Phase 2
N=42
Reduced Intensity Total Body Irradiation + Thymoglobulin Followed by Allogeneic PBSCT
Non-Hodgkin's Lymphoma · Leukemia · Multiple Myeloma · Acute Myeloid Leukemia · Hodgkin Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00709592 ↗Enrolled (actual)
42
Serious AEs
46.3%
Results posted
Feb 2015
Primary outcome: Primary: The Comparison of Functional Immune Reconstitution at 6-9 Months Following Transplant as Measured by Antibody Response to Vaccination With Inactivated Hepatitis A or B Vaccine. — 8; 3; 11; 19 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Thymoglobulin (Biological); Total-Body Irradiation (Radiation); Allogeneic PBSCT or BMT (Procedure); Tacrolimus (Drug); Mycophenolate Mofetil (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Comparison of Functional Immune Reconstitution at 6-9 Months Following Transplant as Measured by Antibody Response to Vaccination With Inactivated Hepatitis A or B Vaccine. |
8; 3; 11; 19 | — |
| SECONDARY Engraftment of Donor Hematopoietic Stem Cells, as Measured by Time in Days to Neutrophil and Platelet Count Recovery Following Allogeneic PBSCT. |
12; 12 | — |
| SECONDARY Survival |
71.3; 62.4 | — |
| SECONDARY Treatment Related Mortality |
0; 0 | — |
| SECONDARY Event-free Survival |
62.2; 44.5 | — |
| SECONDARY Relapse |
28; 50 | — |
| SECONDARY Donor Lymphocyte Infusion |
8.9; 45.5 | — |
| SECONDARY Acute Graft-Versus-Host Disease (GVHD) |
27.2; 4.5 | — |
| SECONDARY Chronic Graft-Versus-Host Disease (GVHD) |
23.8; 31.8 | — |
Summary
One of two different doses of thymoglobulin will allow bone marrow engraftment with minimal Graft-versus-Host Disease and allow adequate immune response to allow the transplanted stem cells to replace the tumor cells.
Eligibility Criteria
Inclusion Criteria
- Patients with hematological malignancies for which allogeneic stem cell transplantation indicated including non-Hodgkin lymphoma (NHL), multiple myeloma (MM), acute myeloid leukemia (AML), Hodgkin lymphoma (HD), chronic lymphocytic leukemia (CLL), chronic myelogenous leukemia (CML), and myelodysplastic syndrome (MDS)
- Patients with HLA compatible related or unrelated stem cell donor, willing and able to serve as an allogenic HSC donor. Unrelated donors have to be matched at HLA-A, B, C and DRB1 loci. A single locus mismatch will be tolerated in the event a more closely matched donor is not available.
- Patients age >/=40 to </=70 with an ECOG performance status < 2
- Patients between 18 and 40 years of age will be eligible only if they have co-morbidities precluding conventional allogeneic transplantation with full intensity myeloablative conditioning
- Adequate cardiac, pulmonary, renal and hepatic function for transplant
- Negative serology for HIV
- Negative serum pregnancy test
- Patients who have received therapeutic radiation to a localized field will be eligible, provided critical structure tolerance doses have not been exceeded
- Patients who have had prior myeloablative autologous transplant will be eligible
Exclusion Criteria
- Evidence of uncontrolled viral, fungal, bacterial infection
- Evidence of active meningeal or CNS disease
- Prior therapy with rabbit ATG, prior treatment with equine ATG is allowed if more than 3 months ago
- Breast feeding mothers are excluded
Data sourced from ClinicalTrials.gov (NCT00709592). 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.