Blood and Lymph Conditions

All Conditions

Neoplasms

Immune System Diseases

Rare Diseases

Thrombocytopenia

Lymphoma

Hodgkin Disease

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Blood Platelet Disorders

Hematologic Diseases

Cytopenia

Lymphosarcoma

Hodgkin Lymphoma

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

AMG 531

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.

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

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.

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

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

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

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

Amgen

Global Development Leader

The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

Romiplostim 100 µg

Romiplostim 300 µg

Romiplostim 700 µg

Romiplostim 1000 µg

Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy

Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy

Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy

Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy

Total

Age Continuous

Sex: Female, Male

White or Caucasian

Black or African American

Hispanic or Latino

Race/Ethnicity, Customized

Study Director

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.

Change in Platelet Nadir

Percentage of Subjects Experiencing Grade 3 or 4 Thrombocytopenia

Duration of Grade 3 or 4 Thrombocytopenia

Percentage of Subjects That Received Platelet Transfusions

Overall Study

Symptoms and General Pathology

Heart and Blood Diseases

Preleukemia

Myelodysplastic Syndromes

Anemia

Anemia, Aplastic

Purpura, Thrombocytopenic, Idiopathic

Purpura

Purpura, Thrombocytopenic

Syndrome

Bone Marrow Failure Disorders

Pancytopenia

Bone Marrow Diseases

Hemostatic Disorders

Blood Coagulation Disorders

Thrombotic Microangiopathies

Hemorrhagic Disorders

Autoimmune Diseases

Hemorrhage

Skin Manifestations

Precancerous Conditions

Aplastic Anemia

Immune Thrombocytopenia

Idiopathic Thrombocytopenic Purpura

The study shall be a single institution prospective cohort study. Comparison will be made among individuals with known ITP . Those with known hypo-proliferative forms of thrombocytopenia \[aplastic anaemia, chemotherapy induced thrombocytopenia, and myelodysplastic thrombocytopenia, and a control population.

The study shall be a single institution prospective cohort study. Comparison will be made between individuals with known ITP versus those with known hypo-proliferative forms of thrombocytopenia \[aplastic anaemia, chemotherapy--induced thrombocytopenia, and myelodysplastic thrombocytopenia\], and a control population.

comprised of healthy individuals with normal platelet counts, to confirm normal values for MPC and MPM

Full blood count with extended platelet parameters

Immune Thrombocytopenics

Hypo-proliferative thrombocytopenics

Control Population

Mala Varma, MD

To utilise extended platelet parameters in order to individuate Immune Thrombocytopenia (ITP) from hypo-proliferative causes of thrombocytopenia.

To develop the clinical potential of the extended platelet parameters as they pertain to distinguishing different causes of thrombocytopenia from one another.

To test the hypothesis that mean platelet component (MPC) and mean platelet mass (MPM) might distinguish between thrombocytopenia related to bone marrow dysfunction and immune mediated destruction of platelets.

Patient to be registered at the Haematology-Oncology department Mount Sinai Roosevelt Hospital.

Inclusion criteria are as follows:

All individuals age 18yrs and above capable of rendering consent Known ITP confirmed by response to IVIG, glucocorticoids, or WinRho and exclusion of all other possible causes of thrombocytopenia Confirmed aplastic anemia \[as assessed through bone marrow trephine biopsy\]. Chemotherapy-induced thrombocytopenia assessed at time of predicted nadir.

Study subjects will have the following collected: Lavender tri-potassium EDTA tubes filled according to the manufacturer's specifications \[approximately 4ML of venous blood\], labeled, and promptly dispatched to the laboratory.The sample will be gently inverted several times prior to analysis on the ADVIA 120 taking care not to overly agitate the sample. Moreover, the specimen shall be inspected for clot formation prior to being assayed. The full blood count shall be obtained and in the configuration sub-menu the extended platelet parameter option shall be selected and thus actuated. A print out will be generated including the MPC, MPM, platelet component distribution width, platelet mass distribution width, and large platelet count in addition to the standard platelet count and mean platelet volume \[MPV\].

Extended Platelet Parameters as a Means to Differentiate Immune Thrombocytopenia From Hypo-proliferative Thrombocytopenias.

Beth Israel Medical Center

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Carboplatin

Cisplatin

Antimetabolites

Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.

Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.

Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.

Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.

Romiplostim is a thrombopoiesis recombinant protein that targets the thrombopoietin (TPO) receptor which results in increased platelet production.

Romiplostim

Placebo

The purpose of this study is to identify an effective, well tolerated dose and schedule of romiplostim that is appropriate for the treatment of chemotherapy induced thrombocytopenia (CIT) in patients with non-small cell lung cancer receiving gemcitabine and platinum.

Dose/ Schedule Finding Trial of Romiplostim for Chemotherapy-Induced Thrombocytopenia (CIT) in Non-Small Cell Lung Cancer (NSCLC)

Phase 2, Randomized, Double Blind, Placebo-Controlled Dose and Schedule Finding Trial to Evaluate the Safety and Efficacy of AMG 531 For Treatment of Chemotherapy-Induced Thrombocytopenia in Subjects With Advanced Non-Small Cell Lung Cancer Already Receiving Gemcitabine and Platinum.

This summary includes all treatment-emergent adverse events recorded from the start of investigational product on this study, or any worsening of adverse events initially experienced before initiation of this study.

The duration of grade 3 or 4 thrombocytopenia (defined as platelet count \<50 x 10\^9/L) experienced during the first on study chemotherapy cycle by treatment group.

The number of participants in each treatment group with grade 3 or 4 thrombocytopenia during the first on study treatment cycle. Per the Common Terminology Criteria for Adverse Events (CTCAE) v3.0, participants with a platelet count \< 50 x 10\^9/L, but ≥ 25 x 10\^9/L are considered to have Grade 3 thrombocytopenia and participants with a platelet count \< 25 x 10\^9/L are considered to have Grade 4 thrombocytopenia. Additionally, participants with a platelet transfusion during the first on-study treatment cycle were classified as having Grade 3/4 thrombocytopenia.

Number of participants who were administered platelet transfusions during first on study treatment cycle.

Platelet count on Day 22 of the first on study chemotherapy treatment cycle (planned Day 1 of next cycle) by treatment group

Number of participants who required a gemcitabine dose reduction on Day 8 of the first on study chemotherapy cycle.

Romiplostim 250 µg

Romiplostim 500 µg

Romiplostim 750 µg

Safety Analysis Set, composed of all randomized participants who received at least one dose of study medication.

Number of Participants With Adverse Events

Efficacy Analysis Set, composed of all randomized participants except those who were replaced (participants who discontinued prior to the completion of at least 1 romiplostim treatment cycle for non-platelet-related reasons).

Efficacy Analysis Set, composed of all randomized participants except those who were replaced.

Number of Participants Experiencing Grade 3 or 4 Thrombocytopenia During the First Treatment Cycle.

Number of Participants With Platelet Transfusions

Efficacy Analysis Set, composed of all randomized participants except those who were replaced

Platelet Count on Day 22

Gemcitabine Dose Reduction on Day 8 of the First Chemotherapy Cycle

Digestive System Diseases

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Pancreatic Cancer

Oxaliplatin

The study in a 2:1 randomization ratio(108 subjects to romiplostim). Amgen investigational product (romiplostim or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection.

The study in a 2:1 randomization ratio (54 subjects to placebo) Amgen investigational product (romiplostim or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection.

This study is designed to study Romiplostim for the treatment of chemotherapy-induced thrombocytopenia (CIT) in patients receiving chemotherapy for the treatment of gastrointestinal/colorectal/pancreatic cancer.

Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects with Gastrointestinal, Pancreatic, or Colorectal Cancer

RECITE: A phase 3 Randomized Placebo-controlled Double-blind Study of Romiplostim for the Treatment of Chemotherapy-induced Thrombocytopenia in Patients Receiving Oxaliplatin-based Chemotherapy for Treatment of Gastrointestinal, Pancreatic, or Colorectal Cancer

Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Gastrointestinal, Pancreatic, or Colorectal Cancer

RECITE: A Phase 3 Randomized Placebo-controlled Double-blind Study of Romiplostim for the Treatment of Chemotherapy- Induced Thrombocytopenia in Patients Receiving Oxaliplatin-based Chemotherapy for Treatment of Gastrointestinal, Pancreatic, or Colorectal Cancer

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

No thrombocytopenia-induced modification of any myelosuppressive treatment agent in the second and third cycles of the planned on-study chemotherapy regimen. Thrombocytopenia-induced modifications include chemotherapy dose reduction, delay, omission, or chemotherapy treatment discontinuation due to platelet counts below 100 x 10 9/L

the depth of the platelet count nadir from the start of the first on-study chemotherapy cycle through the end of the treatment period

