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Donor Peripheral Stem Cell Transplant, Fludarabine, and Busulfan in Treating Patients With Hematologic Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00619645
Recruitment Status : Completed
First Posted : February 21, 2008
Results First Posted : May 8, 2017
Last Update Posted : January 10, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:

Giving chemotherapy drugs, such as fludarabine and busulfan, before a donor peripheral stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil before and after the transplant may stop this from happening.

PURPOSE: This phase II trial is studying the side effects of giving donor peripheral stem cell transplant together with fludarabine and busulfan and to see how well it works in treating patients with hematologic cancers.


Condition or disease Intervention/treatment Phase
Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Drug: busulfan Drug: cyclosporine Drug: fludarabine phosphate Drug: mycophenolate mofetil Procedure: allogeneic hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation Phase 2

Detailed Description:

OUTLINE:

  • Conditioning regimen: Patients receive busulfan IV over 3 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
  • Allogeneic peripheral blood stem cell transplant (PBSC): Patients undergo allogeneic PBSC on day 0.
  • Immunosuppressive therapy/graft-versus-host disease (GVHD) prophylaxis: Patients achieve100% donor T-cell chimerism on day 30 without disease recurrence, and cyclosporine A (CSA) IV continuously over 24 hours or orally every 12 hours on days -1 to 60 followed by a taper until day 100 and oral mycophenolate mofetil (MMF) once every 12 hours on days 1-40, in the absence of ≥ grade 2 GVHD.

Patients with recurrent disease or < 100% donor T-cell chimerism (on day 30) undergo a 12-day CSA and MMF taper followed by escalating doses of previously collected donor leukocyte infusion every 4 weeks until 100% donor T-cell chimerism or disease regression, in the absence of ≥ grade 2 GVHD.

After completion of study treatment, patients are followed periodically.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
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
Study Start Date : June 2007
Actual Primary Completion Date : October 2013
Actual Study Completion Date : November 2013


Arm Intervention/treatment
RIST for Heme malignancies
Busulfan 3.3 mg/kg over 3 hours on day -6 and day -5 Fludarabine 30 mg/m2 IV over 30 minutes on day -6 to day -2 followed by Transplant followed by Immunosuppressive/GVHD therapy
Drug: busulfan
Drug: cyclosporine
Drug: fludarabine phosphate
Drug: mycophenolate mofetil
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation



Primary Outcome Measures :
  1. Number of Patients With Day 100 Transplant-related Mortality [ Time Frame: 24 months after day 100 transplant ]
    Patients were followed for death and whether or not that death was attributed to the day 100 transplant via physician assessment for 24 months after day 100 transplant.


Secondary Outcome Measures :
  1. Number of Patients Without Progression After Day 100 Transplant [ Time Frame: 24 months after day 100 transplant ]
    All patients will be followed for progression for 24 months after their day 100 transplant.

  2. Number of Patients Alive 24 Months Post Day 100 Transplant [ Time Frame: 24 months post day 100 transplant ]
    Patients will be followed for survival for 24 months post day 100 transplant.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosed with any of the following:

    • Acute myeloid leukemia (AML), meeting 1 of the following criteria:

      • Recurrent disease in remission, defined as morphological remission with bone marrow aspirate/biopsy showing ≤ 5% within 4 weeks before the start of study treatment (cytogenetic or molecular remission is not required)
      • In first complete remission (CR1) with poor-risk cytogenetics, antecedent hematological disease (i.e., myelodysplasia), or treatment-related leukemia
    • Acute lymphoblastic leukemia (ALL), meeting 1 of the following criteria:

      • Recurrent disease in remission, defined as morphological remission with bone marrow aspirate/biopsy showing ≤ 5% within 4 weeks before the start of study treatment (cytogenetic or molecular remission is not required)
      • CR1 with Philadelphia chromosome or poor-risk cytogenetics
    • Chronic myelogenous leukemia (CML), meeting the following criteria:

