MDACC Study Summary DM03-0279

Study Summary
No. DM03-0279:.......Lymphoma......Chitra M. Hosing......Stem Cell Transplantation and Cellular Therapy

Study Summary Title



Study Summary Number:	DM03-0279

Study Title:	Study of Allogeneic Transplantation in Patients with Cutaneous T-cell Lymphoma (CTCL)

Physician

New Patient Referral



Name:	Chitra M. Hosing	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:	713-792-8750 Contact us about clinical trials

General Information



Disease Group:	Lymphoma	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	As per bone marrow transplant routine. Patients remain in Houston, TX for 100 days after transplantation.

Treatment Agents:	Fludarabine Melphalan	Home Care:	As per bone marrow transplant routine.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	The length of stay is approximately 30 days in hospital.

Description/
Intervention:

The goal of this clinical research study is to see if receiving a transplant of
blood stem cells (cells that can produce blood) or bone marrow from either a
related donor (brother, sister or other relative) or an unrelated voluntary
donor will help patients with advanced cutaneous T-cell lymphoma. The length
of time that patients who receive the treatment remain free of disease will
also be studied.

Study Objectives / Outcomes

1.To assess the toxicity of allogeneic peripheral blood progenitor cell (PBPC) or marrow

transplantation in patients with cutaneous T-cell lymphoma.

2. To determine the patient's response, long-term overall survival and disease-free survival (DFS).
3. To determine whether a graft vs. CTCL effect can occur.

Study Status Information



Study Activation / Registration Date:	09/26/2003

IRB Review and Approval Date:	09/03/2003

Study Type:	Therapeutic

Recruitment Status:	Closed

Projected Accrual:	N/A

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 with pathologically proven CTCL, disease stage IIB to IVB, patients must be in at least a PR (skin and lymph nodes) after receiving other non-allogeneic transplant therapy, age </= 70 years, Zubrod performance status 0 or 1, left ventricular ejection fraction >/= 50% or approved for transplant by a cardiologist, DLCO >/= 50% predicted or approved for transplant by a pulmonologist, serum creatinine </= 1.5 mg/dL, serum bilirubin < 2mg/dL. SGPT < 3 x upper limit of normal, and no previous history of allogeneic transplantation.

2) Donor: HLA-compatible related (HLA-A, -B, -DRB1 matched or with one-antigen mismatch) or HLA-compatible unrelated (HLA-A, -B, -C and -DRB1 matched or with one-antigen mismatch).

Exclusion Criteria:

1) Patients cannot have active CNS disease.

Links

Registration Number: NCT00506129
Study Information on Clinical Trials Registry (clinicaltrials.gov)