Acute Myeloid LeukemiaPhase 3NCT02298166
Study of Crenolanib in Combination With Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia and Activating FLT3 Mutations
A Phase 3 study testing chemotherapy (Mitoxantrone, Cytarabine), Crenolanib and Allogeneic stem cell transplantation in people with Acute Myeloid Leukemia, run by University of Ulm at 1 site in Germany.
Trial summary
The main trial is a double-blinded, placebo-controlled, randomized, phase III, multi-center trial in adult patients with relapsed or refractory AML harboring an activating FLT3 mutation as defined in the inclusion /exclusion criteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- chemotherapy (Mitoxantrone, Cytarabine), Crenolanib and Allogeneic stem cell transplantation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteGermany
- Study dates
- 17 Nov 2016to 9 Mar 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with confirmed diagnosis of AML either refractory to induction therapy or relapsed after first line treatment including chemotherapy, autologous and allogeneic HCT
- refractory to induction therapy is defined as no CR, CRi, PR (according to standard criteria, 28) after one intensive induction therapy including at least 7 days of cytarabine 100-200mg/m² continuously or an equivalent regimen with cytarabine with total dose not less than 700mg/m² per cycle and 3 days of an anthracycline (e.g. daunorubicin, idarubicin)
- relapsed after first line therapy is defined as relapsed AML (according to standard criteria, 28) after a first line therapy including at least one intensive induction and consolidation therapy
- Presence of FLT3-activating mutation at the time of refractory disease or relapse assessed in the central AMLSG reference laboratory within AMLSG BiO study (ClinicalTrials.gov Identifier: NCT01252485); positivity of FLT3-ITD and FLT3-TKD is defined based on genescan analysis with a mutant to wild-type ratio equal or above 5%
- Patients considered eligible for intensive chemotherapy
- ECOG performance status of ≤ 2
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- Age ≥ 18 years with the capacity to give written informed consent
- Non-pregnant and non-nursing women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within a sensitivity of at least 25 mIU/mL within 72 hours prior to registration ("Women of childbearing potential" is defined as a sexually active mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 consecutive months).
- Female patients of reproductive age must agree to avoid getting pregnant while on therapy and for 3 months after the last dose of crenolanib.
- Women of child-bearing potential must either commit to continued abstinence from heterosexual intercourse or begin one acceptable method of birth control (IUD, tubal ligation, or partner's vasectomy). Hormonal contraception is an inadequate method of birth control.
- Men must use a latex condom during any sexual contact with women of childbearing potential, even if they have undergone a successful vasectomy and must agree to avoid to father a child (while on therapy and for 3 month after the last dose of crenolanib).
- Willing to adhere to protocol specific requirements
- Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study related activity is carried out.
Who cannot join
- The presence of any of the following will exclude a patient from study enrollment:
- Known or suspected hypersensitivity to the study drugs and/or any excipients
- ECOG performance status >2
- Inadequate cardiac, hepatic and/or renal function at the Screening Visit defined as:
- ejection fraction < 45% confirmed by echocardiography
- creatinine >1.5x upper normal serum level
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- total bilirubin > upper normal serum level
- AST or ALT >2x upper normal serum level
- Active central nervous system involvement
- Any clinically significant, advanced or unstable disease or history of that may interfere with primary or secondary variable evaluations or put the patient at special risk, such as:
- Myocardial infarction, unstable angina within 3 months before screening
- Heart failure NYHA III/IV
- Severe obstructive or restrictive ventilation disorder
- Uncontrolled infection
- Severe neurological or psychiatric disorder interfering with ability of giving an informed consent
- Currently receiving a therapy not permitted during the study, as defined in Section 10.6.5
- Active Graft-versus-Host Disease (GvHD) under immunosuppressive therapy different from steroids
- Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse within one year.
