Status:
COMPLETED
Treatment of Relapsed T-cell Acute Lymphoblastic Leukemia or T-lymphoblastic Lymphoma With MabCampath
Lead Sponsor:
Goethe University
Conditions:
Adult Acute Lymphocytic Leukemia T-cell
Lymphoma, Lymphoblastic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 lymp...
Eligibility Criteria
Inclusion
- Both Arms:
- T-ALL or T-lymphoblastic lymphoma
- CD52-expression \> 20%
- Aged \>= 18 years
- ECOG/World Health Organization (WHO) performance status 0-2
- Life expectancy of \> 2 months
- Contraception during, and for at least 6 months after, therapy
- At least a 2 week interval to the last cycle of chemotherapy (decision in individual cases if rapid progression)
- No persistent toxicity from earlier cycles
- Written informed consent
- Arm 1:
- Evidence of MRD \> 10(-4) with confirmation beyond week 16 in the GMALL-Study 07/2003
- Arm 2:
- Relapse with failure to at least one salvage therapy or primary failure after induction therapy and at least one salvage therapy
Exclusion
- Substantial restrictions of heart, lung, liver, or kidney function
- Active infection, HIV seropositivity or cytomegalovirus (CMV) viraemia
- Pretreatment with MabCampath®
- Known anaphylaxis to humanised antibodies
- Permanent systemic therapy with corticosteroids
- Central nervous system (CNS) involvement
- Extramedullary bulky disease
- Active secondary malignancies
- Pregnancy or nursing
- Mental disease or circumstances that prohibit compliance with the protocol procedures
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00199030
Start Date
February 1 2004
End Date
April 1 2008
Last Update
March 20 2023
Active Locations (1)
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1
University Hospital, Medical Dept. II
Frankfurt, Germany, 60590