Know Cancer

or
forgot password

Allogeneic Bone Marrow Transplantation With Matched Unrelated Donors for Patients With Hematologic Malignancies Using a Preparative Regimen of Busulfan, Cyclophosphamide, and Fludarabine


Phase 2
18 Years
N/A
Not Enrolling
Both
Hematologic Malignancies

Thank you

Trial Information

Allogeneic Bone Marrow Transplantation With Matched Unrelated Donors for Patients With Hematologic Malignancies Using a Preparative Regimen of Busulfan, Cyclophosphamide, and Fludarabine


Patients who have cancer of the bone marrow (leukemia) or lymph gland (lymphomas) are being
asked to take part in this study. This study uses a new chemotherapy regimen and matched
volunteer stem cell transplant to treat patients with cancers of this kind.

High dose chemotherapy, followed by a transplant of stem cells collected from either bone
marrow (BMT) or peripheral blood of an HLA (tissue type) matched unrelated donor, offers a
potential cure for several serious blood diseases including acute and chronic leukemia,
myelodysplastic syndrome and lymphoma.

However, the success of allogeneic (unrelated volunteer matched donor) transplant is limited
by treatment related illness, death, and relapse in patients with refractory (resistant)
disease and/or advanced age (older than 40 years).

Patients being sought for this study do not have an HLA-matched relative to donate stem
cell; however, through The National Marrow Donor Program or International Registries, an
HLA-matched unrelated donor has been found to donate stem cells. Preliminary data shows
that the outcome is comparable between bone marrow and peripheral blood stem cell
transplantations, and donor preference will determine which type of cells the patient
receives.

To carry out an unrelated transplant, a normal person with similar HLA type must be
available to donate cells. The patient must be prepared to accept the donor cells by
decreasing the body's immune systems. In addition, the malignant (cancerous) cells must be
destroyed to allow growth and repopulation of healthy donor cells. This is usually done by
giving total body irradiation and chemotherapy, which is associated with severe side effects
in patients over age 40.

In other studies, it has been found that treating the patient with two anticancer drugs,
Busulfan and Cyclophosphamide, without total body irradiation, is safe and sufficiently
immunosuppressive. High dose Busulfan and Cyclophosphamide are frequently used in
combination prior to matched related bone marrow transplant in case of acute leukemia,
myelodysplastic syndrome (MDS), Hodgkin's disease (HD), and chronic myeloid leukemia (CML).
Fludarabine (another anticancer drug) suppresses the immune system and has strong anticancer
effect against chronic lymphocytic leukemia (CLL) and non-Hodgkin's lymphoma (NHL).
Researchers are studying a new chemotherapy regimen that includes fludarabine, along with
busulfan and cyclophosphamide, to provide more immunosuppression and anti-cancer effect
without increasing the chemotherapy related toxicity in patients with CML, acute leukemia
and MDS, CLL, NHL, and HD.

The purposes of this study are: 1) to decrease the side effects due to the chemotherapy used
to treat the bone marrow; and 2) to increase the number of tumor cells killed. There will be
up to 55 patients enrolled in this study at Emory University. The expected duration of each
subject's participation in this study will be for two years.


Inclusion Criteria:



- Patients eligible to participate in this study must have CML in the first chronic
phase, AML in the first complete remission, AML in second remission, ALL or hybrid
leukemia in the first complete remission, ALL in second remission, or advanced MDS.
Final eligibility for this study will be determined by the health professionals
conducting the trial.

Exclusion Criteria:

- Patients with active CNS malignant disease, or an invasive/systemic fungal infection
are not eligible to participate in this study. Patients who are lactating, or who
have an HLA identical or 1 antigen mismatched relative who is eligible and willing to
donate bone marrow will also be excluded from the study. Final eligibility for this
study will be determined by the health professionals conducting the trial.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Assess activity of preparative regimen in patients with CML, AML, RAEB, RAEB-t, CLL, NHL, HD, in all patients with refractory anemia, ringed sideroblasts, undergoing allogeneic stem cell transplantation from volunteer matched unrelated donor (VUD).

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Amelia Langston, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University Winship Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

0709-1997

NCT ID:

NCT00208923

Start Date:

July 1998

Completion Date:

October 2007

Related Keywords:

  • Hematologic Malignancies
  • Hematologic Malignancies
  • Neoplasms
  • Hematologic Neoplasms

Name

Location

Emory Universtiy Winship Cancer InstituteAtlanta, Georgia  30322