Busulfan, Melphalan, and Fludarabine With Peri-transplant Palifermin, Followed by a T-Cell Depleted Hematopoietic Stem Cell Transplant From HLA Matched or Mismatched Related or Unrelated Donors in Patients With Advanced Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | Any - 65 |
| Updated: | 3/7/2019 |
| Start Date: | February 2008 |
| End Date: | February 2020 |
A Phase II Trial of Busulfan, Melphalan, and Fludarabine With Peri-transplant Palifermin, Followed by a T-Cell Depleted Hematopoietic Stem Cell Transplant From HLA Matched or Mismatched Related or Unrelated Donors in Patients With Advanced Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML)
This study will see if the researchers can lower that risk by giving the patient Palifermin.
This drug helps protect the lining of the mouth, throat, and stomach. These areas typically
get sores or ulcers while the blood cell counts are very low. The patient can get infections
in or from these sores. Palifermin might also help the immune system recover faster. It is
currently approved for patients who receive their own stem cells. That is called an
autologous transplant. This study will test the use of Palifermin for T-cell depleted
allogeneic stem cell transplants.
This drug helps protect the lining of the mouth, throat, and stomach. These areas typically
get sores or ulcers while the blood cell counts are very low. The patient can get infections
in or from these sores. Palifermin might also help the immune system recover faster. It is
currently approved for patients who receive their own stem cells. That is called an
autologous transplant. This study will test the use of Palifermin for T-cell depleted
allogeneic stem cell transplants.
Inclusion Criteria:
- Patients should be < 65 years. Patients > or equal to 65 years will be accrued on a
case by case basis after discussion and approval by the BMT Service.
- Patients may be of either gender or any ethnic background.
- Patients must have a Karnofsky or Lansky Performance Status > or equal to 70%.
- Patients must have adequate organ function measured by:
* Cardiac: asymptomatic or if symptomatic then LVEF at rest must be > or equal to 50%
and must improve with exercise.
- Hepatic: < 3x ULN ALT and < 1.5 total serum bilirubin, unless there is congenital
benign hyperbilirubinemia.
- Renal: serum creatinine < than or equal to 1.2 mg/dl or if serum creatinine is
outside the normal range, then CrCl > 60-ml/min/1.73 m2
- Pulmonary: asymptomatic or if symptomatic, DLCO > 50% of predicted (corrected for
hemoglobin)
- Each patient must be willing to participate as a research subject and must sign an
informed consent form.
- Parent or legal guardians of patients who are minors will sign the informed consent
form.
Exclusion Criteria:
- Active CNS or skin leukemic involvement
- Female patients who are pregnant or breast-feeding
- Active viral, bacterial or fungal infection
- Patient seropositive for HIV-I/II; HTLV -I/II
- Patients who have undergone a prior allogeneic or autologous stem cell transplant
within the previous six months.
- Patients who have had a previous malignancy that is not in remission.
We found this trial at
1
site
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
Click here to add this to my saved trials
