MDACC Study Summary 2005-0146

Study Summary
No. 2005-0146:.......Lymphoma......Saroj Vadhan-Raj......Palliative Care & Rehabilitation Medicine

Study Summary Title



Study Summary Number:	2005-0146

Study Title:	Phase 1/2 study of AMG 531 to evaluate the Safety, Efficacy, and Pharmacokinetics in patients with aggressive Non-Hodgkin's Lymphoma receiving R-HyperCVAD alternating with R-Ara-C/MTX

Physician

New Patient Referral



Name:	Saroj Vadhan-Raj	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Palliative Care & Rehabilitation Medicine	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-7966 Contact us about clinical trials

General Information



Disease Group:	Lymphoma	Supported By:	N/A

Phase of Study:	Phase I/Phase II	Return Visit:	Prior to each cycle (every 3-4 weeks).

Treatment Agents:	AMG 531 Cyclophosphamide Cytarabine Dexamethasone Doxorubicin Methotrexate Rituximab Vincristine	Home Care:	Routine labs, supportive care (transfusions, antibiotics as needed).

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to find the highest safe dose of AMG 531 that can be given to treat thrombocytopenia (low platelet counts) in patients who have received chemotherapy. Researchers will also look at the safety and effectiveness of AMG 531.

Study Objectives / Outcomes

Primary
1. To determine the clinical safety and tolerability of AMG 531 administered following chemotherapy (R-HyperCVAD alternating with R-Ara-C/MTX) in patients with non-Hodgkin's lymphoma.
2. To determine an optimal biologic dose (OBD) of AMG 531 in patients receiving R-HyperCVAD and R-Ara-C/MTX.
3. To evaluate the effects of AMG 531 on the degree and duration of thrombocytopenia and platelet recovery following chemotherapy(chemo).

Secondary
1. To evaluate limited pharmacokinetics of AMG 531 administered by S.C. route with chemotherapy.

Study Status Information



Study Activation / Registration Date:	03/02/2006

IRB Review and Approval Date:	04/06/2005

Study Type:	Therapeutic

Recruitment Status:	Closed

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) Patients with a diagnosis of previously untreated aggressive non-Hodgkin's lymphoma, including patients with mantle cell lymphoma, who will be or are receiving treatment with R-HyperCVAD and R-Ara-C/MTX. Patients in whom Rituximab is not used, due to contraindication, will be eligible. Patients whose therapy was switched to (R)Hyper-CVAD after initial treatment with (R)CHOP, because of aggressive disease will also be eligible for the study.

2) Patients age >/= 18 years.

3) Karnofsky Performance Scale >/= 70.

4) Adequate hematologic (ANC >/= 1000/mm(3), platelet count >/= 100,000/mm(3) and Hgb >/= 8gm/dL), renal (serum creatinine < 2mg/dL), and hepatic functions (total bilirubin </= 2 times, SGPT or SGOT </= 3 times the upper limit of the respective normal range).

5) Patients (male and female) with childbearing potential (defined as not post-menopausal for 12 months or no previous surgical sterilization) must use adequate birth control.

6) IRB-approved signed informed consent.

Exclusion Criteria:

1) Pregnant or lactating women.

2) History of CNS involvement.

3) Co-morbid medical or psychiatric illnesses that preclude treatment with intense dose chemotherapy.

4) Patients with history of DVT or pulmonary embolus.

5) History of any platelet disorders including ITP, TTP or bleeding disorders.

6) Prior surgery or Radiation Therapy (RT) within 2 weeks of study entry.

7) Patients with significant cardiac disease (NYHA Class III or IV), dysarrhythmia, or recent history of MI or ischemia, transient ischemic attack or CVA within the previous 6 months of study entry.

Links

Registration Number: NCT00299182
Study Information on Clinical Trials Registry (clinicaltrials.gov)