Leukemia, Myeloid, AcutePhase 2AZALENANCT02472691
Azacitidine, Lenalidomide and DLI as Salvage Therapy for MDS, CMML and sAML Relapsing After Allo-HSCT
A Phase 2 study testing Lenalidomide, Azacitidine and Donor Lymphocyte Infusions in people with Leukemia, Myeloid, Acute and Myelodysplastic Syndromes, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
This is a prospective, open-label, single-arm multi-center phase II study aiming to evaluate the safety and feasibility of the addition of Lenalidomide (investigational drug) to the standard therapy of Azacitidine and DLI (standard of care) as first salvage therapy for relapse of MDS, CMML and AML with MDS-related… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
- What is being tested?
- Lenalidomide, Azacitidine and Donor Lymphocyte Infusions
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- May 2015to 23 Apr 2020
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First relapse of de novo or therapy-related MDS, CMML or AML according to WHO classification (revised version 2016) without FLT3 mutation and without known IDH mutation after first allo-SCT (related or unrelated donor with < 2 HLA mismatches)
- Possibility of DLI (no cord blood, no haploidentical donor)
- no previous therapy for relapse after allo-SCT
- ECOG performance status ≤ 2 at study entry
- no active GvHD treated with systemic immunosuppression within 4 weeks before inclusion
- no uncontrolled infection at inclusion
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- Understand and voluntarily sign an informed consent form.
- Age 18 years at the time of signing the informed consent form.
- Able to adhere to the study visit schedule and other protocol requirements.
- All females must acknowledge to have understood the hazards and necessary precautions associated with the use of lenalidomide
Who cannot join
- Relapse after second allogeneic Transplantation
- AML with FLT3 mutation (ITD or TKD)
- AML with known IDH mutation (IDH1 or IDH2)
- Any previous therapy (chemotherapy, radiation or investigational drugs) administered as therapy for relapse after allo-SCT
- previous transplantation with cord blood, an haploidentical donor or a related/unrelated donor with
- ≥2 HLA mismatches
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- Active GvHD requiring systemic immunosuppression within the last 4 weeks
- Uncontrolled infection
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant or lactating females
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
- Impaired renal function (GFR < 20 ml/min)
- Impaired hepatic function
- Known hypersensitivity to thalidomide, lenalidomide or any components of the treatment
- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
- Concurrent use of other anti-cancer agents or treatments.
- Known positive for HIV or infectious hepatitis, type A, B or C.
- Neuropathy ≥ grade 2
- Prior history of malignancy other than MDS or AML (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for ≥ 3 years
- Participation in another study with ongoing use of unlicensed investigational product from 28 days before study enrollment until the end of the study
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Duesseldorf, Dept. of Hematology, Oncology and Clinical Immunology
Düsseldorf, North Rhine-Westphalia, 40225
About this study
Official title: Phase-II Trial to Assess the Efficacy and Safety of Lenalidomide in Addition to 5-Azacitidine and Donor Lymphocyte Infusions (DLI) for the Treatment of Patients With MDS, CMML or AML Who Relapse After Allogeneic Stem Cell Transplantation
This is a prospective, open-label, single-arm multi-center phase II study aiming to evaluate the safety and feasibility of the addition of Lenalidomide (investigational drug) to the standard therapy of Azacitidine and DLI (standard of care) as first salvage therapy for relapse of MDS, CMML and AML with MDS-related changes (sAML, with 20%-30% bone marrow blasts, formerly RAEB-T) after allo-SCT. The starting dose of Lenalidomid is 2.5 mg per day for 21 days with a 7 day rest. The study incorporates 2 interim safety analyses after 10 and 20 patients in order to find the optimal and safe dose of Lenalidomide.
Read the detailed description
This is a prospective, open-label, single-arm multi-center phase II study aiming to evaluate the safety and feasibility of the addition of Lenalidomide (investigational drug) to the standard therapy of Azacitidine and DLI (standard of care) as first salvage therapy for relapse of MDS, CMML and AML with MDS-related changes (sAML, with 20%-30% bone marrow blasts, formerly RAEB-T) after allo-SCT.
Study Design:
- prospective, open-label, single arm, multicenter phase-II trial
- total patients sample size: 50 patients
- number of trial sites: 6 all located in Germany and members of the EBMT Patients will be included at the time of relapse after first allo-SCT. Starting on day 1 all patients will receive Azacitidine 75 mg/m2/d for 7 days every 28 days for up to 8 cycles. DLIs will be given after cycle 4, 6 and 8. Lenalidomide will be also started on day 1 for 21 days every 28 days for a maximum of 8 cycles. The concomitant administration of Aza and Lenalidomide will be used since safety and efficacy of this schedule has been demonstrated.
Azacitidine and DLI represent a standard of care in this setting and are therefore not considered as investigational. As 5-Azacytidine is given in-label, treatment may be continued beyond 8 cycles. Additional DLIs may be given according to the investigators choice. However, to avoid severe GvHD it is recommended to give at least one more cycle 5-Azacytidine after additional DLIs.
The study incorporates a dose escalating schedule for Lenalidomide and two safety interim analyses. A first interim analysis will be performed as soon as 10 patients have been treated with Lenalidomide at a dose of 2.5mg/day If no dose limiting toxicity is observed in this cohort the next cohort of 10 patients will be treated with 5 mg per day for 21 days starting on day 1. If dose limiting toxicity occurs the study will be closed. A second interim analysis will be performed as soon as 10 patients have been treated with Lenalidomide at a dose of 5mg/day and the 10th patient of this cohort has either completed 4 cycles or has discontinued treatment whichever occurs first. If no dose limiting toxicity is observed in this cohort, the dose of 5 mg per day for 21 days starting on day 1 will be chosen and the remaining patients will be treated with this dose of Lenalidomide. If dose limiting toxicity occurs in patients treated with 5mg per day the remaining patients will be treated with Lenalidomide at a dose of 2.5mg/day. A total number of 50 patients will be treated.
Independent of the dose level, Lenalidomide will be stopped individually in the case of GvHD ≥ grade II.
- Being tested
- Lenalidomide, Azacitidine, Donor Lymphocyte Infusions
- Keywords
- relapse after allogeneic transplantation, MDS, AML, CMML, DLI, Azacitidine, Lenalidomide, C04.557.337.539.275, C15.378.190.625, C04.557.337.539.522
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
Also called Revlimid
Lenalidomide (investigational drug) will be added to standard of care (Aza and DLI) starting from day 1 for 21 days every 28 days for a maximum of 8 cycles. Starting dose of Lenalidomide 2.5 mg per day for the first 10 patients. If no dose limiting toxicity is identified in a first interim analysis, the next 10 patients will be treated with 5 mg per day. In case of no DLT after a second interim analysis, the remaining 30 patients are envisaged to be treated with 5 mg per day.
AzacitidineDrug
Also called Vidaza
Starting on day 1 all patients will receive Azacitidine (standard of care) 75 mg/m2/d for 7 days every 28 days for up to 8 cycles.
Donor Lymphocyte InfusionsBiological
Also called DLI
DLIs will be given after cycle 4, 6 and 8 at a dose of 0.5-1x10^6 CD3/kg (1st DLI), 1-5x10^6 CD3/kg (2nd DLI) and 5-15x10^6 CD3/kg (3rd DLI).
| Study group | Role | What they receive |
|---|---|---|
| Lenalidomide + Aza + DLI | Experimental | Patients will be included at the time of relapse after first allo-SCT. As standard of care all patients will receive Azacitidine 75 mg/m2/d for 7 days every 28 days for up to 8 cycles and DLIs given after cycle 4, 6 and 8 at a dose of 0.5-1x106CD3/kg (1st DLI), 1-5x106CD3/kg (2nd DLI) and 5-15x106CD3/kg (3rd DLI). As intervention (investigational drug), Lenalidomide will be also started on day 1 for 21 days every 28 days for a maximum of 8 cycles. Starting dose of Lenalidomide 2.5 mg per day for the first 10 patients. If no dose limiting toxicity is identified in a first interim analysis, the next 10 patients will be treated with 5 mg per day. In case of no DLT after a second interim analysis, the remaining 30 patients are envisaged to be treated with 5 mg per day. Receives: Drug: Lenalidomide; Drug: Azacitidine; Biological: Donor Lymphocyte Infusions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety
incidence and severity of adverse events
Measured: 56 months (final analysis, two interim analysis after 10 and 20 patients)
Type of Adverse Events as a Measure of Safety
Type of adverse events
Measured: 56 months (final analysis, two interim analysis after 10 and 20 patients)
Severity of Adverse Events as a Measure of Safety
Severity of Adverse Events
Measured: 56 months (final analysis, two interim analysis after 10 and 20 patients)
Secondary outcomes (19)
Number of participants with responses according to International Working Group (IWG) criteria as a measure of efficacy
Best response within the first 8 months of treatment according to the International Working Group (IWG) criteria
Measured: 8 months
Days from the beginning of treatment to best response in individual patients as a measure of efficacy
Time to response
Measured: 56 months
Number of participants achieving complete donor chimerism as a measure of efficacy
Rate of complete donor chimerism
Measured: 56 months
Number of participants with molecular response determined by disease-specific marker (e.g. FISH, mutations like TET2, ASXL1 etc.) or WT1 mRNA expression as a measure of efficacy
Molecular response measured by disease-specific marker (e.g. FISH, mutations like TET2, ASXL1 etc.) or WT1 mRNA expression
Measured: 56 months
Days from beginning of remission to relapse as a measure of efficacy
Duration of remission
Measured: 56 months
Days from start of treatment until death or last follow up as a measure of efficacy
Overall survival
Measured: 56 months
Number of participants with a positive correlation between response and cytogenetics as a measure of efficacy
Correlation of response and cytogenetics/molecular alterations
Measured: 56 months
Number of participants with acute GvHD according to Glucksberg Criteria as a measure of safety.
Incidence of aGvHD
Measured: 56 months
Type of manifestations of acute GvHD according to Glucksberg Criteria as a measure of safety.
Type of aGvHD
Measured: 56 months
Severity of acute GvHD manifestations according to Glucksberg Criteria as a measure of safety.
Severity of aGvHD
Measured: 56 months
Number of hospitalizations per patients as a measure of safety
Number of hospitalizations
Measured: 56 months
Number of participants with Adverse events specifying seriousness and expectedness (AE, SAE, SUSAR) according to ICH-GCP as a measure of safety.
Number of Adverse Events specifying seriousness and expectedness (AE, SAE, SUSAR)
Measured: 56 months
Type of Adverse events specifying seriousness and expectedness (AE, SAE, SUSAR) according to ICH-GCP as a measure of safety.
Type of Adverse Events specifying seriousness and expectedness (AE, SAE, SUSAR)
Measured: 56 months
Severity of Adverse events specifying seriousness and expectedness (AE, SAE, SUSAR) according to ICH-GCP as a measure of safety.
Severity of Adverse Events specifying seriousness and expectedness (AE, SAE, SUSAR)
Measured: 56 months
Days from the beginning of treatment to complete donor chimerism as a measure of efficacy
Time to complete donor chimerisms
Measured: 56 months
Number of participants with relapse as a measure of efficacy
Incidence of relapse
Measured: 56 months
Number of participants with chronic GvHD according to NIH Consensus Criteria as a measure of safety.
Incidence of cGvHD
Measured: 56 months
Type of manifestations of chronic GvHD according to NIH Consensus Criteria as a measure of safety.
Type of cGvHD
Measured: 56 months
Severity of manifestations of chronic GvHD according to NIH Consensus Criteria as a measure of safety.
Severity of cGvHD
Measured: 56 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2015 (estimated)
- Study startMay 2015
- Primary completion23 Apr 2020
- Study completion23 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Leukemia, Myeloid, AcuteStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Guido Kobbe, Prof. Dr., Principal investigator, University Hospital Duesseldorf, Dept. for Hematology, Oncology and Clinical Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02472691
- Sponsor's protocol ID
- AZALENA-2013/RV-MDS-PI-0777
- Acronym
- AZALENA
- Status last verified
- May 2020
- First submitted
- 20 May 2015
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schroeder T, Czibere A, Platzbecker U, Bug G, Uharek L, Luft T, Giagounidis A, Zohren F, Bruns I, Wolschke C, Rieger K, Fenk R, Germing U, Haas R, Kroger N, Kobbe G. Azacitidine and donor lymphocyte infusions as first salvage therapy for relapse of AML or MDS after allogeneic stem cell transplantation. Leukemia. 2013 Jun;27(6):1229-35. doi: 10.1038/leu.2013.7. Epub 2013 Jan 14.
PubMed 23314834Schroeder T, Rachlis E, Bug G, Stelljes M, Klein S, Steckel NK, Wolf D, Ringhoffer M, Czibere A, Nachtkamp K, Dienst A, Kondakci M, Stadler M, Platzbecker U, Uharek L, Luft T, Fenk R, Germing U, Bornhauser M, Kroger N, Beelen DW, Haas R, Kobbe G. Treatment of acute myeloid leukemia or myelodysplastic syndrome relapse after allogeneic stem cell transplantation with azacitidine and donor lymphocyte infusions--a retrospective multicenter analysis from the German Cooperative Transplant Study Group. Biol Blood Marrow Transplant. 2015 Apr;21(4):653-60. doi: 10.1016/j.bbmt.2014.12.016. Epub 2014 Dec 23.
PubMed 25540937Schroeder T, Stelljes M, Christopeit M, Esseling E, Scheid C, Mikesch JH, Rautenberg C, Jager P, Cadeddu RP, Drusenheimer N, Holtick U, Klein S, Trenschel R, Haas R, Germing U, Kroger N, Kobbe G. Azacitidine, lenalidomide and donor lymphocyte infusions for relapse of myelodysplastic syndrome, acute myeloid leukemia and chronic myelomonocytic leukemia after allogeneic transplant: the Azalena-Trial. Haematologica. 2023 Nov 1;108(11):3001-3010. doi: 10.3324/haematol.2022.282570.
PubMed 37259567
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase-II Trial to Assess the Efficacy and Safety of Lenalidomide in Addition to 5-Azacitidine and Donor Lymphocyte Infusions (DLI) for the Treatment of Patients With MDS, CMML or AML Who Relapse After Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT02472691
- Acronym / sponsor ID
- AZALENA / AZALENA-2013/RV-MDS-PI-0777
- Keywords
- relapse after allogeneic transplantation, MDS, AML, CMML, DLI, Azacitidine, Lenalidomide, C04.557.337.539.275
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- May 2015 (actual)
- Primary completion
- 23 Apr 2020 (actual)
- Study completion
- 23 Apr 2020 (actual)
- First posted
- 16 Jun 2015 (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.
This is a prospective, open-label, single-arm multi-center phase II study aiming to evaluate the safety and feasibility of the addition of Lenalidomide (investigational drug) to the standard therapy of Azacitidine and DLI (standard of care) as first salvage therapy for relapse of MDS, CMML and AML with MDS-related changes (sAML, with 20%-30% bone marrow blasts, formerly RAEB-T) after allo-SCT. The starting dose of Lenalidomid is 2.5 mg per day for 21 days with a 7 day rest. The study incorporates 2 interim safety analyses after 10 and 20 patients in order to find the optimal and safe dose of Lenalidomide.
Detailed description
This is a prospective, open-label, single-arm multi-center phase II study aiming to evaluate the safety and feasibility of the addition of Lenalidomide (investigational drug) to the standard therapy of Azacitidine and DLI (standard of care) as first salvage therapy for relapse of MDS, CMML and AML with MDS-related changes (sAML, with 20%-30% bone marrow blasts, formerly RAEB-T) after allo-SCT.
Study Design:
- prospective, open-label, single arm, multicenter phase-II trial
- total patients sample size: 50 patients
- number of trial sites: 6 all located in Germany and members of the EBMT Patients will be included at the time of relapse after first allo-SCT. Starting on day 1 all patients will receive Azacitidine 75 mg/m2/d for 7 days every 28 days for up to 8 cycles. DLIs will be given after cycle 4, 6 and 8. Lenalidomide will be also started on day 1 for 21 days every 28 days for a maximum of 8 cycles. The concomitant administration of Aza and Lenalidomide will be used since safety and efficacy of this schedule has been demonstrated.
Azacitidine and DLI represent a standard of care in this setting and are therefore not considered as investigational. As 5-Azacytidine is given in-label, treatment may be continued beyond 8 cycles. Additional DLIs may be given according to the investigators choice. However, to avoid severe GvHD it is recommended to give at least one more cycle 5-Azacytidine after additional DLIs.
The study incorporates a dose escalating schedule for Lenalidomide and two safety interim analyses. A first interim analysis will be performed as soon as 10 patients have been treated with Lenalidomide at a dose of 2.5mg/day If no dose limiting toxicity is observed in this cohort the next cohort of 10 patients will be treated with 5 mg per day for 21 days starting on day 1. If dose limiting toxicity occurs the study will be closed. A second interim analysis will be performed as soon as 10 patients have been treated with Lenalidomide at a dose of 5mg/day and the 10th patient of this cohort has either completed 4 cycles or has discontinued treatment whichever occurs first. If no dose limiting toxicity is observed in this cohort, the dose of 5 mg per day for 21 days starting on day 1 will be chosen and the remaining patients will be treated with this dose of Lenalidomide. If dose limiting toxicity occurs in patients treated with 5mg per day the remaining patients will be treated with Lenalidomide at a dose of 2.5mg/day. A total number of 50 patients will be treated.
