NCT00493181

The Effect of Interleukin 11 on Thrombocytopenia Associated With Imatinib or Other Tyrosine Kinase Inhibitor Therapy in Patients With Chronic Myelogenous Leukemia

Completed Phase 2 Results posted Last updated 17 February 2012

What this trial tests

Phase 2 trial testing Interleukin-11 (IL-11 or Neumega) in Leukemia in 8 participants. Completed in 1 January 2011.

Timeline

1 October 2005

Primary endpoint
1 January 2011

1 January 2011

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	1 October 2005
Primary completion	1 January 2011
Estimated completion	1 January 2011
Sites	1 location across United States

Drugs / interventions tested

• Interleukin-11 (IL-11 or Neumega) — full drug profile →

Conditions studied

• Leukemia — all drugs for Leukemia →
• Chronic Myelogenous Leukemia — all drugs for Chronic Myelogenous Leukemia →
• Chronic Myeloid Leukemia — all drugs for Chronic Myeloid Leukemia →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

Eligibility, any sex, with Leukemia or Chronic Myelogenous Leukemia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of Participants With Complete Response
  Time frame: Weekly platelet count till stabilized with on-going review while receiving treatment (study total 2 years)
  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.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. IL-6 family cytokines: Key inflammatory mediators as biomarkers and potential therapeutic targets.
   Unver N, McAllister F. · · 2018 · cited 178× · PMID 29699936 · DOI 10.1016/j.cytogfr.2018.04.004
2. Interleukin 11 therapy causes acute left ventricular dysfunction.
   Sweeney M, O'Fee K, Villanueva-Hayes C, Rahman E, et al · · 2024 · cited 7× · PMID 39383190 · DOI 10.1093/cvr/cvae224