Overview

Haploidentical Donor Hematopoietic Stem Cell Transplant in Treating Patients With Hematologic Malignancies

Status:
Terminated

Trial end date:
2016-10-20

Target enrollment:
0

Participant gender:
All

Summary

This phase II trial studies how well haploidentical donor hematopoietic stem cell transplant works in treating patients with hematologic malignancies. Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. Giving an infusion of the donor's T cells (donor lymphocyte infusion) may replace the patient's immune cells and help destroy any remaining cancer cells. When the stem cells from a related donor, that closely matches the patient's blood, are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Sidney Kimmel Cancer Center at Thomas Jefferson University

Treatments:

Cyclophosphamide
Mycophenolate mofetil
Mycophenolic Acid
Tacrolimus

Criteria

Inclusion Criteria:

1. Any patient with a hematologic or oncologic diagnosis without morphological evidence
of disease in which allogeneic HSCT is thought to be beneficial.

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:

1. Performance status < 80 % (TJU Karnofsky)

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