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Phase II Trial of Anti-Angiogenic Therapy With RT-PEPC in Patients With Relapsed Mantle Cell Lymphoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-Hodgkin's Lymphoma

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Trial Information

Phase II Trial of Anti-Angiogenic Therapy With RT-PEPC in Patients With Relapsed Mantle Cell Lymphoma


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

effect of drug combination on mantle cell lymphoma

Outcome Time Frame:

duration of study

Safety Issue:

No

Principal Investigator

John P Leonard, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Weill Medical College of Cornell University

Authority:

United States: Institutional Review Board

Study ID:

047080073974

NCT ID:

NCT00151281

Start Date:

November 2004

Completion Date:

December 2009

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • relapsed mantle cell lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Mantle-Cell

Name

Location

Weill Medical College of Cornell UniversityNew York, New York  10021