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An Open Label Dose and Schedule Finding Trial to Evaluate the Safety and Efficacy of AMG 531 for Treatment of Severe Thrombocytopenia Due to Multi-Cycle Chemotherapy in Adult Subjects With Lymphoma.


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Chemotherapy-Induced Thrombocytopenia, Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma, Cancer, Oncology, Thrombocytopenia

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Trial Information

An Open Label Dose and Schedule Finding Trial to Evaluate the Safety and Efficacy of AMG 531 for Treatment of Severe Thrombocytopenia Due to Multi-Cycle Chemotherapy in Adult Subjects With Lymphoma.


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

- 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

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)

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Change in Platelet Nadir

Outcome Description:

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

Outcome Time Frame:

32 weeks

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20050144

NCT ID:

NCT00283439

Start Date:

October 2005

Completion Date:

September 2008

Related Keywords:

  • Chemotherapy-Induced Thrombocytopenia
  • Hodgkin's Lymphoma
  • Non-Hodgkin's Lymphoma
  • Cancer
  • Oncology
  • Thrombocytopenia
  • NHL
  • chemotherapy induced thrombocytopenia
  • CIT
  • ICE
  • RICE
  • Hodgkin's Lymphoma
  • Non-Hodgkin's Lymphoma
  • CHOP
  • ESHAP
  • DHAP
  • R-CHOP
  • R-ESHAP
  • R-DHAP
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Thrombocytopenia

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