MDACC Study Summary 2007-0264

Study Summary
No. 2007-0264:.......Leukemia......Hagop Kantarjian......Leukemia

Study Summary Title



Study Summary Number:	2007-0264

Study Title:	An Open Label Extension Study Evaluating the Safety of Long Term Dosing of Romiplostim in Thrombocytopenic Subjects with Myelodysplastic Syndromes (MDS)

Physician

New Patient Referral



Name:	Hagop Kantarjian	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:	713-792-7026 Contact us about clinical trials

General Information



Disease Group:	Leukemia	Supported By:	Amgen Inc

Phase of Study:	Phase I/Phase II	Return Visit:	Patients receiving romiplostim on a weekly basis will visit the clinic once a week; patients receiving romiplostim every 2 weeks will visit the clinic every 2 weeks; patients self medicating will return to the clinic every 4 weeks.

Treatment Agents:	AMG 531	Home Care:	Self Medicated

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	NA


Description/ Intervention:	The goal of this clinical research study is to learn about the long-term safety of romiplostim in the treatment of patients with MDS. Researchers also want to learn about the ability of romiplostim to help control low blood counts.

Study Objectives / Outcomes

Primary
The primary objective is to provide long-term safety data for the use of romiplostim in thrombocytopenic subjects with myelodysplastic syndromes (MDS).

Secondary
The secondary objective is to evaluate the effectiveness of romiplostim with respect to platelet response, transfusion, and bleeding events in the treatment of thrombocytopenic subjects with MDS.

Study Status Information



Study Activation / Registration Date:	01/29/2008

IRB Review and Approval Date:	01/29/2008

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Closed

Projected Accrual:	Approximately 250

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) Disease related: Subject completed a romiplostim study for the treatment of thrombocytopenia in subjects with MDS.

2) Demographic: Eastern Cooperative Oncology (ECOG) performance status of 0-2.

3) Laboratory: Subject had a platelet count </= 50 x 10^9/L since the final dose of investigational product in the parent study.

4) General: Subject or his/her legally acceptable representative provided written informed consent before any study-specific procedures were initiated

Exclusion Criteria:

1) Disease Related: Subject has been diagnosed with AML or has a blast count >/= 10% by peripheral blood or bone marrow biopsy; Subject has a prior history of leukemia; Subject has a prior history of bone marrow or stem cell transplantation; Subject has a prior malignancy (other than in situ cervical cancer, controlled prostate cancer, or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for >/= 3 years before randomization; Subject has active or uncontrolled infections;

2) Continued from #1: Disease related, continued:Subject has unstable angina, congestive heart failure [New York Heart Association (NYHA) > class II], uncontrolled hypertension (diastolic > 100 mmHg), uncontrolled cardiac arrhythmia, or recent (within 1 year) myocardial infarction; Subject has a history of arterial thrombosis (eg, stroke or transient ischemic attack) in the past year; Subject has a history of venous thrombosis that currently requires anti-coagulation therapy.

3) Medications: Subject received interleukin (IL)-11 within 4 weeks of screening; Subject previously received a thrombopoietic growth factor (other than romiplostim), Subject has a known hypersensitivity to any recombinant E coli-derived product (eg, Infergen�, Neupogen�, Somatropin, Actimmune).

4) General: Subject is currently enrolled in investigational device or drug study(ies), has not yet completed at least 4 weeks since ending investigational device or drug study(ies) (other than parent romiplostim study), or subject is receiving other investigational agent(s)/device(s), Subject is of child-bearing potential and is evidently pregnant (eg, positive human chorionic gonadotropin [HCG] test) or is breast feeding; Subject is not using adequate contraceptive precautions;

5) Continued from #4 above: General continued: Subject has any kind of disorder that compromises his/her ability to give written informed consent (and does not have a legally acceptable representative) or is unable to comply with study procedures.

Links

Registration Number: NCT00472290
Study Information on Clinical Trials Registry (clinicaltrials.gov)