Acute Myeloid Leukemia (AML) RelapsePhase 1PHIBINCT03207191
Trial to Find and Investigate a Safe Dose of F16IL2 and BI 836858 in Patients With AML Relapse After Allogeneic Hematopoietic Stem Cell Transplantation
A Phase 1 study testing F16IL2 and BI 836858 in people with Acute Myeloid Leukemia (AML) Relapse, run by Philogen S.p.A. at 2 sites in Germany.
Trial summary
Phase I, open label, single arm, non-randomized, multicenter, prospective dose escalation study in subjects with acute myeloid leukemia relapse after allogeneic hematopoietic stem cell transplantation (alloHSCT). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myeloid Leukemia (AML) Relapse
- What is being tested?
- F16IL2 and BI 836858
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesGermany
- Study dates
- 2 Dec 2016to 26 Mar 2020
- Phase
- Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with de novo or secondary AML according to the WHO/FAB classification relapsing after alloHSCT, and fulfilling at least one of the following:
- bone marrow blasts ≥ 5% of all nucleated cells
- appearance of blasts in the peripheral blood
- extramedullary AML relapse
- Age 18 - 75 years.
- ECOG ≤ 2.
Show all 12Show fewer
- Documented negative test for HIV-HBV-HCV. For HBV serology: the determination of HBsAg, anti-HBsAg-Ab and anti-HBCAg-Ab is required. In patients with serology documenting previous exposure to HBV (i.e., anti-HBs Ab with no history of vaccination and/or anti-HBc Ab), negative serum HBV-DNA is required.
- Negative serum pregnancy test for females of childbearing potential* within 14 days of starting treatment.
- Informed consent personally signed and dated to participate in the study.
- Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.
- Women of childbearing potential (WOCBP) must be using, from the screening to six months following the last study drug administration, highly effective contraception methods, as defined by the "Recommendations for contraception and pregnancy testing in clinical trials" issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group (www.hma.eu/ctfg.html) and which include, for instance, progesteron-only or combined (estrogen- and progesteron-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion, vasectomized partner or sexual abstinence. Pregnancy test will be repeated at the end of treatment visit.
- Women of childbearing potential are defined as females who have experienced menarche, are not postmenopausal (12 months with no menses without an alternative medical cause) and are not permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral oophorectomy or bilateral salpingectomy)
Who cannot join
- Known central nervous system manifestation of AML.
- Previous treatment (e.g., stem cell transplantation, chemotherapy, radiotherapy, investigational drugs) within 4 weeks or a minimum of 5 half-lifes of the treatment, whatever is shorter, of the first study drug intake for this current AML relapse after alloHSCT, except hydroxyurea to control peripheral cell counts up to one day before study medication.
- Active GvHD requiring systemic immunosuppression, unless controlled with low dose steroids equivalent to a maximum of 10 mg methylprednisolone per day.
- Chronically impaired renal function (estimated creatinine clearance < 30 ml/min).
- Inadequate liver function (ALT, AST, ALP or total bilirubin ≥ 3.0 x ULN), if not caused by leukemic infiltration.
- Any severe concomitant condition which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol.
Show all 25Show fewer
- History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris.
- Heart insufficiency (> Grade II, New York Heart Association (NYHA) criteria).
- Irreversible cardiac arrhythmias requiring permanent medication.
- Uncontrolled hypertension.
- Ischemic peripheral vascular disease (Grade IIb-IV).
- Severe diabetic retinopathy such as severe non-proliferative retinopathy and proliferative retinopathy.
- Major trauma including major surgery (such as abdominal/cardiac/thoracic surgery) within 4 weeks of administration of study treatment.
- Pregnancy or breast-feeding.
- Requirement of chronic administration of corticosteroids. However, low dose corticosteroids (maximum 10 mg methylprednisolone or equivalent per day when administered for GVHD) are allowed.
- Presence of active and uncontrolled infections or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study.
- Known active or latent tuberculosis (TB).
- Known hereditary fructose intolerance.
- Concurrent malignancies other than AML (except basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the patient has been disease-free for at least 2 years.
- Concomitant treatment with angiogenesis inhibitors or other drugs with proven anti-leukemic activity.
- Prior treatment with CD33 antibody.
- Serious, non-healing wound, ulcer or bone fracture.
- Allergy to study medication or excipients in study medication.
- Concurrent use of other anti-cancer treatments or agents.
- Failure to fulfil inclusion criteria.
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University Medical Center Freiburg
Freiburg im Breisgau
Münster University Hospital
Münster
About this study
Official title: A Phase I Study of the Tumor-targeting Human F16IL2 Monoclonal Antibody-cytokine Fusion Protein in Combination With the Anti-CD33 Antibody BI 836858 in Patients With AML Relapse After Allogeneic Hematopoietic Stem Cell Transplantation
Phase I, open label, single arm, non-randomized, multicenter, prospective dose escalation study in subjects with acute myeloid leukemia relapse after allogeneic hematopoietic stem cell transplantation (alloHSCT).
Read the detailed description
The aim of the study is to determine a recommended dose for F16IL2 in combination with BI 836858 in AML relapse after alloHSCT and investigating safety and tolerability of the combination regimen.
Dose escalation will be guided by a Bayesian logistic regression model (BLRM) with overdose control that will be fitted to binary toxicity outcomes. The estimate of parameters will be updated as data are accumulated using the BLRM. At the end of the dose escalation phase, the probability of toxicity at each dose combination level will be calculated to determine an estimate of the MTD. Once the MTD or a biological active dose has been defined, additional patients (up to 10) will be treated with F16IL2 and BI 836858 dosed at this dose combination in order to confirm the safety profile of the combination.
- Conditions
- Acute Myeloid Leukemia (AML) Relapse
- Being tested
- F16IL2, BI 836858
- 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.
F16IL2Drug
F16IL2 dose escalation with provisional doses of 10, 20 and 30 Mio IU on Day 1, 8, 15 and 22 of each cycle through a rate-controlled intravenous infusion of 3 hours
BI 836858Drug
BI 836858 dose escalation with provisional doses of 10, 20, 40, 80 and 160 mg on days 3, 10, 17 and 24 of each cycle through a rate-controlled intravenous infusion up to 5 hours
| Study group | Role | What they receive |
|---|---|---|
| F16IL2 + BI 836858 | Experimental | Successive cohorts of patients will receive increasing doses of FI6IL2 and BI 836858 until the MTD is reached. The MTD will be defined following a Bayesian logistic regression model (BLRM) with overdose control.
Patients will go off treatment after 6 months (i.e. after 6 cycles of induction combination therapy). Patients achieving CR or CRi will receive maintenance therapy for a maximum of 6 months. Receives: Drug: F16IL2; Drug: BI 836858 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events that are related to treatment and classified as DLTs for each administered dosage
To assess the dose limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended dose (RD) of F16IL2 combined with BI 836858
Measured: Safety assessment will be performed from day 1 up to day 28 of the Cycle 1 (each cycle is 28 days) for every patient until the end of the enrollment
Secondary outcomes (26)
Overall response rate (ORR)
Measured: 1) from week 4 up to week 24, every 4 weeks; 2) for EoT: at week 26 (only induction) or 50 (plus maintenance); 3) for follow-up: from week 28 (only induction) or 52 (plus maintenance) up to week 76, every 4 weeks
Relapse-free survival (RFS)
Measured: 1) from week 4 up to week 24, every 4 weeks; 2) for EoT: at week 26 (only induction) or 50 (plus maintenance); 3) for follow-up: from week 28 (only induction) or 52 (plus maintenance) up to week 76, every 4 weeks
Time to response (CR or CRi) of responding patients
Measured: 1) from week 4 up to week 24, every 4 weeks; 2) for EoT: at week 26 (only induction) or 50 (plus maintenance); 3) for follow-up: from week 28 (only induction) or 52 (plus maintenance) up to week 76, every 4 weeks
Overall survival (OS) rate
Measured: From day 1 up to week 76, every 4 weeks
Rate to complete donor chimerism
Measured: 1) day 0; 2) from week 4 up to week 24, every 4 weeks; 3) for EoT: at week 26 (only induction) or 50 (plus maintenance); 4) for follow-up: from week 28 (only induction) or 52 (plus maintenance) up to week 76 every 4 weeks
Time to complete donor chimerism
Measured: 1) day 0; 2) from week 4 up to week 24, every 4 weeks; 3) for EoT: at week 26 (only induction) or 50 (plus maintenance); 4) for follow-up: from week 28 (only induction) or 52 (plus maintenance) up to week 76 every 4 weeks
Maximum drug concentration [Cmax]
Pharmacokinetics assessment of F16IL2 through blood sampling
Measured: Cycle 1,1) at day 1,2 (week 1); 2) at day 22,23 (week 4)
Time to reach maximum drug concentration [Tmax]
Pharmacokinetics assessment of F16IL2 through blood sampling
Measured: Cycle 1,1) week 1; 2) week 4
Terminal half-life [t1/2]
Pharmacokinetics assessment of F16IL2 through blood sampling
Measured: Cycle 1,1) at day 1,2 (week 1); 2) at day 22,23 (week 4)
Area under the drug concentration-time curve [AUC(0 - t last)] and area under the drug concentration-time curve, extrapolated to infinity [AUC]
Pharmacokinetics assessment of F16IL2 through blood sampling
Measured: Cycle 1, 1) at day 1,2 (week 1); 2) at day 22,23 (week 4)
Accumulation ratio for AUC [R AUC], Cmax [Rmax] and Cmin [R min]
Pharmacokinetics assessment of F16IL2 through blood sampling
Measured: Cycle 1,1) at day 1,2 (week 1); 2) at day 22,23 (week 4)
Total clearance following the dose administered [CL]
Pharmacokinetics assessment of F16IL2 through blood sampling
Measured: Cycle 1,1) at day 1,2 (week 1); 2) at day 22,23 (week 4)
Volume of distribution at steady state [Vss]
Pharmacokinetics assessment of F16IL2 through blood sampling
Measured: Cycle 1,1) at day 1,2 (week 1); 2) at day 22,23 (week 4)
Mean residence time [MRT]
Pharmacokinetics assessment of F16IL2 through blood sampling
Measured: Cycle 1,1) at day 1,2 (week 1); 2) at day 22,23 (week 4)
Maximum drug concentration [Cmax]
Pharmacokinetics assessment of BI 836858 through blood sampling
Measured: Cycle 1 [at day 3,4,6 (week 1); at day 24,25,27 (week 4)]
Time to reach maximum drug concentration [Tmax]
Pharmacokinetics assessment of BI 836858 through blood sampling
Measured: Cycle 1 [at day 3,4,6 (week 1); at day 24,25,27 (week 4)]
Terminal half-life [t1/2]
Pharmacokinetics assessment of BI 836858 through blood sampling
Measured: Cycle 1 [at day 3,4,6 (week 1); at day 24,25,27 (week 4)]
Area under the drug concentration-time curve [AUC(0 - t last)] and area under the drug concentration-time curve, extrapolated to infinity [AUC]
Pharmacokinetics assessment of BI 836858 through blood sampling
Measured: Cycle 1 [at day 3,4,6 (week 1); at day 24,25,27 (week 4)]
Accumulation ratio for AUC [R AUC], Cmax [Rmax] and Cmin [R min]
Pharmacokinetics assessment of BI 836858 through blood sampling
Measured: Cycle 1 [at day 3,4,6 (week 1); at day 24,25,27 (week 4)]
Total clearance following the dose administered [CL]
Pharmacokinetics assessment of BI 836858 through blood sampling
Measured: Cycle 1 [at day 3,4,6 (week 1); at day 24,25,27 (week 4); up to week 21, 22, 23, 24 of Cycle 6, every 4 weeks]
Volume of distribution at steady state [Vss]
Pharmacokinetics assessment of BI 836858 through blood sampling
Measured: Cycle 1 [at day 3,4,6 (week 1); at day 24,25,27 (week 4)]
Mean residence time [MRT]
Pharmacokinetics assessment of BI 836858 through blood sampling
Measured: Cycle 1 [at day 3,4,6 (week 1); at day 24,25,27 (week 4)]
Human anti-fusion protein antibodies (HAFA) levels
Measured: 1) at day 1 of every 28 day cycle, from Cycle 1 up to Cycle 12; 2) for EoT: at week 26 (only induction) or 50 (plus maintenance); 3) for follow-up: at week 28 (only induction) or 52 (plus maintenance)
BI 836858 anti-drug antibodies (ADAs) levels
Measured: From Cycle 1 to Cycle 6, [at day 3 (week 1); at day 10 (week 2); at day 17 (week 3); at day 24 (week 4)]
The rate of acute and chronic GvHD
Measured: From day 1 up to week 76, every 4 weeks
The severity of acute and chronic GvHD
Measured: From day 1 up to week 76, every 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start2 Dec 2016
- Primary completion26 Mar 2020
- Study completion26 Mar 2020
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) RelapseStudies of the same condition, open and under way.
- More trials run by Philogen S.p.A.The 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philogen S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03207191
- Sponsor's protocol ID
- PH-F16IL2CD33-03/15
- Acronym
- PHIBI
- Status last verified
- Apr 2022
- First submitted
- 16 Dec 2016
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of the Tumor-targeting Human F16IL2 Monoclonal Antibody-cytokine Fusion Protein in Combination With the Anti-CD33 Antibody BI 836858 in Patients With AML Relapse After Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT03207191
- Acronym / sponsor ID
- PHIBI / PH-F16IL2CD33-03/15
- Conditions
- Acute Myeloid Leukemia (AML) Relapse
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Philogen S.p.A.Industry (pharma, biotech, devices)
- Collaborators
- Boehringer Ingelheim
- Study start
- 2 Dec 2016 (actual)
- Primary completion
- 26 Mar 2020 (actual)
- Study completion
- 26 Mar 2020 (actual)
- First posted
- 2 Jul 2017 (actual)
- 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.
Phase I, open label, single arm, non-randomized, multicenter, prospective dose escalation study in subjects with acute myeloid leukemia relapse after allogeneic hematopoietic stem cell transplantation (alloHSCT).
Detailed description
The aim of the study is to determine a recommended dose for F16IL2 in combination with BI 836858 in AML relapse after alloHSCT and investigating safety and tolerability of the combination regimen.
Dose escalation will be guided by a Bayesian logistic regression model (BLRM) with overdose control that will be fitted to binary toxicity outcomes. The estimate of parameters will be updated as data are accumulated using the BLRM. At the end of the dose escalation phase, the probability of toxicity at each dose combination level will be calculated to determine an estimate of the MTD. Once the MTD or a biological active dose has been defined, additional patients (up to 10) will be treated with F16IL2 and BI 836858 dosed at this dose combination in order to confirm the safety profile of the combination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| F16IL2 + BI 836858 | Experimental | Drug: F16IL2, Drug: BI 836858Successive cohorts of patients will receive increasing doses of FI6IL2 and BI 836858 until the MTD is reached. The MTD will be defined following a Bayesian logistic regression model (BLRM) with overdose control. Patients will go off treatment after 6 months (i.e. after 6 cycles of induction combination therapy). Patients achieving CR or CRi will receive maintenance therapy for a maximum of 6 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients with de novo or secondary AML according to the WHO/FAB classification relapsing after alloHSCT, and fulfilling at least one of the following:
- Age 18 - 75 years.
- ECOG ≤ 2.
- Documented negative test for HIV-HBV-HCV. For HBV serology: the determination of HBsAg, anti-HBsAg-Ab and anti-HBCAg-Ab is required. In patients with serology documenting previous exposure to HBV (i.e., anti-HBs Ab with no history of vaccination and/or anti-HBc Ab), negative serum HBV-DNA is required.
- Negative serum pregnancy test for females of childbearing potential* within 14 days of starting treatment.
Key exclusion criteria (25 listed)
- Known central nervous system manifestation of AML.
- Previous treatment (e.g., stem cell transplantation, chemotherapy, radiotherapy, investigational drugs) within 4 weeks or a minimum of 5 half-lifes of the treatment, whatever is shorter, of the first study drug intake for this current AML relapse after alloHSCT, except hydroxyurea to control peripheral cell counts up to one day before study medication.
- Active GvHD requiring systemic immunosuppression, unless controlled with low dose steroids equivalent to a maximum of 10 mg methylprednisolone per day.
- Chronically impaired renal function (estimated creatinine clearance < 30 ml/min).
- Inadequate liver function (ALT, AST, ALP or total bilirubin ≥ 3.0 x ULN), if not caused by leukemic infiltration.
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 |
|---|---|---|
| F16IL2F16IL2 dose escalation with provisional doses of 10, 20 and 30 Mio IU on Day 1, 8, 15 and 22 of each cycle through a rate-controlled intravenous infusion of 3 hours | Drug | F16IL2 + BI 836858 |
| BI 836858BI 836858 dose escalation with provisional doses of 10, 20, 40, 80 and 160 mg on days 3, 10, 17 and 24 of each cycle through a rate-controlled intravenous infusion up to 5 hours | Drug | F16IL2 + BI 836858 |
Primary outcome
Number of patients with adverse events that are related to treatment and classified as DLTs for each administered dosage
Time frame: Safety assessment will be performed from day 1 up to day 28 of the Cycle 1 (each cycle is 28 days) for every patient until the end of the enrollment
To assess the dose limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended dose (RD) of F16IL2 combined with BI 836858
26 secondary outcomes
Overall response rate (ORR)
Time frame: 1) from week 4 up to week 24, every 4 weeks; 2) for EoT: at week 26 (only induction) or 50 (plus maintenance); 3) for follow-up: from week 28 (only induction) or 52 (plus maintenance) up to week 76, every 4 weeks
Relapse-free survival (RFS)
Time frame: 1) from week 4 up to week 24, every 4 weeks; 2) for EoT: at week 26 (only induction) or 50 (plus maintenance); 3) for follow-up: from week 28 (only induction) or 52 (plus maintenance) up to week 76, every 4 weeks
Time to response (CR or CRi) of responding patients
Time frame: 1) from week 4 up to week 24, every 4 weeks; 2) for EoT: at week 26 (only induction) or 50 (plus maintenance); 3) for follow-up: from week 28 (only induction) or 52 (plus maintenance) up to week 76, every 4 weeks
Overall survival (OS) rate
Time frame: From day 1 up to week 76, every 4 weeks
Rate to complete donor chimerism
Time frame: 1) day 0; 2) from week 4 up to week 24, every 4 weeks; 3) for EoT: at week 26 (only induction) or 50 (plus maintenance); 4) for follow-up: from week 28 (only induction) or 52 (plus maintenance) up to week 76 every 4 weeks
Time to complete donor chimerism
Time frame: 1) day 0; 2) from week 4 up to week 24, every 4 weeks; 3) for EoT: at week 26 (only induction) or 50 (plus maintenance); 4) for follow-up: from week 28 (only induction) or 52 (plus maintenance) up to week 76 every 4 weeks
Maximum drug concentration [Cmax]
Time frame: Cycle 1,1) at day 1,2 (week 1); 2) at day 22,23 (week 4)
Time to reach maximum drug concentration [Tmax]
Time frame: Cycle 1,1) week 1; 2) week 4
Terminal half-life [t1/2]
Time frame: Cycle 1,1) at day 1,2 (week 1); 2) at day 22,23 (week 4)
Area under the drug concentration-time curve [AUC(0 - t last)] and area under the drug concentration-time curve, extrapolated to infinity [AUC]
Time frame: Cycle 1, 1) at day 1,2 (week 1); 2) at day 22,23 (week 4)
Accumulation ratio for AUC [R AUC], Cmax [Rmax] and Cmin [R min]
Time frame: Cycle 1,1) at day 1,2 (week 1); 2) at day 22,23 (week 4)
Total clearance following the dose administered [CL]
Time frame: Cycle 1,1) at day 1,2 (week 1); 2) at day 22,23 (week 4)
Volume of distribution at steady state [Vss]
Time frame: Cycle 1,1) at day 1,2 (week 1); 2) at day 22,23 (week 4)
Mean residence time [MRT]
Time frame: Cycle 1,1) at day 1,2 (week 1); 2) at day 22,23 (week 4)
Maximum drug concentration [Cmax]
Time frame: Cycle 1 [at day 3,4,6 (week 1); at day 24,25,27 (week 4)]
Time to reach maximum drug concentration [Tmax]
Time frame: Cycle 1 [at day 3,4,6 (week 1); at day 24,25,27 (week 4)]
Terminal half-life [t1/2]
Time frame: Cycle 1 [at day 3,4,6 (week 1); at day 24,25,27 (week 4)]
Area under the drug concentration-time curve [AUC(0 - t last)] and area under the drug concentration-time curve, extrapolated to infinity [AUC]
Time frame: Cycle 1 [at day 3,4,6 (week 1); at day 24,25,27 (week 4)]
Accumulation ratio for AUC [R AUC], Cmax [Rmax] and Cmin [R min]
Time frame: Cycle 1 [at day 3,4,6 (week 1); at day 24,25,27 (week 4)]
Total clearance following the dose administered [CL]
Time frame: Cycle 1 [at day 3,4,6 (week 1); at day 24,25,27 (week 4); up to week 21, 22, 23, 24 of Cycle 6, every 4 weeks]
Volume of distribution at steady state [Vss]
Time frame: Cycle 1 [at day 3,4,6 (week 1); at day 24,25,27 (week 4)]
Mean residence time [MRT]
Time frame: Cycle 1 [at day 3,4,6 (week 1); at day 24,25,27 (week 4)]
Human anti-fusion protein antibodies (HAFA) levels
Time frame: 1) at day 1 of every 28 day cycle, from Cycle 1 up to Cycle 12; 2) for EoT: at week 26 (only induction) or 50 (plus maintenance); 3) for follow-up: at week 28 (only induction) or 52 (plus maintenance)
BI 836858 anti-drug antibodies (ADAs) levels
Time frame: From Cycle 1 to Cycle 6, [at day 3 (week 1); at day 10 (week 2); at day 17 (week 3); at day 24 (week 4)]
The rate of acute and chronic GvHD
Time frame: From day 1 up to week 76, every 4 weeks
The severity of acute and chronic GvHD
Time frame: From day 1 up to week 76, every 4 weeks
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 20 Apr 2022.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing F16IL2 and BI 836858 in people with Acute Myeloid Leukemia (AML) Relapse, run by Philogen S.p.A. at 2 sites 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 12 inclusion and 25 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 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 patients with adverse events that are related to treatment and classified as DLTs for each administered dosage (time frame: Safety assessment will be performed from day 1 up to day 28 of the Cycle 1 (each cycle is 28 days) for every patient until the end of the enrollment). 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 20 Apr 2022.