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Lymphoma, B-CellPhase 2NCT00998946

Study of Pralatrexate to Treat Participants With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma

A Phase 2 study testing Pralatrexate, Vitamin B12 and Folic Acid in people with Lymphoma, B-Cell, run by Spectrum Pharmaceuticals, Inc at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether pralatrexate, given with vitamin B12 and folic acid, is effective in the treatment of relapsed or refractory B-cell Non-Hodgkin's lymphoma (NHL). The study will also investigate the safety of pralatrexate with vitamin B12 and folic acid in this participant population. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, B-Cell
What is being tested?
Pralatrexate, Vitamin B12 and Folic Acid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
11 sitesUnited States
Study dates
Sep 2009to Aug 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Histologically/cytologically confirmed, measurable (lesion or node =2 cm by CT [at least 1 cm if by spiral CT]) B-cell Non-Hodgkin's Lymphoma, using the Revised European American Lymphoma (REAL) World Health Organization (WHO) disease classification
  • Progressive or persistent disease after ≥ 1 prior treatment(s)
  • Recovered from toxic effects of prior treatment
  • At least 4 weeks since most recent cytotoxic therapy
  • Easter Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Adequate blood, liver, and kidney functions as defined by laboratory levels
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  • 1.0 mg/day orally of folic acid for at least 7 days prior \& 1 mg intramuscular of vitamin B12 within 10 weeks of the planned start of pralatrexate
  • Females of childbearing potential must agree to use medically acceptable birth control from start of pralatrexate until at least 30 days after the last administration of pralatrexate and must have a negative serum pregnancy test within 14 days prior to the first day of study treatment
  • Males who are not surgically sterile must agree to use medically acceptable birth control from start of pralatrexate until at least 90 days after the last administration of pralatrexate
  • Available for repeat dosing and follow-up
  • Able to give written informed consent

Who cannot join

  • Relapsed participants with diffuse large B-cell lymphoma (DLBCL) who are candidates for high-dose therapy and autologous stem cell transplantation (SCT) and for whom high-dose therapy and autologous SCT is a standard curative option
  • Active concurrent malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix). If there is a history of prior malignancies other than those exceptions listed above, the participant must be disease-free for ≥ 5 years. Participants with other prior malignancies < 5 years before study entry may still be enrolled if they have received treatment resulting 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 according to the New York Heart Association Functional Classification
  • Uncontrolled hypertension
  • Known human immunodeficiency virus (HIV)-positive diagnosis
  • Symptomatic central nervous system (CNS) metastases or lesions for which treatment is required. Participants who received prophylactic CNS treatment are eligible.
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  • Participants who have undergone an allogeneic SCT
  • Participants who have relapsed < 100 days from the time of an autologous SCT
  • Participants with disease refractory to peripheral blood SCT or who have relapsed < 100 days from the time of transplant
  • Active uncontrolled infection, underlying medical condition, or other serious illness that would impair the ability of the participant to receive protocol treatment.
  • Major surgery within 14 days of enrollment
  • Receipt of any conventional chemotherapy or radiation therapy (encompassing a substantial [> 10%] amount of bone marrow) within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to study treatment or planned use during the course of the study
  • Receipt of systemic corticosteroids within 1 week of study treatment, unless participant has been taking a continuous dose of no more than 10 mg/day of prednisone or its equivalent for at least 1 month
  • Use of any investigational drugs, biologics, or devices within 4 weeks prior to study treatment or planned use during the course of the study
  • Previous exposure to pralatrexate
  • Females who are pregnant or breastfeeding

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • Tower Cancer Research Foundation

    Beverly Hills, California, 90211

  • Frontier Cancer Center and Blood Institute

    Billings, Montana, 59102

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Gundersen Lutheran

    La Crosse, Wisconsin, 54601

  • Owsley Brown Frazier Cancer Center

    Louisville, Kentucky, 40245

  • University of Wisconsin, Paul P. Carbone Comprehensive Cancer Center

    Madison, Wisconsin, 53705-2275

  • The West Clinic (ACORN)

    Memphis, Tennessee, 38120

  • New York University Hospital

    New York, New York, 10016

  • Providence Cancer Center

    Portland, Oregon, 97225

  • Kootenai Cancer Center

    Post Falls, Idaho, 83854

  • Overton Brooks VA Medical Center

    Shreveport, Louisiana, 71101

Other trials in United States

About this study

Official title: A Phase 2, Single-arm, Open-label, Multi-center Study of Pralatrexate in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma

The purpose of this study is to determine whether pralatrexate, given with vitamin B12 and folic acid, is effective in the treatment of relapsed or refractory B-cell Non-Hodgkin's lymphoma (NHL). The study will also investigate the safety of pralatrexate with vitamin B12 and folic acid in this participant population. Additionally, this study includes the collection of blood samples to investigate the pharmacokinetics (PK) of pralatrexate in this participant population (PK is the activity of a drug in the body over a period of time, including how the drug is absorbed, distributed in the body, localized in the tissues, and excreted from the body).

Being tested
Pralatrexate, Vitamin B12, Folic Acid
Keywords
Relapsed, Refractory, Non-Hodgkin's
Medical subject headings
Lymphoma, B-Cell, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PralatrexateDrug

    Also called FOLOTYN, PDX, (RS)-10-propargyl-10-deazaaminopterin

    Pralatrexate injection administered as intravenous (IV) push

  • Vitamin B12Dietary supplement

    Also called Cyanocobalamin

    1 mg intramuscular (IM) injection

  • Folic AcidDietary supplement

    Also called Vitamin B9, Folate, Folacin

    Oral 1 mg tablet

Study groups in NCT00998946
Study groupRoleWhat they receive
PralatrexateExperimentalParticipants received pralatrexate at an initial dose of 30 mg/m^2, as IV push over 30 seconds to 5 minutes via a patent free-flowing IV line containing normal saline on Days 1, 8 and 15 of a 4-week cycle (weekly for 3 weeks with 1 week of rest) until criteria for discontinuation per protocol were met. The initial dose of 30 mg/m^2 may be reduced to 20 mg/m^2 weekly, permitted per protocol defined criteria. If pralatrexate 20 mg/m^2/week was not tolerated, pralatrexate had to be discontinued. Dose re-escalation was not allowed once dose reduction was done. Participants had dietary supplement of vitamin B12 and folic acid along with pralatrexate. Vitamin B12, given as 1mg IM, within 10 weeks of start of pralatrexate dosing, every 8-10 weeks throughout the study and for at least 30 days post last dose of pralatrexate. Folic acid was given 1mg daily, orally, for at least 7 days prior to start of pralatrexate, throughout the study and for at least 30 days post last dose of pralatrexate.
Receives: Drug: Pralatrexate; Dietary Supplement: Vitamin B12; Dietary Supplement: Folic Acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    Objective response rate was defined as the percentage of participants with a complete response (CR) or a partial response (PR). Tumor response was evaluated on the basis of clinical and radiological criteria, assessed according to International Workshop Criteria (IWC) with or without positron emission tomography (PET) scans. Per IWC criteria CR is defined as complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities definitely assignable to non-Hodgkin's lymphoma (NHL) and PR is defined as >= 50% decrease in sum of the product of the perpendicular diameters (SPD) of the six largest dominant nodes or nodal masses and no increase in size of other nodes, liver or spleen.

    Measured: Up to 24 months

Secondary outcomes (3)

  1. Duration of Response (DOR)

    The Duration of Response was defined as the time (in months) from the date the measurement criteria were first met for CR or PR (whichever status was recorded first) until the first subsequent date that relapse or progression was documented. It was assessed according to IWC with or without PET, subject to its availability. Per IWC, progression was defined as a ≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions.

    Measured: Up to 24 months

  2. Progression Free Survival (PFS)

    Progression-free survival (PFS) was the duration of time (in months) from first administration of study treatment to date of first documented progression or death from any cause. It was based on tumor assessments made according to the IWC with or without PET scans, subject to their availability. Per IWC, progression was defined as a ≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions.

    Measured: Up to 24 months

  3. Overall Survival (OS)

    Overall Survival was the time (in months) from first administration of study treatment until the date of death.

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionAug 2012
  4. Study completionAug 2012

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00998946
Sponsor's protocol ID
PDX-015
Status last verified
Oct 2021
First submitted
19 Oct 2009
Last updated
5 Nov 2021
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pralatrexate, Vitamin B12 and Folic Acid in people with Lymphoma, B-Cell, run by Spectrum Pharmaceuticals, Inc at 11 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 11 inclusion and 16 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 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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 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?

Yes. Results are posted in the registry (first posted 5 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Objective Response Rate (ORR) (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00998946.

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 5 Nov 2021.

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