A Dose and Schedule Finding Trial With AMG 531 for CIT in Adults With Lymphoma - Full Text View

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00283439

Purpose

The purpose of this study is to identify a well-tolerated, effective dose and schedule of AMG 531 for the treatment of CIT in subjects with lymphoma receiving multi-cycle chemotherapy.

Condition	Intervention	Phase
Chemotherapy-Induced Thrombocytopenia Hodgkin's Lymphoma Non-Hodgkin's Lymphoma Cancer Oncology Thrombocytopenia	Biological: AMG 531	Phase I Phase II

MedlinePlus related topics: Cancer Hodgkin's Disease Lymphoma

Drug Information available for: AMG 531

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open Label Dose and Schedule Finding Trial to Evaluate the Safety and Efficacy of AMG 531 for Treatment of Severe Thrombocytopenia Due to Muli-Cycle Chemotherapy in Adult Subjects With Lymphoma.

Further study details as provided by Amgen:

Primary Outcome Measures:

Incidence of adverse events including clinically significant changes in laboratory values [ Time Frame: 42 months ] [ Designated as safety issue: Yes ]
Incidence of anti-AMG 531 antibody formation [ Time Frame: 42 months ] [ Designated as safety issue: Yes ]
Change in platelet nadir from the previous qualifying cycle to the first treatment cycle. [ Time Frame: 42 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of subjects experiencing grade 3 and/or 4 thrombocytopenia (<50 x 10^9/L, and <25 x 10^9/L) [ Time Frame: 42 months ] [ Designated as safety issue: No ]
Duration of grade 3 and/or 4 thrombocytopenia (<50 x 10^9/L and <25 x 10^9/L, respectively) [ Time Frame: 42 months ] [ Designated as safety issue: No ]
Proportion of subjects that receive platelet transfusions [ Time Frame: 42 months ] [ Designated as safety issue: No ]

Enrollment:	39
Study Start Date:	October 2005
Study Completion Date:	September 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Single Arm: AMG 531 Dose-Escalating Cohort Study: Experimental	Biological: AMG 531 Planned Cohorts: 100mcg, 300mcg, 700mcg, 1000mcg; Optional Cohorts: cohort expansion, schedule change, new dose

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed Hodgkin's lymphoma or Non-Hodgkin's lymphoma receiving Q14, Q21, or Q28 day CHOP, ICE, ESHAP, or DHAP chemotherapy; with or without Rituximab
Has adequate bone marrow function; platelet count > 100 x 10^9/L on the day of initiation of the on study chemotherapy of the next treatment cycle and absolute neutrophil count, ANC > or = 1 x 10^9/L, and hemoglobin > or = 9.5 g/dL
ECOG performance status of 0 or 1
Has adequate liver function
must be able to receive the same chemotherapy regimen during the first treatment cycle as was received during the prior qualifying cycle
must experience CTC grade 3 or 4 thrombocytopenia (platelet count < 50 x 10^9/L) as a result of the chemotherapy administered in the cycle immediately preceding study entry
has serum creatinine concentration < or = 2 mg/dl

Exclusion Criteria:

More that 1 prior relapse chemotherapy regimen
Sepsis, disseminated coagulation or any other condition that may exacerbate thrombocytopenia
Significant bleeding (CTC grade 3 or 4)
Hx of thromboembolic disease
Subjects who are identified by clinical history and/or serological testing to have either acute or chronic hepatitis B or C infection or to be HIV positive
Use of any nitrosourea or mitomycin-C
Has received any thrombocytopenic growth factor
Has received a marrow or peripheral blood stem cell infusion
Known hypersensitivity to any recombinant E. coli-derived product

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00283439

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20050144
Study First Received:	January 26, 2006
Last Updated:	October 2, 2008
ClinicalTrials.gov Identifier:	NCT00283439
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amgen:

chemotherapy induced thrombocytopenia
NHL
CIT
ICE
RICE
Hodgkin's Lymphoma
Non-Hodgkin's Lymphoma

CHOP
ESHAP
DHAP
R-CHOP
R-ESHAP
R-DHAP

Study placed in the following topic categories:

Immunoproliferative Disorders
Hodgkin's disease
Hematologic Diseases
Blood Platelet Disorders
Hodgkin lymphoma, adult
Lymphoma, small cleaved-cell, diffuse
Thrombocytopathy

Signs and Symptoms
Lymphatic Diseases
Thrombocytopenia
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Hodgkin Disease

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009