Clinical trial · Interventional
Alemtuzumab in Treating Patients With B-Cell Chronic Lymphocytic Leukemia
Consolidation Therapy With Alemtuzumab (MabCampath®) in Patients With Chronic Lymphocytic Leukemia Who Are in Complete or Partial 2nd Remission After Cytoreduction With Fludarabine or Fludarabine Plus Cyclophosphamide or Fludarabine Plus Cyclophosphamide Plus Rituximab or Bendamustine or Bendamustine Plus Rituximab - a Phase I/II Study
- 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)
RATIONALE: Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. PURPOSE: This phase I/II trial is studying the side effects and best dose of alemtuzumab in treating patients with B-cell chronic lymphocytic leukemia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alemtuzumab i.v. | Biological | — | UNRESOLVED |
| Alemtuzumab s.c. | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort A: Alemtuzumab i.v.
- description
- Intravenous administration of alemtuzumab according to the 3 + 3 dose escalation design.
- interventionNames
- Biological: Alemtuzumab i.v.
- type
- EXPERIMENTAL
- label
- Cohort B: Alemtuzumab s.c.
- description
- After i.v. MTD (maximum tolerable dosage) has been determined, subcutaneous dose escalation is performed according to the same escalation rules as for cohort A, starting with the recommended dose level of i.v. application.
- interventionNames
- Biological: Alemtuzumab s.c.
Primary outcomes (2)
- measure
- Dose-limiting toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
Inclusion criteria:
* Diagnosis of B-cell chronic lymphocytic leukemia (B-CLL)
* Disease in complete or partial remission after completion of 4-6 courses of second-line cytoreductive therapy no less than 90 days and no more than 150 days ago
* Second-line cytoreductive therapy must comprise 1 of the following regimens:
* Fludarabine phosphate alone (F)
* Fludarabine phosphate and cyclophosphamide (FC)
* Fludarabine phosphate, cyclophosphamide, and rituximab (FCR)
* Bendamustine hydrochloride alone (B)
* Bendamustine hydrochloride and rituximab chemotherapy (BR)
* Complete minimal residual disease response defined by the following:
* At least negativity of 4-color-cytometry and/or even PCR-amplifiable clonal CDR III rearrangement of the IgV\_H
* For PCR analysis, blood sample need to be taken at beginning or during second-line cytoreductive therapy before achievement of a clinical complete remission
* Disease not refractory to first-line F/FC/FCR/B/BR if received such therapy
Exclusion criteria:
* Presence of bulky lymph nodes (\> 5 cm) after second-line F/FC/FCR/B/BR
* Clinically apparent autoimmune cytopenia (i.e., autoimmune hemolytic anemia, autoimmune thrombocytopenia, or pure red cell aplasia)
* CNS involvement with B-CLL
PATIENT CHARACTERISTICS:
Inclusion criteria:
* ECOG performance status 0-1
* ANC ≥ 1,500/µL
* Platelets ≥ 50,000/µL
* Creatinine ≤ 1.5 times the upper normal limit (ULN)
* Conjugated bilirubin ≤ 2 times ULN
* Thyroid function normal
* Not pregnant or nursing
* Fertile patients must use effective contraception
Exclusion criteria:
* Severe infection during second-line treatment with F/FC/FCR/B/BR, meeting any 1 of the following criteria:
* Any episode of NCI grade 4 infection
* More than 1 episode of NCI grade 3 infection
* Medical condition requiring long-term use of oral corticosteroids for more than 1 month
* Active bacterial, viral, or fungal infection
* HIV, hepatitis B virus, and/or hepatitis C virus-positive serum status
* Concurrent severe diseases that exclude the administration of protocol therapy, including any of the following:
* NYHA class III-IV heart insufficiency
* Severe chronic obstructive lung disease with hypoxemia
* Severe ischemic cardiac disease
* Active secondary malignancy other than B-CLL prior to the study
* Known hypersensitivity or anaphylactic reaction against murine proteins or one of the drug components
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No more than 2 prior chemotherapies, including F/FC/FCR/B/BR therapy
* No more than 1 pretreatment (before second-line therapy) with chlorambucil or F/FC/FCR/B/BR
* No chemotherapy or radiotherapy for any neoplastic disease other than B-CLL prior to the studyReferences
Publications (1)
- RESULTAl-Sawaf O, Fischer K, Herling CD, Ritgen M, Bottcher S, Bahlo J, Elter T, Stilgenbauer S, Eichhorst BF, Busch R, Elberskirch U, Abenhardt W, Kneba M, Hallek M, Wendtner CM. Alemtuzumab consolidation in chronic lymphocytic leukaemia: a phase I/II multicentre trial. Eur J Haematol. 2017 Mar;98(3):254-262. doi: 10.1111/ejh.12825. Epub 2016 Dec 1. PMID 27862308