The time to first platelet response, defined by platelet count ≥ 100 x 109/L in the absence of platelet transfusions during the preceding 7 days

the duration-adjusted event rate of

≥ grade 2 bleeding events, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grading scale

platelet transfusion(s) during the treatment period

achieving a platelet count equal to or greater than 100 x 10 9/L at any time after study day 1 to week 4 (ie, 7 days after the planned third dose of investigational product) and in the absence of platelet transfusions during the preceding 7 days

Anti-Infective Agents

Ammonium trichloro(dioxoethylene-O,O'-)tellurate

Adjuvants, Immunologic

Immunologic Factors

Protective Agents

Radiation-Protective Agents

Reverse Transcriptase Inhibitors

Enzyme Inhibitors

Antiviral Agents

Twenty patients who developed thrombocytopenia after a chemotherapy course will receive i.v. infusions of 3mg/m2 AS101 twice a week in addition to the standard chemotherapy regimen, during the following 4 chemotherapy courses.

Twenty patients who developed thrombocytopenia during chemotherapy course will be treated according to standard of care and will not receive the investigational product. Their medical condition will be followed and a complete blood count will be performed routinely once weekly.

intravenous infusions of 3mg/m2 AS101 twice a week in addition to the standard chemotherapy regimen during the following 4 chemotherapy courses.

AS101

Baruch Klein, Prof

Chemotherapy Induced Thrombocytopenia is a common side-effect of bone marrow suppression as a result of a chemotherapy treatment. AS101 is a tellurium based small compound with immunomodulating characteristics which attributed to the direct inhibition of the anti-inflammatory cytokine IL-10. AS101 was previously shown to induce a significant reduction in thrombocytopenia that accompany cancer therapy with no major toxicity . This phase II randomized open study will evaluate the efficacy of AS101 for the treatment of chemotherapy induced thrombocytopenia in patients with various solid tumors.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Dose and Schedule Finding Trial With AMG 531 for Chemotherapy Induced Thrombocytopenia (CIT) in Adults With Lymphoma	NCT00283439	Chemotherapy-In... Hodgkin's Lymph... Non-Hodgkin's L... Cancer Oncology Thrombocytopeni...	AMG 531	18 Years -	Amgen
Extended Platelet Parameters as a Means to Differentiate Immune Thrombocytopenia From Hypo-proliferative Thrombocytopenias.	NCT01933035	Immune Thromboc... Chemotherapy In... Myelodysplasia Aplastic Anaemi...	Immune Thromboc... Hypo-proliferat... Control Populat...	18 Years -	Beth Israel Medical Center
Dose/ Schedule Finding Trial of Romiplostim for Chemotherapy-Induced Thrombocytopenia (CIT) in Non-Small Cell Lung Cancer (NSCLC)	NCT00413283	Lung Cancer Chemotherapy-In... Non-Small Cell ... Cancer Lung Neoplasms Oncology Solid Tumors Thrombocytopeni...	Romiplostim Placebo Gemcitabine Carboplatin Cisplatin	18 Years -	Amgen
Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Gastrointestinal, Pancreatic, or Colorectal Cancer	NCT03362177	Chemotherapy-in...	Romiplostim Placebo	18 Years - 100 Years	Amgen
A Dose and Schedule Finding Trial With AMG 531 for Chemotherapy Induced Thrombocytopenia (CIT) in Adults With Lymphoma	NCT00283439	Chemotherapy-In... Hodgkin's Lymph... Non-Hodgkin's L... Cancer Oncology Thrombocytopeni...	AMG 531	18 Years -	Amgen
Dose/ Schedule Finding Trial of Romiplostim for Chemotherapy-Induced Thrombocytopenia (CIT) in Non-Small Cell Lung Cancer (NSCLC)	NCT00413283	Lung Cancer Chemotherapy-In... Non-Small Cell ... Cancer Lung Neoplasms Oncology Solid Tumors Thrombocytopeni...	Romiplostim Placebo Gemcitabine Carboplatin Cisplatin	18 Years -	Amgen
Application of AS101 for the Treatment of Thrombocytopenia in Solid Tumor Patients	NCT00926354	Chemotherapy In...	AS101	18 Years -	BioMAS Ltd

Spots Global Cancer Trial Database for chemotherapy induced thrombocytopenia