Pilot Study of Reduced-Intensity Umbilical Cord Blood Transplantation in Adult Patients Wtih Advanced Hematopoietic Malignancies

NCT00513318 | Terminated DMC

• 1 other identifier: UC2407
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study designed to evaluate the safety and feasibility of performing umbilical cord blood transplants in older adults or younger infirm patients with high-risk hematopoeitic malignancies. A novel reduced-intensity preparative regimen for umbilical cord blood transplantation will be used. One to a maximum of three cord blood units, depending on cell count, will be administered to facilitate engraftment. Ten patients will be enrolled with an expected accrual rate of 3-4 patients per year and with a goal of completing accrual within 2-3 years.

Conditions

Acute Myeloid Leukemia; Myelodysplasia; Acute Lymphoblastic Leukemia; Chronic Myelogenous Leukemia; Multiple Myeloma; Lymphomas; Low-grade NHL and Chronic Lymphocytic Leukemia

Keywords

Umbilical cord blood transplantation; hematopoietic malignancies

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with hematopoietic malignancies ages 55 to 70.

You may qualify if:

• Age 55-70 years, or \< 55 years if deemed ineligible for conventional high dose chemotherapy by the UCSF SCT Committee or by protocol eligibility requirements for myeloablative therapy. Reasons for ineligibility for myeloablative therapy include:
• Poor cardiac function (i.e. LVEF \< 40%)
• Poor pulmonary function (i.e. DLCO \< 50%)
• Hepatic dysfunction
• Prior myeloablative therapy
• Availability of donor cord blood (one to three units) matching at \> or equal to 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 the UCSF Immunogenetics Department. The target UCB TNC dose is \> or equal to 3.5 x 10(7) TNC/kg recipient weight, however the absolute minimum TNC requirement is \> 2.5 x 10(7) TNC per kilogram) based on cell counts prior to cryopreservation. 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) must NOT be readily available
• Disease types include:
• 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 (\> or equal to 3 abnormalities), Ph(+), evolution from prior myelodysplasia or AML secondary to prior chemotherapy, failure to achieve remission, second, or subsequent remission or refractory relapse. Marrow blasts must be \< or equal to 10%. This may be achieved using standard chemotherapy treatment.
• Myelodysplasia with high-risk features. This will include patients with IPSS category INT2 or HI-risk MDS or CMML. Marrow blasts must be \< or equal to 20%. If required, chemotherapy may be given to achieve target levels of blasts. Patients are expected to have disease control or not rapidly progressive disease regardless of blast count (but must be \< or equal to 20%).
• Acute lymphoblastic leukemia not expected to be cured 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. Marrow blasts must be \< or equal to 10%. If required, chemotherapy may be given to achieve target level of blasts.
• Chronic myelogenous leukemia- chronic phase failing imatinib mesylate therapy (either progressive disease or failure to achieve a major cytogenetic response at 1 year following initiation of therapy), accelerated phase failing to achieve a complete cytogenetic remission at 1 year following initiation of therapy, accelerated phase failing to achieve any cytogenetic response at 6 months of therapy, accelerated phase with progressive disease as demonstrated by worsening cytogenetic response in two consecutive analyses separated by 4 weeks or CML in blast crisis. Patients with blast phase of CML must have \< 10% blasts in bone marrow.
• Multiple myeloma stage I-III with relapse following autologous transplant, with disease refractory to at least two prior conventional; myeloma therapies or with chromosome 13 abnormalities. Patients with chromosome 13 abnormalities are eligible either at diagnosis or after initial progression.
• Lymphomas including diffuse or follicular large cell lymphoma, mantle cell lymphoma, peripheral T-cell lymphoma, T-NK cell lymphoma, or Hodgkin's disease which has failed to respond to primary therapy, progressed, or recurred after prior therapy. Patients who have relapsed following autologous transplant are eligible.
• Low-grade NHL and Chronic Lymphocytic Leukemia with relapse or refractory disease following, at least, two chemotherapy-based treatment regimens; or with relapse following autologous transplantation.

You may not qualify if:

• Active infection requiring ongoing antibiotic treatment
• HIV infection
• Poor performance status (ECOG \> 2)
• Opinion of BMT Committee that autologous SCT or conventional therapy would be a preferable form of treatment
• Organ function is below requirements
• Pregnancy, or breast-feeding

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Anemia, Refractory, with Excess of Blasts; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Multiple Myeloma; Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia, Refractory; Anemia; Myelodysplastic Syndromes; Bone Marrow Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Myeloproliferative Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Leukemia, B-Cell; Neoplasms by Site

Study Officials

• Thomas G. Martin, M.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2007
• First Posted: August 8, 2007
• Study Start: August 1, 2004
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: August 2, 2013

Record last verified: 2013-08

Locations

US (1)