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

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Antirheumatic Agents

Etoposide

Cytarabine

Rituximab

Etoposide phosphate

Antineoplastic Agents, Immunological

Immunologic Factors

Rituximab 375mg/m2 d1, VP-16 40mg/m2 d1-4, Ara-C 2g/m2 d5, DDP 25mg/m2 d1-4, Met 500mg/m2 d1-5

Rituximab combined with ESHAP

Biyun Wang, M.D.

The purpose of this study is to evaluate the efficacy and toxicity of Rituximab combined with ESHAP (etoposide, methylprednisolone, cytarabine, and cisplatin) in the patients with diffuse large B cell lymphoma (DLBCL).

The salvage therapy in the patients with DLBCL is still controversial. The investigators conducted this study to evaluate the efficacy and tolerability of Rituximab combined with ESHAP in the patients with DLBCL. The patients enrolled were defined to be relapsed or refractory after the first-line chemotherapy like CHOP or other CHOP-like regimens.

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
Rituximab Combined With ESHAP in Patients With Relapse or Refractory Diffuse Large B Cell Lymphoma (DLBCL)	NCT00568815	Lymphoma	Rituximab combi...	18 Years - 70 Years	Fudan University
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

Spots Global Cancer Trial Database for eshap

Every month we try and update this database with for eshap cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for eshap

Every month we try and update this database with for eshap cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for eshap cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.