Acute Myeloid Leukemia (AML)Phase 3NCT00606723
Allogenic Stem Cell Transplantation for Children, Adolescents and Young Adults With Relapsed or Refractory AML
A Phase 3 study testing Hematopoietic stem cells from bone marrow or peripheral blood in people with Acute Myeloid Leukemia (AML), run by Hannover Medical School at 24 sites in 3 countries.
Trial summary
1. To evaluate whether stem cell transplantation from a matched sibling donor is equivalent to a matched unrelated donor in in a second complete remission of acute myeloid leukemia (AML). 2. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Acute Myeloid Leukemia (AML)
- What is being tested?
- Hematopoietic stem cells from bone marrow or peripheral blood
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 24 sitesin 3 countries
- Study dates
- Apr 2010to 24 Feb 2021
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged between 0-21 years
- Patients suffering from either refractory de novo AML or relapsed AML or patients with very high risk AML in CR1
- In sexually active patients two reliable contraception methods are used. This includes every combination of a hormonal contraceptive (such as injection, transdermal patch, implant, cervical ring) or of an intrauterine device(IUD) with a barrier method (e.g. diaphragm, cervical cap, or condom) or with a spermicide.
- Written informed consent of patient, parents or legal guardians
Who cannot join
- Severe renal impairment (GFR < 30% predicted for age)
- Pregnant or lactating females
- Current participation in another clinical trial
- Patients ≥ 12 years old for Group 1 ("BuCyMel") (patients younger that 12 years continue to be included)
Trial locations and contacts
24 sites in 3 countries.
24 sites in 3 countries
Germany20 sites
Charité Campus Rudolf Virchow Hospital
Berlin, 13353
Carl Gustav Carus University Children's Hospital Dresden
Dresden, Saxony, 01307
Düsseldorf University Hospital
Düsseldorf, North Rhine-Westphalia, 40225
University Children's Hospital Erlangen-Nürnberg
Erlangen, Bavaria, 91054
University Hospital Essen
Essen, North Rhine-Westphalia, 45122
J.W. Goethe University Hospital and Faculty of Medicine
Frankfurt am Main, Hesse, 60590
University Hospital Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Gießen University Hospital
Giessen, Hesse, 35385
University Hospital Greifswald
Greifswald, Mecklenburg-West Pomerania, 17475
University Children's Hospital Halle
Halle, Saxony-Anhalt, 06097
Hamburg-Eppendorf University Hospital
Hamburg, 20246
Hannover Medical School, Department of Paediatrics, Paediatric Hematology and Oncology
Hanover, Lower Saxony, 30625
Heidelberg University Hospital
Heidelberg, Baden-Wurttemberg, 69120
University Children's Hospital Jena
Jena, Thuringia, 07724
University Hospital Kiel
Kiel, Schleswig-Holstein, 24105
Dr. von Haunersches Kinderspital
München, Bavaria, 80337
Münster University Hospital
Münster, North Rhine-Westphalia, 48149
University Children's Hospital Tübingen
Tübingen, Baden-Wurttemberg, 72076
University Children's Hospital Ulm
Ulm, Baden-Wurttemberg, 89075
University Hospital Würzburg
Würzburg, Bavaria, 97080
Austria3 sites
Graz University Hospital
Graz, 8036
Innsbruck University Hospital
Innsbruck, 6020
St. Anna Children Hospital
Vienna, 1090
About this study
Official title: Allogenic Stem Cell Transplantation for Children, Adolescents and Young Adults With Relapsed or Refractory AML; Multi Center Therapy Concept
- To evaluate whether stem cell transplantation from a matched sibling donor is equivalent to a matched unrelated donor in in a second complete remission of acute myeloid leukemia (AML).
- To evaluate whether stem cell transplantation (SCT) after chemotherapy (FLAMSA-schema) increases survival compared to a threshold derived from historical data
- To evaluate whether SCT from haploidentical donors for children having no matched donor will result in better survival with acceptable toxicity.
Read the detailed description
Target variables:
- Treatment response
- Event Free Survival
- Leukemia Free Survival
- Graft Versus Host Disease
- Regimen related toxicity
- Conditions
- Acute Myeloid Leukemia (AML)
- Being tested
- Hematopoietic stem cells from bone marrow or peripheral blood
- Keywords
- relapsed or refractory AML, in children, adolescents and young adults
- Medical subject headings
- Leukemia, Myeloid, Acute, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hematopoietic stem cells from bone marrow or peripheral bloodBiological
> = 2 x 10*8 nucleated cells (WBC)/kg body weight of the recipient or rather > = 4 x 10*6 nucleated CD34+ cells / kg body weight are required for engraftment. Suspension of stem cells is administered via intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Group I: Relapsed AML-patients with blast cell reduction to <20% before the second course of induction therapy. These patients will receive conventional SCT.
Group II: Patients with non response to frontline treatment of AML, patients with blast cells <20% before the second course of induction therapy who do not achieve a second remission and relapsed AML-patients with blast cells >=20% before the second course of induction therapy. If these patients have a matched donor (MSD/MD) they will receive SCT with "FLAMSA".
Group III: Patients who are eligible for Group II but have no matched donor. These patients will receive SCT from a haploidentical donor. Receives: Biological: Hematopoietic stem cells from bone marrow or peripheral blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate whether stem cell transplantation (SCT) from a matched sibling donor (MSD) is equivalent to a matched unrelated donor (MUD) in second complete remission (CR2).
Measured: day 100
To evaluate whether "FLAMSA" increases leukemia free survival (LFS) and overall survival (OS) as compared to a historic control group
Measured: day 100
To evaluate whether SCT from haploidentical donors for children having no matched donor will result in an acceptable toxicity profile and a better LFS as compared to historic controls.
Measured: day 100
Secondary outcomes (5)
Prospective evaluation of event free survival (EFS), LFS, and OS after SCT from either a MSD or a MUD
Measured: day 100
To evaluate whether it is feasible to standardize transplantation procedures in children with AML within the AML-Berlin/Frankfurt/Münster (BFM) study network
Measured: day 100
Decrease of transplantation associated mortality by standardized donor selection criteria
Measured: day 100
To further evaluate the contribution of immunomediated effects for the treatment of children suffering from very high risk AML
Measured: day 100
Prospective evaluation of late toxicities
Measured: day 100 and year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2008 (estimated)
- Study startApr 2010
- Primary completion24 Feb 2021
- Study completion24 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia (AML)Studies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Sauer, Prof. Dr., Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00606723
- Sponsor's protocol ID
- AML SCT-BFM 2007
- Other IDs
- 2007-004517-34
- Status last verified
- Mar 2021
- First submitted
- 21 Jan 2008
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogenic Stem Cell Transplantation for Children, Adolescents and Young Adults With Relapsed or Refractory AML; Multi Center Therapy Concept
- ClinicalTrials.gov ID
- NCT00606723
- Acronym / sponsor ID
- AML SCT-BFM 2007
- Conditions
- Acute Myeloid Leukemia (AML)
- Keywords
- relapsed or refractory AML, in children, adolescents and young adults
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- Apr 2010 (actual)
- Primary completion
- 24 Feb 2021 (actual)
- Study completion
- 24 Feb 2021 (actual)
- First posted
- 4 Feb 2008 (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.
- To evaluate whether stem cell transplantation from a matched sibling donor is equivalent to a matched unrelated donor in in a second complete remission of acute myeloid leukemia (AML).
- To evaluate whether stem cell transplantation (SCT) after chemotherapy (FLAMSA-schema) increases survival compared to a threshold derived from historical data
- To evaluate whether SCT from haploidentical donors for children having no matched donor will result in better survival with acceptable toxicity.
Detailed description
Target variables:
- Treatment response
- Event Free Survival
- Leukemia Free Survival
- Graft Versus Host Disease
- Regimen related toxicity
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Hematopoietic stem cells from bone marrow or peripheral bloodGroup I: Relapsed AML-patients with blast cell reduction to <20% before the second course of induction therapy. These patients will receive conventional SCT. Group II: Patients with non response to frontline treatment of AML, patients with blast cells <20% before the second course of induction therapy who do not achieve a second remission and relapsed AML-patients with blast cells >=20% before the second course of induction therapy. If these patients have a matched donor (MSD/MD) they will receive SCT with "FLAMSA". Group III: Patients who are eligible for Group II but have no matched donor. These patients will receive SCT from a haploidentical donor. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Aged between 0-21 years
- Patients suffering from either refractory de novo AML or relapsed AML or patients with very high risk AML in CR1
- In sexually active patients two reliable contraception methods are used. This includes every combination of a hormonal contraceptive (such as injection, transdermal patch, implant, cervical ring) or of an intrauterine device(IUD) with a barrier method (e.g. diaphragm, cervical cap, or condom) or with a spermicide.
- Written informed consent of patient, parents or legal guardians
Key exclusion criteria (4 listed)
- Severe renal impairment (GFR < 30% predicted for age)
- Pregnant or lactating females
- Current participation in another clinical trial
- Patients ≥ 12 years old for Group 1 ("BuCyMel") (patients younger that 12 years continue to be included)
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 |
|---|---|---|
| Hematopoietic stem cells from bone marrow or peripheral blood> = 2 x 10*8 nucleated cells (WBC)/kg body weight of the recipient or rather > = 4 x 10*6 nucleated CD34+ cells / kg body weight are required for engraftment. Suspension of stem cells is administered via intravenous infusion. | Biological | 1 |
Primary outcome
To evaluate whether stem cell transplantation (SCT) from a matched sibling donor (MSD) is equivalent to a matched unrelated donor (MUD) in second complete remission (CR2).
Time frame: day 100
To evaluate whether "FLAMSA" increases leukemia free survival (LFS) and overall survival (OS) as compared to a historic control group
Time frame: day 100
To evaluate whether SCT from haploidentical donors for children having no matched donor will result in an acceptable toxicity profile and a better LFS as compared to historic controls.
Time frame: day 100
5 secondary outcomes
Prospective evaluation of event free survival (EFS), LFS, and OS after SCT from either a MSD or a MUD
Time frame: day 100
To evaluate whether it is feasible to standardize transplantation procedures in children with AML within the AML-Berlin/Frankfurt/Münster (BFM) study network
Time frame: day 100
Decrease of transplantation associated mortality by standardized donor selection criteria
Time frame: day 100
To further evaluate the contribution of immunomediated effects for the treatment of children suffering from very high risk AML
Time frame: day 100
Prospective evaluation of late toxicities
Time frame: day 100 and year 5
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 22 Mar 2021.
Related trials for Acute Myeloid Leukemia (AML)
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
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.
Martin Sauer, Prof. Dr. principal investigator
Hannover Medical School
24 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hematopoietic stem cells from bone marrow or peripheral blood in people with Acute Myeloid Leukemia (AML), run by Hannover Medical School at 24 sites in 3 countries.
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 4 inclusion and 4 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 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Germany, Austria, Czechia. 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?
To evaluate whether stem cell transplantation (SCT) from a matched sibling donor (MSD) is equivalent to a matched unrelated donor (MUD) in second complete remission (CR2). (time frame: day 100). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2021.