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Cellular Therapy With Cord Blood Cells
This study has been completed.

First Received on January 25, 2007.   Last Updated on December 29, 2010   History of Changes
Sponsor: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00427557
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Leukemia
Lymphoma
Drug: Fludarabine
Drug: Melphalan
Procedure: Umbilical Cord Blood
Drug: Rituximab
Other: Peripheral Blood Stem Cell Infusion
Phase II

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Umbilical Cord Blood Cell in the Preparative Regimen of Patients With Advanced Hematologic Malignancies Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Number of Patients with Graft Rejection and/or Acute GVHD [ Time Frame: Baseline - 100 days, follow up to 12 months post engraftement ] [ Designated as safety issue: Yes ]
    Early death or early withdrawals before engraftment will be considered to be graft rejection; patients who die or withdraw early before 100 days after transplantation will be counted as an event of GVHD.


Enrollment: 31
Study Start Date: October 2006
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Fludarabine + Melphalan + Rituximab + Cord Blood Transplantation + Stem Cell Transplantation
Drug: Fludarabine
30 mg/m^2 by vein x 4 Days (Day -10 through Day -7).
Other Names:
  • Fludara
  • Fludarabine Phosphate
Drug: Melphalan
140 mg/m^2 by vein x 1 Day (Day -7).
Procedure: Umbilical Cord Blood
1 UCB Unit by vein on Day -5.
Other Name: UCB
Drug: Rituximab
375 mg/m^2 by vein once weekly (Days -7, -1, +7, +14)x 4 Weeks (if appropriate).
Other Name: Rituxan
Other: Peripheral Blood Stem Cell Infusion
Infusion of blood stem cells on Day 0.
Other Names:
  • SCT
  • Stem Cell Transplant
  • Allogeneic Hematopoietic Stem Cell Transplantation
  • AHSCT

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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), or chronic lymphocytic leukemia (CLL) in greater than first complete remission 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-resolution 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%.
  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00427557

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Partow Kebriaei, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Partow Kebriaei, MD/Asst. Professor, U.T. M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00427557     History of Changes
Other Study ID Numbers: 2006-0553
Study First Received: January 25, 2007
Last Updated: December 29, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Multiple Myeloma
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Acute Lymphoblastic Leukemia
Non-Hodgkin's Lymphoma
Hodgkin's Lymphoma
Chronic Lymphocytic Leukemia
Cellular Therapy
Umbilical Cord Blood Cells
Cord Blood Transplantation
Stem Cells
Stem Cell Transplantation
Allogeneic
Hematopoietic Stem Cell Transplantation
Graft vs. Host Disease
GVD
Fludarabine
Fludarabine Phosphate
Fludara
Melphalan
Rituximab
Rituxan
Leukemia
Lymphoma

Additional relevant MeSH terms:
Leukemia
Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Melphalan
Fludarabine monophosphate
Fludarabine
Rituximab
Vidarabine
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on February 09, 2012