Autologous Stem Cell Transplantation in Chronic Lymphocytic Leukemia (Auto-LLC 2001)

This study has been completed.
Sponsor:
Collaborator:
Direction Générale de la Santé, France
Information provided by:
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT00931645
First received: June 29, 2009
Last updated: July 1, 2009
Last verified: July 2009

June 29, 2009
July 1, 2009
April 2001
December 2007   (final data collection date for primary outcome measure)
Progression free survival [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00931645 on ClinicalTrials.gov Archive Site
Overall survival, response after completion of scheduled treatment, tolerance and adverse events, quality of life, prognostic factors for response and survival. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Autologous Stem Cell Transplantation in Chronic Lymphocytic Leukemia
Randomized Phase III Trial Evaluating the Role of Autologous Stem Cell Transplantation in Previously Untreated Patients With Stage B and C Chronic Lymphocytic Leukemia

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).

All registered patients will be treated with 6 monthly courses of chemotherapy. First three ones will be a CHOP regimen with half dosage of adriamycin, as previously published (Effectiveness of "CHOP" regimen in advanced untreated chronic lymphocytic leukemia. French Cooperative Group on Chronic Lymphocytic Leukemia. Lancet ; 1986, i : 1346-1349), followed by three subsequent courses with IV fludarabine (25 mg/sqm d1-5). Patients in CR (NCI, 1996, including CAT scan evaluation) will be then randomized to surveillance without additional treatment or autologous stem cell transplantation using peripheral stem cells collected after the three first courses of chemotherapy, and/or after the completion of the six courses when necessary. For patients not in CR after the six courses, a rescue regimen with the DHAP association ( cisplatin, 100 mg/sqm d1, cytarabine 2 g/sqm d2, dexamethasone 40 mg/sqm d1-4) will precede an additional stem cell collection if necessary, and patient will be randomized between autologous stem cell transplantation and three additional courses of an association of fludarabine (25 mg/sqm d1-3) and cyclophosphamide (300 mg/sqm d1-3). Conditioning regimen will associate TBI (10 grays, d -3-1) and cyclophosphamide (60 mg/sqm d-5-4).

Evaluation for response wil be performed before randomisation and two months after completion of therapy in each arm.

Follow-up data will be registered and monitored every three month during the first year, and then every six month. Criteria for evaluation of response will use the NCI system (1996).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Lymphocytic Leukemia
  • Procedure: Autologous stem cell transplantation
    TBI (10 grays, d-3-1), cyclophosphamide (60 mg/sqm d-5-4)
    Other Name: ABMT
  • Procedure: DHAP rescue and Autologous stem cell transplantation
    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)
    Other Names:
    • cisplatin
    • dexamethasone
    • cytarabine
  • Procedure: DHAP rescue and F+C
    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)
    Other Names:
    • Fludarabine
    • Cyclophosphamide
  • No Intervention: Complete responders
    watch and wait policy
  • Experimental: arm 2: complete responders patients
    ABMT : TBI, 10 grays d-3-1 & cyclophosphamide 60 mg/sqm d-5-4
    Intervention: Procedure: Autologous stem cell transplantation
  • Experimental: Non CR patients arm 3
    Rescue chemotherapy and ABMT (see arm 2)
    Intervention: Procedure: DHAP rescue and Autologous stem cell transplantation
  • Active Comparator: Non CR patients at random : arm 4
    Rescue DHAP, F+C
    Intervention: Procedure: DHAP rescue and F+C
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
241
December 2008
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00931645
SFGMTC, PHRC
Yes
Laurent Sutton MD, SFGM-TC
University Hospital, Caen
Direction Générale de la Santé, France
Principal Investigator: Sutton Laurent, MD Hospital Victor Dupouy Argenteuil, France
Study Chair: Leporrier Michel, MD CaenUH, France
University Hospital, Caen
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP