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

This study is ongoing, but not recruiting participants.

First Received on October 19, 2009.  
Last Updated on July 3, 2012  
History of Changes
This Clinical Trial Sponsored By: Allos Therapeutics
Information provided by (Responsible Party): Allos Therapeutics
ClinicalTrials.gov Identifier: NCT00998946
 

Purpose for Clinical Trial

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 patient population. Additionally, this study includes the collection of blood samples to investigate the pharmacokinetics (PK) of pralatrexate in this patient 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).

Condition Study Intervention Clinical Trial Phase
Lymphoma, B-Cell Drug: Pralatrexate Injection
Dietary Supplement: Vitamin B12
Dietary Supplement: Folic Acid
Phase 2

Study Type: Study Interventional
Study Design: Allocation: Non-Randomized
Study Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics:
B Vitamins
Lymphoma
Drug Information available for:
Folic acid
Cyanocobalamin
Vitamin B Complex
Hydroxocobalamin
Pralatrexate

U.S. FDA Resources

Further study details as provided by Allos Therapeutics:

Primary Outcome Measures For Clinical Trial:

  • Objective Response Rate (ORR) [ Time Frame: Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care by no more than every 12 weeks (+/- 1 week) if treatment has ended. ] [ Designated as safety issue: No ]

Secondary Outcome Measures For Clinical Trial:

  • Duration of Response (DOR) [ Time Frame: Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care by no more than every 12 weeks (+/- 1 week) if treatment has ended. ] [ Designated as safety issue: No ]
  • Progression Free Survival (PFS) [ Time Frame: Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care by no more than every 12 weeks (+/- 1 week) if treatment has ended. ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no more than every 12 weeks (+/- 1 week) if treatment has ended. ] [ Designated as safety issue: No ]

Estimated Enrollment: 27
Study Start Date: September 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Study Intervention Details:

    Drug: Pralatrexate Injection

    Intravenous (IV) push over 30 seconds to 5 minutes via a patent free-flowing IV line containing normal saline (0.9% sodium chloride).

    Initial dose: 30 mg/m2

    Dose reductions: to 20 mg/m2 weekly per protocol defined criteria.

    Administered on days 1, 8 and 15 of a 4-week (weekly for 3 weeks with one week of rest) until criteria for discontinuation per the protocol are met.

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

    Dietary Supplement: Vitamin B12

    1 mg intramuscular injection

    Administered within 10 weeks of start of pralatrexate dosing, every 8-10 weeks throughout the study and for at least 30 days after the 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of B-cell Non-Hodgkin’s Lymphoma, using the Revised European American Lymphoma (REAL) World Health Organization (WHO) disease classification
  • Measurable disease
  • 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
  • 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

Exclusion Criteria:

  • Relapsed patients 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 patient must be disease-free for ≥ 5 years. Patients 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. Patients who received prophylactic CNS treatment are eligible.
  • Patients who have undergone an allogeneic SCT
  • Patients who have relapsed < 100 days from the time of an autologous SCT
  • Patients with disease refractory to peripheral blood SCT or who have relapsed < 100 days from the time of transplant
  • Active uncon

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