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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00199030

Enrollment

Registered

2005-09-20

Start date

2004-02-29

Completion date

2008-04-30

Last updated

2023-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult Acute Lymphocytic Leukemia T-cell, Lymphoma, Lymphoblastic

Keywords

Relapse, T-ALL, T-LBL, MabCampath, Minimal residual disease, Lymphoma, lymphoblastic, T-cell

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.

Interventions

DRUGAlemtuzumab (MabCampath)

DRUGCladribine

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

2 arms; Allocation by stratification

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026