Hematological MalignanciesPhase 2ITT 08-01NCT00841724
Study of a Reduced-toxicity "Submyeloablative" Conditioning Regimen Prior to Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies
A Phase 2 study testing Fludarabine, Busulfan, Thymoglobuline in people with Hematological Malignancies, run by Nantes University Hospital at 3 sites in France.
Trial summary
The goal of this prospective study is to assess the overall mortality (whether related to relapse/progression or toxicity - TRM-) at one year after allogeneic stem cell transplantation prepared by a so-called reduced-toxicity "submyeloablative" conditioning regimen in patients with hematological malignancies. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hematological Malignancies
- What is being tested?
- Fludarabine, Busulfan, Thymoglobuline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 3 sitesFrance
- Study dates
- Jan 2009to Jan 2012
- Phase
- Phase 2
- 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 affiliated to a social security reimbursement system
- Adults (men or women) aged between 18 and 65 years
- Negative test for pregnancy
- ECOG 0-1 or Karnofsky Index ≥ 70%
- Availability of an HLA-identical sibling donor, or an HLA-matched unrelated donor (10/10 HLA compatibility in A, B, C, DRB1, DQB1 (a single allelic mismatch at the level of Cw can be accepted)
- Life expectancy > 6 months
- Signed informed consent
- Diagnosis of an hematological malignancy that is considered to be eligible for an allogeneic stem cell transplantation
Who cannot join
- Pregnant woman or not willing to take effective contraception
- Classical contra-indications to the allogeneic stem cell transplantation procedure
- Any contra-indication to the use of the drugs contained within the conditioning regimen according to the summary of product characteristics
- Patients aged < 50 years and deemed to be eligible for a "standard" or conventional myeloablative conditioning regimen
- An HLA-matched sibling donor who has a contra-indication for stem cell mobilization and collection
- History of uncontrolled psychiatric condition
- Patients who have participated to another trial testing an experimental drug within one month prior to inclusion in this protocol.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Institut Paoli Calmettes
Marseille, 13273
CHU de Nantes
Nantes, 44093
CHU de Bordeaux
Pessac, 33604
About this study
Official title: Phase II Study of a Reduced-toxicity " Submyeloablative " Conditioning Regimen Prior to Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies
The goal of this prospective study is to assess the overall mortality (whether related to relapse/progression or toxicity - TRM-) at one year after allogeneic stem cell transplantation prepared by a so-called reduced-toxicity "submyeloablative" conditioning regimen in patients with hematological malignancies.
- Conditions
- Hematological Malignancies
- Being tested
- Fludarabine, Busulfan, Thymoglobuline
- Keywords
- Allogeneic stem cell transplantation, Reduced-intensity conditioning, Reduced-toxicity conditioning, Hematological malignancies, IV Busulfan
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fludarabine, Busulfan, ThymoglobulineDrug
| Study group | Role | What they receive |
|---|---|---|
| Busilvex, Fludara, Thymoglobuline | Active comparator | D-6: Fludara D-5: Fludara + Busilvex D-4: Fludara + Busilvex D-3: Fludara + Busilvex D-2: Fludara + Thymoglobuline D-1: Thymoglobuline D0: graft infusion Receives: Drug: Fludarabine, Busulfan, Thymoglobuline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the overall mortality rate at 12 months after allogeneic stem cell transplantation
Measured: 12 months after transplantation
Secondary outcomes (1)
To assess the "classical" criteria (clinical and biological) associated with outcome after allogeneic stem cell transplantation. To evaluate the impact of the modified Charlson comorbidity score (Sorror Score) on TRM and 1-year overall survival
Measured: 12 months after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2012
- Study completionJan 2012
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 Hematological MalignanciesStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Mohamad Mohty, MD, PhD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00841724
- Sponsor's protocol ID
- BRD/08/09-P
- Acronym
- ITT 08-01
- Status last verified
- May 2012
- First submitted
- 10 Feb 2009
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Mohty M, Malard F, Blaise D, Milpied N, Furst S, Tabrizi R, Guillaume T, Vigouroux S, El-Cheikh J, Delaunay J, Le Gouill S, Moreau P, Labopin M, Chevallier P. Reduced-toxicity conditioning with fludarabine, once-daily intravenous busulfan, and antithymocyte globulins prior to allogeneic stem cell transplantation: results of a multicenter prospective phase 2 trial. Cancer. 2015 Feb 15;121(4):562-9. doi: 10.1002/cncr.29087. Epub 2014 Oct 3.
