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Phase II Study of RT-PEPC in Relapsed Mantle Cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00151281
Recruitment Status : Completed
First Posted : September 8, 2005
Results First Posted : September 12, 2017
Last Update Posted : June 28, 2018
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:

Primary Objective:

Evaluate the clinical activity of the RT-PEPC combination regimen (rituximab, thalidomide, and prednisone, etoposide, procarbazine, cyclophosphamide) in patients with relapsed mantle cell lymphoma. Specifically, response rate (RR) and time to disease progression (TTP) will be assessed.

Secondary Objectives:

  1. Assess the toxicity profiles of RT-PEPC treatment in patients with relapsed mantle cell lymphoma.
  2. Prospectively characterize the angiogenic profile of patients with mantle cell lymphoma during treatment with RT-PEPC. The dynamics of the angiogenic profile will be correlated with clinical response to RT-PEPC therapy.
  3. Assess the quality of life of patients receiving RT-PEPC treatment

Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Drug: PEPC Drug: Thalidomide Drug: Rituximab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Anti-Angiogenic Therapy With RT-PEPC in Patients With Relapsed Mantle Cell Lymphoma
Study Start Date : November 2004
Actual Primary Completion Date : December 2009
Actual Study Completion Date : April 7, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Study Treatment Arm Drug: PEPC

Induction phase (month 1-3)

• PEPC daily (prednisone 20 mg/day, cyclophosphamide 50 mg/day, etoposide 50 mg/day, and procarbazine 50 mg/day) until expected drop in neutrophil count (ANC < 3000), unless due to disease. After ANC returns to above 2,000/ul, PEPC resumes at alternate day or fractionated weekly basis.

Maintenance phase (month 4-12) • PEPC QOD or fractionated weekly basis.

Post-Month 12 Maintenance phase (post-month 12 until disease progression)

• PEPC QOD or fractionated weekly basis

Other Name: Prednisone, Cyclophosphamide, Etoposide, Procarbazine

Drug: Thalidomide

Induction phase (month 1-3)

• Daily thalidomide at 50 mg/day for the first 8 weeks, then dose escalated as tolerated to a maximum of 100 mg/day.

Maintenance phase (month 4-12) • Daily low dose thalidomide (50-100 mg/d)

Post-Month 12 Maintenance phase (post-month 12 until disease progression)

• Daily low dose thalidomide (50-100mg/d)

Drug: Rituximab

Induction phase (month 1-3)

• Rituximab weekly x 4 (375 mg/m2/week) starting at week 1.

Maintenance phase (month 4-12) • Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months.

Post-Month 12 Maintenance phase (post-month 12 until disease progression)

• Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months

Primary Outcome Measures :
  1. Overall Survival and Progression Free Survival [ Time Frame: 38 months ]
    measured by overall Response Rate (ORR), which includes Complete response and partial response.

Secondary Outcome Measures :
  1. Asses the Toxicity Profiles [ Time Frame: 38 months ]
    Toxicities were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0.

  2. Dynamic Levels of Plasma VEGF [ Time Frame: 38 months ]
    Stromal angiogenesis was assessed using blood vascular and perivascular markers, including VEGFR-1, VEGFR-2, CD34, and a-SMA, as well as lymphatic vascular markers ofVEGFR-3, podoplanin, and Lyve-1.

  3. The Quality of Life (QoL) of Patients Receiving RT-PEPC Treatment [ Time Frame: baseline, every 2 months until Month 6, and every 6 months until disease progression ]

    QoL assessments were obtained with version 3 of the Functional Assessment of Cancer Therapy-General (FACT-G) instrument. The FACT-G is comprised of four subscales: physical well-being (7-items, score range 0-28), social/family well-being (7-items, score range 0-28), emotional well-being (6-items, score range 0-24), and functional well-being (7-items, score range 0-28). Users of the FACT-G are able to generate an overall score and four subscale scores with ranges and distributions that are sample-specific. All questions in the FACT-G use a 5-point rating scale (0 = Not at all to 4 = Very much) A higher number indicates a better Quality of Life, and has a possible range of 0-108 points.

    ANOVA was used to compare the difference in the means of total score among the different time points (baseline, every 2M until 6M, and every 6M until PD). The mean of the total FACT-G scores at baseline and mean of total score at all timepoints (using ANOVA) are reported below.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed diagnosis of mantle cell Non-Hodgkin's Lymphoma with characteristic immunophenotypic profiles: CD5(+),CD23(-), CD19(+) or CD20(+), cyclin D1(+), and CD10(-)
  • Patient has persistent / recurrent disease after standard chemotherapy
  • Patient has not received either standard or investigational drugs within the last 3 weeks
  • Available frozen tumor tissue obtained since completion of last prior therapy (rebiopsy if needed)
  • Patient has measurable disease as defined by a tumor mass > 1.5 cm in one dimension
  • Age > 18 years
  • Absolute granulocyte count > 1000 cells/mm3
  • Platelet count > 50,000 cells/mm3
  • Creatinine < 2.0 x ULN
  • Total bilirubin < 2.0 x ULN
  • Patient has KPS > 50%
  • Patient agrees to use birth control if of reproductive potential

Exclusion Criteria:

  • Known central nervous system (CNS) involvement by lymphoma
  • Known HIV disease
  • Known peripheral neuropathy > grade 2
  • Patient is pregnant or nursing
  • Patient has had major surgery within the last 3 weeks
  • Patient is receiving other investigational drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00151281

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United States, New York
Weill Medical College of Cornell University
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
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Principal Investigator: John P Leonard, MD Weill Medical College of Cornell University
Publications of Results:
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Responsible Party: Weill Medical College of Cornell University Identifier: NCT00151281    
Other Study ID Numbers: 047080073974
First Posted: September 8, 2005    Key Record Dates
Results First Posted: September 12, 2017
Last Update Posted: June 28, 2018
Last Verified: June 2018
Keywords provided by Weill Medical College of Cornell University:
relapsed mantle cell lymphoma
Additional relevant MeSH terms:
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Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal