Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00199030
Status:
COMPLETED
Last Update Posted:
2023-03-20
First Post:
2005-09-12
Brief Title:
Treatment of Relapsed T-cell Acute Lymphoblastic Leukemia or T-lymphoblastic Lymphoma With MabCampath
Sponsor:
Goethe University
Organization:
Goethe University
Study Overview
Official Title:
German Multicenter Phase II Trial to Study Effectivity and Feasibility of Alemtuzumab MabCampath in T-ALL and T-Lymphoblastic Lymphomas With Minimal Residual Disease MRD in Refractory Relapse or in Primary Failure
Status:
COMPLETED
Status Verified Date:
2023-03
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:
This study tests the effectivity and tolerability of treatment with alemtuzumab MabCampath in patients with relapsed or refractory T-cell acute lymphoblastic leukemia T-ALL or T-lymphoblastic lymphoma In Arm A patients with refractory relapse receive a 2 week treatment with MabCampath followed by remission evaluation In case of insufficient response treatment with cladribine is added In Arm B patients with molecular relapse minimal residual disease receive a 4 week treatment with MabCampath followed by remission evaluation In both arms treatment is continued in case of response for up to two months
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None