Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Acute Lymphocytic Leukemia T-cell | — | UNRESOLVED | — |
| Lymphoma, Lymphoblastic | Lymphoblastic Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alemtuzumab (MabCampath) | Drug | Alemtuzumab | ALIAS |
| Cladribine | Drug | Cladribine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- 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.
- interventionNames
- Drug: Alemtuzumab (MabCampath)
- Drug: Cladribine
- type
- EXPERIMENTAL
- label
- Arm B
- description
- In Arm B, patients with molecular relapse (minimal residual disease) receive a 4 week treatment with MabCampath followed by remission evaluation.
- interventionNames
- Drug: Alemtuzumab (MabCampath)
Primary outcomes (2)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available