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

Goethe University

Status and phase: Completed; Phase 2

Conditions: Adult Acute Lymphocytic Leukemia T-cell; Lymphoma, Lymphoblastic

Treatments: Drug: Alemtuzumab (MabCampath); Drug: Cladribine

Study type: Interventional

Funder types: Other

Identifiers

NCT00199030

GMALL07

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Arm A

Experimental group

Description:

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.

Treatment:

Drug: Cladribine

Drug: Alemtuzumab (MabCampath)

Arm B

Experimental group

Description:

In Arm B, patients with molecular relapse (minimal residual disease) receive a 4 week treatment with MabCampath followed by remission evaluation.

Treatment:

Drug: Alemtuzumab (MabCampath)