Cellular Therapy With Cord Blood Cells

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00427557
First received: January 25, 2007
Last updated: May 23, 2012
Last verified: May 2012
  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 2

Study Type: Interventional
Study Design: 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 Participants With Engraftment [ Time Frame: Baseline to 100 days post-engraftment ] [ Designated as safety issue: No ]
    Engraftment defined as first of three (3) consecutive days with Absolute neutrophil count (ANC) equal to or more than 0.5 * 10^9/L; assessed from baseline to 100 days post-engraftment.


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: Cellular Therapy with Cord Blood Cells
Fludarabine 30 mg/m^2 intravenous (IV) for 4 Days + Melphalan 140 mg/m^2 IV for 1 Day + Rituximab 375 mg/m^2 IV once weekly + Cord Blood Transplantation + Stem Cell Transplantation Infusion
Drug: Fludarabine
30 mg/m^2 by vein for 4 Days (Day -10 through Day -7).
Other Names:
  • Fludara
  • Fludarabine Phosphate
Drug: Melphalan
140 mg/m^2 by vein for 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) for 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

Detailed Description:

Cord blood is a source of blood-forming cells that can be used for transplantation. Cord blood cells are taken from the umbilical cords of women who have given birth, and who have volunteered to donate their umbilical cord. Researchers hope that using cord blood before a stem cell transplant will help to reduce the risk of graft-versus-host-disease (GVHD). GVHD occurs when donor cells attack the cells of the person receiving the transplant.

If you are found to be eligible to take part in this study, you will receive chemotherapy for 5 days. You will receive fludarabine over about 30 minutes through a needle in your vein on Days 1-4. You will receive melphalan through a needle in your vein over about 30 minutes on Day 5.

On Day 7, you will receive the cord blood cells through a needle in your vein over about 30 minutes.

On Day 12, you will receive blood stem cells through a needle in your vein over 30-60 minutes. The stem cells you receive will be from a stem cell donor whose human leukocyte antigen (HLA- proteins on cells) type matches yours.

If appropriate for the disease, you will also receive rituximab about once weekly for 4 weeks, beginning on the day you receive melphalan. Rituximab is given though a needle in your vein over 2-3 hours.

You will receive the drugs tacrolimus and methotrexate to lower the risk of GVHD. Tacrolimus will be given through a needle in your vein non-stop for 2 weeks, starting 12 hours after the stem cell transplant. After the first 2 weeks, you will continue to receive tacrolimus by mouth, for at least 3 months. You will receive methotrexate though a needle in your vein over 30 minutes, starting 1 day after the stem cell transplant, for a total of 3 doses over the first 6 days after the stem cell transplant.

You will receive the G-CSF (granulocyte-colony stimulating factor) to help you blood cell counts recover. G-CSF will be given as an injection under the skin, beginning 1 week after the stem cell transplant. You will continue to receive G-CSF once a day until your blood cell counts reach a certain high enough level.

You will need to stay in the hospital for about 4 weeks beginning on Day 1. While you are in the hospital, blood (about 2 teaspoons) will be drawn every day for routine tests.

After you leave the hospital, you will return to the hospital for visits 2-3 times a week for at least 100 days after the transplant. During these visits, you will have a physical exam and blood (about 2 teaspoons) will be drawn for routine tests.

You will be asked to come back to the clinic for follow-up visits at 3, 6, 9 and 12 months after your transplant for routine safety testing. This will include a physical exam, a bone marrow biopsy, and blood (about 2 teaspoons) will be drawn for routine testing.

You will be considered off-study after the 12-month follow-up visit.

This is an investigational study. The stem cell transplant, the umbilical cord transplant, and all drugs used on this study are FDA approved. The use of umbilical cord blood and stem cells together is investigational. Up to 30 patients will take part in this study. All will be enrolled at M. D. Anderson.

  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 * 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 * upper limit of normal, SGPT <4 * 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00427557     History of Changes
Other Study ID Numbers: 2006-0553
Study First Received: January 25, 2007
Results First Received: April 19, 2012
Last Updated: May 23, 2012
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
Fludarabine phosphate
Rituximab
Vidarabine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Myeloablative Agonists
Immunosuppressive Agents

ClinicalTrials.gov processed this record on September 11, 2014