Clinical trial NCT00283439: A Dose and Schedule Finding Trial With AMG 531 for Chemotherapy Induced Thrombocytopenia (CIT) in Adults With Lymphoma
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 Multi-Cycle Chemotherapy in Adult Subjects With Lymphoma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chemotherapy-Induced Thrombocytopenia
Hodgkin's Lymphoma
Non-Hodgkin's Lymphoma
Cancer
Oncology
Thrombocytopenia
Keywords: NHL
chemotherapy induced thrombocytopenia
CIT
ICE
RICE
Hodgkin's Lymphoma
Non-Hodgkin's Lymphoma
CHOP
ESHAP
DHAP
R-CHOP
R-ESHAP
R-DHAP
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2006-01-30
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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
* 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

Primary outcomes:
measure: Change in Platelet Nadir
timeFrame: 32 weeks
Secondary outcomes:
measure: Percentage of Subjects Experiencing Grade 3 or 4 Thrombocytopenia
timeFrame: 32 weeks
measure: Duration of Grade 3 or 4 Thrombocytopenia
timeFrame: 32 weeks
measure: Percentage of Subjects That Received Platelet Transfusions
timeFrame: 32 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: