MDACC Study Summary 2006-0553

Study Summary
No. 2006-0553:.......Leukemia; Lymphoma; Myeloma......Partow Kebriaei......Stem Cell Transplantation and Cellular Therapy

Study Summary Title



Study Summary Number:	2006-0553

Study Title:	Use of Umbilical Cord Blood Cell in the Preparative Regimen of Patients with Advanced Hematologic Malignancies Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Physician

New Patient Referral



Name:	Partow Kebriaei	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:	713-745-0663 Contact us about clinical trials

General Information



Disease Group:	Leukemia Lymphoma Myeloma	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Every 3 months during the first year as feasible.

Treatment Agents:	Cord Blood Transplantation Fludarabine Melphalan Rituximab	Home Care:	IV fluids, etc. as determined by patient's clinical status.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	100 days post transplant, and will include inpatient and out patient care during this time period.


Description/ Intervention:	The goal of this clinical research study is to learn if giving umbilical cord blood along with standard stem cells after high-dose chemotherapy will improve the response to a stem cell transplant. The safety of this treatment will also be studied.

Study Objectives / Outcomes

1. Primary Objectives:
1.1 To assess the safety and efficacy, with respect to acute graft vs. host disease (GVHD) and engraftment, of adding one umbilical cord blood (UCB) unit to a reduced intensity transplant conditioning regimen in efforts to increase the graft vs. malignancy (GVM) effect in patients with advanced hematologic malignancies undergoing allogeneic peripheral blood stem cell (PBSC) transplantation.

2. Secondary Objectives:
2.1 To describe the rate of acute and chronic GVHD with this approach.
2.2 To describe progression free survival (PFS) rate with this approach.
2.3 To describe the relative engraftment kinetics of PBSC and UCB when co-infused.
2.4 To describe the tissue repair capability of infused UCB.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	09/06/2006

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Open

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 multiple myeloma (MM), acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), acute lymphoblastic leukemia (ALL), non-Hodgkin's lymphoma (NHL), Hodgkin's lymphoma (HL), chronic myeloid leukemia (CML), or chronic lymphocytic leukemia (CLL) beyond first complete remission or first chronic phase who are candidates for a non-ablative or reduced intensity conditioning regimen.

2) Age up to 80 years.

3) A related or unrelated donor who is HLA-matched at HLA, A, B, C, DR and DQ loci is acceptable (i.e. 10/10 matched related or unrelated donor, matched with molecular high-resoulation technique per current standard for the BMT program). Donor must be willing to donate peripheral blood or bone marrow progenitor cells.

4) Available cord blood unit must contain a minimum of 1.5 x 10^7 total nucleated cells per kg, and be at least a 4/6 HLA match with patient.

5) Zubrod PS less than or equal to 2 or Lansky PS greater than or equal to 50%.

6) Left ventricular ejection fraction >40%. No uncontrolled arrhythmias or symptomatic heart disease.

7) Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC) and Diffusion Capacity (DLCO) >40%. Children unable to perform pulmonary function tests (e.g. less than 7 years old) pulse oximetry of > 92% on room air.

8) Serum creatinine <2.0 mg/dL. Serum bilirubin <3 X upper limit of normal, SGPT <4 X upper limit of normal.

Exclusion Criteria:

1) Patients with active CNS disease

2) Positive Beta HCG in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.

3) Serious medical or psychiatric illness likely to interfere with participation in this clinical study, including but not limited to active uncontrolled infection, uncontrolled cardiac arrhythmia or ischemic event, or uncontrolled psychosis, major depression, or mania.

4) Evidence of chronic, active hepatitis or cirrhosis, or HIV.

Links

Registration Number: NCT00427557
Study Information on Clinical Trials Registry (clinicaltrials.gov)