Chronic Lymphocytic LeukemiaPhase 3Auto-LLC 2001NCT00931645
Autologous Stem Cell Transplantation in Chronic Lymphocytic Leukemia
A Phase 3 study testing Autologous stem cell transplantation, DHAP rescue and Autologous stem cell transplantation and DHAP rescue and F+C in people with Chronic Lymphocytic Leukemia, run by University Hospital, Caen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- What is being tested?
- Autologous stem cell transplantation, DHAP rescue and Autologous stem cell transplantation and DHAP rescue and F+C
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2001to Dec 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with stage B \& C CLL, 18- 65 years.
- previously untreated
- given written informed consent
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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).
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- Autologous stem cell transplantation, DHAP rescue and Autologous stem cell transplantation, DHAP rescue and F+C
- Keywords
- Chronic lymphocytic leukemia,, autologous stem cell transplantation
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous stem cell transplantationProcedure or surgery
Also called ABMT
TBI (10 grays, d-3-1), cyclophosphamide (60 mg/sqm d-5-4)
DHAP rescue and Autologous stem cell transplantationProcedure or surgery
Also called cisplatin, dexamethasone, cytarabine
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)
DHAP rescue and F+CProcedure or surgery
Also called Fludarabine, Cyclophosphamide
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Autologous stem cell transplantation |
| Non CR patients arm 3 | Experimental | Rescue chemotherapy and ABMT (see arm 2) Receives: Procedure: DHAP rescue and Autologous stem cell transplantation |
| Non CR patients at random : arm 4 | Active comparator | Rescue DHAP, F+C Receives: Procedure: DHAP rescue and F+C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: 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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2009 (estimated)
- Study startApr 2001
- Primary completionDec 2007
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sutton Laurent, MD, Principal investigator, Hospital Victor Dupouy Argenteuil, FranceLeporrier Michel, MD, Study chair, CaenUH, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00931645
- Sponsor's protocol ID
- SFGMTC
- Other IDs
- PHRC
- Acronym
- Auto-LLC 2001
- Status last verified
- Jul 2009
- First submitted
- 29 Jun 2009
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00931645
- Acronym / sponsor ID
- Auto-LLC 2001 / SFGMTC
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- Chronic lymphocytic leukemia,, autologous stem cell transplantation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Apr 2001
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 2 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Complete responders | No intervention | –watch and wait policy |
| arm 2: complete responders patients | Experimental | Procedure: Autologous stem cell transplantationABMT : TBI, 10 grays d-3-1 \& cyclophosphamide 60 mg/sqm d-5-4 |
| Non CR patients arm 3 | Experimental | Procedure: DHAP rescue and Autologous stem cell transplantationRescue chemotherapy and ABMT (see arm 2) |
| Non CR patients at random : arm 4 | Active comparator | Procedure: DHAP rescue and F+CRescue DHAP, F+C |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with stage B \& C CLL, 18- 65 years.
- previously untreated
- given written informed consent
Key exclusion criteria (10 listed)
- Childbearing women
- OMS Performance status > 2
- Binet stage A
- Autoimmune hemolytic anemia
- Active or previous (< 5 years) malignant disease, except cutaneous cell carcinoma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous stem cell transplantationAlso: ABMTTBI (10 grays, d-3-1), cyclophosphamide (60 mg/sqm d-5-4) | Procedure or surgery | arm 2: complete responders patients |
| DHAP rescue and Autologous stem cell transplantationAlso: cisplatin, dexamethasone, cytarabineDHAP :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) | Procedure or surgery | Non CR patients arm 3 |
| DHAP rescue and F+CAlso: Fludarabine, CyclophosphamideDHAP :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) | Procedure or surgery | Non CR patients at random : arm 4 |
Primary outcome
Progression free survival
Time frame: 3 year
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Results publicationLaurent 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sutton Laurent, MD principal investigator
Hospital Victor Dupouy Argenteuil, France
Leporrier Michel, MD study chair
CaenUH, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Autologous stem cell transplantation, DHAP rescue and Autologous stem cell transplantation and DHAP rescue and F+C in people with Chronic Lymphocytic Leukemia, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00931645, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.