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Phase 2 N=39 Supportive Care

A Dose and Schedule Finding Trial With AMG 531 for Chemotherapy Induced Thrombocytopenia (CIT) in Adults With Lymphoma

Chemotherapy-Induced Thrombocytopenia · Hodgkin's Lymphoma · Non-Hodgkin's Lymphoma · Cancer · Oncology

Bottom Line

View on ClinicalTrials.gov: NCT00283439 ↗
Enrolled (actual)
39
Serious AEs
18.0%
Results posted
Sep 2010
Primary outcome: Primary: Change in Platelet Nadir — 17.1; 11.2; 5.1; -5.2 10^9/L — p=0.9654

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
AMG 531 (Biological)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Amgen
Primary completion
May 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Platelet Nadir		 17.1; 11.2; 5.1; -5.2 0.9654
SECONDARY
Percentage of Subjects Experiencing Grade 3 or 4 Thrombocytopenia		 62.5; 81.8; 80.0; 88.9 0.294
SECONDARY
Duration of Grade 3 or 4 Thrombocytopenia		 3.9; 3.6; 6.0; 8.3 0.091
SECONDARY
Percentage of Subjects That Received Platelet Transfusions		 12.5; 0.0; 30.0; 33.3 0.576

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00283439). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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