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TERMINATEDPHASE2

Flu,Alemtuzumab,and TBI Followed By Donor Stem Cell Chronic Phase CML

Fludarabine, Campath, TBI T-Cell Deplete NMSCT With Post-Transplant T-Cell Infusions for CML Failing Imatinib Therapy With Imatinib (STI571)

NCT00416884•OHSU Knight Cancer Institute

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Summary

RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and total-body irradiation (TBI) before a donor 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 system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) that have been treated in the laboratory after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and alemtuzumab, and removing the T lymphocyte cells(T cells) from the donor cells before transplant, may stop this from happening. PURPOSE: This clinical trial is studying how well giving fludarabine, alemtuzumab, and total-body irradiation together with donor stem cell transplant and donor white blood cell (WBC) infusion works in treating patients with chronic phase chronic myelogenous leukemia (CML) that did not respond to previous imatinib mesylate.

Detailed Description

OBJECTIVES: * Determine the treatment-related mortality in patients with imatinib mesylate-resistant chronic phase chronic myelogenous leukemia treated with nonmyeloablative conditioning comprising fludarabine, alemtuzumab, and total-body irradiation followed by T-cell-depleted allogeneic stem cell transplantation and post-transplantation allogeneic T-cell infusion. * Determine if donor engraftment can be safely established using partial T-cell depletion with additional T-cell infusions in these patients. OUTLINE: Patients receive alemtuzumab IV over 5-6 hours on day -8 and fludarabine IV on days -4 to -2. Patients undergo total-body irradiation followed by T-cell-depleted (CD34+ selected) allogeneic stem cell transplantation on day 0. Patients receive allogeneic T-cell infusion on days 30 and 60. Patients also receive cyclosporine twice daily beginning on day -3 and continuing until day 100 followed by a taper until day 177. PROJECTED ACCRUAL: Not specified.

Eligibility

Age

4 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients aged 4-75 with chronic myelogenous leukemia (CML) treatable by allogeneic hematopoietic stem cell transplant.
•Patients with cytogenetically confirmed chronic phase CML.
•o Hematologic parameters for chronic phase are: i) Percentage of blasts in peripheral blood or marrow \< 15% ii) Percentage of blasts + promyelocytes in the peripheral blood or bone marrow \< 30% iii) Percentage of basophils in blood or marrow \<20% iv) Platelet count \> 100 x 109/l
•Patients must have demonstrated refractoriness/resistance to STI571 defined as follows:
•i) Hematologically resistant- failure to achieve a complete hematologic remission (CHR) despite 3 months of STI571 therapy.
•ii) Hematologically refractory - a rising WBC count \> 20 x 109/l confirmed by two samples taken two weeks apart in a patient with a previous CHR despite concurrent treatment with STI571 iii) Cytogenetically resistant - bone marrow cytogenetics showing \> 65% Philadelphia chromosome positivity (Ph+) after 6 months of STI571 based therapy.
•iv) Cytogenetically refractory - An increase in the number of Philadelphia chromosome positive (Ph+) bone marrow cells by at least 30%, or an increase to \> 65%, confirmed by samples at least 1 month apart following a previous STI571 induced cytogenetic response, while continuing STI571 therapy.
•Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
•Patients with a human leukocyte antigen (HLA) matched sibling donor at the HLA-A, B, and DR loci.
•Patients with an unrelated hematopoietic stem cell donor must be matched using high resolution typing for class II human leukocyte antigen (HLA-DR beta-1, 3, 4, 5 and DQ beta-1) and matched with intermediate to high resolution molecular typing at class I human leukocyte antigen (HLA-A, B, and C) loci.
+10 more criteria

Exclusion Criteria

•Patients who have received another investigational drug within 30 days.
•Fertile men unwilling to use contraceptive techniques during and for 24 months following treatment.
•Females who are pregnant or fertile women unwilling to use contraceptive techniques for two months prior to entering the study and for 24 months following treatment.
•Patients with active bacterial or fungal infections unresponsive to medical therapy.
•Patients with organ dysfunction including cardiac ejection fraction of less than 35% or pulmonary status with a diffusing capacity of the lung for carbon monoxide(DLCO) of less than 40% and/or receiving supplemental oxygen.
•Liver Function Abnormalities: patients will be excluded if they are found to have fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, varices, history of bleeding varices, hepatic encephalopathy or chronic viral hepatitis where the total serum bilirubin is greater than 3 mg per deciliter with symptomatic biliary disease.
•Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable.
•Patients with a history of any prior bone marrow or peripheral blood stem cell transplantation.
•Patients with any other serious, uncontrolled, concomitant medical condition
•HIV positive patients
+1 more criteria

Locations (1)

OHSU Knight Cancer Institute

Portland, Oregon, United States

Key Dates

Start Date

May 1, 2003

Primary Completion Date

March 1, 2008

Completion Date

March 1, 2008

Last Updated

September 27, 2017

Enrollment

ACTUAL participants

Conditions

Leukemia

Interventions

Campath

DRUG

Fludarabine

DRUG

Total Body Irradiation (TBI)

RADIATION

T-Cell Deplete

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 27, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Flu,Alemtuzumab,and TBI Followed By Donor Stem Cell Chronic Phase CML

Inclusion Criteria

Exclusion Criteria

Venetoclax for the Treatment of Patients With Relapsed Hairy Cell Leukemia

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants

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