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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT01350245
Date of registration: 04/05/2011
Prospective Registration: No
Primary sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
Public title: Bone Marrow Transplantation of Patients in Remission Using Partially Matched Relative Donor
Scientific title: A Two Step Approach to Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematologic Malignancies in Remission From HLA Partially-Matched Related Donors
Date of first enrolment: July 2010
Target sample size: 28
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01350245
Study type:  Interventional
Study design:   
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     Dolores Grosso, DNP, CRNP
Address: 
Telephone:
Email:
Affiliation:  Thomas Jefferson University
Name:     Neal Flomenberg, MD
Address: 
Telephone:
Email:
Affiliation:  Thomas Jefferson University
Key inclusion & exclusion 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.

- Diagnoses include:

Acute Myeloid Leukemia Myelodysplastic Syndromes Biphenotypic Leukemia Acute
Lymphocytic Leukemia Chronic Myeloid Leukemia Chronic Lymphocytic Leukemia Plasma Cell
Neoplasms Lymphoma Hodgkin Disease Aplastic Anemia

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 adequate organ function:

- LVEF of > or = 50%

- DLCO > or = 50% of predicted corrected for hemoglobin

- Adequate liver function as defined by a serum bilirubin < or = 1.8, AST or ALT <
or = 2.5X upper limit of normal

- Creatinine clearance of > or = 60 ml/min

4. Performance status > or = 70% (TJU Karnofsky)

5. HCT-CI Score < 5 Points

6. Patients must be willing to use contraception if they have childbearing potential

7. Able to give informed consent

Exclusion Criteria:

1. Performance status < or = 70% (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 < or = 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 ant-thymocyte globulin and have an ATG
level of > or = 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Acute Lymphocytic Leukemia
Acute Myeloid Leukemia
Aplastic Anemia
Biphenotypic Leukemia
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Hodgkin's Disease
Lymphoma
Myelodysplastic Syndromes
Plasma Cell Neoplasms
Intervention(s)
Biological: Donor Lymphocyte Infusion (DLI)
Device: Hematopoietic stem cell transplantation (HSCT)
Drug: Cyclophosphamide
Drug: Mycophenolate Mofetil (MMF)
Drug: Tacrolimus
Radiation: Total Body Irradiation (TBI)
Primary Outcome(s)
Disease-Free Survival (DFS) [Time Frame: 1 year post-transplant]
Probability of Overall Survival at 15 Months Post-treatment [Time Frame: 15 months]
Secondary Outcome(s)
Secondary ID(s)
10D.219
2010-10
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 13/10/2014
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01350245
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