Clinical trial · Interventional
Combination Chemotherapy, Total-Body Irradiation, and Alemtuzumab in Treating Patients Undergoing an Autologous Stem Cell Transplant for Stage I, Stage II, Stage III, or Stage IV Chronic Lymphocytic Leukemia
Campath 1H (Alemtuzumab) Combined With High-Dose Therapy and Autologous Stem Cell Transplantation in Chronic Lymphocytic Leukemia
- 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: Giving combination chemotherapy before a peripheral blood stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. A monoclonal antibody, such as alemtuzumab, is given to kill any remaining cancer cells. Chemotherapy and radiation therapy (total-body irradiation) are given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy. Giving combination chemotherapy, total-body irradiation, and alemtuzumab together with autologous peripheral stem cell transplant may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with total-body irradiation and alemtuzumab works in treating patients undergoing an autologous stem cell transplant for stage I, stage II, stage III, or stage IV 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 (12)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alemtuzumab | Biological | Alemtuzumab | ALIAS |
| autologous bone marrow transplantation | Procedure | — | UNRESOLVED |
| carmustine | Drug | Carmustine | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Safety and feasibility of CAMPATH-1H included into the myeloablative regimen (cyclophosphamide and TBI) of the CLL3 protocol monitoring of treatment related mortality and morbidity (CTC scale) continuous
Secondary outcomes (3)
- measure
- Rate and duration of molecular responses MRD levels continuous
- measure
- Rate and duration of clinical remissions NCIE sponsored remission criteria for CLL continuous
- measure
- Overall survival time from treatment to death continuous
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Chronic lymphocytic leukemia (CLL), meeting 1 of the following stage criteria:
* Stage I-IV disease
* Binet stage B or C disease
* Binet stage A disease at high risk for rapid disease progression, as defined by both of the following criteria:
* Nonnodular marrow infiltration and/or lymphocyte doubling time \< 12 months
* Thymidine kinase \> 7.0 U/L and/or ß-2-microglobulin \> 3.5 mg/L
* Polymerase chain reaction-amplifiable clonal CDR III rearrangement of the immunoglobulin variable heavy chain gene
* No Richter's syndrome or B-prolymphocytic leukemia
PATIENT CHARACTERISTICS:
* ECOG performance status 0-1
* No concurrent disease resulting in major organ dysfunction
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other concurrent malignancy
* No New York Heart Association class III or IV cardiac failure
* No cardiomyopathy
* No history of myocardial infarction
* No symptomatic coronary heart disease
* No severe cardiac arrhythmia
* No severe or uncontrolled hypertension
* No chronic pulmonary disease
* No pulmonary function test impairment
* No severe or uncontrolled diabetes mellitus
* Bilirubin or transaminases ≤ 1.5 times upper limit of normal
* Creatinine ≤ 1.4 mg/dL
* No cerebral dysfunction
* No severe psychiatric impairment
* No drug addiction or alcoholism
* Negative HIV
* Negative Hepatitis B or C
* No allergy to any of the protocol drugs
* No history of anaphylactic reaction to monoclonal antibodies
* No active infection
PRIOR CONCURRENT THERAPY:
* No more than 1 prior chemotherapy regimen OR chemotherapy that lasted \> 6 months
* No prior radiotherapy
* No prior treatment with alemtuzumab
* No prior long-term (\> 1 month) systemic corticosteroids
* No prior therapy with dexamethasone, carmustine, etoposide, cytarabine, and melphalan (Dexa-BEAM)References
Publications (0)
Data not yet available