Chemotherapy-induced ThrombocytopeniaPhase 3NCT03343847
Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Lymphoma.
A Phase 3 study testing Romiplostim in people with Chemotherapy-induced Thrombocytopenia, run by Amgen.
Trial summary
To evaluate the efficacy of romiplostim for the treatment of CIT in patients receiving chemotherapy for the treatment of lymphomas measured by the ability to administer on-time, full-dose chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chemotherapy-induced Thrombocytopenia
- What is being tested?
- Romiplostim
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 27 Jan 2018to 17 Jul 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 101 Subject has provided informed consent/assent prior to initiation of any study-specific activities/procedures or subject's legally acceptable representative has provided informed consent prior to any study-specific activities/procedures being initiated when the subject has any kind of condition that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent.
- 102 Males or females ≥ 18 years of age at signing of the informed consent.
- 103 Documented active lymphoma.
- 104 Receiving cancer treatment with 14-, 21-, or 28-day cycles, using medication such as alkylating agents, anthracyclines, carboplatin, cisplatin, nucleoside analogs, or any other chemotherapy agents with thrombocytopenia as a warning or adverse reaction.
- 105 Subjects must have 2 platelet counts < 30 x 109/L at least 7 days apart as a result of the chemotherapy administered in the cycle immediately preceding study entry, and no platelet count ≥ 50 x 109/L during 3-week period prior to enrollment despite dose delay or dose modification of chemotherapy regimen. The first platelet count < 30 x 109/L may be collected from local lab platelet count and must be confirmed within the 28-day screening period.
- 106 Subjects must not have received chemotherapy within 14 days prior to first dose of investigational product.
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- 107 Subjects must have at least 4 additional planned cycles of chemotherapy at study enrollment.
- 108 Subjects must be able to receive the same chemotherapy regimen (when possible, same schedule and same agents) for at least 2 additional cycles per investigator judgement.
- 109 Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Who cannot join
- 201 Acute lymphoblastic leukemia.
- 202 Acute myeloid leukemia.
- 203 Any myeloid malignancy.
- 204 Myelodysplastic syndrome.
- 205 Myeloproliferative disease.
- 206 Multiple myeloma.
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- 207 Within 4 months prior to enrollment, any history of active congestive heart failure (New York Heart Association [NYHA] class III to IV), symptomatic ischemia, uncontrolled arrhythmias, clinically significant electrocardiogram (ECG) abnormalities, screening ECG with corrected QT (QTc) interval of > 470 msec, pericardial disease, or myocardial infarction.
- 208 New or uncontrolled venous thromboembolism or thrombotic events within 3 months prior to screening.
- 209 Known human immunodeficiency virus infection, hepatitis C infection, or hepatitis B infection (subjects with hepatitis B surface antigen or core antibody receiving and responding to antiviral therapy directed at hepatitis B are allowed).
- 210 Secondary malignancy within the past 5 years except: Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. Adequately treated cervical carcinoma in situ without evidence of disease. Adequately treated breast ductal carcinoma in situ without evidence of disease. Prostatic intraepithelial neoplasia without evidence of prostate cáncer. Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ.
- Malignancy treated with curative intent and with no known active disease present for ≥ 3 years before enrollment and felt to be at low risk for recurrence by the treating physician (excluding malignancies listed in exclusion criteria 201 to 206).
- 211 Previous use of romiplostim, pegylated recombinant human megakaryocyte growth and development factor, eltrombopag, recombinant human TPO, any other TPO receptor agonist, or any investigational platelet producing agent.
- 212 Currently receiving treatment in another investigational device or drug study, or less than 28 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
- 213 Anemia (hemoglobin < 8 g/dL) on the day of initiation of investigational product. Use of red cell transfusions and erythropoietic stimulating agents is permitted as per institutional guidelines.
- 214 Neutropenia (absolute neutrophil count < 1 x 109/L) on the day of initiation of investigational product. Use granulocyte-colony stimulating factor is permitted as per institutional guidelines.
- 215 Abnormal renal function with serum creatinine ≥ 1.5 times [X] the upper limit of normal [ULN] OR creatinine clearance ≤ 60 mL/min using Cockcroft-Gault estimated creatinine clearance as assessed by central laboratory during screening.
