Clinical trial · Interventional
Cyclophosphamide and Total Body Irradiation in Treating Patients Who Are Undergoing an Autologous Peripheral Stem Cell Transplant For Chronic Lymphocytic Leukemia
Pivotal Study for High Dose Therapy and Autologous Stem Cell Transplantation in Early Stages of CLL
- 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 chemotherapy before a peripheral 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. Chemotherapy or radiation therapy is then 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. PURPOSE: This phase II trial is studying how well giving cyclophosphamide together with total-body irradiation works in treating patients who are undergoing an peripheral stem cell transplant for 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 (11)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bone marrow ablation with stem cell support | 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 |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- High dose therapy + autologous PBSCT
- description
- 1. Cytoreductive treatment: (preferentially) FC (2-4 cycles) 2. Mobilization: Dexa-BEAM + G-CSF (1-2 cycles) 3. Myeloablation: fractionated TBI (e.g. 6x2Gy) + Cyclophosphamide (2 x 60 mg/kg; d -4 to -3) 4. autologous peripheral blood stem cell transplantation (PBSCT) (d 0)
- interventionNames
- Biological: filgrastim
- Drug: carmustine
- Drug: cyclophosphamide
- Drug: cytarabine
- Drug: dexamethasone
- Drug: etoposide
- Drug: fludarabine phosphate
- Drug: melphalan
- Procedure: bone marrow ablation with stem cell support
- Procedure: peripheral blood stem cell transplantation
- Radiation: radiation therapy
Primary outcomes (2)
- measure
- Safety of autologous peripheral stem cell transplantation (PBSCT) as measured by a treatment-related mortality of < 5% at 12 months following transplant
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Patients with chronic lymphocytic leukemia, meeting 1 of the following criteria:
* Binet stage B or C disease
* Binet stage A disease and at high risk for disease progression, defined as the following:
* Non-nodular marrow infiltration or lymphocyte doubling time \< 12 months
* Thymidine kinase \> 7.0 U/L or ß-2-microglobulin \> 3.5 mg/L
* Polymerase chain reaction-amplifiable clonal CDRIII rearrangement of the IgV\_H
PATIENT CHARACTERISTICS:
* ECOG performance status 0-1
* No concurrent disease resulting in major organ dysfunction
PRIOR CONCURRENT THERAPY:
* No prior combination therapy comprising melphalan, dexamethasone, carmustine, cytarabine, and etoposide (DEXA-Beam)
* No more than 1 prior chemotherapy regimen
* No prior chemotherapy regimen longer than 6 months in durationReferences
Publications (1)
- RESULTDreger P, Dohner H, McClanahan F, Busch R, Ritgen M, Greinix H, Fink AM, Knauf W, Stadler M, Pfreundschuh M, Duhrsen U, Brittinger G, Hensel M, Schetelig J, Winkler D, Buhler A, Kneba M, Schmitz N, Hallek M, Stilgenbauer S; German CLL Study Group. Early autologous stem cell transplantation for chronic lymphocytic leukemia: long-term follow-up of the German CLL Study Group CLL3 trial. Blood. 2012 May 24;119(21):4851-9. doi: 10.1182/blood-2011-09-378505. Epub 2012 Apr 5. PMID 22490331