Independent of the dose level, Lenalidomide will be stopped individually in the case of GvHD ≥ grade II.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenalidomide + Aza + DLI | Experimental | Drug: Lenalidomide, Drug: Azacitidine, Biological: Donor Lymphocyte InfusionsPatients will be included at the time of relapse after first allo-SCT. As standard of care all patients will receive Azacitidine 75 mg/m2/d for 7 days every 28 days for up to 8 cycles and DLIs given after cycle 4, 6 and 8 at a dose of 0.5-1x106CD3/kg (1st DLI), 1-5x106CD3/kg (2nd DLI) and 5-15x106CD3/kg (3rd DLI). As intervention (investigational drug), Lenalidomide will be also started on day 1 for 21 days every 28 days for a maximum of 8 cycles. Starting dose of Lenalidomide 2.5 mg per day for the first 10 patients. If no dose limiting toxicity is identified in a first interim analysis, the next 10 patients will be treated with 5 mg per day. In case of no DLT after a second interim analysis, the remaining 30 patients are envisaged to be treated with 5 mg per day. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- First relapse of de novo or therapy-related MDS, CMML or AML according to WHO classification (revised version 2016) without FLT3 mutation and without known IDH mutation after first allo-SCT (related or unrelated donor with < 2 HLA mismatches)
- Possibility of DLI (no cord blood, no haploidentical donor)
- no previous therapy for relapse after allo-SCT
- ECOG performance status ≤ 2 at study entry
- no active GvHD treated with systemic immunosuppression within 4 weeks before inclusion
Key exclusion criteria (20 listed)
- Relapse after second allogeneic Transplantation
- AML with FLT3 mutation (ITD or TKD)
- AML with known IDH mutation (IDH1 or IDH2)
- Any previous therapy (chemotherapy, radiation or investigational drugs) administered as therapy for relapse after allo-SCT
- previous transplantation with cord blood, an haploidentical donor or a related/unrelated donor with
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 |
|---|---|---|
| LenalidomideAlso: RevlimidLenalidomide (investigational drug) will be added to standard of care (Aza and DLI) starting from day 1 for 21 days every 28 days for a maximum of 8 cycles. Starting dose of Lenalidomide 2.5 mg per day for the first 10 patients. If no dose limiting toxicity is identified in a first interim analysis, the next 10 patients will be treated with 5 mg per day. In case of no DLT after a second interim analysis, the remaining 30 patients are envisaged to be treated with 5 mg per day. | Drug | Lenalidomide + Aza + DLI |
| AzacitidineAlso: VidazaStarting on day 1 all patients will receive Azacitidine (standard of care) 75 mg/m2/d for 7 days every 28 days for up to 8 cycles. | Drug | Lenalidomide + Aza + DLI |
| Donor Lymphocyte InfusionsAlso: DLIDLIs will be given after cycle 4, 6 and 8 at a dose of 0.5-1x10^6 CD3/kg (1st DLI), 1-5x10^6 CD3/kg (2nd DLI) and 5-15x10^6 CD3/kg (3rd DLI). | Biological | Lenalidomide + Aza + DLI |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety
Time frame: 56 months (final analysis, two interim analysis after 10 and 20 patients)
incidence and severity of adverse events
Type of Adverse Events as a Measure of Safety
Time frame: 56 months (final analysis, two interim analysis after 10 and 20 patients)
Type of adverse events
Severity of Adverse Events as a Measure of Safety
Time frame: 56 months (final analysis, two interim analysis after 10 and 20 patients)
Severity of Adverse Events
19 secondary outcomes
Number of participants with responses according to International Working Group (IWG) criteria as a measure of efficacy
Time frame: 8 months
Days from the beginning of treatment to best response in individual patients as a measure of efficacy
Time frame: 56 months
Number of participants achieving complete donor chimerism as a measure of efficacy
Time frame: 56 months
Number of participants with molecular response determined by disease-specific marker (e.g. FISH, mutations like TET2, ASXL1 etc.) or WT1 mRNA expression as a measure of efficacy
Time frame: 56 months
Days from beginning of remission to relapse as a measure of efficacy
Time frame: 56 months
Days from start of treatment until death or last follow up as a measure of efficacy
Time frame: 56 months
Number of participants with a positive correlation between response and cytogenetics as a measure of efficacy
Time frame: 56 months
Number of participants with acute GvHD according to Glucksberg Criteria as a measure of safety.
