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Reduced Intensity Stem Cell Transplantation (RIST) for Patients With Hematological Malignancies Conditioned With Fludarabine and Busulfan

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00843947
First received: February 12, 2009
Last updated: June 26, 2017
Last verified: June 2017
  Purpose

This is a Phase II trial designed to evaluate the efficacy and toxicity of RIST, conditioned with fludarabine and busulfan, using G-CSF mobilized PBSC from an HLA-matched sibling or an unrelated volunteer donor. The primary endpoint of this study is day 100 TRM (Treatment Related Mortality). Secondary endpoints include response, engraftment times, acute and chronic GVHD, chimerism, toxicities, progression-free survival and overall survival.

Objectives

  • To assess the efficacy and toxicity of Reduced Intensity Transplant (RIST) for patients with hematological malignancies, conditioned with fludarabine (Fludara®) and busulfan intravenous (Busulfex™).
  • To evaluate progression-free survival and overall survival.
  • To determine donor chimerism.
  • To assess the risk of acute and chronic graft versus host disease (GVHD).

Condition Intervention Phase
Hematologic Malignancies Procedure: Reduced Intensity Stem Cell Transplantation Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reduced Intensity Stem Cell Transplantation (RIST) for Patients With Hematological Malignancies Conditioned With Fludarabine and Busulfan

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • To assess the efficacy and toxicity of Reduced Intensity Transplant (RIST) for patients with hematological malignancies, conditioned with fludarabine (Fludara®) and busulfan intravenous (Busulfex™) [ Time Frame: 3 years ]

Enrollment: 8
Actual Study Start Date: June 2007
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Reduced Intensity Stem Cell Transplantation
    Reduced Intensity Stem Cell Transplantation
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • Diagnosed with (any of the following)

Disease Subtype Disease Status Leukemia Acute myelogenous leukemia (AML) Recurrent disease in remission* OR CR1 with poor-risk cytogenetics, antecedent hematological disease (i.e. myelodysplasia) or treatment-related leukemia Acute lymphoblastic leukemia (ALL) Recurrent disease in remission* OR CR1 with Philadelphia chromosome or poor risk cytogenetics Chronic myelogenous leukemia (CML) First or second chronic phase. There must be documented disease progression after imatinib mesylate (Gleevec) therapy OR documented lack of cytogenetic response 6 months post-imatinib initiation OR imatinib intolerance.

Patient - Inclusion criteria (Continued) Chronic lymphocytic leukemia (CLL) Recurrent disease after fludarabine-based therapy. Patients must have chemosensitive** disease at the time of relapse.

Lymphoma Recurrent Hodgkin's Lymphoma

Recurrent Non-Hodgkin's lymphoma (NHL) (Low, intermediate or high grade)

Transformed NHL Patients must have had prior autologous transplantation and received cytoreductive therapy at the time of relapse to achieve complete remission (CR) or CR/unconfirmed (CRu) as defined by the International Workshop

OR

Patient with relapsed disease and required >2 salvage regimens to achieve CR or CRu.

Multiple Myeloma Recurrent Myeloma Patients must have had prior autologous transplantation and demonstrate chemosensitivity** at the time of relapse Myelodysplastic Syndrome # RA/RARS RCMD/RCMD-RS RAEB-1 Patients must be transfusion-dependent and have International prostate symptom score (IPSS) of 1.5 or higher Advanced myeloproliferative disease Myelofibrosis with myeloid metaplasia; primary or evolved from other MPD Patient must be transfusion dependent or have evidence of progressive organomegaly or evidence of myelodysplasia

  • remission is defined as morphological remission with bone marrow aspirate/biopsy showing <= 5% blasts within 4 weeks before the start of therapy. (Cytogenetic or molecular remission is not required)

    • In CLL, chemosensitivity is defined as greater than 50% reduction of wbc and lymphadenopathy. In MM, it is defined as greater than 50% reduction of M-component or plasma-cell marrow infiltration.

      • based on WHO classification system. Patients with RAEB-2 or del(5q) are excluded

        • 5-6/6 HLA-matched sibling or 9-10/10 matched unrelated donor
        • Age > 50 OR age 18-50, but have preexisting medical conditions, or have received prior therapy (i.e. prior) autologous transplantation) and are considered to be a too high a risk for conventional myeloablative transplantation

Exclusion Criteria:

  • • Karnofsky performance status of less than 50%

    • Positive pregnancy test, inability or unable to pursue effective means of birth control, failure to willingly accept or comprehend irreversible sterility as a side effect of therapy
    • Corrected pulmonary-diffusing capacity of less than 35%
    • A cardiac ejection fraction of less than 30%
    • A serologic evidence of infection with the human immunodeficiency virus
    • Inability to give informed consent
    • Psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible
    • Decompensated liver disease with serum bilirubin > 2.0 mg/dl
    • Serum creatinine > 2.0 mg/dl
    • Uncontrolled active infection
    • Uncontrolled CNS metastasis
  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: NCT00843947

Locations
United States, California
University of CA, Davis Cancer Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
  More Information

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00843947     History of Changes
Other Study ID Numbers: 200715041
UCD196
Study First Received: February 12, 2009
Last Updated: June 26, 2017

Additional relevant MeSH terms:
Neoplasms
Fludarabine
Fludarabine phosphate
Busulfan
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Alkylating Agents
Antineoplastic Agents, Alkylating
Myeloablative Agonists

ClinicalTrials.gov processed this record on September 21, 2017