Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003984
Status:
WITHDRAWN
Last Update Posted:
2012-07-11
First Post:
1999-11-01
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Primary Myelodysplastic Syndrome
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Phase II Trial With a Recombinant Humanized Anti-CD33 Monoclonal Antibody HuM195 in Patients With High Risk Primary Myelodysplastic Syndromes
Status:
WITHDRAWN
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
PURPOSE Phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have primary myelodysplastic syndrome
PURPOSE Phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have primary myelodysplastic syndrome
Detailed Description:
OBJECTIVES I Assess the therapeutic activity of monoclonal antibody HuG1-M195 on peripheral blood and bone marrow blast cell count blood leukocyte reticulocyte and platelet counts and hemoglobin levels in patients with myelodysplastic syndrome with refractory anemia with excess blasts RAEB greater than 10 bone marrow myeloblasts or RAEB in transformation II Assess the efficacy of this drug in terms of duration of response in these patients III Evaluate the toxicity of this drug in these patients
OUTLINE Patients receive monoclonal antibody HuG1-M195 IV over 4 hours on days 1-4 Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Patients with progressive disease after 2 courses are removed from study Patients with stable disease receive no further treatment after 4 courses Patients with complete or partial response receive treatment for 4 additional courses Patients are followed at 11 and 39 days after end of course 4 monthly for 4 months then every 3 months thereafter for 1 year from study entry
PROJECTED ACCRUAL A total of 14-25 patients will be accrued for this study
OUTLINE Patients receive monoclonal antibody HuG1-M195 IV over 4 hours on days 1-4 Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Patients with progressive disease after 2 courses are removed from study Patients with stable disease receive no further treatment after 4 courses Patients with complete or partial response receive treatment for 4 additional courses Patients are followed at 11 and 39 days after end of course 4 monthly for 4 months then every 3 months thereafter for 1 year from study entry
PROJECTED ACCRUAL A total of 14-25 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EORTC-13981 | None | None | None |