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

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johann Wolfgang Goethe University Hospital
• Treatments: Alemtuzumab; Cladribine

Criteria

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