Phase 2
Completed N=12
Alemtuzumab, Fludarabine Phosphate, and Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer
leukemia · Non-Hodgkin's Lymphoma · Angioimmunoblastic T-cell lymphoma · Diffuse Large B-Cell Lymphoma
Source: ClinicalTrials.gov NCT00118352 ↗
Enrolled (actual)
12
Serious AEs
16.7%
Results posted
May 2017
Primary outcomePrimary: Incidence of Grade III-IV Acute GVHD — 25 percentage of participants
Summary
This phase II trial is studying the side effects and best dose of alemtuzumab when given together with fludarabine phosphate and total-body irradiation followed by cyclosporine and mycophenolate mofetil in treating patients who are undergoing a donor stem cell transplant for hematologic cancer. Giving low doses of chemotherapy, such as fludarabine phosphate, a monoclonal antibody, such as alemtuzumab, and radiation therapy before a donor stem cell transplant helps stop the growth of cancer cells. Giving chemotherapy or radiation therapy before or after transplant also stops the patient's immune system from rejecting the donor's bone marrow stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Grade III-IV Acute GVHD |
25 | — |
| SECONDARY Incidence of Graft Rejection |
— | — |
| SECONDARY Incidence of High-dose Corticosteroid Utilization. |
83.3 | — |
| SECONDARY Incidence of Non-relapse Mortality |
8.3 | — |
| SECONDARY Incidence of Infection |
100 | — |
| SECONDARY Immune Reconstitution |
— | — |
| SECONDARY Disease Progression/Relapse |
25 | — |
Eligibility Criteria
Inclusion Criteria
- The patient must be not eligible for conventional transplants and must have disease expected to be stable for at least 100 days without chemotherapy
- Patients with hematologic malignancies treatable with HCT will be included:
- Aggressive non-Hodgkin lymphomas (NHLs) and other histologies such as diffuse large B-cell NHL: not eligible for autologous HCT, not eligible for conventional myeloablative HCT, or after failed autologous HCT;
- Low grade NHL: with 20% risk of disease recurrence
- Patient has a fungal infection with radiological progression after receipt of amphotericin B or active triazole for greater than 1 month
- Patient has the following organ dysfunction:
- Symptomatic coronary artery disease or ejection fraction 50 years or if the patient has a history of anthracyclines or history of cardiac disease;
- Diffusion capacity of the lung for carbon monoxide (DLCO) 3mg/dL, or symptomatic biliary disease
- Patient has poorly controlled hypertension and on multiple antihypertensives
- Karnofsky performance score < 70 for adult patients
- Lansky play-performance score < 70 for pediatric patients
- Patient received cytotoxic agents for "cytoreduction" within three weeks (or the interval in which a cycle of standard chemotherapy would be administered in a non-transplant setting) prior to initiating the nonmyeloablative transplant conditioning; (exceptions are hydroxyurea and imatinib mesylate)
- DONOR: Marrow donors
- DONOR: Positive crossmatch between donor and recipient
- DONOR: Donor is HIV-positive and/or has a medical condition that would result in increased risk for filgrastim (G-CSF) mobilization and harvest of PBSC
- DONOR: Donor age < 12 years
Data sourced from ClinicalTrials.gov (NCT00118352). 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.