Non Hodgkin's LymphomaPhase 1NCT01789723
Phase 1 Study of Fusilev to Prevent or Reduce Mucositis in Patients With Non-Hodgkin's Lymphoma Receiving Folotyn
A Phase 1 study testing Fusilev and Folotyn in people with Non Hodgkin's Lymphoma, run by Acrotech Biopharma Inc..
Trial summary
The purpose of this study is determine the optimal dose and schedule of Fusilev to prevent or reduce Mucositis in patients with Non-Hodgkin's Lymphoma receiving Folotyn treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Hodgkin's Lymphoma
- What is being tested?
- Fusilev and Folotyn
- 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
- Mar 2013to Mar 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Patients with relapsed or refractory NHL who are eligible for Folotyn treatment. Patient has histologically/cytologically confirmed, measurable (lesion or node ≥ 2 cm by computed tomography [CT]
- Progressive disease or persistent disease after at least 1 prior treatment
- ECOG performance status ≤ 2
- Adequate hematological, hepatic, and renal function
Who cannot join
- Active concurrent malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix)
- Congestive heart failure
- Uncontrolled hypertension
- Known human immunodeficiency virus (HIV)-positive diagnosis
- Active uncontrolled infection, underlying medical condition, or other serious illness that would impair the ability of the patient to receive protocol treatment
- Major surgery within 14 days of enrollment
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- Pregnant or breast-feeding women
- Symptomatic central nervous system (CNS) metastases or lesions for which treatment is required. Patients who received prophylactic CNS treatment are eligible
- Previous exposure to pralatrexate
About this study
Official title: An Open Label, Multicenter, Dose Finding, Phase 1 Study of Fusilev® (Levoleucovorin) to Prevent or Reduce Mucositis in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma Receiving Folotyn® (Pralatrexate)
The purpose of this study is determine the optimal dose and schedule of Fusilev to prevent or reduce Mucositis in patients with Non-Hodgkin's Lymphoma receiving Folotyn treatment.
Read the detailed description
This is an open label, uncontrolled, nonrandomized, multicenter, dose finding, Phase 1 study primarily to determine the optimal dose and schedule of Fusilev to prevent or reduce Folotyn-related Grade 3 or higher oral Mucositis.
- Conditions
- Non Hodgkin's Lymphoma
- Being tested
- Fusilev, Folotyn
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FusilevDrug
Also called Fusilev - (Levoleucovorin)
Fusilev will be administered by IV push (3-5 minutes) at a dose of 5 mg/m2. Fusilev administration, QID or BID will start 24 ± 3 hours after Folotyn administration depending on the dose cohort.
FolotynDrug
Also called Folotyn - (Pralatrexate)
A cycle of Folotyn treatment is 7 weeks, 6 weeks of treatment followed by 1 week of rest.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Fusilev - 10 doses | Experimental | Fusilev: 5 mg/m2 QID, starting on Day 2 (24 ± 3 hours after Folotyn dose) for a total of 10 doses Day 2: 4 doses Day 3: 4 doses Day 4: 2 doses.
Folotyn: 30 mg/m2 once weekly for 6 weeks Receives: Drug: Fusilev; Drug: Folotyn |
| Cohort 2: Fusilev - 6 doses | Experimental | Fusilev: 5 mg/m2 BID, on Days 2 (24 ± 3 hours after Folotyn dose), 3, and 4.
Folotyn: 30 mg/m2 once weekly for 6 weeks Receives: Drug: Fusilev; Drug: Folotyn |
| Cohort 3: Fusilev - 4 doses | Experimental | 5 mg/m2 BID, on Days 2 (24 ± 3 hours after Folotyn dose) and 3.
Folotyn: 30 mg/m2 once weekly for 6 weeks Receives: Drug: Fusilev; Drug: Folotyn |
| Cohort 4: Fusilev - 2 doses | Experimental | 5 mg/m2 BID, on Day 2 (24 ± 3 hours after Folotyn dose.
Folotyn: 30 mg/m2 once weekly for 6 weeks Receives: Drug: Fusilev; Drug: Folotyn |
| Cohort 5: Fusilev - 1 dose | Experimental | Fusilev: 5 mg/m2 once on Day 2.
Folotyn: 30 mg/m2 once weekly for 6 weeks Receives: Drug: Fusilev; Drug: Folotyn |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal dose and schedule of Fusilev to prevent or reduce mucositis
The patient will be seen in the clinic for an oral mucositis assessment at baseline. During the 6 weeks of Folotyn treatment, oral mucositis assessment will be performed weekly prior to each Folotyn dose and again on Day 4 (prior to the Fusilev dose when applicable) by a qualified health care professional. Patients will complete an Oral Mucositis Daily Questionnaire (OMQD) starting at Day 1 of Week 1 and ending at the End of Treatment Visit.
Measured: Up to 8 weeks
Secondary outcomes (2)
Impact of Fusilev on Folotyn related Oral Mucositis
To determine the impact of Fusilev on the number of Folotyn-related dose modifications secondary to oral mucositis To determine the impact of Fusilev on the frequency of Folotyn-related oral mucositis To determine the impact of Fusilev on the number of Folotyn doses delivered
Measured: 7 weeks
Relationship between Fusilev use and oral mucositis
To determine the relationship between Fusilev use and oral mucositis as a function of the pretreatment homocysteine (HCY) and methylmalonic acid (MMA) levels
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2015 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Hodgkin's LymphomaStudies 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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acrotech Biopharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ahmed Sawas, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01789723
- Sponsor's protocol ID
- SPI-FUS-12-102
- Status last verified
- Jan 2020
- First submitted
- 7 Feb 2013
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multicenter, Dose Finding, Phase 1 Study of Fusilev® (Levoleucovorin) to Prevent or Reduce Mucositis in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma Receiving Folotyn® (Pralatrexate)
- ClinicalTrials.gov ID
- NCT01789723
- Acronym / sponsor ID
- SPI-FUS-12-102
- Conditions
- Non Hodgkin's Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Acrotech Biopharma Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 12 Feb 2013 (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 determine the optimal dose and schedule of Fusilev to prevent or reduce Mucositis in patients with Non-Hodgkin's Lymphoma receiving Folotyn treatment.
Detailed description
This is an open label, uncontrolled, nonrandomized, multicenter, dose finding, Phase 1 study primarily to determine the optimal dose and schedule of Fusilev to prevent or reduce Folotyn-related Grade 3 or higher oral Mucositis.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Fusilev - 10 doses | Experimental | Drug: Fusilev, Drug: FolotynFusilev: 5 mg/m2 QID, starting on Day 2 (24 ± 3 hours after Folotyn dose) for a total of 10 doses Day 2: 4 doses Day 3: 4 doses Day 4: 2 doses. Folotyn: 30 mg/m2 once weekly for 6 weeks |
| Cohort 2: Fusilev - 6 doses | Experimental | Drug: Fusilev, Drug: FolotynFusilev: 5 mg/m2 BID, on Days 2 (24 ± 3 hours after Folotyn dose), 3, and 4. Folotyn: 30 mg/m2 once weekly for 6 weeks |
| Cohort 3: Fusilev - 4 doses | Experimental | Drug: Fusilev, Drug: Folotyn5 mg/m2 BID, on Days 2 (24 ± 3 hours after Folotyn dose) and 3. Folotyn: 30 mg/m2 once weekly for 6 weeks |
| Cohort 4: Fusilev - 2 doses | Experimental | Drug: Fusilev, Drug: Folotyn5 mg/m2 BID, on Day 2 (24 ± 3 hours after Folotyn dose. Folotyn: 30 mg/m2 once weekly for 6 weeks |
| Cohort 5: Fusilev - 1 dose | Experimental | Drug: Fusilev, Drug: FolotynFusilev: 5 mg/m2 once on Day 2. Folotyn: 30 mg/m2 once weekly for 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years of age
- Patients with relapsed or refractory NHL who are eligible for Folotyn treatment. Patient has histologically/cytologically confirmed, measurable (lesion or node ≥ 2 cm by computed tomography [CT]
- Progressive disease or persistent disease after at least 1 prior treatment
- ECOG performance status ≤ 2
- Adequate hematological, hepatic, and renal function
Key exclusion criteria (9 listed)
- Active concurrent malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix)
- Congestive heart failure
- Uncontrolled hypertension
- Known human immunodeficiency virus (HIV)-positive diagnosis
- Active uncontrolled infection, underlying medical condition, or other serious illness that would impair the ability of the patient to receive protocol treatment
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 |
|---|---|---|
| FusilevAlso: Fusilev - (Levoleucovorin)Fusilev will be administered by IV push (3-5 minutes) at a dose of 5 mg/m2. Fusilev administration, QID or BID will start 24 ± 3 hours after Folotyn administration depending on the dose cohort. | Drug | Cohort 1: Fusilev - 10 doses, Cohort 2: Fusilev - 6 doses, Cohort 3: Fusilev - 4 doses, Cohort 4: Fusilev - 2 doses, Cohort 5: Fusilev - 1 dose |
| FolotynAlso: Folotyn - (Pralatrexate)A cycle of Folotyn treatment is 7 weeks, 6 weeks of treatment followed by 1 week of rest. | Drug | Cohort 1: Fusilev - 10 doses, Cohort 2: Fusilev - 6 doses, Cohort 3: Fusilev - 4 doses, Cohort 4: Fusilev - 2 doses, Cohort 5: Fusilev - 1 dose |
Primary outcome
Optimal dose and schedule of Fusilev to prevent or reduce mucositis
Time frame: Up to 8 weeks
The patient will be seen in the clinic for an oral mucositis assessment at baseline. During the 6 weeks of Folotyn treatment, oral mucositis assessment will be performed weekly prior to each Folotyn dose and again on Day 4 (prior to the Fusilev dose when applicable) by a qualified health care professional. Patients will complete an Oral Mucositis Daily Questionnaire (OMQD) starting at Day 1 of Week 1 and ending at the End of Treatment Visit.
2 secondary outcomes
Impact of Fusilev on Folotyn related Oral Mucositis
Time frame: 7 weeks
Relationship between Fusilev use and oral mucositis
Time frame: 7 weeks
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 23 Jan 2020.
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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.
Ahmed Sawas, MD principal investigator
Columbia University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fusilev and Folotyn in people with Non Hodgkin's Lymphoma, run by Acrotech Biopharma Inc..
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 5 inclusion and 9 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 23 Jan 2020. 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 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?
Optimal dose and schedule of Fusilev to prevent or reduce mucositis (time frame: Up to 8 weeks). 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 23 Jan 2020.