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Fludarabine Based Conditioning for Allogeneic Transplantation for Advanced Hematologic Malignancies

10 Years
65 Years
Open (Enrolling)
Acute Myeloid Leukemia, Acute Leukemia, Chronic Myelogenous Leukemia, Malignant Lymphoma, Hodgkin's Disease, Multiple Myeloma, Lymphocytic Leukemia, Myeloproliferative Disorder, Polycythemia Vera, Myelofibrosis, Aplastic Anemia

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Trial Information

Fludarabine Based Conditioning for Allogeneic Transplantation for Advanced Hematologic Malignancies

Treatment-related mortality and recurrence of disease account for the majority of treatment
failures in allogeneic transplantation for advanced hematologic malignancies. The most
commonly utilized conditioning regimens consist of cyclophosphamide and total-body
irradiation or busulfan and cyclophosphamide. Other agents such as etoposide or thiotepa are
sometimes added to maximize the antileukemic effect. New conditioning regimens are however
still needed to maximize efficacy and limit treatment-related deaths. Over the past several
years, the investigators have evaluated several new conditioning regimens that incorporate
fludarabine, a novel immunosuppressant that has limited toxicity and that has synergistic
activity with alkylating agents. Recent data have suggested that fludarabine may be used in
combination with standard doses of oral or IV busulfan, thus reducing the toxicity
previously observed with cyclophosphamide/ busulfan regimens.

Inclusion Criteria:

- Patients with the following diseases:

- Acute myeloid or lymphocytic leukemia in first remission at standard or
high-risk for recurrence.

- Acute leukemia in greater than or equal to second remission, or with early
relapse, or partial remission.

- Chronic myelogenous leukemia in accelerated phase or blast-crisis.

- Chronic myelogenous leukemia in chronic phase

- Recurrent or refractory malignant lymphoma or Hodgkin's disease

- Multiple myeloma.

- Chronic lymphocytic leukemia, relapsed or with poor prognostic features.

- Myeloproliferative disorder (polycythemia vera, myelofibrosis) with poor
prognostic features.

- Severe aplastic anemia after failure of immunosuppressive therapy.

- Age 10-65 years.

- Zubrod performance status less than or equal to 2.

- Adequate cardiac and pulmonary function. Patients with decreased LVEF < 40% or DLCO <
50% of predicted will be evaluated by cardiology or pulmonary prior to enrollment on
this protocol.

- Patient or guardian able to sign informed consent.

Exclusion Criteria:

- Life expectancy is severely limited by concomitant illness.

- Serum creatinine greater than 1.5 mg/dL or Creatinine Clearance less than 50 ml/min

- Serum bilirubin greater than or equal to 2.0 mg/dl, SGPT greater than 3 x upper limit
of normal

- Evidence of chronic active hepatitis or cirrhosis

- HIV-positive

- Patient is pregnant

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the rate of engraftment.

Outcome Time Frame:

Up to 30 days post-transplant

Safety Issue:


Principal Investigator

Damiano Rondelli, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Illinois


United States: Institutional Review Board

Study ID:




Start Date:

February 2000

Completion Date:

February 2015

Related Keywords:

  • Acute Myeloid Leukemia
  • Acute Leukemia
  • Chronic Myelogenous Leukemia
  • Malignant Lymphoma
  • Hodgkin's Disease
  • Multiple Myeloma
  • Lymphocytic Leukemia
  • Myeloproliferative Disorder
  • Polycythemia Vera
  • Myelofibrosis
  • Aplastic Anemia
  • Acute myeloid leukemia
  • First remission
  • Acute lymphocytic leukemia
  • Acute leukemia
  • Second remission
  • Early relapse
  • Partial remission
  • Chronic myelogenous leukemia
  • Accelerated phase
  • Blast-crisis
  • Chronic phase
  • Recurrent malignant lymphoma
  • Refractory malignant lymphoma
  • Hodgkin's disease
  • Multiple myeloma.
  • Chronic lymphocytic leukemia
  • Myeloproliferative disorder
  • Polycythemia vera
  • Myelofibrosis
  • Severe aplastic anemia
  • Primary Myelofibrosis
  • Anemia
  • Anemia, Aplastic
  • Neoplasms
  • Hodgkin Disease
  • Leukemia
  • Leukemia, Lymphoid
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Myeloproliferative Disorders
  • Polycythemia
  • Polycythemia Vera
  • Acute Disease
  • Hematologic Neoplasms



University of Illinois at Chicago Medical Center Chicago, Illinois  60612