Lymphoma, Non-Hodgkin's, AdultPhase 1/2NCT03417765
Safety, Tolerability, PK/PD of FE 203799 in Adults With Lymphomas
A Phase 1/2 study testing FE 203799 in people with Lymphoma, Non-Hodgkin's, Adult and Lymphoma, Hodgkin's, Adult, run by GlyPharma Therapeutics.
Trial summary
RATIONALE: The integrity of the intestinal mucosa is a key factor for the preservation of a normal gut function. Damage of the epithelium (i.e. by chemotherapy) results in significant cellular and molecular alterations that ultimately lead to intestinal dysfunction/failure. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lymphoma, Non-Hodgkin's, Adult, Lymphoma, Hodgkin's, Adult
- What is being tested?
- FE 203799
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2018to 31 Mar 2019
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male and non-pregnant or lactating female patients diagnosed with Hodgkin's lymphoma (HL) or non- Hodgkin's lymphoma (NHL; T- or B-cell variants) based on histological or cytological evidence.
- Patients are eligible to receive myeloablative chemotherapy as per center eligibility criteria, followed by AHSCT.
- Patients between 18 years and 65 years of age with a Hematopoietic Cell Transplant- Co-morbidity Index (HCT-CI) ≤5. Patients between 65 years and 70 years will be eligible if their HCT-CI score is ≤3.
- Patients, or their legal representatives, must have the ability to read, understand and provide written informed consent prior to the initiation of any study related procedures.
- Patients must have chemo-sensitive disease and be in partial or complete remission following the most recent anti-neoplastic therapy regimen, according to the Lugano revision of the International Working Group (IWG) response criteria [1].
- Patients must have available a cryopreserved autologous hematopoietic stem cell graft containing ≥ 2.0 x 106 cryopreserved CD34+ cells/kg.
Show all 23Show fewer
- Patients must have a Karnofsky score ≥ 70%.
- Patients must have adequate hepatic function as evidenced by bilirubin ≤ upper limit of normal (ULN), unless felt to be related to Gilbert's syndrome or hemolysis; patients must also have AST and ALT ≤ 1.5 x ULN and alkaline phosphatase ≤ 2.5 x ULN.
- Patients must have an estimated or measured creatinine clearance ≥ 30 ml/min/1.73 m2 by the Cockcroft-Gault equation.
- Patients must have left ventricular ejection fraction ≥ 50%.
- Patients must have forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1) and diffusing capacity corrected for hemoglobin (DLCOc) ≥ 50% of predicted.
- Patients must have recovered from the effects of any prior chemotherapy, radiotherapy or surgery; for patients who have been on monoclonal antibody therapy, at least one half-life or 4 weeks (whichever is longer) should have elapsed prior to the first scheduled day of dosing with FE 203799.
- A female recipient of childbearing potential must meet the following criteria:
- Participant has a negative pregnancy test at Screening.
- Participant agrees to use one of the accepted contraceptive regimens from at least 14 days prior to the first administration of the Study Drug, during the study and for at least 90 days after the last dose of the Study Drug. An acceptable method of contraception includes one of the following:
- Abstinence from heterosexual intercourse
- Systemic contraceptives (birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch)
- Intrauterine device (with or without hormones)
- Diaphragm with spermicidal gel
- Condom with spermicide gel
- A male patient, with sexual partners who are pregnant, possibly pregnant, or who could become pregnant, agrees to use one of the accepted contraceptive regimens throughout the entire duration of the study and until at least 3 months after the last drug administration. An acceptable method of contraception includes one of the following:
- Abstinence from heterosexual intercourse
- Condom with spermicide
Who cannot join
- Patient is unable or unwilling to give informed consent.
- Patients who are unable to comply with the treatment protocol including appropriate supportive care, follow-up and tests.
- Patients with known hypersensitivity to FE 203799, or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions to any drugs.
- Patients with an active infection or with a fever ≥38.5oC within 3 days of the first scheduled day of dosing.
