Chemotherapy-Induced ThrombocytopeniaPhase 1/2NCT00283439

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

A Phase 1/2 study testing AMG 531 in people with Chemotherapy-Induced Thrombocytopenia and Hodgkin's Lymphoma, run by Amgen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chemotherapy-Induced Thrombocytopenia, Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma
What is being tested?: AMG 531
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: No sites listed yet
Study dates: Oct 2005to Sep 2008
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

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

About this study

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.

Conditions: Chemotherapy-Induced Thrombocytopenia, Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma, Cancer, Oncology, Thrombocytopenia
Being tested: AMG 531
Keywords: NHL, chemotherapy induced thrombocytopenia, CIT, ICE, RICE, Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma, CHOP, ESHAP, DHAP, R-CHOP, R-ESHAP, R-DHAP
Medical subject headings: Hodgkin Disease, Lymphoma, Non-Hodgkin, Neoplasms, Thrombocytopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00283439
Study group	Role	What they receive
Single Arm: AMG 531 Dose-Escalating Cohort Study	Experimental	Not described Receives: Biological: AMG 531

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Platelet Nadir
Change in platelet nadir from the previous qualifying cycle to the first treatment cycle.
Measured: 32 weeks

Secondary outcomes (3)

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)
Measured: 32 weeks
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)
Measured: 32 weeks
Percentage of Subjects That Received Platelet Transfusions
Percentage of subjects that received platelet transfusions during the first romiplostim treatment cycle
Measured: 32 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2005Sep 2008

First posted30 Jan 2006 (estimated)
Study startOct 2005
Primary completionMay 2008
Study completionSep 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chemotherapy-Induced ThrombocytopeniaStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Supportive care
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00283439
Sponsor's protocol ID: 20050144
Status last verified: Jun 2011
First submitted: 26 Jan 2006
Last updated: 20 Jun 2011
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingPhase 3
Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer
Chemotherapy-induced Thrombocytopenia
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Hetrombopag Olamine Tablets Vs Placebo in Patients With Chemotherapy-Induced Thrombocytopenia (ExCIT)
Patients With Chemotherapy-Induced Thrombocytopenia
Not yet recruitingPhase 2/3
Early Prophylactic rhTPO Administration for Thrombocytopenia Associated With EAP Regimen-Based Hematopoietic Stem Cell Mobilization
Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma, Hematopoietic Stem Cell Mobilization
Not yet recruitingPhase 2
Romiplostim N01 for Injection for Secondary Prophylaxis of CIT in Breast Cancer
Thrombocytopenia Chemotherapy Induced
Not yet recruitingPhase 2
A Clinical Study on Prophylactic RespOnse To hEtrombopag for Secondary Prevention in Anti-Cancer Therapy-induced Thrombocytopeniae
Breast Cancer Patients at High Risk of Chemotherapy-induced Thrombocytopenia (CTIT)

All Chemotherapy-Induced Thrombocytopenia trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT00283439
Acronym / sponsor ID: 20050144
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
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: Oct 2005
Primary completion: May 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 30 Jan 2006 (estimated)
Results: Posted 13 Sep 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Single Arm: AMG 531 Dose-Escalating Cohort Study	Experimental	Biological: AMG 531

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AMG 531Planned Cohorts: 1. 100 mcg, 2. 300 mcg, 3. 700 mcg, 4. 1000 mcg; Optional Cohorts: 5. cohort expansion, 6. schedule change, 7. new dose	Biological	Single Arm: AMG 531 Dose-Escalating Cohort Study

Primary outcome

Change in Platelet Nadir
Time frame: 32 weeks
Change in platelet nadir from the previous qualifying cycle to the first treatment cycle.

3 secondary outcomes

Percentage of Subjects Experiencing Grade 3 or 4 Thrombocytopenia
Time frame: 32 weeks
Duration of Grade 3 or 4 Thrombocytopenia
Time frame: 32 weeks
Percentage of Subjects That Received Platelet Transfusions
Time frame: 32 weeks

Results and safety

Results posted to the registry on 13 Sep 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Romiplostim 100 µg	8	0
Romiplostim 300 µg	11	0
Romiplostim 700 µg	11	0
Romiplostim 1000 µg	9	0

Primary outcome: Change in Platelet Nadir

Time frame: 32 weeks. Mean (Standard Error). Unit: 10^9/L

Measure	Romiplostim 100 µg n = 8	Romiplostim 300 µg n = 11	Romiplostim 700 µg n = 10	Romiplostim 1000 µg n = 9
Value	17.1 (8.3)	11.2 (6.1)	5.1 (6.1)	-5.2 (7.8)

Romiplostim 100 µg vs Romiplostim 1000 µg: p = 0.9654, Satterhwaite t-test
Romiplostim 100 µg vs Romiplostim 700 µg: p = 0.8690, Satterhwaite t-test
Romiplostim 100 µg vs Romiplostim 300 µg: p = 0.7133, Satterhwaite t-test

Population analysed: Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim, completed the first treatment cycle, and were not replaced per the protocol.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Romiplostim 100 µg	0 of 8 (0%)	6 of 8 (75%)	Not reported
Romiplostim 300 µg	1 of 11 (9.1%)	9 of 11 (81.8%)	Not reported
Romiplostim 700 µg	3 of 11 (27.3%)	7 of 11 (63.6%)	Not reported
Romiplostim 1000 µg	3 of 9 (33.3%)	9 of 9 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
AmgenTrials clinical trials websiteLink provided by the sponsor.
FDA-approved Drug LabelingLink provided by the sponsor.

Related trials for Chemotherapy-Induced Thrombocytopenia

Active, not recruitingPhase 3
Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer
Chemotherapy-induced Thrombocytopenia
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Hetrombopag Olamine Tablets Vs Placebo in Patients With Chemotherapy-Induced Thrombocytopenia (ExCIT)
Patients With Chemotherapy-Induced Thrombocytopenia
Not yet recruitingPhase 2/3
Early Prophylactic rhTPO Administration for Thrombocytopenia Associated With EAP Regimen-Based Hematopoietic Stem Cell Mobilization
Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma, Hematopoietic Stem Cell Mobilization
Not yet recruitingPhase 2
Romiplostim N01 for Injection for Secondary Prophylaxis of CIT in Breast Cancer
Thrombocytopenia Chemotherapy Induced
Not yet recruitingPhase 2
A Clinical Study on Prophylactic RespOnse To hEtrombopag for Secondary Prevention in Anti-Cancer Therapy-induced Thrombocytopeniae
Breast Cancer Patients at High Risk of Chemotherapy-induced Thrombocytopenia (CTIT)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AMG 531 in people with Chemotherapy-Induced Thrombocytopenia and Hodgkin's Lymphoma, run by Amgen.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Platelet Nadir (time frame: 32 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00283439.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2011; AzTrials last refreshed its copy on 2 Nov 2026.