Overview

Study of AMG 531 to Evaluate the Safety & Efficacy in Patients With Non-Hodgkin's Lymphoma

Status:
Completed

Trial end date:
2012-04-01

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 1/Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

M.D. Anderson Cancer Center

Collaborator:

Amgen

Treatments:

BB 1101
Cyclophosphamide
Cytarabine
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Doxorubicin
Liposomal doxorubicin
Methotrexate
Rituximab
Vincristine

Criteria

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, serum glutamate pyruvate transaminase (SGPT) or serum glutamate oxaloacetate
transaminase (SGOT)
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. Institutional Review Board (IRB)-approved signed informed consent.

Exclusion Criteria:

1. Pregnant or lactating women.

2. History of Central Nervous System (CNS) involvement.

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

4. Patients with history of deep vein thrombosis (DVT) or pulmonary embolus.

5. History of any platelet disorders including Idiopathic thrombocytopenic purpura (ITP),
Thrombotic thrombocytopenic purpura (TTP) or bleeding disorders.

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

7. Patients with significant cardiac disease (New York Heart Association (NYHA) Class III
or IV), dysrrhythmia, or recent history of myocardial ischemia (MI) or ischemia,
transient ischemic attack or cerebrovascular accident (CVA) within the previous 6
months of study entry.