      • First or second chronic phase

        • Must be documented disease progression after imatinib mesylate therapy OR documented lack of cytogenetic response 6 months post-imatinib mesylate initiation OR imatinib mesylate intolerance
    • Chronic lymphocytic leukemia (CLL), meeting the following criteria:

      • Recurrent disease after fludarabine-based therapy

        • Must have chemosensitive disease at the time of relapse, defined as greater than 50% reduction of WBC and lymphadenopathy
    • Recurrent Hodgkin lymphoma, recurrent non-Hodgkin lymphoma (NHL) (low-, intermediate-, or high-grade disease*), or transformed NHL, meeting 1 of the following criteria:

      • Received prior autologous transplantation and cytoreductive therapy at the time of relapse to achieve complete remission (CR) or CR/unconfirmed (CRu) as defined by the International Workshop
      • Relapsed disease that required more than 2 salvage regimens to achieve CR or CRu
    • Recurrent multiple myeloma, meeting the following criteria:

      • Must have received prior autologous transplantation and demonstrate chemosensitivity at the time of relapse, defined as greater than 50% reduction of M-component or plasma-cell marrow infiltration
    • Myelodysplastic syndrome

      • Refractory anemia (RA)/RA with ringed sideroblasts (RARS), refractory cytopenia with multilineage dysplasia (RCMD)/refractory cytopenia with multilineage dysplasia with ringed sideroblasts (RCMD-RS), or RA with excess blasts (RAEB) I, meeting the following criteria:

        • Must be transfusion-dependent and have an IPSS score ≥ 1.5, based on WHO criteria
        • No RAEB II or del(5q)
  • No uncontrolled CNS metastases
  • 5-6/6 HLA-matched sibling or 9-10/10 matched unrelated donor (both patient and donor) available

PATIENT CHARACTERISTICS:

  • Karnofsky performance status ≥ 50%
  • Serum creatinine ≤ 2 mg/dL
  • Not pregnant
  • Fertile patients must use effective contraception
  • 50 years of age or older

    • Patients 18-50 years of age are eligible if meeting 1 of the following criteria:

      • Have a preexisting medical condition
      • Received prior therapy (i.e., autologous transplantation) and are considered to be too high risk for conventional myeloablative transplantation
  • Must be willing to accept or comprehend irreversible sterility as a side effect of therapy
  • No uncontrolled active infection
  • No psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible
  • Cardiac ejection fraction ≥ 30%
  • Corrected pulmonary-diffusing capacity ≥ 35%
  • No serologic evidence of infection with HIV
  • No decompensated liver disease with serum bilirubin > 2.0 mg/dL

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00619645


Locations
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United States, California
University of California Davis Cancer Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
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Study Chair: Carol M. Richman, MD University of California, Davis
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00619645    
Other Study ID Numbers: UCDCC#196
288263 ( Other Identifier: UC Davis )
UCD-196 ( Other Identifier: UCDCC )
First Posted: February 21, 2008    Key Record Dates
Results First Posted: May 8, 2017
Last Update Posted: January 10, 2018
Last Verified: January 2018
Keywords provided by University of California, Davis:
recurrent adult acute myeloid leukemia
adult acute lymphoblastic leukemia in remission
refractory anemia with excess blasts
refractory anemia with ringed sideroblasts
refractory anemia
refractory cytopenia with multilineage dysplasia
previously treated myelodysplastic syndromes
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia in remission
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
chronic phase chronic myelogenous leukemia
relapsing chronic myelogenous leukemia
refractory chronic lymphocytic leukemia
recurrent adult Hodgkin lymphoma
refractory multiple myeloma
recurrent adult acute lymphoblastic leukemia
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
secondary acute myeloid leukemia
recurrent small lymphocytic lymphoma
stage III small lymphocytic lymphoma
stage IV small lymphocytic lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Multiple Myeloma
Neoplasms, Plasma Cell
Preleukemia
Myelodysplastic Syndromes
Syndrome
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Precancerous Conditions
Cyclosporine
Mycophenolic Acid
Fludarabine
Fludarabine phosphate
Busulfan
Cyclosporins