Autologous and Allogenic Transplantation With Campath-1H for T-Cell Lymphoma

This study is currently recruiting participants.

Verified by M.D. Anderson Cancer Center, May 2009

First Received: July 20, 2007 Last Updated: May 22, 2009 History of Changes

Sponsors and Collaborators:	M.D. Anderson Cancer Center Bayer
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00505921

Purpose

Primary Objectives:

To evaluate the role of autologous and allogenic stem cell transplantation with Campath-1H for patients with peripheral T-cell lymphoma (PTCL).
To examine the impact of in-vivo purging with Campath -1H pre-autologous stem transplantation for patients with PTCL.
To evaluate the impact of soluble CD52 upon in-vivo purging with Campath-1H.
To evaluate the role of Campath -1H in the treatment minimal residual disease after autologous transplantation for PTCL.

Condition	Intervention	Phase
Lymphoma	Drug: Campath-1H	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Autologous and Allogeneic Transplantation for T-Cell Lymphoma: Impact of Campath -1H and Soluble CD52

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Campath Alemtuzumab

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Full disease staging [ Time Frame: 1 month, 3 months, 6 months and then every 6 months for 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	March 2003
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Campath-1H: Experimental	Drug: Campath-1H Starting Dose of 3 mg By Vein On Day 1 then 10mg on Day 2, and 30 mg on Days 3 and 10.

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Eligibility

Ages Eligible for Study:	up to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must be less then 70 years old.
Patients must have chemosensitive disease, having undergone at least partial remission with less then 10% marrow involvement by gross pathologic examination if autologous transplantation is considered.
Newly diagnosed patients are eligible for autologous transplant. Patients in relapse would receive a non-myeloablative transplant if a sibling donor is available. Otherwise, patients would undergo autologous transplant if IPI is 0-1, or unrelated transplant if IPI is > 1.

Exclusion Criteria:

Criteria for exclusion are HIV or HTLV seropositivity, pregnancy, cardiac ejection fraction by echo-cardiogram less than 40%, active central nervous system involvement, serum creatinine greater than 1.6 mg/dl or serum bilirubin greater than 1.5 mg/dl unless due to tumor, ANC less than 1,000/mm3 and platelets less than 100,000/mm3 unless due to tumor, performance status (ECOG scale) greater than 2, pulmonary function test-DLCO less than 40% of predicted, and severe concomitant medical or psychiatric illnesses.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00505921

Contacts

Contact: Issa F. Khouri, MD

713-745-2803

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Issa F. Khouri, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Bayer

Investigators

Principal Investigator:

Issa F. Khouri, MD

U.T.M.D. Anderson Cancer Center

More Information

Additional Information:

The University of Texas M.D.Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Issa F. Khouri, MD/Professor )
Study ID Numbers:	ID02-645
Study First Received:	July 20, 2007
Last Updated:	May 22, 2009
ClinicalTrials.gov Identifier:	NCT00505921 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

T-Cell Lymphoma
Lymphoma
Campath-1H

Allogenic Transplantation
Stem Cell Transplant
Alemtuzumab

Study placed in the following topic categories:

Lymphatic Diseases
Immunoproliferative Disorders
Alemtuzumab
Lymphoma, T-Cell

Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Pharmacologic Actions
Lymphatic Diseases
Neoplasms

Lymphoma, T-Cell
Alemtuzumab
Therapeutic Uses
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

ClinicalTrials.gov processed this record on September 11, 2009