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CompletedNCT00283439Updated Jun 20, 2011Results posted

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

A Phase 1/2 interventional study of AMG 531 in Chemotherapy-Induced Thrombocytopenia, Hodgkin's Lymphoma and Non-Hodgkin's Lymphoma, sponsored by Amgen. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-06-20.

Sponsored by Amgen · Phase 1/2, Interventional, and Supportive care

Phase
Phase 1/2
Study type
Interventional
Enrollment
39
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • 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
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 39 is close to the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.

Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Supportive care
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
39 participants (actual)

Study arms

  • Experimental
    Single Arm: AMG 531 Dose-Escalating Cohort Study

    Biological: AMG 531

Interventions

  • BiologicalAMG 531

    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

06

What researchers measure

Primary outcomes

  1. Change in Platelet Nadir

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

    Time frame: 32 weeks

Secondary outcomes

  1. Percentage of Subjects Experiencing Grade 3 or 4 Thrombocytopenia

    Percentage of subjects experiencing grade 3 and/or 4 thrombocytopenia (\<50 x 10\^9/L, and \<25 x 10\^9/L)

    Time frame: 32 weeks

  2. Duration of Grade 3 or 4 Thrombocytopenia

    Duration of grade 3 and/or 4 thrombocytopenia (\<50 x 10\^9/L and \<25 x 10\^9/L, respectively)

    Time frame: 32 weeks

  3. Percentage of Subjects That Received Platelet Transfusions

    Percentage of subjects that received platelet transfusions during the first romiplostim treatment cycle

    Time frame: 32 weeks

07

Results

Posted Sep 13, 2010

Participant flow

Participants were enrolled from 15 March 2006 through 28 April 2008

Participant flow — Overall Study
MilestoneRomiplostim 100 µgRomiplostim 300 µgRomiplostim 700 µgRomiplostim 1000 µg
Started811119
Completed0000
Not completed811119
Withdrew: Adverse event0001
Withdrew: Death0010
Withdrew: Disease progression0100
Withdrew: Requirement for alternative therapy1252
Withdrew: Stem cell transplant6643
Withdrew: Treatment discontinued0213
Withdrew: Other1000

Outcome measures

PrimaryChange in Platelet Nadir

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

Time frame:
32 weeks
Reported as:
Mean · 10^9/L
Change in Platelet Nadir
10^9/LRomiplostim 100 µgRomiplostim 300 µgRomiplostim 700 µgRomiplostim 1000 µg
Change in Platelet Nadir17.1 ± 8.311.2 ± 6.15.1 ± 6.1-5.2 ± 7.8
Statistical analysis
  • Romiplostim 100 µg vs Romiplostim 1000 µg · Satterhwaite t-test · p = 0.9654 (One-sided test)
  • Romiplostim 100 µg vs Romiplostim 700 µg · Satterhwaite t-test · p = 0.8690 (One-sided test)
  • Romiplostim 100 µg vs Romiplostim 300 µg · Satterhwaite t-test · p = 0.7133 (One-sided test)
SecondaryPercentage of Subjects Experiencing Grade 3 or 4 Thrombocytopenia

Percentage of subjects experiencing grade 3 and/or 4 thrombocytopenia (\<50 x 10\^9/L, and \<25 x 10\^9/L)

Time frame:
32 weeks
Reported as:
Number · Percentage of participants
Percentage of Subjects Experiencing Grade 3 or 4 Thrombocytopenia
Percentage of participantsRomiplostim 100 µgRomiplostim 300 µgRomiplostim 700 µgRomiplostim 1000 µg
Percentage of Subjects Experiencing Grade 3 or 4 Thrombocytopenia62.581.880.088.9
Statistical analysis
  • Romiplostim 100 µg vs Romiplostim 1000 µg · Fisher Exact · p = 0.294
  • Romiplostim 100 µg vs Romiplostim 700 µg · Fisher Exact · p = 0.608
  • Romiplostim 100 µg vs Romiplostim 300 µg · Fisher Exact · p = 0.603
SecondaryDuration of Grade 3 or 4 Thrombocytopenia

Duration of grade 3 and/or 4 thrombocytopenia (\<50 x 10\^9/L and \<25 x 10\^9/L, respectively)

Time frame:
32 weeks
Reported as:
Mean · Day
Duration of Grade 3 or 4 Thrombocytopenia
DayRomiplostim 100 µgRomiplostim 300 µgRomiplostim 700 µgRomiplostim 1000 µg
Duration of Grade 3 or 4 Thrombocytopenia3.9 ± 1.33.6 ± 0.96.0 ± 1.58.3 ± 2.1
Statistical analysis
  • Romiplostim 100 µg vs Romiplostim 1000 µg · Satterhwaite t-test · p = 0.091
  • Romiplostim 100 µg vs Romiplostim 700 µg · Satterhwaite t-test · p = 0.300
  • Romiplostim 100 µg vs Romiplostim 300 µg · Satterhwaite t-test · p = 0.881
SecondaryPercentage of Subjects That Received Platelet Transfusions

Percentage of subjects that received platelet transfusions during the first romiplostim treatment cycle

Time frame:
32 weeks
Reported as:
Number · Percentage of participants
Percentage of Subjects That Received Platelet Transfusions
Percentage of participantsRomiplostim 100 µgRomiplostim 300 µgRomiplostim 700 µgRomiplostim 1000 µg
Percentage of Subjects That Received Platelet Transfusions12.50.030.033.3
Statistical analysis
  • Romiplostim 100 µg vs Romiplostim 1000 µg · Fisher Exact · p = 0.576
  • Romiplostim 100 µg vs Romiplostim 700 µg · Fisher Exact · p = 0.588
  • Romiplostim 100 µg vs Romiplostim 300 µg · Fisher Exact · p = 0.421

Adverse events

Collected over From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Romiplostim 100 µg—0/8 (0%)6/8 (75%)
Romiplostim 300 µg—1/11 (9.1%)9/11 (81.8%)
Romiplostim 700 µg—3/11 (27.3%)7/11 (63.6%)
Romiplostim 1000 µg—3/9 (33.3%)9/9 (100%)
Most frequent serious events
Showing 10 of 13
Most frequent serious events
EventRomiplostim 100 µgRomiplostim 300 µgRomiplostim 700 µgRomiplostim 1000 µg
Febrile neutropeniaBlood and lymphatic system disorders0/81/111/112/9
Abdominal painGastrointestinal disorders0/80/111/111/9
Mucosal inflammationGeneral disorders0/80/110/111/9
BacteraemiaInfections and infestations0/80/110/111/9
Clostridium difficile colitisInfections and infestations0/80/110/111/9
Upper respiratory tract infectionInfections and infestations0/80/110/111/9
Urinary tract infectionInfections and infestations0/80/110/111/9
Renal failure acuteRenal and urinary disorders0/80/110/111/9
HypoxiaRespiratory, thoracic and mediastinal disorders0/80/110/111/9
Gastrointestinal haemorrhageGastrointestinal disorders0/80/111/110/9
Most frequent other events
Showing 10 of 88
Most frequent other events
EventRomiplostim 100 µgRomiplostim 300 µgRomiplostim 700 µgRomiplostim 1000 µg
NauseaGastrointestinal disorders0/85/111/111/9
FatigueGeneral disorders1/82/111/114/9
AnaemiaBlood and lymphatic system disorders1/83/110/113/9
NeutropeniaBlood and lymphatic system disorders0/80/111/113/9
Oedema peripheralGeneral disorders1/80/110/113/9
HypokalaemiaMetabolism and nutrition disorders0/80/111/113/9
InsomniaPsychiatric disorders2/80/110/110/9
AlopeciaSkin and subcutaneous tissue disorders2/81/110/110/9
ThrombocytopeniaBlood and lymphatic system disorders0/80/110/112/9
PyrexiaGeneral disorders0/81/110/112/9

Baseline characteristics

Age Continuous
Age Continuous(Year)Romiplostim 100 µgRomiplostim 300 µgRomiplostim 700 µgRomiplostim 1000 µgTotal
Mean61.3 ± 6.258.1 ± 9.554.0 ± 16.359.9 ± 10.658.0 ± 11.5
Sex: Female, Male
Sex: Female, Male(Participants)Romiplostim 100 µgRomiplostim 300 µgRomiplostim 700 µgRomiplostim 1000 µgTotal
Female334515
Male587424
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participant)Romiplostim 100 µgRomiplostim 300 µgRomiplostim 700 µgRomiplostim 1000 µgTotal
White or Caucasian61010834
Black or African American00112
Hispanic or Latino21003
08

Study locations

No study locations are listed for this record.

09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 20, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00283439
Lead sponsor
Amgen
First posted
Jan 30, 2006
Start date
Oct 2005
Primary completion
May 2008
Completion
Sep 2008
Results posted
Sep 13, 2010
Last update
Jun 20, 2011

Study contacts

MD
study director · Amgen
View the source record on ClinicalTrials.gov ↗

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