Autologous Stem Cell Transplantation in Chronic Lymphocytic Leukemia

NCT00931645 | Completed Phase 3 DMC

• 2 other identifiers: SFGMTCPHRC
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 1

Brief Summary

Phase III trial evaluating the role of autologous stem cell transplantation in previously untreated patients under 65 years with stage B and C B-cell chronic lymphocytic leukemia. Endpoints of the trial :

• major : progression free survival at 3 years
• secondary : overall survival, tolerance, prognostic factors according to baseline clinical stage and biological characteristics (IgHv mutational status, expression of ZAP70 and CD38, cytogenetics).

Conditions

Chronic Lymphocytic Leukemia

Keywords

Chronic lymphocytic leukemia,; autologous stem cell transplantation

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  3 year

Secondary Outcomes (1)

• Overall survival, response after completion of scheduled treatment, tolerance and adverse events, quality of life, prognostic factors for response and survival.

  36 months

Study Arms (4)

Complete responders

NO INTERVENTION

watch and wait policy

arm 2: complete responders patients

EXPERIMENTAL

ABMT : TBI, 10 grays d-3-1 \& cyclophosphamide 60 mg/sqm d-5-4

Procedure: Autologous stem cell transplantation

Non CR patients arm 3

EXPERIMENTAL

Rescue chemotherapy and ABMT (see arm 2)

Procedure: DHAP rescue and Autologous stem cell transplantation

Non CR patients at random : arm 4

ACTIVE COMPARATOR

Rescue DHAP, F+C

Procedure: DHAP rescue and F+C

Interventions

Autologous stem cell transplantation PROCEDURE

TBI (10 grays, d-3-1), cyclophosphamide (60 mg/sqm d-5-4)

Also known as: ABMT

arm 2: complete responders patients

DHAP rescue and Autologous stem cell transplantation PROCEDURE

DHAP :IV cisplatin 100 mg/sqm d1, IV cytarabine 2 g/sqm d2,, IV dexamethasone 40 mg/sqm d1-4, TBI (10 grays d-3-1), cyclophosphamide (60 mg/sqm d-5-4)

Also known as: cisplatin, dexamethasone, cytarabine

Non CR patients arm 3

DHAP rescue and F+C PROCEDURE

DHAP :IV cisplatin 100 mg/sqm d1, IV Cytarabine 2 g/sqm d2, IV dexamethasone 40 mg/sqm d1-4, Followed by 3 monthly cycles with IV d1-3 fludarabine (25 mg/sqm) \& cyclophosphamide (300 mg/sqm)

Also known as: Fludarabine, Cyclophosphamide

Non CR patients at random : arm 4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with stage B \& C CLL, 18- 65 years.
• previously untreated
• given written informed consent

You may not qualify if:

• Childbearing women
• OMS Performance status \> 2
• Binet stage A
• Autoimmune hemolytic anemia
• Active or previous (\< 5 years) malignant disease, except cutaneous cell carcinoma.
• Previous CLL treatment
• HIV seropositivity
• Abnormal renal or liver function tests (creatinine \> 1,5N, transaminases \> 2N, bilirubin \> 1,5N)
• Cardiac failure (ejection fraction \< 50%)
• Lung disease or perturbed ventilation tests

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

DBIM Hopital Saint Louis

Paris, 75000, France

Location

Related Publications (1)

• Laurent Sutton, Sylvie Chevret, Karim Maloum, Olivier Tournilhac, Marine Diviné, Veronique Leblond, Bernadette Corront, Stephane Lepretre, Houchingue Eghbali, Eric Van Den Neste, Mauricette Michallet, Frederic Maloisel, Krimo Bouabdallah, Christian Berthou, Pauline Brice, Didier Decaudin, Hugo Gonzalez, Florence Nguyen Khac, Frederic Davi, Julie Lejeune, Helene Merle-Beral, Michel Leporrier, for the French Study Group on CLL, the SFGM -TC; Autologous Stem Cell Transplantation (ASCT) in CLL. Results of a Phase III Randomized Multicenter Trial.. Blood 2009; 114 (22): 878. doi: https://doi.org/10.1182/blood.V114.22.878.878

  RESULT

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Cisplatin; Dexamethasone; Cytarabine; fludarabine; Cyclophosphamide

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Sutton Laurent, MD

  Hospital Victor Dupouy Argenteuil, France

  PRINCIPAL INVESTIGATOR

• Leporrier Michel, MD

  CaenUH, France

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2009
• First Posted: July 2, 2009
• Study Start: April 1, 2001
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2008
• Last Updated: April 2, 2026

Record last verified: 2009-07

Locations

FR (1)