- 216 Abnormal liver function (TBL > 3x ULN; alanine aminotransferase [ALT] or aspartate aminotransferase [AST] > 3x ULN for subjects without liver metastases or ≥ 5x ULN for subjects with liver metastases) as assessed by central laboratory during screening.
About this study
Official title: A Phase 3 Randomized Placebo-controlled Double-blind Study of Romiplostim for the Treatment of Chemotherapy-induced Thrombocytopenia in Patients Receiving Chemotherapy for Treatment of Lymphomas
To evaluate the efficacy of romiplostim for the treatment of CIT in patients receiving chemotherapy for the treatment of lymphomas measured by the ability to administer on-time, full-dose chemotherapy.
Read the detailed description
This is a phase 3, randomized, placebo-controlled, multicenter, international study for the treatment of CIT in adult subjects receiving chemotherapy for the treatment of lymphomas, defined by 2 platelet counts < 30 x 10^9/L at least 7 days apart. The study will consist of a screening period of up to 4 weeks, a 16-week treatment period, an end-of-treatment (EOT) visit, and long-term follow-up.
- Conditions
- Chemotherapy-induced Thrombocytopenia
- Being tested
- Romiplostim, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RomiplostimBiological
This trial is designed to study romiplostim for the treatment of chemotherapy-induced thrombocytopenia (CIT) in patients receiving chemotherapy for the treatment of lymphoma.
PlaceboOther
Placebo Comparator
| Study group | Role | What they receive |
|---|---|---|
| Romiplostim | Experimental | the study in a 2:1 randomization ratio(108 subjects to romiplostim) Receives: Biological: Romiplostim |
| Placebo | Placebo comparator | the study in a 2:1 randomization ratio (54 subjects to placebo) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chemotherapy dose delay or reduction
Either a chemotherapy dose delay by
≥ 4 days or chemotherapy dose reduction by ≥ 15% due to thrombocytopenia as measured in any 2 planned cycles of chemotherapy during the treatment period.
Measured: 17 weeks
Secondary outcomes (9)
Platelet recovery
The time to first platelet recovery, defined by platelet count ≥ 50 x 10^9/L in the absence of platelet transfusions during the preceding 7 days
Measured: 7 days post transfusion through platelet recovery
Platelet count
Achieving a platelet count
≥ 50 x 10^9/L, assessed 7 days after the third dose of investigational product and in the absence of platelet transfusions during the preceding 7 days
Measured: 7 days after 3rd dose of IP with no transfusions in preceding 7 days
Depth of the platelet count
The depth of the platelet count nadir for chemotherapy cycles administered after the third dose of investigational product through the end of the treatment period
Measured: 3rd dose of IP through End of treatment, up to 43 months
Subject Incidence of Platelet Transfusion
Incidence of platelet transfusions during the treatment period
Measured: Through treatment period, up to 17 weeks
Bleeding events
the duration-adjusted event rate of
≥ grade 2 bleeding events, as assessed by the Common Terminology Criteria for Adverse Events (CTCAE), during the treatment period
Measured: Through treatment period, up to 17 weeks
Adverse Events, Serious Adverse Events, clinically significant lab value changes
adverse events, including treatment-emergent adverse events, serious adverse events and clinically significant changes in laboratory values
Measured: Through treatment period, up to 17 weeks
Antibody Formation
anti-romiplostim antibodies and antibodies to TPO
Measured: throughout treatment period, up to 17 weeks
Vital Status
vital status
Measured: treatment period through end of study, up to 43 months
Changes in health
myelodysplastic syndromes and secondary malignancies
Measured: treatment period through end of study, up to 43 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start27 Jan 2018 (estimated)
- Primary completion17 Jul 2021 (estimated)
- Study completion17 Jul 2021 (estimated)
Why it stopped: Study was not feasible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343847
- Sponsor's protocol ID
- 20140347
- Other IDs
- 2017-002995-16, 2017
- Status last verified
- Jan 2018
- First submitted
- 12 Oct 2017
- Last updated
- 19 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized Placebo-controlled Double-blind Study of Romiplostim for the Treatment of Chemotherapy-induced Thrombocytopenia in Patients Receiving Chemotherapy for Treatment of Lymphomas
- ClinicalTrials.gov ID
- NCT03343847
- Acronym / sponsor ID
- 20140347
- Conditions
- Chemotherapy-induced Thrombocytopenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was not feasible
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 27 Jan 2018 (estimated)
- Primary completion
- 17 Jul 2021 (estimated)
- Study completion
- 17 Jul 2021 (estimated)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy of romiplostim for the treatment of CIT in patients receiving chemotherapy for the treatment of lymphomas measured by the ability to administer on-time, full-dose chemotherapy.
