Acute Lymphoblastic Leukemia (ALL)Phase 1NCT02647190
Intravenous Erwinia Chrysanthemi Asparaginase in Patients With Newly Diagnosed Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia Aged 60 Years or Older
A Phase 1 study testing Erwinia Chrysanthemi asparaginase in people with Acute Lymphoblastic Leukemia (ALL) and Newly Diagnosed Philadelphia Chromosome Negative, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to test the safety of Erwinia Chrysanthemi asparaginase when used alone and together with chemotherapy and find out what effects, if any, it has on people. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia (ALL), Newly Diagnosed Philadelphia Chromosome Negative, Aged 60 Years or Older
- What is being tested?
- Erwinia Chrysanthemi asparaginase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Jun 2017
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 60 years or older
- Previously untreated Philadelphia chromosome negative acute lymphoblastic leukemia
- No prior treatment for ALL, except steroids or hydroxyurea (stopped within 24 hour before start of protocol treatment)
- Serum creatinine ≤ 2 x upper limit of normal (ULN)
- Adequate liver function, including total bilirubin ≤ 1.5 x ULN unless the patient has documented Gilbert syndrome, and aspartate and alanine aminotransferase (AST and ALT) ≤ 5 x ULN. If organ function abnormalities are considered due to leukemic infiltration, total bilirubin must be ≤ 2 x ULN.
- ECOG performance status ≤3
Show all 10Show fewer
- Male and female patients of childbearing potential must agree to use a highly effective method of contraception throughout the study and for a minimum of 90 days after the last dose of treatment on protocol. A patient is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active. Female patients who are not of childbearing potential should meet at least one of the following criteria:
- Have undergone hysterectomy or bilateral oophorectomy; or
- Have medically confirmed ovarian failure; or
- Are medically confirmed to be post-menopausal (cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause
Who cannot join
- Lymphoblastic crisis of CML
- Mature B cell (Burkitt's) ALL
- Active central nervous system (CNS) leukemia, as defined by unequivocal morphologic evidence of lymphoblasts in the cerebrospinal fluid (CSF), use of CNS-directed local treatment for active disease within the prior 28 days, symptomatic CNS leukemia (i.e., cranial nerve palsies or other significant neurologic dysfunction) within 28 days. Prophylactic intrathecal medication is not a reason for exclusion.
- Pregnant women or women who are breast-feeding
- Concurrent active malignancy requiring immediate therapy
- Patients with human immunodeficiency virus (HIV)
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: A Phase I Study to Determine the Safety and Pharmacokinetics of Intravenous Erwinia Chrysanthemi Asparaginase in Patients With Newly Diagnosed Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia Aged 60 Years or Older
The purpose of this study is to test the safety of Erwinia Chrysanthemi asparaginase when used alone and together with chemotherapy and find out what effects, if any, it has on people.
Read the detailed description
The study consists of three treatment phases.
- Steroid prophase (days -3 to -1): To prevent rapid leukemia progression and reduce tumor load, patients will receive either prednisone 60mg/m2 oral daily or equivalent corticosteroid daily for 3 days.
- Asparaginase phase (days 1 - 14): Patients will receive Erwinia asparaginase 25,000 IU/m2 IV three times a week on a Monday, Wednesday, Friday (MWF) schedule for 2 weeks. Patients are permitted to begin Erwinia asparaginase on Monday, Wednesday, or Friday, so that their schedules are defined as MWF, WFM, or FMW. For rapid progression of disease (defined by rising WBC >30K with > 50% peripheral blasts), prednisone 60mg/m2 oral daily or equivalent corticosteroid daily may be added. Bone marrow aspirate and/or biopsy will be performed on days 13-15 of the asparaginase treatment for early disease response assessment.
- Chemotherapy phase (days 15 - 42):
- Cyclophosphamide 650 mg/m2 IV on day 15
- Vincristine 1.4 mg/m2 (max 2mg) IV on days 15, 22, 29, and 36
- Prednisone 60mg/m2 (or equivalent corticosteroid) oral daily for 28 days on days 15 - 42
- Erwinia asparaginase 25,000 IU/m2 IV three times a week on a MWF schedule for 2 weeks on days 29 - 42 (after a two week interval without Erwinia asparaginase administered on days 1 - 14) Upon cell count recovery, a bone marrow aspirate and/or biopsy will be performed to assess the disease response. Subsequent treatments following the bone marrow evaluation will be left up to the discretion of the treating physicians. If the first 6 patients have no response or progress during the 2 weeks of asparaginase phase of treatment with or without steroid, the next 6 patients will start directly with the chemotherapy phase (days 15-42) of treatment consisting of cyclophosphamide, vincristine, and prednisone with Erwinia asparaginase.
CNS prophylaxis:
- IT methotrexate 12mg (flat dose) between days 15 - 22
- IT methotrexate 12mg (flat dose) between days 22- 29
- There will be a minimal interval between doses of 7 days
- Conditions
- Acute Lymphoblastic Leukemia (ALL), Newly Diagnosed Philadelphia Chromosome Negative, Aged 60 Years or Older
- Being tested
- Erwinia Chrysanthemi asparaginase
- Keywords
- Erwinia Chrysanthemi Asparaginase, 15-107
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erwinia Chrysanthemi asparaginaseDrug
| Study group | Role | What they receive |
|---|---|---|
| Erwinia Chrysanthemi asparaginase | Experimental | This is a phase I trial designed to assess the safety of IV Erwinia Chrysanthemi asparaginase during initial induction in patients aged 60 years or older with newly diagnosed Ph-negative ALL. A total of 12 patients will be accrued to the study. Receives: Drug: Erwinia Chrysanthemi asparaginase |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients who have a dose limiting toxicity (DLT)
DLTs are defined as any of the following: grade 4 pancreatitis, grade 4 hemorrhage, grade 4 thromboembolism, grade 4 hyperbilirubinemia and any grade 5 toxicity attributable (definitely, probably or possible) to Erwinia asparaginase.
Measured: with in 6 weeks of starting the study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic Leukemia (ALL)Studies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Jazz Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Jae Park, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647190
- Sponsor's protocol ID
- 15-107
- Status last verified
- Jun 2017
- First submitted
- 5 Jan 2016
- Last updated
- 2 Jun 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Determine the Safety and Pharmacokinetics of Intravenous Erwinia Chrysanthemi Asparaginase in Patients With Newly Diagnosed Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia Aged 60 Years or Older
- ClinicalTrials.gov ID
- NCT02647190
- Acronym / sponsor ID
- 15-107
- Conditions
- Acute Lymphoblastic Leukemia (ALL), Newly Diagnosed Philadelphia Chromosome Negative, Aged 60 Years or Older
- Keywords
- Erwinia Chrysanthemi Asparaginase, 15-107
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Jazz Pharmaceuticals
- Study start
- Jan 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 6 Jan 2016 (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 purpose of this study is to test the safety of Erwinia Chrysanthemi asparaginase when used alone and together with chemotherapy and find out what effects, if any, it has on people.
Detailed description
The study consists of three treatment phases.
- Steroid prophase (days -3 to -1): To prevent rapid leukemia progression and reduce tumor load, patients will receive either prednisone 60mg/m2 oral daily or equivalent corticosteroid daily for 3 days.
- Asparaginase phase (days 1 - 14): Patients will receive Erwinia asparaginase 25,000 IU/m2 IV three times a week on a Monday, Wednesday, Friday (MWF) schedule for 2 weeks. Patients are permitted to begin Erwinia asparaginase on Monday, Wednesday, or Friday, so that their schedules are defined as MWF, WFM, or FMW. For rapid progression of disease (defined by rising WBC >30K with > 50% peripheral blasts), prednisone 60mg/m2 oral daily or equivalent corticosteroid daily may be added. Bone marrow aspirate and/or biopsy will be performed on days 13-15 of the asparaginase treatment for early disease response assessment.
- Chemotherapy phase (days 15 - 42):
- Cyclophosphamide 650 mg/m2 IV on day 15
- Vincristine 1.4 mg/m2 (max 2mg) IV on days 15, 22, 29, and 36
- Prednisone 60mg/m2 (or equivalent corticosteroid) oral daily for 28 days on days 15 - 42
- Erwinia asparaginase 25,000 IU/m2 IV three times a week on a MWF schedule for 2 weeks on days 29 - 42 (after a two week interval without Erwinia asparaginase administered on days 1 - 14) Upon cell count recovery, a bone marrow aspirate and/or biopsy will be performed to assess the disease response. Subsequent treatments following the bone marrow evaluation will be left up to the discretion of the treating physicians. If the first 6 patients have no response or progress during the 2 weeks of asparaginase phase of treatment with or without steroid, the next 6 patients will start directly with the chemotherapy phase (days 15-42) of treatment consisting of cyclophosphamide, vincristine, and prednisone with Erwinia asparaginase.
CNS prophylaxis:
- IT methotrexate 12mg (flat dose) between days 15 - 22
- IT methotrexate 12mg (flat dose) between days 22- 29
- There will be a minimal interval between doses of 7 days
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erwinia Chrysanthemi asparaginase | Experimental | Drug: Erwinia Chrysanthemi asparaginaseThis is a phase I trial designed to assess the safety of IV Erwinia Chrysanthemi asparaginase during initial induction in patients aged 60 years or older with newly diagnosed Ph-negative ALL. A total of 12 patients will be accrued to the study. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Ages 60 years or older
- Previously untreated Philadelphia chromosome negative acute lymphoblastic leukemia
- No prior treatment for ALL, except steroids or hydroxyurea (stopped within 24 hour before start of protocol treatment)
- Serum creatinine ≤ 2 x upper limit of normal (ULN)
- Adequate liver function, including total bilirubin ≤ 1.5 x ULN unless the patient has documented Gilbert syndrome, and aspartate and alanine aminotransferase (AST and ALT) ≤ 5 x ULN. If organ function abnormalities are considered due to leukemic infiltration, total bilirubin must be ≤ 2 x ULN.
Key exclusion criteria (6 listed)
- Lymphoblastic crisis of CML
- Mature B cell (Burkitt's) ALL
- Active central nervous system (CNS) leukemia, as defined by unequivocal morphologic evidence of lymphoblasts in the cerebrospinal fluid (CSF), use of CNS-directed local treatment for active disease within the prior 28 days, symptomatic CNS leukemia (i.e., cranial nerve palsies or other significant neurologic dysfunction) within 28 days. Prophylactic intrathecal medication is not a reason for exclusion.
- Pregnant women or women who are breast-feeding
- Concurrent active malignancy requiring immediate therapy
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 |
|---|---|---|
| Erwinia Chrysanthemi asparaginase | Drug | Erwinia Chrysanthemi asparaginase |
Primary outcome
proportion of patients who have a dose limiting toxicity (DLT)
Time frame: with in 6 weeks of starting the study drug
DLTs are defined as any of the following: grade 4 pancreatitis, grade 4 hemorrhage, grade 4 thromboembolism, grade 4 hyperbilirubinemia and any grade 5 toxicity attributable (definitely, probably or possible) to Erwinia asparaginase.
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 2 Jun 2017.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Jae Park, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Erwinia Chrysanthemi asparaginase in people with Acute Lymphoblastic Leukemia (ALL) and Newly Diagnosed Philadelphia Chromosome Negative, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
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 6 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 2 Jun 2017. 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 United States. 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 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?
proportion of patients who have a dose limiting toxicity (DLT) (time frame: with in 6 weeks of starting the study drug). 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 2 Jun 2017.