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

Study Overview
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Brief Summary
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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.

Official Title
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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

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

Intervention / Treatment
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* Drug: Alemtuzumab (MabCampath)
* Drug: Cladribine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 arms; Allocation by stratification
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>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. | Drug: Alemtuzumab (MabCampath)<br> <br> Drug: Cladribine<br> <br> |
| Experimental: Arm B<br>In Arm B, patients with molecular relapse (minimal residual disease) receive a 4 week treatment with MabCampath followed by remission evaluation. | Drug: Alemtuzumab (MabCampath)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 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 |  | after 1 Cycle - approximately 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Relapse, T-ALL, T-LBL, MabCampath, Minimal residual disease, Lymphoma, lymphoblastic, T-cell