Safety and Efficacy of Pentostatin and Low Dose TBI With Allogenic Peripheral Blood Stem Cell Transplant
Source: ClinicalTrials.gov NCT00571662 ↗Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Participants With Chimerism: Full Donor Chimerism Defined as >95% Donor CD3+ Cell in Blood as Assessed by DNA Fingerprinting |
85; 90 | — |
| PRIMARY Toxicity for the Combination of Pentostatin and Low Dose Total Body Irradiation (TBI) |
40; 29; 2; 1; 2; 6 | — |
| SECONDARY Incidence of Acute and Chronic Graft-versus-host Disease |
31; 33 | — |
| SECONDARY Responses to Therapy |
52; 59 | — |
| SECONDARY Kinetics of Immunologic Reconstitution |
13; 7; 5; 3.5; 5; 1.7 | — |
Eligibility Criteria
Inclusion Criteria
Age 19-75 years
- Patients who relapse after autologous stem cell transplantation.
- Patients who are candidates for an autologous or conventional allogeneic stem cell transplantation from a disease standpoint but who do not qualify functionally (from the point of view of organ function, or performance status) for a myeloablative protocol.
- Any patient, where in the opinion of the primary treating oncologist, nonmyleoablative therapy would be the treatment option in the best patients interest providing the patient fits all other eligibility criteria for this protocol.
Identification of a matched related or unrelated stem cell donor
Diseases:
Acute myelogenous leukemia first complete remission with high-risk cytogenetics>second complete remission minimal residual disease ( second complete remission minimal residual disease ( 2 prior regimens. Mantle Cell Lymphoma: first complete or partial remission, refractory disease, or failed prior ASCT. Diffuse Large B-cell Lymphoma, Follicular Large cell Lymphoma, Peripheral T-cell Lymphoma, Anaplastic Large Cell Lymphoma: refractory disease, or failed prior ASCT. Burkitt or Acute Lymphoblastic Lymphomas: high-risk disease in remission, chemosensitive persistent or recurrent disease. Cutaneous T-cell Lymphomas: (Mycosis Fungoides, Sezary Syndrome): chemorefractory disease of > 2 prior regimens
Hodgkins Disease: refractory or persistent disease and not candidate for ASCT, or failed prior ASCT.
Peripheral T-cell Lymphoma
Exclusion Criteria
- Age > 75 years and 2x upper limit of normal (unless due to Gilberts disease or malignancy), ALT and AST 4x the upper limit of normal
- Karnofsky score <60%
- Patients with uncontrolled medical illnesses (e.g., uncontrolled systemic hypertension, diabetes)
Donor Inclusion Criteria:
- HLA genotypically matched relative
- siblings or first-degree relatives matched at HLA-A, B, or DR loci (6 antigen match) are acceptable donors
- HLA matched unrelated volunteer donor
- unrelated donor matched at HLA-A, B, or DR loci (6 antigen match) are acceptable donors
- One antigen mismatch related or unrelated donor will also be acceptable, molecular typing needs to be used at each H LA-A, B, or DR loci in case of mismatched unrelated donor.
Donor Exclusion Criteria:
- Identical twin
- Pregnancy
- HIV positive
- Serious Allergy to G-CSF
- Current serious systemic illness
- Failure to meet the UNMC or NMDP criteria for donors
Data sourced from ClinicalTrials.gov (NCT00571662). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.