Cutaneous T-cell LymphomaPhase 1NCT00554827
Study of Pralatrexate in Patients With Relapsed or Refractory Cutaneous T-cell Lymphoma
A Phase 1 study testing Vitamin B12, Folic Acid and Pralatrexate in people with Cutaneous T-cell Lymphoma, run by Acrotech Biopharma Inc. at 10 sites in United States.
Trial summary
This study is being conducted to identify how much and how often pralatrexate, given with vitamin B12 and folic acid, can be given safely to patients with cutaneous T-cell lymphoma (CTCL) that has relapsed (returned after responding to previous treatment) or is refractory (has not responded to previous treatment). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous T-cell Lymphoma
- What is being tested?
- Vitamin B12, Folic Acid and Pralatrexate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 10 sitesUnited States
- Study dates
- Aug 2007to Feb 2012
- 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
- Confirmed relapsed or refractory cutaneous T-cell lymphoma (CTCL):
- Mycosis fungoides Stage IB or higher
- Sézary syndrome
- Primary cutaneous anaplastic large cell
- No curative treatment options.
- Progression of disease (PD) or relapse of disease after at least 1 previous systemic therapy, PD after last prior treatment regimen, and recovered from the toxic effects of prior therapy.
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- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
- Life expectancy ≥ 3 months.
- Adequate blood, liver, and kidney function as determined by laboratory tests.
- Methylmalonic acide (MMA) serum concentration < 200 nmol/L and homocysteine (Hcy) concentration < 10 μmol/L at screening, or receipt of 1 mg daily oral folic acid for at least 10 days prior to the planned start of pralatrexate and 1 mg intramuscular vitamin B12 within 10 weeks of the planned start of pralatrexate.
- Women of childbearing potential must use a medically acceptable contraceptive regimen from study treatment initiation until at least 30 days after the last dose of pralatrexate and must have a negative serum pregnancy test within 14 days prior to the first day of study treatment. Serum pregnancy test not required for patients who are postmenopausal (greater than 12 months since last menses) or are surgically sterilized.
- Women who are breastfeeding.
- Men who are not surgically sterile must use a medically acceptable contraceptive regimen from start of pralatrexate until at least 90 days after the last administration of pralatrexate.
- Written informed consent and privacy authorization.
Who cannot join
- Active concurrent malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix). If there is a history of prior malignancy, the patient must be disease-free for ≥ 5 years. Patients with other prior malignancies < 5 years before study entry may be enrolled if treatment resulted in complete resolution of the cancer and currently have no clinical, radiologic, or laboratory evidence of active or recurrent disease.
- Congestive heart failure Class III/IV per the New York Heart Association Heart Failure Guidelines.
- Uncontrolled hypertension.
- Human immunodeficiency virus (HIV)-positive diagnosis with a CD4 count of <100 mm3 or detectable viral load within the past 3 months, and is receiving combination anti-retroviral therapy.
- Symptomatic central nervous system metastases or lesions for which treatment is required.
- Active uncontrolled infection, underlying medical condition that would impair ability to receive protocol treatment.
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- Major surgery within 2 weeks of planned start of treatment.
- Receipt of any conventional chemotherapy or radiation therapy (RT) encompassing >10% of bone marrow within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to study treatment or planned use during the study.
- Receipt of systemic corticosteroids within 3 weeks of study treatment, unless on a continuous dose of ≤10 mg/day of prednisone for at least 1 month.
- Initiation of or change in dosage of topical corticosteroids within 3 weeks of study treatment (topical steroid use within 3 weeks is allowed if strength/use has been stable for at least 1 month; topical corticosteroids cannot be started during the study).
- Use of investigational drugs, biologics, or devices within 4 weeks prior to study treatment or planned use during the study.
- Receipt of a monoclonal antibody within 3 months without evidence of progression.
- Use of oral retinoids within 4 weeks of study treatment or high-dose vitamin A.
- Previous exposure to pralatrexate, unless the patient was on this study, achieved a complete or partial response, and was taken off study treatment because of investigator decision, and subsequently experienced disease recurrence or progressive disease.
- Re-entering patients: must not have received subsequent therapy for CTCL during the time off initial study treatment.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Emory University
Atlanta, Georgia, 30322
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
City of Hope National Medical Center
Duarte, California, 91010
University of Texas MD Anderson Cancer Center
Houston, Texas, 77080-4009
Yale University School of Medicine
New Haven, Connecticut, 06519
Memorial Sloan-Kettering Cancer Center
New York, New York, 10017
Columbia University Medical Center
New York, New York, 10032
Stanford University School of Medicine
Redwood City, California, 94063
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Phase 1, Open-label Study of Pralatrexate With Vitamin B12 and Folic Acid Supplementation in Patients With Relapsed or Refractory Cutaneous T-cell Lymphoma
This study is being conducted to identify how much and how often pralatrexate, given with vitamin B12 and folic acid, can be given safely to patients with cutaneous T-cell lymphoma (CTCL) that has relapsed (returned after responding to previous treatment) or is refractory (has not responded to previous treatment). It is also being conducted to get information on whether or not pralatrexate is effective in treating relapsed or refractory CTCL.
Read the detailed description
This is a Phase 1, single-arm, open-label, multi-center study designed to determine an effective and well-tolerated dose and schedule of pralatrexate when administered concurrently with vitamin B12 and folic acid supplementation to patients with relapsed or refractory CTCL. The start of study treatment is defined as the initiation of pralatrexate. A patient may begin pralatrexate, provided he/she has methylmalonic acid (MMA) serum concentrations < 200 nmol/L and homocysteine (Hcy) concentrations < 10 μmol/L at screening. If a patient has elevated MMA and/or Hcy concentrations, vitamin supplementation will be initiated at least 10 days prior to pralatrexate initiation. Once the patient is on study, the dosing of vitamin supplementation must adhere to the schedule defined by the protocol. Vitamin supplementation will consist of vitamin BB12
1 mg intramuscular (IM) every (q) 8-10 weeks, and folic acid 1 mg by mouth (PO) once a day (QD).
- Conditions
- Cutaneous T-cell Lymphoma
- Being tested
- Vitamin B12, Folic Acid, Pralatrexate
- Keywords
- Relapsed or Refractory Cutaneous T-cell Lymphoma, Lymphoma, Cutaneous T-cell Lymphoma, T-cell Lymphoma, Mycosis fungoides, Sézary syndrome, Primary cutaneous anaplastic large cell
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous, Recurrence, Lymphoma, Lymphoma, T-Cell, Mycosis Fungoides, Sezary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin B12Dietary supplement
Also called Cyanocobalamin
1 mg intramuscular injection
Administered at least 10 days prior to start of pralatrexate if patient has elevated methylmalonic acid (MMA) and/or homocysteine(Hcy) levels.
Administered every 8-10 weeks throughout the study and for at least 30 days after last dose of pralatrexate.
Folic AcidDietary supplement
Also called Vitamin B9, Folate, Folacin
1 mg orally
Administered at least 10 days prior to start of pralatrexate if patient has elevated methylmalonic acid (MMA) and/or homocysteine(Hcy) levels.
Administered daily throughout the study and for at least 30 days after last dose of pralatrexate.
PralatrexateDrug
Also called FOLOTYN,PDX,Pralatrexate,(RS)-10-propargyl-10-deazaaminopterin
Intravenous (IV) push over 3-5 minutes into a patent IV line containing normal saline (0.9% sodium chloride). Pralatrexate will be administered via intravenous (IV) push over 3-5 minutes. The frequency of pralatrexate will be administered weekly for 3 or
| Study group | Role | What they receive |
|---|---|---|
| Pralatrexate Injection (FOLOTYN,PDX,Pralatrexate(R | Experimental | Intravenous (IV) push over 3-5 minutes into a patent IV line containing normal saline (0.9% sodium chloride).
Pralatrexate will be administered via intravenous (IV) push over 3-5 minutes. The frequency of pralatrexate will be administered weekly for 3 or 4 weeks (depending on cohort), with 1 week of rest. Receives: Dietary Supplement: Vitamin B12; Dietary Supplement: Folic Acid; Drug: Pralatrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine an Effective and Well-tolerated Dose and Schedule of Pralatrexate with Vitamin B12 and Folic Acid Supplementation for Patients with Relapsed or Refractory Cutaneous T-cell Lymphoma (CTCL)
Response rate was used as the primary measure of efficacy during the process of identifying a well-tolerated and effective dosing regimen of pralatrexate in patients with relapsed/refractory CTCL. Duration of response was defined as the number of days between the date of first tumor response assessment of objective response (CR, CRu, or PR, whichever was recorded first) and the first date that recurrent disease or PD was objectively documented or death.
Measured: Assessed at the end of every even-numbered cycle (every 8 weeks) for the first 6 months, then every 4 cycles (16 weeks)
Secondary outcomes (1)
Characterize the Safety Profile of Pralatrexate in Patients with Relapsed or Refractory CTCL.
The safety analysis set included all patients who received at least 1 dose of pralatrexate. In order to be considered evaluable in the dose-finding phase of the study, patients must have
(a) either experienced a DLT or (b) received all planned doses within the first cycle. Patients who terminated from the study prior to completion of cycle 1 for reasons other than DLTs were replaced.
Measured: Assessed at all study visits: weekly while on treatment and at safety follow-up (35 +/- 5 days post-last dose) or early termination visit (at time of withdrawal)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2007 (estimated)
- Study startAug 2007
- Primary completionJan 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous T-cell 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acrotech Biopharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Saunders, MD, Study director, Spectrum Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00554827
- Sponsor's protocol ID
- PDX-010
- Status last verified
- Jan 2020
- First submitted
- 5 Nov 2007
- Last updated
- 3 Jan 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study of Pralatrexate With Vitamin B12 and Folic Acid Supplementation in Patients With Relapsed or Refractory Cutaneous T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT00554827
- Acronym / sponsor ID
- PDX-010
- Conditions
- Cutaneous T-cell Lymphoma
- Keywords
- Relapsed or Refractory Cutaneous T-cell Lymphoma, Lymphoma, Cutaneous T-cell Lymphoma, T-cell Lymphoma, Mycosis fungoides, Sézary syndrome, Primary cutaneous anaplastic large cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Acrotech Biopharma Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Jan 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 7 Nov 2007 (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.
This study is being conducted to identify how much and how often pralatrexate, given with vitamin B12 and folic acid, can be given safely to patients with cutaneous T-cell lymphoma (CTCL) that has relapsed (returned after responding to previous treatment) or is refractory (has not responded to previous treatment). It is also being conducted to get information on whether or not pralatrexate is effective in treating relapsed or refractory CTCL.
Detailed description
This is a Phase 1, single-arm, open-label, multi-center study designed to determine an effective and well-tolerated dose and schedule of pralatrexate when administered concurrently with vitamin B12 and folic acid supplementation to patients with relapsed or refractory CTCL. The start of study treatment is defined as the initiation of pralatrexate. A patient may begin pralatrexate, provided he/she has methylmalonic acid (MMA) serum concentrations < 200 nmol/L and homocysteine (Hcy) concentrations < 10 μmol/L at screening. If a patient has elevated MMA and/or Hcy concentrations, vitamin supplementation will be initiated at least 10 days prior to pralatrexate initiation. Once the patient is on study, the dosing of vitamin supplementation must adhere to the schedule defined by the protocol. Vitamin supplementation will consist of vitamin BB12
1 mg intramuscular (IM) every (q) 8-10 weeks, and folic acid 1 mg by mouth (PO) once a day (QD).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pralatrexate Injection (FOLOTYN,PDX,Pralatrexate(R | Experimental | Dietary Supplement: Vitamin B12, Dietary Supplement: Folic Acid, Drug: PralatrexateIntravenous (IV) push over 3-5 minutes into a patent IV line containing normal saline (0.9% sodium chloride). Pralatrexate will be administered via intravenous (IV) push over 3-5 minutes. The frequency of pralatrexate will be administered weekly for 3 or 4 weeks (depending on cohort), with 1 week of rest. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Confirmed relapsed or refractory cutaneous T-cell lymphoma (CTCL):
- No curative treatment options.
- Progression of disease (PD) or relapse of disease after at least 1 previous systemic therapy, PD after last prior treatment regimen, and recovered from the toxic effects of prior therapy.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
- Life expectancy ≥ 3 months.
Key exclusion criteria (15 listed)
- Active concurrent malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix). If there is a history of prior malignancy, the patient must be disease-free for ≥ 5 years. Patients with other prior malignancies < 5 years before study entry may be enrolled if treatment resulted in complete resolution of the cancer and currently have no clinical, radiologic, or laboratory evidence of active or recurrent disease.
- Congestive heart failure Class III/IV per the New York Heart Association Heart Failure Guidelines.
- Uncontrolled hypertension.
- Human immunodeficiency virus (HIV)-positive diagnosis with a CD4 count of <100 mm3 or detectable viral load within the past 3 months, and is receiving combination anti-retroviral therapy.
- Symptomatic central nervous system metastases or lesions for which treatment is required.
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 |
|---|---|---|
| Vitamin B12Also: Cyanocobalamin1 mg intramuscular injection Administered at least 10 days prior to start of pralatrexate if patient has elevated methylmalonic acid (MMA) and/or homocysteine(Hcy) levels. Administered every 8-10 weeks throughout the study and for at least 30 days after last dose of pralatrexate. | Dietary supplement | Pralatrexate Injection (FOLOTYN,PDX,Pralatrexate(R |
| Folic AcidAlso: Vitamin B9, Folate, Folacin1 mg orally Administered at least 10 days prior to start of pralatrexate if patient has elevated methylmalonic acid (MMA) and/or homocysteine(Hcy) levels. Administered daily throughout the study and for at least 30 days after last dose of pralatrexate. | Dietary supplement | Pralatrexate Injection (FOLOTYN,PDX,Pralatrexate(R |
| PralatrexateAlso: FOLOTYN,PDX,Pralatrexate,(RS)-10-propargyl-10-deazaaminopterinIntravenous (IV) push over 3-5 minutes into a patent IV line containing normal saline (0.9% sodium chloride). Pralatrexate will be administered via intravenous (IV) push over 3-5 minutes. The frequency of pralatrexate will be administered weekly for 3 or | Drug | Pralatrexate Injection (FOLOTYN,PDX,Pralatrexate(R |
Primary outcome
Determine an Effective and Well-tolerated Dose and Schedule of Pralatrexate with Vitamin B12 and Folic Acid Supplementation for Patients with Relapsed or Refractory Cutaneous T-cell Lymphoma (CTCL)
Time frame: Assessed at the end of every even-numbered cycle (every 8 weeks) for the first 6 months, then every 4 cycles (16 weeks)
Response rate was used as the primary measure of efficacy during the process of identifying a well-tolerated and effective dosing regimen of pralatrexate in patients with relapsed/refractory CTCL. Duration of response was defined as the number of days between the date of first tumor response assessment of objective response (CR, CRu, or PR, whichever was recorded first) and the first date that recurrent disease or PD was objectively documented or death.
1 secondary outcome
Characterize the Safety Profile of Pralatrexate in Patients with Relapsed or Refractory CTCL.
Time frame: Assessed at all study visits: weekly while on treatment and at safety follow-up (35 +/- 5 days post-last dose) or early termination visit (at time of withdrawal)
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 3 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.
Michael Saunders, MD study director
Spectrum Pharmaceuticals, Inc
10 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 Vitamin B12, Folic Acid and Pralatrexate in people with Cutaneous T-cell Lymphoma, run by Acrotech Biopharma Inc. at 10 sites 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 14 inclusion and 15 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 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 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?
Determine an Effective and Well-tolerated Dose and Schedule of Pralatrexate with Vitamin B12 and Folic Acid Supplementation for Patients with Relapsed or Refractory Cutaneous T-cell Lymphoma (CTCL) (time frame: Assessed at the end of every even-numbered cycle (every 8 weeks) for the first 6 months, then every 4 cycles (16 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 3 Jan 2020.