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

Phase 2

Completed

• Conditions: Lymphoma, Lymphoblastic; Adult Acute Lymphocytic Leukemia T-cell
• Interventions: Drug: Alemtuzumab (MabCampath); Drug: Cladribine

• Registration Number: NCT00199030
• Lead Sponsor: Goethe University

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-16
• Last Update Posted: 2023-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

University Hospital, Medical Dept. II; 🇩🇪 Frankfurt, Germany