Phase II Trial of Alemtuzumab (Campath) and Dose-Adjusted EPOCH-Rituximab (DA-EPOCH-R) in Relapsed or Refractory Diffuse Large B-Cell and Hodgkin Lymphomas

This study is currently recruiting participants.
Verified May 2012 by National Institutes of Health Clinical Center (CC)

First Received on December 11, 2009.  
Last Updated on June 28, 2012  
History of Changes
This Clinical Trial Sponsored By: National Cancer Institute (NCI)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01030900
 

Purpose for Clinical Trial

Background:

  • Studies conducted at the National Cancer Institute suggest that certain chemotherapy drugs may be more effective if given by continuous infusion into the vein rather than by the standard method of rapid intravenous injection. One combination of six chemotherapy drugs, known as EPOCH-R, has had a high degree of effectiveness in people with certain kinds of cancer.
  • Recent evidence also indicates that the effects of chemotherapy may be improved by combining the treatment with monoclonal antibodies, which are purified proteins that are specially made to attach to foreign substances such as cancer cells. A monoclonal antibody called campath (alemtuzumab) has been manufactured to attach to a protein called CD52 that may target tumor cells or the surrounding inflammatory cells.
  • Researchers are interested in developing new treatments for large B-cell lymphoma or Hodgkin lymphoma that can best be treated with chemotherapy. This protocol is specifically for people with diffuse large B-cell or Hodgkin lymphomas that have not responded to standard treatments.

Objectives:

– To test whether giving campath (alemtuzumab) in combination with continuous infusion EPOCH-R chemotherapy will improve the outcome of lymphoma treatment.

Eligibility:

– Individuals 18 years of age and older who have large B-cell lymphoma or Hodgkin lymphoma that has not responded well to standard treatments.

Design:

  • During the study, patients will receive standard EPOCH-R chemotherapy, which includes the following drugs: etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab. The additional drug, campath, will be given by IV infusion on the first day of treatment over several hours.
  • When the campath IV infusion and rituximab IV infusion are complete, the drugs doxorubicin, etoposide, and vincristine will each be given by continuous IV infusion over the next 4 days (that is, continuously for a total of 96 hours). Cyclophosphamide will be given by IV infusion over several hours on Day 5. Prednisone will be given by mouth twice each day for 5 days.
  • Patients may be given other drugs to treat the side effects of chemotherapy, to prevent possible infections, and to improve white blood cell counts.
  • The campath-EPOCH-R therapy will be repeated every 21 days, as a cycle of therapy, for a total of 6 cycles. Following the fourth and sixth treatment cycles (approximately weeks 12 and 18) of campath-EPOCH-R treatment, study researchers will perform blood tests and CT/MRI scans on all patients to assess their response to the treatment.

Condition Study Intervention Phase
Hodgkin Lymphoma
Diffuse Large B-Cell Lymphoma
Drug: Cylcophosphamide
Drug: Etoposide
Drug: Alemtuzumab
Drug: Doxorubicin
Drug: Prednisone
Drug: Filgrastim
Drug: Rituximab
Drug: Vincristine
Phase 2

Study Type: Study Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Study Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Alemtuzumab (Campath) and Dose-Adjusted EPOCH-Rituximab (DA-EPOCH-R) in Relapsed or Refractory Diffuse Large B-Cell and Hodgkin Lymphomas

Resource links provided by NLM:

MedlinePlus related topics:
Cancer
Hodgkin Disease
Lymphoma
Drug Information available for:
Prednisone
Vincristine sulfate
Doxorubicin
Doxorubicin hydrochloride
Etoposide
Etoposide phosphate
Filgrastim
Lenograstim
Granulocyte colony-stimulating factor
Rituximab
Alemtuzumab

U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures For Clinical Trial:

  • Assess response, progression free survival (PFS) and overall survival (OS) in relapsed/refractory DLBCL and Hodgkin lymphoma. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures For Clinical Trial:

  • Correlate clinical outcomes with microenvironment/stromal molecular signatures by gene expression profiling and immunohistochemistry on study and at relapse after DA-EPOCH-RC. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 47
Study Start Date: October 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)

Arms

Assigned Study Interventions

Active Comparator: Group 1 Drug: Cylcoph

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