MDACC Study Summary 2006-0435 (Archived)

Study Summary
No. 2006-0435:.......Blood And Marrow Transplantation......Amin Alousi......Stem Cell Transplantation and Cellular Therapy

Study Summary Title



Study Summary Number:	2006-0435

Study Title:	Thymoglobulin, Sirolimus and Mycophenolate Mofetil for Prevention of Acute GVHD Following Allogeneic Hematopoietic Stem Cell Transplantation

Physician

New Patient Referral



Name:	Amin Alousi	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:	Patients will return for post transplant follow up per routine.

Treatment Agents:	Mycophenolate Mofetil Rapamycin Thymoglobulin	Home Care:	N/A

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to learn if the combination of rabbit anti-thymocyte globulin (Thymoglobulin®), sirolimus (Rapamune®), and mycophenolate mofetil (Cellcept®) can help to prevent graft versus host disease (GVHD). The safety of this drug combination will also be studied.

Study Objectives / Outcomes

1. Primary

To determine efficacy and toxicity

of a regimen of thymoglobulin, sirolimus and mycophenolate mofetil for prevention of acute GVHD after allogeneic stem cell transplantation from HLA identical related or unrelated donors

2. Secondary

Assess engraftment, chronic GVHD, relapse and survival.

Study Status Information



Study Activation / Registration Date:	08/22/2006

IRB Review and Approval Date:	07/05/2006

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Terminated

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 high risk hematological malignancies, including those with induction failure and after treated or untreated relapse. High risk hematological malignancies include: Acute myelogenous or lymphocytic leukemia with induction failure of after relapse, myelodysplastic syndrome of intermediate and high risk according to Greenberg criteria, chronic myelogemous leukemia in accelerated phase or blast crisis, non-Hodgkin's and Hodgkin's lymphoma with induction failure or relapse after chemotherapy and refractory or relapsed chronic lymphocytic leukemia.

2) HLA-identical sibling or matched unrelated donor transplants not eligible for protocols of higher priority.

3) Age 18-75 years.

4) Bilirubin </=1.5 mg/dl, SGPT </= 200 IU/ml.

5) Creatinine </=1.6 mg/dl.

Exclusion Criteria:

1) Regimens including rituximab or alemtuzumab in the preparative regimen.

2) Patients can not have received prior treatment with gemtuzimab.

3) Planned conditioning chemotherapy for transplant can not include gemtuzimab.

4) Planned conditioning chemotherapy for transplant can not include the busulfan and cyclophosphamide regimen.

5) HIV seropositivity

6) Uncontrolled infection, not responding to adequate antimicrobial therapy after 7 days of treatment. The protocol PI is the final arbiter of eligibility.

7) Pregnancy

8) Inability to sign consent.

9) Patients who are past recipients of allogeneic or autologous stem cell transplants from any source.

Links

Registration Number: NCT00506948
Study Information on Clinical Trials Registry (clinicaltrials.gov)