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A Phase II Study of Reduced-Intensity Allogeneic Peripheral Blood Stem Cell Transplantation (PBSCT) for Treatment of Hematologic Malignancies and Hematopoietic Failure States


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Hematologic Neoplasms, Multiple Myeloma, Anemia, Aplastic, Hemoglobinuria, Paroxysmal, Myelofibrosis

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Trial Information

A Phase II Study of Reduced-Intensity Allogeneic Peripheral Blood Stem Cell Transplantation (PBSCT) for Treatment of Hematologic Malignancies and Hematopoietic Failure States


Transplantation of related or unrelated allogeneic peripheral blood stem cells (PBSCs) after
administration of a reduced-intensity regimen of busulfan, melphalan and alemtuzumab will be
associated with satisfactory engraftment and acceptable post-transplant non-relapse
mortality.


Inclusion Criteria:



- Age 50 to 75 years or age 18 to 49 with one or more of these risk factors: prior
autologous, allogeneic or syngeneic HCT (Hematopoietic cell transplantation); not in
first complete remission or first chronic phase; and/or presence of one or more
medical conditions that would place the subject at high risk such as heart and kidney
disease.

- Subjects with hematologic cancers must have received at least one previous course of
chemotherapy or biological therapy. In other words, the subject cannot enroll in
this trial for initial treatment of the disease.

- Availability of a healthy related or unrelated volunteer allogeneic donor.

Exclusion Criteria:

- Eligible for another study or standard of care treatment that offers higher
probability of cure or long-term control of subject's disease.

- Severe abnormal function of organs such as heart, kidneys, liver.

- Untreated or progressive central nervous system involvement by the disease.

- Subject is pregnant or breast-feeding.

- Performance score is below 50: at the least, requires considerable assistance and
frequent medical care.

- Positive for the HIV [AIDS] virus

- Life expectancy less than 12 weeks with conventional treatments.

- For subjects capable of having children, refusal to practice birth control while on
this study and for at least 12 months after PBSCT or after stopping post-transplant
immunosuppressive treatments, whichever occurs later.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The primary efficacy endpoint is the presence of donor lymphohematopoietic chimerism (defined as at least 50% donor cells in the peripheral blood) in peripheral blood by day +100 (i.e., 100 days after allogeneic PBSCT).

Outcome Time Frame:

Day +100

Safety Issue:

Yes

Authority:

United States: Institutional Review Board

Study ID:

09-0679-04

NCT ID:

NCT00997386

Start Date:

September 2009

Completion Date:

September 2014

Related Keywords:

  • Hematologic Neoplasms
  • Multiple Myeloma
  • Anemia, Aplastic
  • Hemoglobinuria, Paroxysmal
  • Myelofibrosis
  • Hematologic malignancies
  • lymphoma, leukemia, MDS (myelodysplastic syndrome)
  • reduced-intensity preparative regimen
  • allogeneic peripheral blood stem cell transplant
  • myelofibrosis or other myeloproliferative syndromes
  • Primary Myelofibrosis
  • Anemia
  • Anemia, Aplastic
  • Neoplasms
  • Hemoglobinuria
  • Hemoglobinuria, Paroxysmal
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Hematologic Neoplasms

Name

Location

University Medical Center and UMC-North ClinicTucson, Arizona  85719