Treatment of Relapsed T-cell Acute Lymphoblastic Leukemia or T-lymphoblastic Lymphoma With MabCampath

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

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.

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