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

Sponsor

Johann Wolfgang Goethe University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00199030

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adult Acute Lymphocytic Leukemia T-Cell Lymphoma, Lymphoblastic	Drug: Alemtuzumab (MabCampath) Drug: Cladribine	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2004

Study Completion Date :

Dec 1, 2007

Outcome Measures

Primary Outcome Measures

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 []
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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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