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

NCT00151281 | Completed Phase 2 Results

• 1 other identifier: 047080073974
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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. 1.Assess the toxicity profiles of RT-PEPC treatment in patients with relapsed mantle cell lymphoma.
2. 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. 3.Assess the quality of life of patients receiving RT-PEPC treatment

Conditions

Non-Hodgkin's Lymphoma

Keywords

relapsed mantle cell lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival and Progression Free Survival

  measured by overall Response Rate (ORR), which includes Complete response and partial response.

  38 months

Secondary Outcomes (3)

• Asses the Toxicity Profiles

  38 months

• Dynamic Levels of Plasma VEGF

  38 months

• The Quality of Life (QoL) of Patients Receiving RT-PEPC Treatment

  baseline, every 2 months until Month 6, and every 6 months until disease progression

Study Arms (1)

Study Treatment Arm

EXPERIMENTAL

Drug: PEPC; Drug: Thalidomide; Drug: Rituximab

Interventions

PEPC DRUG

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

Also known as: Prednisone, Cyclophosphamide, Etoposide, Procarbazine

Study Treatment Arm

Thalidomide DRUG

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)

Study Treatment Arm

Rituximab DRUG

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

Study Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

Related Publications (1)

• Ruan J, Martin P, Coleman M, Furman RR, Cheung K, Faye A, Elstrom R, Lachs M, Hajjar KA, Leonard JP. Durable responses with the metronomic rituximab and thalidomide plus prednisone, etoposide, procarbazine, and cyclophosphamide regimen in elderly patients with recurrent mantle cell lymphoma. Cancer. 2010 Jun 1;116(11):2655-64. doi: 10.1002/cncr.25055.

  PMID: 20235190 RESULT

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, Mantle-Cell

Interventions

Prednisone; Cyclophosphamide; Etoposide; Procarbazine; Thalidomide; Rituximab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Glucosides; Glycosides; Carbohydrates; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Phthalimides; Phthalic Acids; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Jia Ruan
• Organization: Weill Cornell Medical College

jruan@med.cornell.edu

646-962-2068

Study Officials

• John P Leonard, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 8, 2005
• Study Start: November 1, 2004
• Primary Completion: December 1, 2009
• Study Completion: April 7, 2011
• Last Updated: June 28, 2018
• Results First Posted: September 12, 2017

Record last verified: 2018-06

Locations

US (1)