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

NCT ID: NCT00199030

Last Updated: 2023-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2008-04-30

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.

Conditions

Adult Acute Lymphocytic Leukemia T-cell; Lymphoma, Lymphoblastic

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

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.

Group Type: EXPERIMENTAL

Alemtuzumab (MabCampath)

Intervention Type: DRUG

Cladribine

Intervention Type: DRUG

Arm B

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

Group Type: EXPERIMENTAL

Alemtuzumab (MabCampath)

Intervention Type: DRUG

Interventions

Alemtuzumab (MabCampath)

Intervention Type: DRUG

Cladribine

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Goethe University

OTHER

Sponsor Role: lead

Responsible Party

Nicola Goekbuget

Head of GMALL

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dieter Hoelzer, MD, PhD

Role: STUDY_CHAIR

University Hospital Frankfurt, Medical Dept. II

Locations

University Hospital, Medical Dept. II

Frankfurt, , Germany

Countries

Germany

Other Identifiers

GMALL07

Identifier Type: -

Identifier Source: org_study_id