Detailed description
This is a phase 3, randomized, placebo-controlled, multicenter, international study for the treatment of CIT in adult subjects receiving chemotherapy for the treatment of lymphomas, defined by 2 platelet counts < 30 x 10^9/L at least 7 days apart. The study will consist of a screening period of up to 4 weeks, a 16-week treatment period, an end-of-treatment (EOT) visit, and long-term follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Romiplostim | Experimental | Biological: Romiplostimthe study in a 2:1 randomization ratio(108 subjects to romiplostim) |
| Placebo | Placebo comparator | Other: Placebothe study in a 2:1 randomization ratio (54 subjects to placebo) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 101 Subject has provided informed consent/assent prior to initiation of any study-specific activities/procedures or subject's legally acceptable representative has provided informed consent prior to any study-specific activities/procedures being initiated when the subject has any kind of condition that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent.
- 102 Males or females ≥ 18 years of age at signing of the informed consent.
- 103 Documented active lymphoma.
- 104 Receiving cancer treatment with 14-, 21-, or 28-day cycles, using medication such as alkylating agents, anthracyclines, carboplatin, cisplatin, nucleoside analogs, or any other chemotherapy agents with thrombocytopenia as a warning or adverse reaction.
- 105 Subjects must have 2 platelet counts < 30 x 109/L at least 7 days apart as a result of the chemotherapy administered in the cycle immediately preceding study entry, and no platelet count ≥ 50 x 109/L during 3-week period prior to enrollment despite dose delay or dose modification of chemotherapy regimen. The first platelet count < 30 x 109/L may be collected from local lab platelet count and must be confirmed within the 28-day screening period.
Key exclusion criteria (17 listed)
- 201 Acute lymphoblastic leukemia.
- 202 Acute myeloid leukemia.
- 203 Any myeloid malignancy.
- 204 Myelodysplastic syndrome.
- 205 Myeloproliferative disease.
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 |
|---|---|---|
| RomiplostimThis trial is designed to study romiplostim for the treatment of chemotherapy-induced thrombocytopenia (CIT) in patients receiving chemotherapy for the treatment of lymphoma. | Biological | Romiplostim |
| PlaceboPlacebo Comparator | Other | Placebo |
Primary outcome
Chemotherapy dose delay or reduction
Time frame: 17 weeks
Either a chemotherapy dose delay by ≥ 4 days or chemotherapy dose reduction by ≥ 15% due to thrombocytopenia as measured in any 2 planned cycles of chemotherapy during the treatment period.
9 secondary outcomes
Platelet recovery
Time frame: 7 days post transfusion through platelet recovery
Platelet count
Time frame: 7 days after 3rd dose of IP with no transfusions in preceding 7 days
Depth of the platelet count
Time frame: 3rd dose of IP through End of treatment, up to 43 months
Subject Incidence of Platelet Transfusion
Time frame: Through treatment period, up to 17 weeks
Bleeding events
Time frame: Through treatment period, up to 17 weeks
Adverse Events, Serious Adverse Events, clinically significant lab value changes
Time frame: Through treatment period, up to 17 weeks
Antibody Formation
Time frame: throughout treatment period, up to 17 weeks
Vital Status
Time frame: treatment period through end of study, up to 43 months
Changes in health
Time frame: treatment period through end of study, up to 43 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2018.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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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 3 study testing Romiplostim in people with Chemotherapy-induced Thrombocytopenia, 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 9 inclusion and 17 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: withdrawn, as of the sponsor's last update on 19 Jan 2018. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Chemotherapy dose delay or reduction (time frame: 17 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jan 2018.