- Patients who had an autologous stem cell transplant within 24 months.
- Patients who had an available cryopreserved autologous graft with a CD34+ cell count of < 2 x 106/kg.
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- Patients undergoing AHSCT for conditions other than lymphoma.
- Presence of a malignancy other than the one for which the transplant is being performed (except for baso-cellular skin carcinoma).
- Patients who are receiving investigational therapies or who have been treated with investigational therapies or investigational devices within 30 days prior to the first scheduled day of dosing with FE 203799.
- Patients with cardiovascular congestive heart failure, unstable angina pectoris, cardiac arrhythmias requiring a pacemaker; myocardial infarction within the past six months; stroke within the past 6 months; or uncontrolled hypertension.
- Patients with mean QTcF values of >450 msec (in males) or >470 msec (in females) following ECGs conducted in triplicate 5 minutes apart from each other; patients who are known to have congenital prolonged QT syndromes, including patients who are already on medication known to cause prolonged QT intervals on ECG.
- Presence of out-of-range cardiac interval (PR < 110 msec, PR > 220 msec, QRS < 60 msec, QRS >119 msec) on the screening ECG or other clinically significant ECG abnormalities.
- Patients with history or presence of GI tract cancer, polyps, ulcerative colitis, Crohn's disease, coeliac disease, tropical sprue, etc.
- Presence of active pancreatic disease.
- Presence of active liver disease (i.e. cirrhosis; bilirubin > ULN; transaminases > 1.5 x ULN; alkaline phosphatase > 2.5 x ULN).
- Presence of autoimmune disease.
- Patients with suicidal tendency or clinically relevant psychiatric diseases or substance abuse.
- Positive results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HbsAG (B) (hepatitis B)) or anti-Hepatitis C Virus (HCV (C)) tests.
- Any abnormal condition or laboratory result that is considered by the PI capable of altering patient's condition or study outcome.
- Patients who are pregnant or lactating.
- Patients who are unwilling to use appropriate contraception.
About this study
Official title: Double-blind, Placebo Controlled, Ascending Dose, Randomized Phase 1B/2A Study, Investigating Safety, Tolerability, PK/PD of FE 203799 in Lymphoma Patients, Undergoing Myeloablative Chemotherapy Before Autologous Transplantation
RATIONALE:
The integrity of the intestinal mucosa is a key factor for the preservation of a normal gut function. Damage of the epithelium (i.e. by chemotherapy) results in significant cellular and molecular alterations that ultimately lead to intestinal dysfunction/failure. This intestinal dysfunction manifests as several pathological processes, such as inability to absorb nutrients, intestinal inflammation, immune system dysregulation, and disequilibrium of normal intestinal microbiota leading to increased risk of infection due to bacterial translocation and septicaemia. Gastrointestinal (GI) mucositis is a well-known, frequent and debilitating side effect of most anticancer regimens with a very high incidence in hemato-oncology. The most common symptoms are nausea, vomiting, weight loss, abdominal cramps and pain, diarrhea, and electrolyte imbalance. Patients may also experience ulceration/bleeding and injury of the lining of the entire gastrointestinal tract from the esophagus to the colon. Currently no therapy is available for the prevention or treatment of GI intestinal injury. Treatment of related symptoms is limited to supportive measures to decrease diarrhea and to preventive antibiotic therapy. The GLP-2 analogue, FE 203799, has a favorable pharmacology profile for clinical development in the intended therapeutic indication of myeloablative chemotherapy-induced GI damage. The data collected from animal studies has shown that FE 203799 stimulates the proliferation of the intestinal epithelium and protects the GI mucosa from chemotherapy-induced injury. Hence, the primary pharmacologic activity of FE 203799 would promote a healthy GI microenvironment, thus preventing intestinal dysfunction and related complications.
PURPOSE: Prevention by FE 203799 of chemotherapy-induced intestinal damage and related complications in patients with lymphoma receiving Melphalan based (BEAM) myeloablative conditioning regimen followed by hematopoietic stem cell transplantation.
Read the detailed description
OUTLINE:
Multi-center, double-blind, placebo-controlled, ascending dose, randomized Phase IB/2A study to assess the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) profile of s.c. FE 203799 in patients diagnosed with Hodgkin's lymphoma (HL) or non-Hodgkin's lymphoma (NHL) undergoing Melphalan-based myeloablative chemotherapy (BEAM) followed by autologous human stem cell transplantation (AHSCT). In addition, the impact of FE 203799 on post-transplantation outcomes will be assessed. These outcomes include assessment of intestinal mucosal injury and inflammation, incidence of infection and bacteremia, development of neutropenic fever, assessment of nutritional parameters, modification of the composition of the gut microbiome, recovery of the hematopoietic system and quality of life. More specifically:
- PRIMARY OBJECTIVE: Safety and tolerability of s.c. FE 203799
- SECONDARY OBJECTIVES:
- Determine the PK profile and dose-effect of s.c. FE 203799.
- Determine the PD profile of s.c. FE 203799, based on the plasma concentration of citrulline (indicative of intestinal mass) and of C-Reactive Protein (CRP) (indicative of inflammation).
- Determine the dose/response (PK/PD) relationship of s.c. FE 203799.
- Determine the impact of treatment with s.c. FE 203799 on the incidence and severity of chemotherapy induced intestinal toxicity, as assessed by both symptomatic and visual manifestations of mucosal injury and associated complications.
- Assess the effect of s.c. FE 203799 on the prevention of development of neutropenic fever and bacteremia.
METHODOLOGY - STUDY DESIGN The patient population will consist of adult female and male Hodgkin's or non-Hodgkin's lymphomas patients who are eligible to receive BEAM as conditioning regimen followed by autologous type AHSCT using peripheral blood or bone marrow stem cells. At the time of enrollment, patients must be in complete or partial remission following their most recent anti-neoplastic therapy. Patients are required to have available a cryopreserved autologous stem cell graft with a minimum CD34+ cell dose of 2 x 106 cells/kg.
Three ascending dose levels of FE 203799 will be investigated (5 mg, 10 mg and 25 mg), with 16 patients required per dose cohort. Patients in each dose cohort will be randomized to FE 203799 vs. Placebo in a 3:1 ratio (12 patients per dose level receiving FE 203799, and 4 patients receiving Placebo), in a double-blind manner. Randomization will occur during the screening period upon confirmation that the patient has met all inclusion and exclusion criteria. A total of 48 subjects, completing the study, is targeted for enrollment. The study will be conducted in approximately 10 clinical centers.
Eligibility will be determined at the Screening Visit following signature of the informed consent form (ICF). The inclusion and exclusion criteria will be used to qualify the patient for study entry. Within each cohort, patients will receive 4 doses of the Study Drug (FE 203799 or Placebo). As such, patients will be required to be dosed with the Study Drug the day prior the initiation of the BEAM regimen and subsequently on a weekly basis for 3 consecutive weeks after initiation of chemotherapy. Assessments performed prior to the first dose, will be considered as Baseline. Serial blood samples for determination of the plasma concentration of FE 20799/Placebo, as well as the plasma levels of citrulline and C-Reactive protein (CRP) will be obtained at pre-specified time points. During the Study, patients will be hospitalized during the duration of the conditioning chemotherapy to approximately 3 or 4 weeks post-transplantation depending on their recovery and physical condition.
All patients who received at least one treatment, will be required to return to the hospital for the End of Study Visit (Day 30 ±5 post-transplantation) and for two additional follow-up safety visits on Days 45 (±5) and 100 (±5) post-transplantation.
A Data Monitoring Committee (DMC) will convene at pre-determined timepoints, or as needed. The grading of adverse events (AEs) will be based on the Common Terminology Criteria for Adverse Events version 4.03 (CTCAE v4.03) (Grade 1 to 5).
- Being tested
- FE 203799
- Keywords
- gastrointestinal mucositis, myeloablative chemotherapy, autologous transplantation
- Medical subject headings
- Lymphoma, Hodgkin Disease, Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FE 203799Drug
GLP-2 analogue, once weekly, subcutaneous administration
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: 5 mg (FE 203799/Placebo) | Experimental | Drug: FE 203799 Drug: BEAM Procedure: myeloablative chemotherapy Procedure: autologous stem cell transplantation Receives: Drug: FE 203799 |
| Cohort B: 10 mg (FE 203799/Placebo) | Experimental | Drug: FE 203799 Drug: BEAM Procedure: myeloablative chemotherapy Procedure: autologous stem cell transplantation Receives: Drug: FE 203799 |
| Cohort C: 25 mg (FE 203799/Placebo) | Experimental | Drug: FE 203799 Drug: BEAM Procedure: myeloablative chemotherapy Procedure: autologous stem cell transplantation Receives: Drug: FE 203799 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events
Adverse events as assessed by CTCAE v4.03
Measured: Day -8 to Day 100
Secondary outcomes (19)
Maximum observed plasma concentration (Cmax) of FE 203799
Cmax in ng/ml
Measured: Day -8 to Day 13
Cumulative area under the plasma concentration (AUC) time curve from 0-168 hours of FE 203799
AUC0-168 in ng*hr/ml
Measured: Day -8 to Day 13
Cumulative area under the plasma concentration (AUC) from time zero to infinity of FE 203799
AUC0-inf in ng*hr/ml
Measured: Day -8 to Day 13
Terminal elimination half-life (T1/2) of FE 203799
T1/2 in hours
Measured: Day -8 to Day 13
Apparent total body clearance (CL) of the drug from plasma of FE 203799
CL in ml/hr
Measured: Day -8 to Day 13
Apparent volume of distribution (Vz) of FE 203799 during terminal phase
Vz in ml
Measured: Day -8 to Day 13
Biomarker assessment for gut healing
Plasma concentration of citrulline (ng/ml)
Measured: Day -8 to Day -1, Day 1 to Day 14 and Day 30
Biomarker assessment for gut inflammation
Plasma concentration of C-Reactive Protein (ng/ml)
Measured: Day -8 to Day -1, Day 1 to Day 14 and Day 30
Assessment of infection - Incidence and duration of fever
Body temperature ≥38.2oC
Measured: Day -8 to Day 20 and Day 30
Assessment of infection - Incidence and duration of neutropenic fever
Development of fever when absolute neutrophil count (ANC) ≤ 0.5 x 109 and body temperature ≥ 38.2 ◦C for two consecutive values over a 30 minute period of time; or ANC < 0.5 x 109 and body temperature ≥ 38.5◦C at any single timepoint
Measured: Day -8 to Day 20 and Day 30
Incidence of microbiologically detected infection
Blood cultures once daily
Measured: Day 5 to Day 15
Assessment of gastrointestinal mucositis and related clinical symptoms
Grading as by the CTCAE v4.03
Measured: Day -8 to Day 20 and Day 30
Assessment of gastrointestinal mucositis by video-capsule endoscopy
Gastrointestinal damage assessed by the Lewis Score; this is evaluation of villous edema, ulcers and stenosis graded collectively; Normal < 135, Mild 135-790, Moderate - severe ≥790
Measured: Day -8, Day 6 and Day 20
Assessment of nutrients absorption
Body weight (kg)
Measured: Days -8, -1, 6, 13 and 30
Assessment of nutrients absorption
Assessment of duration of parenteral nutrition (L)
Measured: Days -8, 0, 3, 6, 9, 12, 15, 18
Assessment of nutrients absorption
Assessment of caloric intake (calories)
Measured: Days -8, 0, 3, 6, 9, 12, 15, 18
Microbiome composition
Determination of microbial populations by genomic analysis (relative abundance of taxonomic levels)
Measured: Once a week over 4 weeks
Time to neutrophil and platelet engraftment
Hematological analysis
Measured: Day-8 and then on Days -2, 5, 12 and 30
Assessment of quality of life
Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) questionnaire
Measured: Days -8, -1, 6, 13 and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start1 Sep 2018 (estimated)
- Primary completion31 Mar 2019 (estimated)
- Study completion31 Mar 2019 (estimated)
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-Hodgkin's, AdultStudies 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 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Placebo-control, ascending dose
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlyPharma Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- VectivBio AG
- Responsible party
- Sponsor
- Investigators
- Tomasz Masior, Study director, VectivBio AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03417765
- Sponsor's protocol ID
- GLY-211-2017
- Status last verified
- Oct 2018
- First submitted
- 13 Nov 2017
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Placebo Controlled, Ascending Dose, Randomized Phase 1B/2A Study, Investigating Safety, Tolerability, PK/PD of FE 203799 in Lymphoma Patients, Undergoing Myeloablative Chemotherapy Before Autologous Transplantation
- ClinicalTrials.gov ID
- NCT03417765
- Acronym / sponsor ID
- GLY-211-2017
- Keywords
- gastrointestinal mucositis, myeloablative chemotherapy, autologous transplantation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlyPharma TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- VectivBio AG
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 31 Mar 2019 (estimated)
- Study completion
- 31 Mar 2019 (estimated)
- First posted
- 31 Jan 2018 (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.
RATIONALE:
The integrity of the intestinal mucosa is a key factor for the preservation of a normal gut function. Damage of the epithelium (i.e. by chemotherapy) results in significant cellular and molecular alterations that ultimately lead to intestinal dysfunction/failure. This intestinal dysfunction manifests as several pathological processes, such as inability to absorb nutrients, intestinal inflammation, immune system dysregulation, and disequilibrium of normal intestinal microbiota leading to increased risk of infection due to bacterial translocation and septicaemia. Gastrointestinal (GI) mucositis is a well-known, frequent and debilitating side effect of most anticancer regimens with a very high incidence in hemato-oncology. The most common symptoms are nausea, vomiting, weight loss, abdominal cramps and pain, diarrhea, and electrolyte imbalance. Patients may also experience ulceration/bleeding and injury of the lining of the entire gastrointestinal tract from the esophagus to the colon. Currently no therapy is available for the prevention or treatment of GI intestinal injury. Treatment of related symptoms is limited to supportive measures to decrease diarrhea and to preventive antibiotic therapy. The GLP-2 analogue, FE 203799, has a favorable pharmacology profile for clinical development in the intended therapeutic indication of myeloablative chemotherapy-induced GI damage. The data collected from animal studies has shown that FE 203799 stimulates the proliferation of the intestinal epithelium and protects the GI mucosa from chemotherapy-induced injury. Hence, the primary pharmacologic activity of FE 203799 would promote a healthy GI microenvironment, thus preventing intestinal dysfunction and related complications.
PURPOSE: Prevention by FE 203799 of chemotherapy-induced intestinal damage and related complications in patients with lymphoma receiving Melphalan based (BEAM) myeloablative conditioning regimen followed by hematopoietic stem cell transplantation.
Detailed description
OUTLINE:
Multi-center, double-blind, placebo-controlled, ascending dose, randomized Phase IB/2A study to assess the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) profile of s.c. FE 203799 in patients diagnosed with Hodgkin's lymphoma (HL) or non-Hodgkin's lymphoma (NHL) undergoing Melphalan-based myeloablative chemotherapy (BEAM) followed by autologous human stem cell transplantation (AHSCT). In addition, the impact of FE 203799 on post-transplantation outcomes will be assessed. These outcomes include assessment of intestinal mucosal injury and inflammation, incidence of infection and bacteremia, development of neutropenic fever, assessment of nutritional parameters, modification of the composition of the gut microbiome, recovery of the hematopoietic system and quality of life. More specifically:
- PRIMARY OBJECTIVE: Safety and tolerability of s.c. FE 203799
- SECONDARY OBJECTIVES:
- Determine the PK profile and dose-effect of s.c. FE 203799.
- Determine the PD profile of s.c. FE 203799, based on the plasma concentration of citrulline (indicative of intestinal mass) and of C-Reactive Protein (CRP) (indicative of inflammation).
- Determine the dose/response (PK/PD) relationship of s.c. FE 203799.
- Determine the impact of treatment with s.c. FE 203799 on the incidence and severity of chemotherapy induced intestinal toxicity, as assessed by both symptomatic and visual manifestations of mucosal injury and associated complications.
- Assess the effect of s.c. FE 203799 on the prevention of development of neutropenic fever and bacteremia.
METHODOLOGY - STUDY DESIGN The patient population will consist of adult female and male Hodgkin's or non-Hodgkin's lymphomas patients who are eligible to receive BEAM as conditioning regimen followed by autologous type AHSCT using peripheral blood or bone marrow stem cells. At the time of enrollment, patients must be in complete or partial remission following their most recent anti-neoplastic therapy. Patients are required to have available a cryopreserved autologous stem cell graft with a minimum CD34+ cell dose of 2 x 106 cells/kg.
Three ascending dose levels of FE 203799 will be investigated (5 mg, 10 mg and 25 mg), with 16 patients required per dose cohort. Patients in each dose cohort will be randomized to FE 203799 vs. Placebo in a 3:1 ratio (12 patients per dose level receiving FE 203799, and 4 patients receiving Placebo), in a double-blind manner. Randomization will occur during the screening period upon confirmation that the patient has met all inclusion and exclusion criteria. A total of 48 subjects, completing the study, is targeted for enrollment. The study will be conducted in approximately 10 clinical centers.
Eligibility will be determined at the Screening Visit following signature of the informed consent form (ICF). The inclusion and exclusion criteria will be used to qualify the patient for study entry. Within each cohort, patients will receive 4 doses of the Study Drug (FE 203799 or Placebo). As such, patients will be required to be dosed with the Study Drug the day prior the initiation of the BEAM regimen and subsequently on a weekly basis for 3 consecutive weeks after initiation of chemotherapy. Assessments performed prior to the first dose, will be considered as Baseline. Serial blood samples for determination of the plasma concentration of FE 20799/Placebo, as well as the plasma levels of citrulline and C-Reactive protein (CRP) will be obtained at pre-specified time points. During the Study, patients will be hospitalized during the duration of the conditioning chemotherapy to approximately 3 or 4 weeks post-transplantation depending on their recovery and physical condition.
All patients who received at least one treatment, will be required to return to the hospital for the End of Study Visit (Day 30 ±5 post-transplantation) and for two additional follow-up safety visits on Days 45 (±5) and 100 (±5) post-transplantation.
A Data Monitoring Committee (DMC) will convene at pre-determined timepoints, or as needed. The grading of adverse events (AEs) will be based on the Common Terminology Criteria for Adverse Events version 4.03 (CTCAE v4.03) (Grade 1 to 5).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Placebo-control, ascending dose
| Arm | Type | Receives |
|---|---|---|
| Cohort A: 5 mg (FE 203799/Placebo) | Experimental | Drug: FE 203799Drug: FE 203799 Drug: BEAM Procedure: myeloablative chemotherapy Procedure: autologous stem cell transplantation |
| Cohort B: 10 mg (FE 203799/Placebo) | Experimental | Drug: FE 203799Drug: FE 203799 Drug: BEAM Procedure: myeloablative chemotherapy Procedure: autologous stem cell transplantation |
| Cohort C: 25 mg (FE 203799/Placebo) | Experimental | Drug: FE 203799Drug: FE 203799 Drug: BEAM Procedure: myeloablative chemotherapy Procedure: autologous stem cell transplantation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Adult male and non-pregnant or lactating female patients diagnosed with Hodgkin's lymphoma (HL) or non- Hodgkin's lymphoma (NHL; T- or B-cell variants) based on histological or cytological evidence.
- Patients are eligible to receive myeloablative chemotherapy as per center eligibility criteria, followed by AHSCT.
- Patients between 18 years and 65 years of age with a Hematopoietic Cell Transplant- Co-morbidity Index (HCT-CI) ≤5. Patients between 65 years and 70 years will be eligible if their HCT-CI score is ≤3.
- Patients, or their legal representatives, must have the ability to read, understand and provide written informed consent prior to the initiation of any study related procedures.
- Patients must have chemo-sensitive disease and be in partial or complete remission following the most recent anti-neoplastic therapy regimen, according to the Lugano revision of the International Working Group (IWG) response criteria [1].
Key exclusion criteria (21 listed)
- Patient is unable or unwilling to give informed consent.
- Patients who are unable to comply with the treatment protocol including appropriate supportive care, follow-up and tests.
- Patients with known hypersensitivity to FE 203799, or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions to any drugs.
- Patients with an active infection or with a fever ≥38.5oC within 3 days of the first scheduled day of dosing.
- Patients who had an autologous stem cell transplant within 24 months.
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 |
|---|---|---|
| FE 203799GLP-2 analogue, once weekly, subcutaneous administration | Drug | Cohort A: 5 mg (FE 203799/Placebo), Cohort B: 10 mg (FE 203799/Placebo), Cohort C: 25 mg (FE 203799/Placebo) |
Primary outcome
Incidence of treatment-emergent adverse events
Time frame: Day -8 to Day 100
Adverse events as assessed by CTCAE v4.03
19 secondary outcomes
Maximum observed plasma concentration (Cmax) of FE 203799
Time frame: Day -8 to Day 13
Cumulative area under the plasma concentration (AUC) time curve from 0-168 hours of FE 203799
Time frame: Day -8 to Day 13
Cumulative area under the plasma concentration (AUC) from time zero to infinity of FE 203799
Time frame: Day -8 to Day 13
Terminal elimination half-life (T1/2) of FE 203799
Time frame: Day -8 to Day 13
Apparent total body clearance (CL) of the drug from plasma of FE 203799
Time frame: Day -8 to Day 13
Apparent volume of distribution (Vz) of FE 203799 during terminal phase
Time frame: Day -8 to Day 13
Biomarker assessment for gut healing
Time frame: Day -8 to Day -1, Day 1 to Day 14 and Day 30
Biomarker assessment for gut inflammation
Time frame: Day -8 to Day -1, Day 1 to Day 14 and Day 30
Assessment of infection - Incidence and duration of fever
Time frame: Day -8 to Day 20 and Day 30
Assessment of infection - Incidence and duration of neutropenic fever
Time frame: Day -8 to Day 20 and Day 30
Incidence of microbiologically detected infection
Time frame: Day 5 to Day 15
Assessment of gastrointestinal mucositis and related clinical symptoms
Time frame: Day -8 to Day 20 and Day 30
Assessment of gastrointestinal mucositis by video-capsule endoscopy
Time frame: Day -8, Day 6 and Day 20
Assessment of nutrients absorption
Time frame: Days -8, -1, 6, 13 and 30
Assessment of nutrients absorption
Time frame: Days -8, 0, 3, 6, 9, 12, 15, 18
Assessment of nutrients absorption
Time frame: Days -8, 0, 3, 6, 9, 12, 15, 18
Microbiome composition
Time frame: Once a week over 4 weeks
Time to neutrophil and platelet engraftment
Time frame: Day-8 and then on Days -2, 5, 12 and 30
Assessment of quality of life
Time frame: Days -8, -1, 6, 13 and 30
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Individual participant dataSharing planned: No
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Chronic Myeloproliferative Disorders, Leukemia
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.
Tomasz Masior study director
VectivBio AG
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing FE 203799 in people with Lymphoma, Non-Hodgkin's, Adult and Lymphoma, Hodgkin's, Adult, run by GlyPharma Therapeutics.
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 23 inclusion and 21 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: withdrawn, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
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 was withdrawn before enrolling participants, so there are no results.
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?
Incidence of treatment-emergent adverse events (time frame: Day -8 to Day 100). 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 24 Oct 2024.