MDACC Study Summary 2003-1010

Study Summary
No. 2003-1010:.......Leukemia......Paolo Anderlini......Stem Cell Transplantation and Cellular Therapy

Study Summary Title



Study Summary Number:	2003-1010

Study Title:	A Phase III Randomized, Multicenter Trial Comparing G-CSF Mobilized Peripheral Blood Stem Cell with Marrow Transplantation from HLA Compatible Unrelated Donors

Physician

New Patient Referral



Name:	Paolo Anderlini	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:	Leukemia	Supported By:	N/A

Phase of Study:	Phase III	Return Visit:	Stay in Houston area 100 days

Treatment Agents:	Busulfan Cyclophosphamide Fludarabine Melphalan Radiation	Home Care:	Not applicable

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	Initially 4-5 weeks for uncomplicated transplants


Description/ Intervention:	The goal of this clinical research study is to see if patients receiving a transplant from an unrelated donor have better results using blood stem cells from bone marrow or from peripheral blood.

Study Objectives / Outcomes

Primary Objective: The primary objective is to compare two-year survival probabilities between patients in the two study arms using an intent-to-treat analysis.

Secondary Objectives: Patients randomized to the two study arms and actually transplanted will be compared for the following endpoints (patients who do not receive a transplant will be excluded from the following analyses): survival, incidences of neutrophil and platelet engraftment, graft failure, acute graft-versus-host disease (GVHD), chronic GVHD, time off all immunosuppressive therapy, relapse, infections, adverse events, immune reconstitution, and quality of life. Donors in each arm of the study will be compared for time to return to baseline functional score, toxicity score, and CBC and WBC differential values after donation and quality of life.

Study Status Information



Study Activation / Registration Date:	08/23/2004

IRB Review and Approval Date:	07/21/2004

Study Type:

Recruitment Status:	Closed

Projected Accrual:	652 patients

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) Patient Inclusion Criteria Diagnoses to be included: Acute Myelogenous Leukemia, Acute and Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, Myelodysplastic syndromes, Myeloproliferative Disorders. Patients with therapy-related AML or MDS whose prior malignancy has been in remission for at least 12 months. If the remission is less than 12 months, Medical Monitor or Protocol Chair approval is required

2) Signed informed consent.

3) Age between 0 and 66.

4) Transplant center located within the United States or Canada.

5) Adequate organ function.

6) A 6/6 or 5/6 HLA-A,B, and DRB1 matched unrelated donor.

Exclusion Criteria:

1) Patients with prior allogeneic or autologous transplants using any hematopoietic stem cell source will be excluded from this trial. Patients with secondary malignancies who have had a prior autologous transplant will be eligible. The prior autologous transplant must have been performed for the primary malignancy (such as lymphoma) and must have occurred 12 or more months prior to enrollment.

2) HIV infection or other active uncontrolled infection.

3) Pregnancy or breastfeeding.

4) Creatinine, bilirubin, ALT or AST greater than two times the ULN.

5) Pulmonary disease with FVC, FEV1 or DLCO parameters <45% or O2 saturation <92% on room air.

6) Cardiac insufficiency or CAD requiring treatment.

7) Concomitant enrollment on Phase I study.

8) Additional Patient Exclusion Criteria for Transplant Conditioning: Patients with prior malignancies except resected basal cell carcinoma or treated carcinoma in-situ. Cancer treated with curative intent < 5 years previously will not be allowed unless approved by the Medical Monitor or Protocol Chair. Cancer treated with curative intent > 5 years previously will be allowed.

Links

Registration Number: NCT00075816
Study Information on Clinical Trials Registry (clinicaltrials.gov)