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
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Caen:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 241
Study Start Date: April 2001
Study Completion Date: December 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00931645

Locations
France
DBIM Hopital Saint Louis
Paris, France, 75000
Sponsors and Collaborators
University Hospital, Caen
Direction Générale de la Santé, France
Investigators
Principal Investigator: Sutton Laurent, MD Hospital Victor Dupouy Argenteuil, France
Study Chair: Leporrier Michel, MD CaenUH, France
  More Information

No publications provided

Responsible Party: Laurent Sutton MD, SFGM-TC
ClinicalTrials.gov Identifier: NCT00931645     History of Changes
Other Study ID Numbers: SFGMTC, PHRC
Study First Received: June 29, 2009
Last Updated: July 1, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Caen:
Chronic lymphocytic leukemia,
autologous stem cell transplantation

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Cisplatin
Cyclophosphamide
Dexamethasone
Cytarabine
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on October 19, 2014