Organization
The University of Texas M. D. Anderson Cancer Center
eharriso@mdanderson.org
713/794-5783

Study Officials

  • Jorge E. Cortes, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

June 26, 2007

First Posted

June 28, 2007

Study Start

October 1, 2005

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

February 20, 2012

Results First Posted

May 4, 2011

Record last verified: 2012-02

Locations

US(1)