Fludarabine Phosphate and Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate, Dasatinib, or Nilotinib
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|ClinicalTrials.gov Identifier: NCT00036738|
Recruitment Status : Active, not recruiting
First Posted : January 27, 2003
Results First Posted : August 22, 2017
Last Update Posted : July 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Adult Acute Lymphoblastic Leukemia in Remission Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 Blastic Phase Childhood Acute Lymphoblastic Leukemia in Remission Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 Chronic Myelogenous Leukemia, BCR-ABL1 Positive Chronic Phase of Disease Recurrent Adult Acute Lymphoblastic Leukemia Recurrent Childhood Acute Lymphoblastic Leukemia Recurrent Disease||Drug: Cyclosporine Drug: Dasatinib Drug: Fludarabine Phosphate Drug: Imatinib Mesylate Drug: Mycophenolate Mofetil Drug: Nilotinib Procedure: Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation Procedure: Peripheral Blood Stem Cell Transplantation Biological: Therapeutic Allogeneic Lymphocytes Radiation: Total-Body Irradiation||Phase 2|
I. To determine whether the rate of leukemia relapse can be decreased for patients with chronic myelogenous leukemia in blast crisis (CML-BC) and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) responsive to imatinib mesylate (or either dasatinib or nilotinib for patients who have imatinib-resistant disease or who are intolerant of imatinib) followed by nonmyeloablative hematopoietic stem cell transplantation (HSCT) compared to historical controls given high-dose conventional allogeneic HSCT or chemotherapy.
II. To determine whether the rate of transplantation-related mortality (TRM) can be decreased for patients with CML-BC and Ph+ ALL responsive to imatinib mesylate (or dasatinib or nilotinib) followed by nonmyeloablative HSCT compared to historical controls given high-dose conventional allogeneic HSCT or chemotherapy.
I. To evaluate whether donor lymphocyte infusion (DLI) can be safely used in patients with mixed or full donor chimerism as preemptive therapy to eliminate minimal residual disease.
INDUCTION THERAPY: Patients continue to receive imatinib mesylate orally (PO), dasatinib PO, or nilotinib PO once or twice daily until day -2 and resume on day 14 or when blood counts recover after peripheral blood stem cell (PBSC) transplantation.
NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine intravenously (IV) on days -4 to -2; and undergo TBI on day 0.
TRANSPLANTATION: Patients undergo allogeneic PBSC transplantation on day 0.
GRAFT-VERSUS-HOST-DISEASE (GVHD) PROPHYLAXIS: Patients receive mycophenolate mofetil (MMF) PO every 12 hours on days 0-27 (related donor recipients) or every 8 hours on days 0-96 with taper on day 40 (unrelated donor recipients). Patients also receive cyclosporine IV or PO every 12 hours on days -3 to 56, followed by taper on days 57-180 (related donor recipients) or on days -3 to 100, followed by taper on days 101-177 (unrelated donor recipients).
DONOR LYMPHOCYTE INFUSION: Patients with persistent disease and no GVHD after stopping GVHD prophylaxis receive donor lymphocyte infusion IV over 30 minutes once every 28 days for 3 doses.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed up periodically for 2 years and then annually thereafter for 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Allogeneic Nonmyeloablative Hematopoietic Stem Cell Transplant for Patients With BCR-ABL Tyrosine Kinase Inhibitor Responsive Ph+ Acute Leukemia ? A Multi-center Trial|
|Actual Study Start Date :||July 13, 2001|
|Actual Primary Completion Date :||July 14, 2014|
|Estimated Study Completion Date :||June 27, 2021|
Experimental: Treatment (allogeneic nonmyeloablative HSCT)
See Detailed Description
Given IV or PO
Drug: Fludarabine Phosphate
Drug: Imatinib Mesylate
Drug: Mycophenolate Mofetil
Procedure: Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation
Undergo nonmyeloablative allogeneic PBSC transplantation
Procedure: Peripheral Blood Stem Cell Transplantation
Undergo allogeneic PBSC transplantation
Biological: Therapeutic Allogeneic Lymphocytes
Other Name: Allogeneic Lymphocytes
Radiation: Total-Body Irradiation
- Relapse Free Survival [ Time Frame: Assessed up to 1 year ]Number of patients with relapsed disease within 1 Year post-transplant. Relapse is defined as the detection of > 5% blasts after a documented complete remission.
- Leukemia-free Survival [ Time Frame: Assessed up to 5 years ]Number of patients surviving in CR up to five years post-transplant.
- Overall Survival [ Time Frame: Assessed up to 5 years ]Number of patients surviving up to five years post-transplant.
- Transplant-related Mortality [ Time Frame: At day 100 ]Number of patients with TRM within 100 days post-transplant.
- Transplant-related Mortality [ Time Frame: At 1 year ]Number of patients with TRM within one year post-transplant.
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): NCT00036738
|United States, Colorado|
|Presbyterian - Saint Lukes Medical Center - Health One|
|Denver, Colorado, United States, 80218|
|United States, Washington|
|VA Puget Sound Health Care System|
|Seattle, Washington, United States, 98101|
|Fred Hutch/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||George Georges||Fred Hutch/University of Washington Cancer Consortium|