Haploidentical Donor Hematopoietic Stem Cell Transplant in Treating Patients With Hematologic Malignancies
NCT ID: NCT01871441
Last Updated: 2025-05-16
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
4 participants
INTERVENTIONAL
2013-05-17
2016-10-20
Brief Summary
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Detailed Description
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I. Examine the 1 year disease free survival (DFS) rate of patients with maternal donors or sibling donors who share the maternal haplotype (maternal group) and compare them to patients receiving cells from donors who have points from other characteristics such as killer immunoglobulin-like receptor (KIR) ligand mismatching, minor histocompatibility antigen (MHag) differences, or number of human leukocyte antigen (HLA) mismatches (non-maternal group).
SECONDARY OBJECTIVES:
I. Assess the incidences of relapse and graft-versus-host disease (GVHD) in maternal recipients whose only eligible donors are offspring.
II. Assess the incidence of grades III-IV GVHD in female recipients with male donors.
III. Compare the rates of DFS in recipient-donor combinations in which there is at least 1 KIR ligand mismatch versus those without a KIR ligand mismatch.
OUTLINE:
Patients undergo total body irradiation (TBI) twice daily (BID) on days -9 to -6, undergo donor lymphocyte infusion (DLI) on day -6, and receive cyclophosphamide intravenously (IV) over 2 hours on days -3 and -2.
TRANSPLANT: Patients undergo haploidentical allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV beginning on day -1 with taper beginning on day 42, and mycophenolate mofetil IV BID from day -1 to day 28.
After completion of study treatment, patients are followed up at 90, 180, and 270 days, and 1 year.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (haploidentical allogeneic HSCT)
Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.
TRANSPLANT: Patients undergo haploidentical allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV beginning on day -1 with taper beginning on day 42, and mycophenolate mofetil IV BID from day -1 to day 28.
Total-body irradiation
Undergo TBI
Donor lymphocytes infusion (DLI)
Undergo DLI
Cyclophosphamide
Given IV
Allogeneic hematopoietic stem cell transplantation (HSCT)
Undergo haploidentical allogeneic HSCT
Tacrolimus
Given IV
Mycophenolate mofetil
Given IV
Interventions
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Total-body irradiation
Undergo TBI
Donor lymphocytes infusion (DLI)
Undergo DLI
Cyclophosphamide
Given IV
Allogeneic hematopoietic stem cell transplantation (HSCT)
Undergo haploidentical allogeneic HSCT
Tacrolimus
Given IV
Mycophenolate mofetil
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients must have a related donor who is a two or more allele mismatch at the HLA-A; B; C; DR loci.
3. Patients must have adequate organ function:
1. LVEF (Left ventricular ejection fraction) of \>50%
2. Diffusion Capacity for Carbon Monoxide (DLCO) \>50% of predicted corrected for hemoglobin
3. Adequate liver function as defined by a serum bilirubin \<1.8, Aspartate Aminotransferase (AST) or alanine aminotransferase (ALT) \< 2.5X upper limit of normal
4. Creatinine clearance of \> 60 ml/min
4. Performance status \> 80% (TJU Karnofsky)
5. Hematopoietic Comorbidity Index (HCT-CI) Score \< 5 Points
6. Patients must be willing to use contraception if they have childbearing potential
7. Able to give informed consent, or if decisionally impaired, have a legal next of kin or guardian that can give informed consent
Exclusion Criteria
2. HCT-CI Score \> 5 Points
3. Combination of Performance status of \< 80% (TJU Karnofsky) and an HCT-CI of 4 points or more.
4. HIV positive
5. Active involvement of the central nervous system with malignancy
6. Psychiatric disorder that would preclude patients from signing an informed consent
7. Pregnancy
8. Patients with life expectancy of \< 6 months for reasons other than their underlying hematologic/oncologic disorder
9. Patients who have received alemtuzumab within 8 weeks of the transplant admission, or who have recently received horse or rabbit anti-thymocyte globulin and have an ATG level of \> 2 ugm/ml
10. Patients who cannot receive cyclophosphamide
11. Patients with evidence of another malignancy, exclusive of a skin cancer that requires only local treatment, should not be enrolled on this protocol
18 Years
ALL
No
Sponsors
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Sidney Kimmel Cancer Center at Thomas Jefferson University
OTHER
Responsible Party
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Principal Investigators
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Dolores Grosso, DNP, CRNP
Role: PRINCIPAL_INVESTIGATOR
Thomas Jefferson University
Locations
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Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Countries
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Related Links
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Thomas Jefferson University Hospitals
Other Identifiers
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2012-104
Identifier Type: OTHER
Identifier Source: secondary_id
JT 3048
Identifier Type: OTHER
Identifier Source: secondary_id
13D.127
Identifier Type: -
Identifier Source: org_study_id
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