Time frame: 56 months
Type of manifestations of acute GvHD according to Glucksberg Criteria as a measure of safety.
Time frame: 56 months
Severity of acute GvHD manifestations according to Glucksberg Criteria as a measure of safety.
Time frame: 56 months
Number of hospitalizations per patients as a measure of safety
Time frame: 56 months
Number of participants with Adverse events specifying seriousness and expectedness (AE, SAE, SUSAR) according to ICH-GCP as a measure of safety.
Time frame: 56 months
Type of Adverse events specifying seriousness and expectedness (AE, SAE, SUSAR) according to ICH-GCP as a measure of safety.
Time frame: 56 months
Severity of Adverse events specifying seriousness and expectedness (AE, SAE, SUSAR) according to ICH-GCP as a measure of safety.
Time frame: 56 months
Days from the beginning of treatment to complete donor chimerism as a measure of efficacy
Time frame: 56 months
Number of participants with relapse as a measure of efficacy
Time frame: 56 months
Number of participants with chronic GvHD according to NIH Consensus Criteria as a measure of safety.
Time frame: 56 months
Type of manifestations of chronic GvHD according to NIH Consensus Criteria as a measure of safety.
Time frame: 56 months
Severity of manifestations of chronic GvHD according to NIH Consensus Criteria as a measure of safety.
Time frame: 56 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 28 May 2020.
- Background: PubMed 23314834Schroeder T, Czibere A, Platzbecker U, Bug G, Uharek L, Luft T, Giagounidis A, Zohren F, Bruns I, Wolschke C, Rieger K, Fenk R, Germing U, Haas R, Kroger N, Kobbe G. Azacitidine and donor lymphocyte infusions as first salvage therapy for relapse of AML or MDS after allogeneic stem cell transplantation. Leukemia. 2013 Jun;27(6):1229-35. doi: 10.1038/leu.2013.7. Epub 2013 Jan 14.
- Results publication: PubMed 25540937Schroeder T, Rachlis E, Bug G, Stelljes M, Klein S, Steckel NK, Wolf D, Ringhoffer M, Czibere A, Nachtkamp K, Dienst A, Kondakci M, Stadler M, Platzbecker U, Uharek L, Luft T, Fenk R, Germing U, Bornhauser M, Kroger N, Beelen DW, Haas R, Kobbe G. Treatment of acute myeloid leukemia or myelodysplastic syndrome relapse after allogeneic stem cell transplantation with azacitidine and donor lymphocyte infusions--a retrospective multicenter analysis from the German Cooperative Transplant Study Group. Biol Blood Marrow Transplant. 2015 Apr;21(4):653-60. doi: 10.1016/j.bbmt.2014.12.016. Epub 2014 Dec 23.
- Derived from this study: PubMed 37259567Schroeder T, Stelljes M, Christopeit M, Esseling E, Scheid C, Mikesch JH, Rautenberg C, Jager P, Cadeddu RP, Drusenheimer N, Holtick U, Klein S, Trenschel R, Haas R, Germing U, Kroger N, Kobbe G. Azacitidine, lenalidomide and donor lymphocyte infusions for relapse of myelodysplastic syndrome, acute myeloid leukemia and chronic myelomonocytic leukemia after allogeneic transplant: the Azalena-Trial. Haematologica. 2023 Nov 1;108(11):3001-3010. doi: 10.3324/haematol.2022.282570.
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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.
Guido Kobbe, Prof. Dr. principal investigator
University Hospital Duesseldorf, Dept. for Hematology, Oncology and Clinical Immunology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lenalidomide, Azacitidine and Donor Lymphocyte Infusions in people with Leukemia, Myeloid, Acute and Myelodysplastic Syndromes, run by Heinrich-Heine University, Duesseldorf 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 10 inclusion and 20 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 28 May 2020. 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 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?
Number of Participants with Adverse Events as a Measure of Safety (time frame: 56 months (final analysis, two interim analysis after 10 and 20 patients)). 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?
On the ClinicalTrials.gov record for NCT02472691, which also lists 3 linked publications.
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 28 May 2020.