A Dose and Schedule Finding Trial With AMG 531 for Chemotherapy Induced Thrombocytopenia (CIT) in Adults With Lymphoma
NCT00283439 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 39
Last updated 2011-06-20
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.
Conditions
- Chemotherapy-Induced Thrombocytopenia
- Hodgkin's Lymphoma
- Non-Hodgkin's Lymphoma
- Cancer
- Oncology
- Thrombocytopenia
Interventions
- BIOLOGICAL
-
AMG 531
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
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
MD · Amgen
Study Design
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-10-31
- Primary Completion
- 2008-05-31
- Completion
- 2008-09-30
More Related Trials
-
A Study to Assess the Safety and Efficacy of Two Combinations of Isocitrate Dehydrogenase (IDH) Mutant Targeted Therapies Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) Harboring IDH Mutations Who Are Not Candidates to Receive Intensive Induction Chemotherapy
NCT02677922 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in Participants With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS).
NCT01835587 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study Evaluating the Safety and Pharmacology of Atezolizumab Administered in Combination With Immunomodulatory Agents in Participants With Acute Myeloid Leukemia (AML)
NCT02892318 ·Status: COMPLETED ·Phase: PHASE1
-
S0106 Cytarabine and Daunorubicin w/ or w/o Gemtuzumab Followed By HD Cytarabine and Either Gemtuzumab or Nothing in de Novo AML
NCT00085709 ·Status: COMPLETED ·Phase: PHASE3
-
Gemtuzumab Ozogamicin With G-CSF, Cladribine, Cytarabine & Mitoxantrone for Untreated AML & High-Grade Myeloid Neoplasm
NCT03531918 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Phase I Study of HMPL-523+Azacitidine in Elderly Patients With Acute Myeloid Leukemia
NCT03483948 ·Status: TERMINATED ·Phase: PHASE1
-
Study Evaluating the Safety, Tolerability, and Efficacy of FLT3 CAR-T AMG 553 in FLT3-positive Relapsed/Refractory AML
NCT03904069 ·Status: WITHDRAWN ·Phase: PHASE1
-
Study Evaluating Gemtuzumab Ozogamicin in Acute Myeloid Leukemia
NCT00037596 ·Status: COMPLETED ·Phase: PHASE2
-
Demethylating Agents Combined With Venetoclax for High-risk T-cell Lymphoblastic Lymphoma/Leukemia Post-Transplant Relapse Prevention
NCT06686108 ·Status: RECRUITING ·Phase: PHASE2
-
Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With AML Leukemia
NCT00049517 ·Status: COMPLETED ·Phase: PHASE3
-
Combination 5-azacitidine and Gemtuzumab Ozogamicin Therapy for Treatment of Relapsed Acute Myeloid Leukemia (AML)
NCT00766116 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia
NCT03150693 ·Status: RECRUITING ·Phase: PHASE3
-
AMG 176 With Azacitidine in Subjects With Myelodysplastic Syndrome /Chronic Myelomonocytic Leukemia
NCT05209152 ·Status: TERMINATED ·Phase: PHASE1
-
SGI-110 in Adults With Untreated Acute Myeloid Leukemia (AML), Not Considered Candidates for Intensive Remission Induction
NCT02348489 ·Status: COMPLETED ·Phase: PHASE3
-
Allogeneic Donor Lymphocyte Infusions Combined With Blinatumomab
NCT03982992 ·Status: WITHDRAWN ·Phase: PHASE2
-
Combination Chemotherapy With or Without Gemtuzumab in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia
NCT00372593 ·Status: COMPLETED ·Phase: PHASE3
-
Testing the Combination of Inotuzumab Ozogamicin and Lower Dose Chemotherapy Compared to Usual Chemotherapy for Adults With B-Cell Acute Lymphoblastic Leukemia or B-Cell Lymphoblastic Lymphoma
NCT05303792 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Safety, Tolerability, Pharmacokinetics and Efficacy of AZD1208 in Acute Myelogenous Leukemia (AML) Patients
NCT01489722 ·Status: TERMINATED ·Phase: PHASE1
-
Efficacy of Intermediate-Dose Cytarabine Induction Regimen in Adult AML
NCT03021330 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Combination Chemotherapy and Dasatinib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
NCT01238211 ·Status: COMPLETED ·Phase: PHASE2
-
Tagraxofusp and Azacitidine for Maintenance Treatment in Patients With CD123 Positive AML and MDS Following Donor Hematopoietic Cell Transplant
NCT06498973 ·Status: RECRUITING ·Phase: PHASE1
-
Gemtuzumab Ozogamicin With or Without Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia
NCT00006122 ·Status: COMPLETED ·Phase: PHASE2
-
Study Evaluating the Safety and Efficacy of Gemtuzumab Ozogamicin in Patients With Acute Myeloid Leukemia
NCT00037583 ·Status: COMPLETED ·Phase: PHASE2
-
Treatment for Relapsed/Refractory AML Based on a High Throughput Drug Sensitivity Assay
NCT01872819 ·Status: COMPLETED ·Phase: NA
-
Azacitidine, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With High-Risk Acute Myeloid Leukemia
NCT01839240 ·Status: COMPLETED ·Phase: PHASE1