- Pre-existing liver disease (e.g.,. cirrhosis, chronic hepatitis B or C, nonalcoholic steatohepatitis, sclerosing cholangitis)
- Known history of positive test for hepatitis B surface antigen (HsbAg) or hepatitis C antibody or history of positive test for Human Immunodeficiency Virus (HIV)
- Hematologic disorder independent of leukemia
- No consent for registration, storage and processing of the individual disease characteristics and course as well as information of the family physician and/or other physicians involved in the treatment of the patient about study participation
- No consent for biobanking
- Current participation in any other interventional clinical study within 30 days before the first administration of the investigational product or at any time during the study
- Patients known or suspected of not being able to comply with this trial protocol
- Breast feeding women or women with a positive pregnancy test at Screening visit
- Patients of childbearing potential not willing to use adequate contraception during study and 3 months after last dose of crenolanib.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dose-Finding Run-in Phase I Followed by a Phase III, Multicenter, Randomized, Double-Blind, Placebo-controlled Study of Crenolanib in Combination With Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia and Activating FLT3 Mutations
The main trial is a double-blinded, placebo-controlled, randomized, phase III, multi-center trial in adult patients with relapsed or refractory AML harboring an activating FLT3 mutation as defined in the inclusion /exclusion criteria.
An initial open label dose-finding run-in phase I of the study will be performed administering the study drug crenolanib with salvage chemotherapy consisting of mitoxantrone and cytarabine (MC) in 18 patients according to the experimental arm of the study. After completion of this dose-finding run-in phase I, toxicity and response data will be provided to the external Data and Safety Monitoring Board (DSMB) and the Trial Committee by the Coordinating Investigator. The Trial Committee will decide on the basis of these data and the recommendation of the DSMB on dose modification and the further conduct of the study with regard to the double-blinded, placebo-controlled, randomized phase of the study.
Read more
The double-blinded, placebo-controlled randomized portion will start after the completion of the dose-finding run-in phase I and positive opinion of the Trial Committee.
Crenolanib starts on day 7 of MC and is given continuously until 48 hours prior to the next chemotherapy; if receiving allogeneic HCT, crenolanib is held 48 hours prior to conditioning and restarts no sooner than 30 days and not later than day 100 after transplant.
Sample size randomized phase: 276 patients
Primary objective: To evaluate the impact of crenolanib given in combination with salvage chemotherapy and consolidation including allogeneic hematopoietic cell transplantation and ongoing single agent maintenance therapy with crenolanib on event-free (EFS) and overall survival (OS) in adult patients with relapsed or refractory AML harboring FLT3 activating mutations.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- chemotherapy (Mitoxantrone, Cytarabine), Placebo, Crenolanib, Allogeneic stem cell transplantation
- Keywords
- Acute myeloid leukemia, FLT3 mutations, Crenolanib, Relapsed, Refractory
- 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.
chemotherapy (Mitoxantrone, Cytarabine)Drug
Induction therapy:
- Mitoxantrone 10 mg/m² IV, push (8 mg/m² for patients > 60 years of age and/or previous allogeneic HCT) d 1-3
- Cytarabine 1000 mg/m² IV (500 mg/m² for patients > 60 years of age and/or previous allogeneic HCT), over 3 hours, d 1-6
Consolidation therapy:
Younger adult patients (18 to 60 yrs):
Cytarabine 1500 mg/m² by i.v infusion over 3 hours BID on days 1-3 (total dose 9000 mg/m²).
Older patients (> 60 yrs) and or previous allogeneic HCT:
Cytarabine 1000 mg/m² by i.v. infusion over 3 hours BID on days 1-3 (total dose 6000 mg/m²).
PlaceboDrug
Induction therapy:
Placebo to be given as p.o. TID starting d 7+, given continuously thereafter until 48 hours prior to the next chemotherapy.
Consolidation therapy:
Placebo will start on day 4, thereafter with continuous dosing until 48h before start of subsequent consolidation chemotherapy.
Maintenance therapy with placebo is intended in all patients after allogeneic HCT or intermediate-dose cytarabine consolidation therapy. Maintenance therapy will be given for 364 days (equivalent to 13 cycles à 28 days) after recovery from allogeneic HCT or IDAC.
Maintenance with placebo will be given at the same dose tolerated during induction therapy.
CrenolanibDrug
Induction therapy:
Crenolanib to be given as p.o. TID starting d 7+, given continuously until 48 hours prior to the next chemotherapy.
Consolidation therapy:
Crenolanib will start on day 4, thereafter with continuous dosing until 48h before start of subsequent consolidation chemotherapy.
Maintenance therapy with Crenolanib is intended in all patients after allogeneic HCT or intermediate-dose cytarabine consolidation therapy. Maintenance therapy will be given for 364 days (equivalent to 13 cycles à 28 days) after recovery from allogeneic HCT or IDAC.
Maintenance with Crenolanib will be given at the same dose tolerated during induction therapy.
Allogeneic stem cell transplantationOther
In patients achieving a CR or CRi after salvage-reinduction chemotherapy allogeneic HCT from a matched related or unrelated donor is the preferred form of consolidation. Preferred source of allogeneic HSC are mobilized peripheral blood stem cells. Other forms of allogeneic transplantation (haploidentical donor; cord blood) are allowed.
Allogeneic HCT should be conducted at the earliest time point after the start of the last chemotherapy but no later than after 56 days. A delay of transplant beyond this time window need to be discussed with the Coordinating Investigator. Patients can receive allogeneic HCT directly after salvage re-induction chemotherapy with MC, but also later on following consolidation with IDAC.
| Study group | Role | What they receive |
|---|---|---|
| Standard arm | Placebo comparator | chemotherapy (MC) in combination with placebo Receives: Drug: chemotherapy (Mitoxantrone, Cytarabine); Drug: Placebo; Other: Allogeneic stem cell transplantation |
| Experimental arm | Experimental | chemotherapy (MC) in combination with crenolanib Receives: Drug: chemotherapy (Mitoxantrone, Cytarabine); Drug: Crenolanib; Other: Allogeneic stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free Survival (EFS)
Measured: 4 years
Overall Survival (OS)
Measured: 4 years
Secondary outcomes (6)
Rates of complete remission (CR) and complete remission with incomplete blood count recovery (CRi) after induction therapy
Measured: 2 months
Cumulative incidence of relapse (CIR)
Measured: 4 years
Cumulative incidence of death (CID)
Measured: 4 years
Quality of life (QoL)
Quality of life assessed by the EORTC Quality of Life Core Questionnaire (QLQ-C30), supplemented by information on self-assessed concomitant diseases, late treatment effects, and demographics (24) at the Screening visit, after last induction cycle, after last consolidation cycle, at end of treatment visit and every year thereafter.
Measured: 5.5 years
Rate of early deaths or hypoplastic deaths (ED or HD)
Measured: 2 months
Toxicity: Type, frequency, severity, timing and relatedness of hematologic and non-hematologic toxicities
Type, frequency, severity, timing and relatedness of hematologic and non-hematologic toxicities
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study start17 Nov 2016
- Primary completion9 Mar 2020
- Study completion9 Mar 2020
Why it stopped: The manufacturer Arog Pharmaceuticals Inc has terminated the Agreement Concerning the Support of an Investigator Initiated Trial this became valid on 2020/03/09
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Hartmut Doehner, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02298166
- Sponsor's protocol ID
- AMLSG 19-13 / ARO-007
- Status last verified
- Sep 2021
- First submitted
- 19 Nov 2014
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Finding Run-in Phase I Followed by a Phase III, Multicenter, Randomized, Double-Blind, Placebo-controlled Study of Crenolanib in Combination With Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia and Activating FLT3 Mutations
- ClinicalTrials.gov ID
- NCT02298166
- Acronym / sponsor ID
- AMLSG 19-13 / ARO-007
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute myeloid leukemia, FLT3 mutations, Crenolanib, Relapsed, Refractory
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The manufacturer Arog Pharmaceuticals Inc has terminated the Agreement Concerning the Support of an Investigator Initiated Trial this became valid on 2020/03/09
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- 17 Nov 2016 (actual)
- Primary completion
- 9 Mar 2020 (actual)
- Study completion
- 9 Mar 2020 (actual)
- First posted
- 21 Nov 2014 (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 main trial is a double-blinded, placebo-controlled, randomized, phase III, multi-center trial in adult patients with relapsed or refractory AML harboring an activating FLT3 mutation as defined in the inclusion /exclusion criteria.
An initial open label dose-finding run-in phase I of the study will be performed administering the study drug crenolanib with salvage chemotherapy consisting of mitoxantrone and cytarabine (MC) in 18 patients according to the experimental arm of the study. After completion of this dose-finding run-in phase I, toxicity and response data will be provided to the external Data and Safety Monitoring Board (DSMB) and the Trial Committee by the Coordinating Investigator. The Trial Committee will decide on the basis of these data and the recommendation of the DSMB on dose modification and the further conduct of the study with regard to the double-blinded, placebo-controlled, randomized phase of the study.
The double-blinded, placebo-controlled randomized portion will start after the completion of the dose-finding run-in phase I and positive opinion of the Trial Committee.
Crenolanib starts on day 7 of MC and is given continuously until 48 hours prior to the next chemotherapy; if receiving allogeneic HCT, crenolanib is held 48 hours prior to conditioning and restarts no sooner than 30 days and not later than day 100 after transplant.
Sample size randomized phase: 276 patients
Primary objective: To evaluate the impact of crenolanib given in combination with salvage chemotherapy and consolidation including allogeneic hematopoietic cell transplantation and ongoing single agent maintenance therapy with crenolanib on event-free (EFS) and overall survival (OS) in adult patients with relapsed or refractory AML harboring FLT3 activating mutations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard arm | Placebo comparator | Drug: chemotherapy (Mitoxantrone, Cytarabine), Drug: Placebo, Other: Allogeneic stem cell transplantationchemotherapy (MC) in combination with placebo |
| Experimental arm | Experimental | Drug: chemotherapy (Mitoxantrone, Cytarabine), Drug: Crenolanib, Other: Allogeneic stem cell transplantationchemotherapy (MC) in combination with crenolanib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients with confirmed diagnosis of AML either refractory to induction therapy or relapsed after first line treatment including chemotherapy, autologous and allogeneic HCT
- Presence of FLT3-activating mutation at the time of refractory disease or relapse assessed in the central AMLSG reference laboratory within AMLSG BiO study (ClinicalTrials.gov Identifier: NCT01252485); positivity of FLT3-ITD and FLT3-TKD is defined based on genescan analysis with a mutant to wild-type ratio equal or above 5%
- Patients considered eligible for intensive chemotherapy
- ECOG performance status of ≤ 2
- Age ≥ 18 years with the capacity to give written informed consent
Key exclusion criteria (27 listed)
- Known or suspected hypersensitivity to the study drugs and/or any excipients
- ECOG performance status >2
- Inadequate cardiac, hepatic and/or renal function at the Screening Visit defined as:
- Active central nervous system involvement
- Any clinically significant, advanced or unstable disease or history of that may interfere with primary or secondary variable evaluations or put the patient at special risk, such as:
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 |
|---|---|---|
| chemotherapy (Mitoxantrone, Cytarabine)Induction therapy: * Mitoxantrone 10 mg/m² IV, push (8 mg/m² for patients > 60 years of age and/or previous allogeneic HCT) d 1-3 * Cytarabine 1000 mg/m² IV (500 mg/m² for patients > 60 years of age and/or previous allogeneic HCT), over 3 hours, d 1-6 Consolidation therapy: Younger adult patients (18 to 60 yrs): Cytarabine 1500 mg/m² by i.v infusion over 3 hours BID on days 1-3 (total dose 9000 mg/m²). Older patients (> 60 yrs) and or previous allogeneic HCT: Cytarabine 1000 mg/m² by i.v. infusion over 3 hours BID on days 1-3 (total dose 6000 mg/m²). | Drug | Experimental arm, Standard arm |
| PlaceboInduction therapy: Placebo to be given as p.o. TID starting d 7+, given continuously thereafter until 48 hours prior to the next chemotherapy. Consolidation therapy: Placebo will start on day 4, thereafter with continuous dosing until 48h before start of subsequent consolidation chemotherapy. Maintenance therapy with placebo is intended in all patients after allogeneic HCT or intermediate-dose cytarabine consolidation therapy. Maintenance therapy will be given for 364 days (equivalent to 13 cycles à 28 days) after recovery from allogeneic HCT or IDAC. Maintenance with placebo will be given at the same dose tolerated during induction therapy. | Drug | Standard arm |
| CrenolanibInduction therapy: Crenolanib to be given as p.o. TID starting d 7+, given continuously until 48 hours prior to the next chemotherapy. Consolidation therapy: Crenolanib will start on day 4, thereafter with continuous dosing until 48h before start of subsequent consolidation chemotherapy. Maintenance therapy with Crenolanib is intended in all patients after allogeneic HCT or intermediate-dose cytarabine consolidation therapy. Maintenance therapy will be given for 364 days (equivalent to 13 cycles à 28 days) after recovery from allogeneic HCT or IDAC. Maintenance with Crenolanib will be given at the same dose tolerated during induction therapy. | Drug | Experimental arm |
| Allogeneic stem cell transplantationIn patients achieving a CR or CRi after salvage-reinduction chemotherapy allogeneic HCT from a matched related or unrelated donor is the preferred form of consolidation. Preferred source of allogeneic HSC are mobilized peripheral blood stem cells. Other forms of allogeneic transplantation (haploidentical donor; cord blood) are allowed. Allogeneic HCT should be conducted at the earliest time point after the start of the last chemotherapy but no later than after 56 days. A delay of transplant beyond this time window need to be discussed with the Coordinating Investigator. Patients can receive allogeneic HCT directly after salvage re-induction chemotherapy with MC, but also later on following consolidation with IDAC. | Other | Experimental arm, Standard arm |
Primary outcome
Event-free Survival (EFS)
Time frame: 4 years
Overall Survival (OS)
Time frame: 4 years
6 secondary outcomes
Rates of complete remission (CR) and complete remission with incomplete blood count recovery (CRi) after induction therapy
Time frame: 2 months
Cumulative incidence of relapse (CIR)
Time frame: 4 years
Cumulative incidence of death (CID)
Time frame: 4 years
Quality of life (QoL)
Time frame: 5.5 years
Rate of early deaths or hypoplastic deaths (ED or HD)
Time frame: 2 months
Toxicity: Type, frequency, severity, timing and relatedness of hematologic and non-hematologic toxicities
Time frame: 1.5 years
Results and safety
The study was stopped early (reason given: The manufacturer Arog Pharmaceuticals Inc has terminated the Agreement Concerning the Support of an Investigator Initiated Trial this became valid on 2020/03/09). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 chemotherapy (Mitoxantrone, Cytarabine), Crenolanib and Allogeneic stem cell transplantation in people with Acute Myeloid Leukemia, run by University of Ulm 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 13 inclusion and 27 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 6 Oct 2021. 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. Some participants in this study may receive a placebo. 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: The manufacturer Arog Pharmaceuticals Inc has terminated the Agreement Concerning the Support of an Investigator Initiated Trial this became valid on 2020/03/09). 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?
Event-free Survival (EFS) (time frame: 4 years). The study lists 2 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 6 Oct 2021.