Bone Marrow Transplantation of Patients in Remission Using Partially Matched Relative Donor

• 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
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Dolores Grosso, DNP, CRNP
• Affiliation: Thomas Jefferson University

• Name: Neal Flomenberg, MD
• 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

Chronic Myeloid Leukemia

Hodgkin's Disease

Acute Myeloid Leukemia

Biphenotypic Leukemia

Lymphoma

Chronic Lymphocytic Leukemia

Myelodysplastic Syndromes

Acute Lymphocytic Leukemia

Aplastic Anemia

Plasma Cell Neoplasms

Intervention(s)

Drug: Cyclophosphamide

Biological: Donor Lymphocyte Infusion (DLI)

Radiation: Total Body Irradiation (TBI)

Device: Hematopoietic stem cell transplantation (HSCT)

Drug: Tacrolimus

Drug: Mycophenolate Mofetil (MMF)

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 ID(s)

10D.219

2010-10

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 13/10/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01350245