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

Phase 2CompletedNCT00199030

Goethe University8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Adult Acute Lymphocytic Leukemia T-cell Lymphoma, Lymphoblastic

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: after 1 cycle - approximately 3 weeks

Arm B: response (CR/PR/MR), toxicity according to CTC, SCT rate, remission duration/survival, feasibility of i.v. dose escalation/long term therapy, mortality

Time frame: after 1 Cycle - approximately 3 weeks