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Pilot Study of Umbilical Cord Blood Transplantation in Adult Patient With Advanced Hematopoietic Malignancies


N/A
18 Years
55 Years
Not Enrolling
Both
Acute Myeloid Leukemia, Myelodysplasia, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, Multiple Myeloma, Lymphoma, Large-Cell, Diffuse, Lymphoma, Mantle-Cell, Lymphoma, T-Cell, Peripheral, T-NK Cell Lymphoma, Hodgkin Disease

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Trial Information

Pilot Study of Umbilical Cord Blood Transplantation in Adult Patient With Advanced Hematopoietic Malignancies


This study intends to demonstrate an engraftment rate of >80% at day 100
post-transplantation and a transplant related mortality rate of < or equal to 50%. A TRM of
>50% will be considered unacceptable. The present research will also:

- Evaluate the toxicity of busulfan, fludarabine, and etoposide as preparative therapy
prior to umbilical cord blood cell transplantation.

- Evaluate neutrophil and platelet recovery following UCB transplantation.

- Evaluate lineage-specific chimerism following transplantation and to assess the
contribution of each individual CB unit to post-transplantation hematopoiesis.

- Evaluate event free and overall survival.

- Evaluate the incidence, severity and timing of acute and chronic GVHD following UCB
transplantation.


Inclusion Criteria:



- Age < or equal to 55

- Availability of donor cord blood (one to three units) matching at least 4 of 6 HLA
antigens (A, B, and DR). HLA class I antigens will be determined by serologic
methods, and Class II antigens will be determined by high-resolution DNA typing.
Typing will be confirmed by UCSF Immunogenetics Department following infusion. The
UCB units must contain >2.5 x 10(7) TNC per kilogram recipient body weight. Cord
blood units will be obtained from all available international banks.

- HLA identical or 1 antigen mismatched related donors or potential HLA-matched
unrelated donors (MUD) matching at >6/8 (A, B,C, DR) alleles must NOT be available.

- Disease types:

- Acute myeloid leukemia not expected to be curable with chemotherapy. This will
include patients with high-risk cytogenetics (-7, -7q, -5, -5q, t(6,9), t(9,11),
complex, Ph+), evolution from prior myelodysplasia or AML secondary to prior
chemotherapy, failure to achieve remission, or second or subsequent remission.
To ensure adequate time until disease progression, marrow blasts must be < or
equal to 10%. This may be achieved using chemotherapy treatment.

- Myelodysplasia with high-risk features. This will include patients with IPSS
category INT2 or HI-risk MDS. Marrow blasts must be < or equal to 20%. If
required, chemotherapy may be given to achieve target levels of blasts.

- Acute lymphoblastic leukemia not expected to be curable with chemotherapy. This
will include patients with high-risk cytogenetics (Ph+, t(4,11), 11q23
abnormalities, and monosomy 7), patients requiring more than one induction
course to achieve remission, as well as patients failing to enter remission or
in second or subsequent remission. To ensure adequate time until disease
progression, marrow blasts must be < or equal to 10%. If required, chemotherapy
may be given to achieve target levels of blasts.

- Chronic myelogenous leukemia with advanced disease. This will include patients
with accelerated or blastic phase or patients with chronic phase refractory to
STI-5741. To ensure adequate time until disease progression, patients with blast
crisis must show marrow blasts < or equal to 10%. If required, chemotherapy may
be given to achieve target levels of blasts.

- Multiple myeloma, stage II-III with >1st relapse or refractory disease or newly
diagnosed with chromosome 13 abnormalities.

- Lymphoma: diffuse large cell, mantle cell, peripheral T-cell, T-NK cell, or
Hodgkin's disease which has failed to respond to primary therapy, progressed or
recurred after prior therapy. Patients who have failed autologous transplant are
eligible if they are >1 year post-transplant.

- Patients must have an ECOG PS< or equal to 2

- Laboratory requirements:

- Creatinine <2.0mg/dL and creatinine clearance >40/m/min (calculated or based on 24
hour urine collection)

- Bilirubin <2.0 mg/dL, AST/alkaline phosphatase <3x upper limit of normal

- Patients with hepatitis C and active Hepatitis B are eligible only if a liver biopsy
is performed and there is a < or equal to grade 2 inflammation or fibrosis.

- Cardiac ejection fraction >40%

- DLCO >40%

- Negative pregnancy test (females of reproductive age)

Exclusion Criteria:

- Active infection requiring ongoing antibiotic treatment

- HIV infection

- Poor performance status (ECOG >2)

- Rapid progression of malignant disease

- Opinion of BMT Committee that autologous transplant would be a preferable form of
treatment

- Organ function is below requirements

- Pregnancy or breast-feeding

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

efficacy

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

Thomas G. Martin, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Institutional Review Board

Study ID:

UC2207

NCT ID:

NCT00514722

Start Date:

October 2002

Completion Date:

March 2009

Related Keywords:

  • Acute Myeloid Leukemia
  • Myelodysplasia
  • Acute Lymphoblastic Leukemia
  • Chronic Myelogenous Leukemia
  • Multiple Myeloma
  • Lymphoma, Large-Cell, Diffuse
  • Lymphoma, Mantle-cell
  • Lymphoma, T-Cell, Peripheral
  • T-NK Cell Lymphoma
  • Hodgkin Disease
  • Hematopoietic malignancies
  • Umbilical cord blood transplantation
  • Lymphoma: diffuse large cell, mantle cell, peripheral T-cell, T-NK cell, or Hodgkin's
  • Neoplasms
  • Hodgkin Disease
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Myelodysplastic Syndromes
  • Preleukemia
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Peripheral
  • Lymphoma, Mantle-Cell
  • Hematologic Neoplasms

Name

Location

University of California, San FranciscoSan Francisco, California  94143