Clinical trial NCT00199030: Treatment of Relapsed T-cell Acute Lymphoblastic Leukemia or T-lymphoblastic Lymphoma With MabCampath
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adult Acute Lymphocytic Leukemia T-cell
Lymphoma, Lymphoblastic
Keywords: Relapse
T-ALL
T-LBL
MabCampath
Minimal residual disease
Lymphoma, lymphoblastic, T-cell
Lead sponsor: Goethe University
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 arms; Allocation by stratification
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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
timeFrame: after 1 cycle - approximately 3 weeks
measure: 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
timeFrame: after 1 Cycle - approximately 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: University Hospital, Medical Dept. II
Study officials:
affiliation: University Hospital Frankfurt, Medical Dept. II
name: Dieter Hoelzer, MD, PhD
role: STUDY_CHAIR
References: