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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00931645
Recruitment Status : Completed
First Posted : July 2, 2009
Last Update Posted : July 2, 2009
Direction Générale de la Santé, France
Information provided by:
University Hospital, Caen

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).

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Procedure: Autologous stem cell transplantation Procedure: DHAP rescue and Autologous stem cell transplantation Procedure: DHAP rescue and F+C Phase 3

Detailed Description:

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 241 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase III Trial Evaluating the Role of Autologous Stem Cell Transplantation in Previously Untreated Patients With Stage B and C Chronic Lymphocytic Leukemia
Study Start Date : April 2001
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
Procedure: Autologous stem cell transplantation
TBI (10 grays, d-3-1), cyclophosphamide (60 mg/sqm d-5-4)
Other Name: ABMT

Experimental: Non CR patients arm 3
Rescue chemotherapy and ABMT (see arm 2)
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

Active Comparator: Non CR patients at random : arm 4
Rescue DHAP, F+C
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

Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 3 year ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00931645

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DBIM Hopital Saint Louis
Paris, France, 75000
Sponsors and Collaborators
University Hospital, Caen
Direction Générale de la Santé, France
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Principal Investigator: Sutton Laurent, MD Hospital Victor Dupouy Argenteuil, France
Study Chair: Leporrier Michel, MD CaenUH, France
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Responsible Party: Laurent Sutton MD, SFGM-TC Identifier: NCT00931645    
Other Study ID Numbers: SFGMTC
First Posted: July 2, 2009    Key Record Dates
Last Update Posted: July 2, 2009
Last Verified: July 2009
Keywords provided by University Hospital, Caen:
Chronic lymphocytic leukemia,
autologous stem cell transplantation
Additional relevant MeSH terms:
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Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents