Phase 2
N=60
Alemtuzumab, Fludarabine Phosphate, and Low-Dose Total Body Irradiation Before Donor Stem Cell Transplantation in Treating Patients With Hematological Malignancies
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities · Adult Acute Myeloid Leukemia With Del(5q) · Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) · Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) · Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Bottom Line
View on ClinicalTrials.gov: NCT00040846 ↗Enrolled (actual)
60
Serious AEs
40.0%
Results posted
Mar 2017
Primary outcome: Primary: Evaluate the Risk of Transplant Related Mortality. — 20 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- alemtuzumab (Biological); fludarabine phosphate (Drug); total-body irradiation (Radiation); allogeneic hematopoietic stem cell transplantation (Procedure); peripheral blood stem cell transplantation (Procedure); mycophenolate mofetil (Drug); cyclosporine (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Fred Hutchinson Cancer Center
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluate the Risk of Transplant Related Mortality. |
20 | — |
| PRIMARY Evaluate the Risk of Occurrence of Acute and Chronic GVHD |
23.3; 41.7 | — |
| PRIMARY Determine Whether Engraftment Can be Maintained With a Single Dose Fludarabine, DLI and Continued MMF/CSP, Defined as Rejection Rate < 20%. |
3.3; 18.3; 70; 8.33; 1.7; 3.3 | — |
| SECONDARY Evaluate the Risk/Incidence of Infections |
91.7 | — |
| SECONDARY Evaluate the Risk for Disease Progression and Relapse |
21.7 | — |
Summary
This phase II trial studies the side effects and the best dose of alemtuzumab when given together with fludarabine phosphate and low-dose total body irradiation (TBI) and how well it works before donor stem cell transplant in treating patients with hematological malignancies. Giving chemotherapy and low-dose TBI before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. Also, monoclonal antibodies, such as alemtuzumab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine (CSP) and mycophenolate mofetil (MMF) after transplant may stop this from happening.
Eligibility Criteria
Inclusion Criteria
- Patients 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 hematopoietic stem cell transplant (HSCT) or with a B cell malignancy except those treatable with autologous transplant will be included
- Aggressive non-Hodgkin lymphomas (NHLs) and Other Histologies Such as Diffuse large B cell NHL
- Patients with primary refractory or relapsed disease not eligible for an autologous transplant
- Patients are eligible following an autologous transplant in remission or in relapse
- Planned tandem transplant is allowed for patients at high risk of relapse
- Low grade NHL with 20% risk of disease recurrence
- Fungal infections with radiological progression after receipt of amphotericin B or active triazole for greater than 1 month
- Patients with active bacterial or fungal infections unresponsive to medical therapy
- Patients with the following organ dysfunction symptomatic coronary artery disease or ejection fraction 50 years of age, or history of cardiac disease or anthracycline exposure
- Diffusion capacity of carbon monoxide (DLCO) 3 mg/dL; or symptomatic biliary disease
- Patients with poorly controlled hypertension on multiple antihypertensives
- Karnofsky score < 70 for adult patients
- Lansky-Play Performance Score < 50 for pediatric patients
- DONOR: Bone marrow (BM) donors
- DONOR: Donors who are HIV-positive and/or, medical conditions that would result in increased risk for granulocyte colony-stimulating factor (G-CSF) mobilization and harvest of peripheral blood stem cell (PBSC)
- DONOR: Donors < 12 years of age
Data sourced from ClinicalTrials.gov (NCT00040846). 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.