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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

March 31, 2006

Primary Completion Date

April 30, 2012

Study Completion Date

April 30, 2012

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.

Trial Locations (1)

77030

UT MD Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Amgen

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER