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Trial record 26 of 35 for:    pralatrexate AND cells

Study of Pralatrexate & Gemcitabine With B12 & Folic Acid to Treat Relapsed/Refractory Lymphoproliferative Malignancies

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ClinicalTrials.gov Identifier: NCT00481871
Recruitment Status : Completed
First Posted : June 4, 2007
Results First Posted : September 18, 2012
Last Update Posted : May 10, 2013
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc

Tracking Information
First Submitted Date  ICMJE June 1, 2007
First Posted Date  ICMJE June 4, 2007
Results First Submitted Date  ICMJE August 20, 2012
Results First Posted Date  ICMJE September 18, 2012
Last Update Posted Date May 10, 2013
Study Start Date  ICMJE May 2007
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2012)
Objective Responses Assessed by International Workshop Criteria (IWC) [ Time Frame: Assessed every 8 weeks (+/- 1 week) for Phase II and no less than every 3 cycles for Phase I ]
Number of participants who achieved an objective response. Objective response was defined as a tumor response assessment of either complete response (CR) or partial response (PR) and was determined only for patients with measurable disease at baseline. A tumor response assessment reported by IWC without PET was used for any analyses in cases where an IWC+PET evaluation was not done.
Original Primary Outcome Measures  ICMJE
 (submitted: June 1, 2007)
Phase 1: MTD and recommended phase 2 dose, safety and tolerability, and PK profile. Phase 2a: tolerability and preliminary efficacy (based on investigator assessment of response) in relapsed/refractory PTCL.
Change History Complete list of historical versions of study NCT00481871 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2012)
  • Duration of Response [ Time Frame: Response assessments were performed no less than every 3 cycles in the Phase 1 part of the study and every 8 weeks (± 1 week) in the Phase 2a part of the study ]
    Duration of response was defined as the number of days between the date of first tumor response assessment of objective response to the time of the first tumor response assessment of progressive disease (PD) or death due to any cause (date of first PD assessment or death - date of first objective response assessment + 1)
  • Progression-free Survival (PFS) Time [ Time Frame: Response assessments were performed no less than every 3 cycles in the Phase 1 part of the study and every 8 weeks (± 1 week) in the Phase 2a part of the study ]
    PFS time was calculated as the number of days from study day 1 to the date of PD or death, regardless of cause (date of PD or death - study day 1 + 1).
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Pralatrexate & Gemcitabine With B12 & Folic Acid to Treat Relapsed/Refractory Lymphoproliferative Malignancies
Official Title  ICMJE A Phase 1/2a Open-label Study of Pralatrexate and Gemcitabine With Vitamin B12 and Folic Acid Supplementation in Patients With Relapsed or Refractory Lymphoproliferative Malignancies
Brief Summary

This study is for patients with lymphoproliferative malignancies that have progressed after receiving a previous treatment (relapsed) or are no longer responding to treatment (refractory). To be in this study, patients must have certain types of Hodgkin's lymphoma (HL), peripheral T-cell lymphoma (PTCL), or B-cell lymphoma, including Waldenstrom's macroglobulinemia.

This study is being done to find doses of the combination of pralatrexate and gemcitabine with vitamin B12 and folic acid that can be safely given to patients with these types of lymphoma and explore the effectiveness of the treatment.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Relapsed or Refractory Lymphoproliferative Malignancies
  • Hodgkin's Lymphoma
  • Peripheral T-cell Lymphoma
  • B-cell Lymphoma
  • Waldenstrom's Macroglobulinemia
Intervention  ICMJE
  • Drug: Pralatrexate Injection

    Intravenous (IV) push administration over 30 seconds to 5 minutes into a patent IV line containing normal saline (0.9% sodium chloride).

    Sequential Dosing: 10 mg/m2 every 2 weeks (days 1 and 15) of a 4-week cycle until criteria for discontinuation per the protocol are met.

    Same Day Dosing: 15 mg/m2 every 2 weeks (days 1 and 15) of a 4-week cycle until criteria for discontinuation per the protocol are met.

    Other Names:
    • FOLOTYN
    • PDX
    • Pralatrexate
    • (RS)-10-propargyl-10-deazaaminopterin
  • Drug: Gemcitabine Hydrochloride

    Gemcitabine will be prepared and administered as an IV infusion as per manufacturer instructions.

    Sequential Dosing: 400 mg/m2 every 2 weeks (days 2 and 16) of a 4-week cycle until criteria for discontinuation per the protocol are met.

    Same Day Dosing: 600 mg/m2 every 2 weeks (days 1 and 15) of a 4-week cycle until criteria for discontinuation per the protocol are met.

    Other Names:
    • Gemcitabine
    • Gemzar®, Eli Lilly and Company
    • Gemcitabine Hydrochloride (HCl) for Injection
  • Dietary Supplement: Vitamin B12

    1 mg intramuscular injection

    Administered within 10 weeks of enrollment, every 8-10 weeks throughout the study and for at least 30 days after last dose of pralatrexate.

    Other Name: Cyanocobalamin
  • Dietary Supplement: Folic Acid

    1 mg orally

    Administered daily for at least 7 days prior to start of pralatrexate, throughout the study and for at least 30 days after last dose of pralatrexate.

    Other Names:
    • Vitamin B9
    • Folate
    • Folacin
Study Arms  ICMJE
  • Experimental: Pralatrexate & Gemcitabine - Sequential Days
    Interventions:
    • Drug: Pralatrexate Injection
    • Drug: Gemcitabine Hydrochloride
    • Dietary Supplement: Vitamin B12
    • Dietary Supplement: Folic Acid
  • Experimental: Pralatrexate & Gemcitabine - Same Day
    Interventions:
    • Drug: Pralatrexate Injection
    • Drug: Gemcitabine Hydrochloride
    • Dietary Supplement: Vitamin B12
    • Dietary Supplement: Folic Acid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 16, 2012)
119
Original Estimated Enrollment  ICMJE
 (submitted: June 1, 2007)
84
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Phase 1: Histologically/cytologically confirmed lymphoproliferative malignancy. Patients with Hodgkin lymphoma (HL) or non-HL are eligible, with exceptions per exclusion criteria.
  • Phase 2a: Histologically/cytologically confirmed HL, peripheral T-cell lymphoma (PTCL), or B-cell lymphoma including Waldenström's macroglobulinemia, with exceptions per exclusion criteria.
  • Progression of disease (PD) after at least 1 prior treatment (any number of prior therapies allowed). PD after last prior treatment and recovered from toxic effects of prior therapy. Patients treated with an FDA-approved monoclonal antibody therapy may be enrolled at any time after the therapy if they have PD.
  • PTCL patients must have received single-agent pralatrexate as a prior therapy.
  • Eastern Cooperative Oncology Group performance status ≤ 2.
  • Adequate blood, liver and kidney function per laboratory tests.
  • Has taken 1 mg daily oral folic acid for at least 7 days prior to planned start of pralatrexate and received 1 mg vitamin B12 intramuscularly within 10 weeks of the planned start of pralatrexate.
  • Females of childbearing potential must practice a medically acceptable contraceptive regimen from first dose until at least 30 days after last dose of pralatrexate and have a negative serum pregnancy test within 14 days prior to the first day of study treatment. Postmenopausal (defined as greater than 12 months since last menses) and surgically sterilized females do not require this test.
  • Males who are not surgically sterile must practice a medically acceptable contraceptive regimen from first dose until at least 90 days after last dose of pralatrexate.
  • Give written informed consent.

Exclusion Criteria:

  • Phase 1

    1. B-cell: lymphoplasmacytic lymphoma (± Waldenström's macroglobulinemia); plasma cell myeloma/plasmacytoma; hairy cell leukemia.

  • Phase 2a

    1. PTCL: precursor T/Natural Killer (NK) neoplasms, with the exception of blastic NK lymphoma; T-cell prolymphocytic leukemia; T-cell large granular lymphocytic leukemia; mycosis fungoides (MF), except transformed MF; Sézary syndrome; primary cutaneous CD30+ disorders: Anaplastic large cell lymphoma and lymphomatoid papulosis.
    2. B-cell: plasma cell myeloma/plasmacytoma; hairy cell leukemia.
  • Relapsed HL or diffuse large B-cell lymphoma patients who are candidates for high dose therapy and autologous stem cell transplantation (SCT) and for whom it 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 malignancy, must be disease free for at least 5 years.
  • Congestive heart failure Class III/IV.
  • Uncontrolled hypertension.
  • Human immunodeficiency virus (HIV)- positive diagnosis with CD4 less than 100 or detectable viral load within past 3 months and receiving anti-retroviral therapy.
  • Hepatitis B or C virus with detectable viral load or immunological evidence of chronic active disease or receiving/requiring antiviral therapy.
  • Central nervous system disease.
  • Undergone an allogeneic SCT.
  • Patients with disease refractory to peripheral blood SCT, or who have relapsed less than 100 days since an autologous or peripheral blood SCT.
  • Active uncontrolled infection, underlying medical condition including unstable heart disease, or other serious illness impairing the ability to receive protocol treatment.
  • Major surgery within 2 weeks of planned start of treatment.
  • Receipt of any conventional chemotherapy or radiation therapy (encompassing greater than 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 7 days of study treatment, unless on a continuous dose of no more than 10 mg/day of prednisone for at least 1 month.
  • Use of investigational drugs, biologics, or devices within 4 weeks prior to study treatment or planned use during the study.
  • Received a monoclonal antibody within 3 months without evidence of PD.
  • Previous exposure to pralatrexate and/or gemcitabine if discontinued due to treatment-related toxicity.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00481871
Other Study ID Numbers  ICMJE PDX-009
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Spectrum Pharmaceuticals, Inc
Study Sponsor  ICMJE Spectrum Pharmaceuticals, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Michael Saunders, MD Spectrum Pharmaceuticals, Inc
PRS Account Spectrum Pharmaceuticals, Inc
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP