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Low-Intensity Preparative Regimen and Allogeneic Peripheral Blood Stem Cell Transplantation From Unrelated Donor in Patients With Hematologic Malignancy

Phase 2
Not Enrolling
Myeloma, Plasma-Cell, Lymphoma, Malignant, Myeloproliferative Disorders, Myelodysplastic Syndromes, Waldenstrom's Macroglobulinemia

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Trial Information

Low-Intensity Preparative Regimen and Allogeneic Peripheral Blood Stem Cell Transplantation From Unrelated Donor in Patients With Hematologic Malignancy

Combinations of high-dose chemotherapy and radiation therapy (preparative regimen) followed
with allogeneic bone marrow or stem cell transplantation from an unrelated donor is a
current treatment approach. Chemotherapeutic drugs and radiation are given in higher doses
to increase their effectiveness. High-dose chemotherapy and radiation therapy generally
affect cells that are dividing. They are used to treat cancer because cancer cells divide
more often than most other cells. High-dose treatment severely damages the patient's bone
marrow so that the patient no longer is able to produce needed blood cells. Peripheral stem
cell transplantation allows stem cells that were damaged by treatment to be replaced with
healthy stem cells that can produce the blood cells the patient needs. Patients experience a
number of complications after transplantation. Some are temporary and relatively minor; yet
others can be life threatening. Many doctors consider high-dose chemotherapy, by itself or
with radiation, and bone marrow or stem cell transplantation as the best available treatment
option for diseases under specific circumstances. However, this study will explore whether a
less-intensive preparative therapy before the peripheral stem cell transplantation will
prove to be safer, have less side effects, and be an effective treatment for certain

Inclusion Criteria:

Patients must be a candidate for unrelated donor stem cell transplantation and the donor
and recipient must be 5/6 or 6/6 matched. In addition, patients must have one of the
following histologically confirmed diagnosis :

1. Patients with previously treated AML (M0 - M7 by FAB classification)

- who are in not in complete remission (CR).

- who are in second or later CR.

- who have 5-30% persistent blasts in bone marrow following induction or salvage

- who have high-risk feature in first complete remission e.g. presence of
Philadelphia chromosome or non-core-binding factor type of chromosomal

2. Patients with myelodysplastic syndromes and IPS int-1, int-2 or high-risk scores who
are transfusion-dependent.

3. Patients with chronic myeloid leukemia who are in accelerated, blastic, or or chronic

4. Patients with acute lymphoblastic leukemia

- who are in first complete remission and have high risk disease [Ph' or t (4; 11)
, WBC> 30,000, > 4 weeks to achieve CR].

- who are in second or greater CR.

- who did not achieve a CR following induction or salvage therapy.

5. Patients with Hodgkin's or non-Hodgkin's lymphoma who are not curable with
conventional chemotherapy and do not have any tumor larger than 5 centimeters in

6. Patients with myeloma or plasma cell neoplasms who are :

- stage III at presentation.

- stage I-II at presentation but were not responding or progressed after first
line therapy.

7. Patient with chronic lymphocytic leukemia or Waldenström's macroglobulinemia who
progressed after first-line therapy.

8. Patients with MDS or myeloproliferative disorders who had history of life-threatening
complications related to thrombosis, hemorrhagic diathesis or intractable
hypercatabolic state (fever cachexia).

Exclusion Criteria:

1. Cardiac disease of symptomatic nature; < 25% ejection fraction.

2. Severe renal disease; creatinine > 2.O mg/dl or creatinine clearance < 40 ml/min.
(Corrected for age)

3. Severe pulmonary disease < 60% normal (FEV1 & FVC).

4. Severe hepatic disease; bilirubin >2.0, and/or transaminase > 3 x normal corrected
for age.

5. Karnofsky performance status of < 60%.

6. Patients with evidence of HIV infection by western blot.

7. Any conditions, in the opinion of the transplant team such as substance abuse, or
severe personality disorder that would keep the patients from complying with the
needs of the protocol and would markedly increase the morbidity and mortality from
the procedure.

Type of Study:


Study Design:

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

Outcome Measure:

- To evaluate the toxicity of low-intensity regimen for allogeneic stem cell transplantation from an unrelated donor.

Principal Investigator

John E. Levine, MS MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Univeristy of Michigan


United States: Institutional Review Board

Study ID:

UMCC 9970



Start Date:

March 2000

Completion Date:

October 2007

Related Keywords:

  • Myeloma, Plasma-Cell
  • Lymphoma, Malignant
  • Myeloproliferative Disorders
  • Myelodysplastic Syndromes
  • Waldenstrom's Macroglobulinemia
  • Lymphoma
  • Waldenstrom Macroglobulinemia
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders



The University of Michigan Ann Arbor, Michigan  48109