MDACC Study Summary ID02-645 (Archived)

Study Summary
No. ID02-645:.......Blood And Marrow Transplantation......Issa F. Khouri......Stem Cell Transplantation and Cellular Therapy

Study Summary Title



Study Summary Number:	ID02-645

Study Title:	Autologous and Allogeneic Transplantation for T-Cell Lymphoma: Impact of Campath -1H and Soluble CD52

Physician

New Patient Referral



Name:	Issa F. Khouri	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Stem Cell Transplantation and Cellular Therapy	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-2803 Contact us about clinical trials

General Information



Disease Group:	Blood And Marrow Transplantation	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	3 to 5 times weekly up to day 100 (if allogeneic), Every 3 to 6 months for 2 years for all patients.

Treatment Agents:	Campath-1H	Home Care:	None

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	3 to 4 weeks


Description/ Intervention:	The goal of this clinical research study is to see if high dose chemotherapy and Campath -1H followed by a transplant of the patient's own blood stem cells can shrink or slow the growth of the lymphoma. The safety of this treatment will also be studied.

Study Objectives / Outcomes

1.1 To evaluate the role of autologous and allogenic stem cell transplantation with Campath -1H for patients with PTCL.

1.2 To examine the impact of in-vivo purging with Campath -1H pre-autologous stem transplantation for patients with Peripheral T-cell lymphoma (PTCL).

1.3 To evaluate the impact of soluble CD52 upon in-vivo purging with Campath -1H.

1.4 To evaluate the role of Campath -1H in the treatment minimal residual disease after autolougous transplantation for PTCL.

Study Status Information



Study Activation / Registration Date:	03/11/2003

IRB Review and Approval Date:	03/05/2003

Study Type:	Therapeutic

Recruitment Status:	Terminated

Projected Accrual:	30

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patients must be less then 70 years old.

2) 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.

3) 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:

1) 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.

Links

Registration Number: NCT00505921
Study Information on Clinical Trials Registry (clinicaltrials.gov)