MDACC Study Summary 2004-0113 (Archived)

Study Summary
No. 2004-0113:.......Leukemia......Jorge Cortes......Leukemia

Study Summary Title



Study Summary Number:	2004-0113

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

Physician

New Patient Referral



Name:	Jorge Cortes	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Leukemia	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-794-5783 Contact us about clinical trials

General Information



Disease Group:	Leukemia	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Every 3 to 6 months

Treatment Agents:	Neumega	Home Care:	IL-11 can be self-administered

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	none anticipated


Description/ Intervention:	The goal of this clinical research study is to find out if IL-11 (NeumegaTM) may increase the platelet count in patients with 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.

Study Objectives / Outcomes

Primary
To determine efficacy of low-dose interleukin-11, (IL-11, oprelvekin, Neumega^TM) in improving the thrombocytopenia associate with imatinib or other tyrosine kinase inhibitor therapy in patients with CML.

Secondary
To determine the safety of low-dose IL-11 in patients with CML and thrombocytopenia associated with imatinib or other tyrosine kinase inhibitors

Study Status Information



Study Activation / Registration Date:	10/17/2005

IRB Review and Approval Date:	02/02/2005

Study Type:	Therapeutic

Recruitment Status:	Terminated

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) CML patients in chronic or accelerated phase receiving treatment with imatinib mesylate (Gleevec), or other tyrosine kinase inhibitors such as AMN107, dasatinib, or SK1606.

2) Grade >/= 3 thrombocytopenia (platelets <50 x 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.

3) Signed informed consent.

4) Expected to have therapy with imatinib continued for > 3 months.

Exclusion Criteria:

1) Known allergies to E. coli.

2) New York Heart Association (NYHA) class III or IV.

3) Patient has known hypersensitivity to Neumega or any component of Neumega.

4) Thrombocytopenia that is considered to be unrelated to treatment with imatinib.

5) Stem cell transplantation within 60 days.

6) History of atrial arrhythmias

7) Pregnancy

8) Papilledema

Links

Registration Number: NCT00493181
Study Information on Clinical Trials Registry (clinicaltrials.gov)