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
18 Years
N/A
Both
Adult Acute Lymphocytic Leukemia T-Cell, Lymphoma, Lymphoblastic
Trial Information
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
Inclusion Criteria:
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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Arm A: rate of molecular remissions (MRD < 10(-4), toxicity according to CTC, remission duration/survival, feasibility of s.c. dose escalation and long term therapy, mortality
Principal Investigator
Dieter Hoelzer, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
University Hospital Frankfurt, Medical Dept. II
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
GMALL07
NCT ID:
NCT00199030
Start Date:
February 2004
Completion Date:
December 2007
Related Keywords:
- Adult Acute Lymphocytic Leukemia T-Cell
- Lymphoma, Lymphoblastic
- Relapse
- T-ALL
- T-LBL
- MabCampath
- Minimal residual disease
- Lymphoma, lymphoblastic, T-cell
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, T-Cell
- Lymphoma
- Lymphoma, Non-Hodgkin
- Neoplasm, Residual
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
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