PubMed 25283774
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of a Reduced-toxicity " Submyeloablative " Conditioning Regimen Prior to Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies
- ClinicalTrials.gov ID
- NCT00841724
- Acronym / sponsor ID
- ITT 08-01 / BRD/08/09-P
- Conditions
- Hematological Malignancies
- Keywords
- Allogeneic stem cell transplantation, Reduced-intensity conditioning, Reduced-toxicity conditioning, Hematological malignancies, IV Busulfan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 11 Feb 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.
The goal of this prospective study is to assess the overall mortality (whether related to relapse/progression or toxicity - TRM-) at one year after allogeneic stem cell transplantation prepared by a so-called reduced-toxicity "submyeloablative" conditioning regimen in patients with hematological malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Busilvex, Fludara, Thymoglobuline | Active comparator | Drug: Fludarabine, Busulfan, ThymoglobulineD-6: Fludara D-5: Fludara + Busilvex D-4: Fludara + Busilvex D-3: Fludara + Busilvex D-2: Fludara + Thymoglobuline D-1: Thymoglobuline D0: graft infusion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients affiliated to a social security reimbursement system
- Adults (men or women) aged between 18 and 65 years
- Negative test for pregnancy
- ECOG 0-1 or Karnofsky Index ≥ 70%
- Availability of an HLA-identical sibling donor, or an HLA-matched unrelated donor (10/10 HLA compatibility in A, B, C, DRB1, DQB1 (a single allelic mismatch at the level of Cw can be accepted)
Key exclusion criteria (7 listed)
- Pregnant woman or not willing to take effective contraception
- Classical contra-indications to the allogeneic stem cell transplantation procedure
- Any contra-indication to the use of the drugs contained within the conditioning regimen according to the summary of product characteristics
- Patients aged < 50 years and deemed to be eligible for a "standard" or conventional myeloablative conditioning regimen
- An HLA-matched sibling donor who has a contra-indication for stem cell mobilization and collection
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 |
|---|---|---|
| Fludarabine, Busulfan, Thymoglobuline | Drug | Busilvex, Fludara, Thymoglobuline |
Primary outcome
Evaluation of the overall mortality rate at 12 months after allogeneic stem cell transplantation
Time frame: 12 months after transplantation
1 secondary outcome
To assess the "classical" criteria (clinical and biological) associated with outcome after allogeneic stem cell transplantation. To evaluate the impact of the modified Charlson comorbidity score (Sorror Score) on TRM and 1-year overall survival
Time frame: 12 months after transplantation
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 14 Sep 2026.
- Results publication: PubMed 25283774Mohty M, Malard F, Blaise D, Milpied N, Furst S, Tabrizi R, Guillaume T, Vigouroux S, El-Cheikh J, Delaunay J, Le Gouill S, Moreau P, Labopin M, Chevallier P. Reduced-toxicity conditioning with fludarabine, once-daily intravenous busulfan, and antithymocyte globulins prior to allogeneic stem cell transplantation: results of a multicenter prospective phase 2 trial. Cancer. 2015 Feb 15;121(4):562-9. doi: 10.1002/cncr.29087. Epub 2014 Oct 3.
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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.
Mohamad Mohty, MD, PhD principal investigator
Nantes University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fludarabine, Busulfan, Thymoglobuline in people with Hematological Malignancies, run by Nantes University Hospital at 3 sites 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 8 inclusion and 7 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 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Evaluation of the overall mortality rate at 12 months after allogeneic stem cell transplantation (time frame: 12 months after transplantation). 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 NCT00841724, 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 14 Sep 2026.