Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Lymphoma.

NCT03343847 | Withdrawn Phase 3 DMC FDA Drug

• 2 other identifiers: 201403472017-002995-16
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chemotherapy-induced Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• 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.

  17 weeks

Secondary Outcomes (9)

• Platelet recovery

  7 days post transfusion through platelet recovery

• Platelet count

  7 days after 3rd dose of IP with no transfusions in preceding 7 days

• Depth of the platelet count

  3rd dose of IP through End of treatment, up to 43 months

• Subject Incidence of Platelet Transfusion

  Through treatment period, up to 17 weeks

• Bleeding events

  Through treatment period, up to 17 weeks

Other Outcomes (8)

• Platelet count

  treatment period through end of study, up to 43 months

• Change in Clinical Outcome Assessment (COA) scores

  Through treatment period, up to 17 weeks

• Change in Health-Related Quality of Life (HRQoL) score

  Through treatment period, up to 17 weeks

Study Arms (2)

Romiplostim

EXPERIMENTAL

the study in a 2:1 randomization ratio(108 subjects to romiplostim)

Biological: Romiplostim

Placebo

PLACEBO COMPARATOR

the study in a 2:1 randomization ratio (54 subjects to placebo)

Other: Placebo

Interventions

Romiplostim BIOLOGICAL

This trial is designed to study romiplostim for the treatment of chemotherapy-induced thrombocytopenia (CIT) in patients receiving chemotherapy for the treatment of lymphoma.

Romiplostim

Placebo OTHER

Placebo Comparator

Placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Males or females ≥ 18 years of age at signing of the informed consent.
• Documented active lymphoma.
• 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.
• 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.
• Subjects must not have received chemotherapy within 14 days prior to first dose of investigational product.
• Subjects must have at least 4 additional planned cycles of chemotherapy at study enrollment.
• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

You may not qualify if:

• Acute lymphoblastic leukemia.
• Acute myeloid leukemia.
• Any myeloid malignancy.
• Myelodysplastic syndrome.
• Myeloproliferative disease.
• Multiple myeloma.
• 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.
• New or uncontrolled venous thromboembolism or thrombotic events within 3 months prior to screening.
• 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).
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Amgen: lead

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Interventions

romiplostim

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: November 17, 2017
• Study Start: January 27, 2018
• Primary Completion: July 17, 2021
• Study Completion: July 17, 2021
• Last Updated: January 19, 2018

Record last verified: 2018-01