Acute Myeloid LeukemiaPhase 3NCT00125606
Phase 3 Trial for AML Patients in CR2 Comparing 8Gy TBI /Fludarabine to Conditioning With TBI 12Gy/Cyclophosphamide
A Phase 3 study testing conditioning for allogeneic HSCT in people with Acute Myeloid Leukemia, run by University Hospital Muenster at 1 site in Germany.
Trial summary
For patients with acute myeloid leukemia (AML), allogeneic hematopoetic stem cell transplantation (HSCT) is one of the most potent treatment options currently available. In order to overcome the high risk of fatal treatment-related complications, reduced intensity and nonmyeloablative conditioning regimens for… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- conditioning for allogeneic HSCT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2004to Jul 2011
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with AML in second complete remission
- HLA-identical related (HLA * A, B, and DR) or HLA-compatible unrelated donor with maximum of one Ag mismatch
- Ages 18-60 years
- Written informed consent from the patient
- Written informed consent from the donor
- No major organ dysfunction
Who cannot join
- Cardiac failure (New York Heart Association [NYHA] grade II-IV)
- Renal failure (creatinine > 2.0 mg/dl)
- Hepatic failure (total bilirubin > 3 mg/dl)
- Severe neurological/psychiatric disorder
- Previous allogeneic HSCT
- Contra-indications for used drugs
- HIV infection
- Non-compliance to processing of personal data according to the protocol
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Medicine/Hematology and Oncology
Münster, North Rhine-Westphalia, 48149
About this study
Official title: Randomized Phase 3 Trial for Patients With AML in CR2 Comparing Total Body Irradiation (TBI) With 8Gy/Fludarabine to Conditioning With TBI 12Gy/Cyclophosphamide
For patients with acute myeloid leukemia (AML), allogeneic hematopoetic stem cell transplantation (HSCT) is one of the most potent treatment options currently available. In order to overcome the high risk of fatal treatment-related complications, reduced intensity and nonmyeloablative conditioning regimens for allogeneic HSCT are currently being explored in various hematological malignancies including AML. At least for allogeneic HSCT in AML, the optimal dose-intensity of preparative regimens for disease control at an acceptable rate of treatment-related lethal complications has not been determined. The investigators, therefore, evaluated reduced intensity myeloablative conditioning with 8 Gy TBI and fludarabine in AML patients considered ineligible for conventional conditioning in a phase 2 trial (data published in BLOOD by Stelljes et al., 2005). The results suggest that with 8 Gy TBI/fludarabine, conditioning related and unrelated donor transplants can be performed in AML patients in first or second complete remission (CR) with a remarkably low 2-year non relapse mortality (NRM) and satisfactory disease control. Based on these data a randomized phase 3 trial for patients with AML in CR≥2 is currently being conducted by the Cooperative German Transplant Study Group comparing TBI 8 Gy/fludarabine to conventionally dosed conditioning with TBI 12 Gy/cyclophosphamide.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- conditioning for allogeneic HSCT
- Keywords
- AML, allogeneic HSCT, reduced intensity conditioning, randomized trail
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conditioning for allogeneic HSCTProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| conditioning therapy with 12 Gy TBI / cyclophosphamide 120 | Active comparator | Not described Receives: Procedure: conditioning for allogeneic HSCT |
| conditioning therapy with 8 Gy TBI / fludarabine 120 | Experimental | Not described Receives: Procedure: conditioning for allogeneic HSCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment related mortality
Secondary outcomes (5)
event free survival
overall survival
cumulative incidence of acute and chronic graft-versus-host disease (GvHD)
activity index (ECOG)
organ function
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2005 (estimated)
- Study startOct 2004
- Primary completionJul 2011
- Study completionJul 2011
Why it stopped: insufficient patient recruitement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- Technische Universität Dresden, Philipps University Marburg, Universitätsklinikum Hamburg-Eppendorf, Hannover Medical School, Ludwig-Maximilians - University of Munich, University Hospital, Essen, Johann Wolfgang Goethe University Hospital, Deutsche Klinik fuer Diagnostik, Charite University, Berlin, Germany
- Responsible party
- Sponsor
- Investigators
- Matthias Stelljes, M.D., Principal investigator, Department of Medicine/Hematology and Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00125606
- Sponsor's protocol ID
- AML_CR2_allo_HSCT
- Status last verified
- Dec 2012
- First submitted
- 26 Jul 2005
- Last updated
- 18 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase 3 Trial for Patients With AML in CR2 Comparing Total Body Irradiation (TBI) With 8Gy/Fludarabine to Conditioning With TBI 12Gy/Cyclophosphamide
- ClinicalTrials.gov ID
- NCT00125606
- Acronym / sponsor ID
- AML_CR2_allo_HSCT
- Conditions
- Acute Myeloid Leukemia
- Keywords
- AML, allogeneic HSCT, reduced intensity conditioning, randomized trail
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient patient recruitement
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- Technische Universität Dresden, Philipps University Marburg, Universitätsklinikum Hamburg-Eppendorf, Hannover Medical School, Ludwig-Maximilians - University of Munich, University Hospital, Essen, Johann Wolfgang Goethe University Hospital, Deutsche Klinik fuer Diagnostik, Charite University, Berlin, Germany
- Study start
- Oct 2004
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 1 Aug 2005 (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.
For patients with acute myeloid leukemia (AML), allogeneic hematopoetic stem cell transplantation (HSCT) is one of the most potent treatment options currently available. In order to overcome the high risk of fatal treatment-related complications, reduced intensity and nonmyeloablative conditioning regimens for allogeneic HSCT are currently being explored in various hematological malignancies including AML. At least for allogeneic HSCT in AML, the optimal dose-intensity of preparative regimens for disease control at an acceptable rate of treatment-related lethal complications has not been determined. The investigators, therefore, evaluated reduced intensity myeloablative conditioning with 8 Gy TBI and fludarabine in AML patients considered ineligible for conventional conditioning in a phase 2 trial (data published in BLOOD by Stelljes et al., 2005). The results suggest that with 8 Gy TBI/fludarabine, conditioning related and unrelated donor transplants can be performed in AML patients in first or second complete remission (CR) with a remarkably low 2-year non relapse mortality (NRM) and satisfactory disease control. Based on these data a randomized phase 3 trial for patients with AML in CR≥2 is currently being conducted by the Cooperative German Transplant Study Group comparing TBI 8 Gy/fludarabine to conventionally dosed conditioning with TBI 12 Gy/cyclophosphamide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conditioning therapy with 12 Gy TBI / cyclophosphamide 120 | Active comparator | Procedure: conditioning for allogeneic HSCT |
| conditioning therapy with 8 Gy TBI / fludarabine 120 | Experimental | Procedure: conditioning for allogeneic HSCT |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients with AML in second complete remission
- HLA-identical related (HLA * A, B, and DR) or HLA-compatible unrelated donor with maximum of one Ag mismatch
- Ages 18-60 years
- Written informed consent from the patient
- Written informed consent from the donor
Key exclusion criteria (8 listed)
- Cardiac failure (New York Heart Association [NYHA] grade II-IV)
- Renal failure (creatinine > 2.0 mg/dl)
- Hepatic failure (total bilirubin > 3 mg/dl)
- Severe neurological/psychiatric disorder
- Previous allogeneic HSCT
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 |
|---|---|---|
| conditioning for allogeneic HSCT | Procedure or surgery | conditioning therapy with 12 Gy TBI / cyclophosphamide 120, conditioning therapy with 8 Gy TBI / fludarabine 120 |
Primary outcome
treatment related mortality
5 secondary outcomes
event free survival
overall survival
cumulative incidence of acute and chronic graft-versus-host disease (GvHD)
activity index (ECOG)
organ function
Results and safety
The study was stopped early (reason given: insufficient patient recruitement). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2012.
Related trials for Acute Myeloid Leukemia
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.
Matthias Stelljes, M.D. principal investigator
Department of Medicine/Hematology and Oncology
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 conditioning for allogeneic HSCT in people with Acute Myeloid Leukemia, run by University Hospital Muenster at 1 site in Germany.
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 6 inclusion and 8 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: stopped early, as of the sponsor's last update on 18 Dec 2012. 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 Germany. 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 was stopped early (reason given: insufficient patient recruitement). Results are not available in the source record.
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?
treatment related mortality. 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 18 Dec 2012.