NCT00283439

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2005

Typical duration for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 30, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
2 years until next milestone

Results Posted

Study results publicly available

September 13, 2010

Completed
Last Updated

June 20, 2011

Status Verified

June 1, 2011

Enrollment Period

2.6 years

First QC Date

January 26, 2006

Results QC Date

August 13, 2010

Last Update Submit

June 16, 2011

Conditions

Chemotherapy-Induced ThrombocytopeniaHodgkin's LymphomaNon-Hodgkin's LymphomaCancerOncologyThrombocytopenia

Keywords

NHLchemotherapy induced thrombocytopeniaCITICERICEHodgkin's LymphomaNon-Hodgkin's LymphomaCHOPESHAPDHAPR-CHOPR-ESHAPR-DHAP

Outcome Measures

Primary Outcomes (1)

  • Change in Platelet Nadir

    Change in platelet nadir from the previous qualifying cycle to the first treatment cycle.

    32 weeks

Secondary Outcomes (3)

  • Percentage of Subjects Experiencing Grade 3 or 4 Thrombocytopenia

    32 weeks

  • Duration of Grade 3 or 4 Thrombocytopenia

    32 weeks

  • Percentage of Subjects That Received Platelet Transfusions

    32 weeks

Study Arms (1)

Single Arm: AMG 531 Dose-Escalating Cohort Study

EXPERIMENTAL
Biological: AMG 531

Interventions

AMG 531BIOLOGICAL

Planned Cohorts: 1. 100 mcg, 2. 300 mcg, 3. 700 mcg, 4. 1000 mcg; Optional Cohorts: 5. cohort expansion, 6. schedule change, 7. new dose

Single Arm: AMG 531 Dose-Escalating Cohort Study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Eastern Cooperative Oncology Group (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 Common Terminology Criteria (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

You may not qualify if:

  • 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)
  • History 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Hodgkin DiseaseLymphoma, Non-HodgkinNeoplasmsThrombocytopenia

Interventions

romiplostim

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBlood Platelet DisordersHematologic DiseasesCytopenia

Results Point of Contact

Title
Study Director
Organization
Amgen Inc.
866-572-6436

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 26, 2006

First Posted

January 30, 2006

Study Start

October 1, 2005

Primary Completion

May 1, 2008

Study Completion

September 1, 2008

Last Updated

June 20, 2011

Results First Posted

September 13, 2010

Record last verified: 2011-06