Expired Study
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Sacramento, California 95817


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

UCDCC#196


NCT ID:

NCT00619645


Secondary ID:

288263


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

120 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, Davis


Oversight Authority:

  • United States: Food and Drug Administration
  • United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

8


Enrollment Type:

Actual


Overall Contact Information

Official Name:Carol M. Richman, MD
Study Chair
University of California, Davis

Study Dates

Start Date:June 2007
Completion Date:November 2013
Completion Type:Actual
Primary Completion Date:October 2013
Primary Completion Type:Actual
Verification Date:January 2018
Last Changed Date:January 5, 2018
First Received Date:February 20, 2008
First Results Date:January 13, 2017

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Number of Patients Without Progression After Day 100 Transplant
Time Frame:24 months after day 100 transplant
Safety Issues:False
Description:All patients will be followed for progression for 24 months after their day 100 transplant.
Outcome Type:Secondary Outcome
Measure:Number of Patients Alive 24 Months Post Day 100 Transplant
Time Frame:24 months post day 100 transplant
Safety Issues:False
Description:Patients will be followed for survival for 24 months post day 100 transplant.
Outcome Type:Primary Outcome
Measure:Number of Patients With Day 100 Transplant-related Mortality
Time Frame:24 months after day 100 transplant
Safety Issues:False
Description: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.

Study Interventions

Intervention Type:Drug
Name:busulfan
Arm Name:RIST for Heme malignancies
Intervention Type:Drug
Name:cyclosporine
Arm Name:RIST for Heme malignancies
Intervention Type:Drug
Name:fludarabine phosphate
Arm Name:RIST for Heme malignancies
Intervention Type:Drug
Name:mycophenolate mofetil
Arm Name:RIST for Heme malignancies
Intervention Type:Procedure
Name:allogeneic hematopoietic stem cell transplantation
Arm Name:RIST for Heme malignancies
Intervention Type:Procedure
Name:peripheral blood stem cell transplantation
Arm Name:RIST for Heme malignancies

Study Arms

Study Arm Type:Other
Arm Name:RIST for Heme malignancies
Description: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

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, Davis

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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