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

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.

Conditions

• Lymphoma

Interventions

DRUG

AMG 531

Arm A: AMG531 - 1, 3, or 10 mcg/kg subcutaneous injection administered on on days -5 and 5 (pre and post chemotherapy dose) beginning with Cycle 2; OR, Arm A: AMG531 - 1, 3, or 10 mcg/kg subcutaneous injection administered on on days 5 and 7 (post chemotherapy doses only) beginning with Cycle 2.

DRUG

Rituximab

375 mg/m\^2 by vein over 4-6 hour infusion day 1, each cycle.

DRUG

Cyclophosphamide

300 mg/m\^2 by vein over 3 hours every 12 hours for 6 doses (days 2-4), Cycles 1,3, \& 5.

DRUG

Vincristine

1.4 mg/m\^2/dose (maximum 2 mg) by vein over 15 minutes Days 5 and 12, Cycles 1,3,\& 5.

DRUG

Doxorubicin

50 mg/m\^2/dose by vein over 15 minutes on Day 5 or by continuous infusion over 24-48 hours (days 5-6), Cycles 1,3,\& 5.

DRUG

Dexamethasone

40 mg/day by mouth or by vein days 2-5 and 12-15, Cycles 1,3,\& 5.

DRUG

Methotrexate

200 mg/m\^2 by vein over 2 hours followed by 800 mg/m\^2 over 22 hours Day 2, Cycles 2, 4 \& 6.

DRUG

Cytarabine

3 g/m\^2 by vein over 2 hours every 12 hours for 4 doses, days 3 \& 4; OR,1 g/m\^2 by vein over 2 hours every 12 hours for 4 doses, days 3 \& 4 for patients \> 60 years and for patients with serum creatinine \> 1.5 mg/dL; Cycles 2,4,\& 6.

DRUG

Placebo

Arm A: Placebo - subcutaneous injection administered on days -5 and 5 (pre and post chemotherapy dose) beginning with Cycle 2; OR, Arm B: Placebo - subcutaneous injection administered on days 5 and 7 (post chemotherapy doses only) beginning with Cycle 2.

Sponsors & Collaborators

• Amgen

  collaborator INDUSTRY

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Saroj Vadhan-Raj, MD · M.D. Anderson Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-03-31

Primary Completion

2012-04-30

Completion

2012-04-30

Countries

• United States

Study Locations