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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)


Phase 2
N/A
65 Years
Open (Enrolling)
Both
Acute Myeloid Leukemia, Advanced Myelodysplastic Syndromes

Thank you

Trial Information

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)


Inclusion Criteria:



- Patients should be < 65 years. There is no lower age limit. 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 (adult) or Lansky (pediatric) 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.

- Patients with known hypersensitivity to mouse proteins (murine antibodies in ISOLEX)
if receiving PBSC or bovine proteins if receiving SBA-E- bone marrow, or chicken egg
products.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To reduce the early transplant-related mortality.

Outcome Time Frame:

conclusion of study

Safety Issue:

Yes

Principal Investigator

Hugo Castro-Malaspina, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

08-008

NCT ID:

NCT00629798

Start Date:

February 2008

Completion Date:

February 2014

Related Keywords:

  • Acute Myeloid Leukemia
  • Advanced Myelodysplastic Syndromes
  • Busulfan
  • Melphalan
  • Fludarabine
  • 08-108
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021