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A Study of Allogeneic Blood Stem Cell Transplantation With Purine Analog-Based Conditioning For Patients With Advanced Hodgkin's Disease

65 Years
Not Enrolling
Hodgkin's Disease

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Trial Information

A Study of Allogeneic Blood Stem Cell Transplantation With Purine Analog-Based Conditioning For Patients With Advanced Hodgkin's Disease

All patients in this study must have a plastic tube (catheter) inserted into a vein under
the collarbone. Drugs and stem cells will be given through this tube.

Fludarabine will be given through the catheter once a day for four days. Patients will also
receive melphalan for two days through the catheter. Patients receiving a transplant from a
matched unrelated donor (i.e. not a blood relative) or a mismatched related donor (i.e. a
blood relative, but not a full match) will also receive antithymocyte globulin (ATG) once a
day for three days. ATG can help preventing graft-versus-host disease. All patients are
expected to need blood transfusions as part of this treatment.

Beginning two days before the transplant, tacrolimus will be given through the catheter. It
will be given 24 hours a day until the patient can swallow. The patient will then swallow
one or more tacrolimus pills a day for about 6 months.

On the transplant day ("day 0"), the stem cells or bone marrow obtained from the donor will
be infused through the catheter ("transplant"). Drugs will be given to reduce the chance of
allergic reactions. Starting on day 7 after the transplant, filgrastim will be given
through a needle to increase the growth of white blood cells. Methotrexate will be given by
IV on days 1,3,6, 11 after the transplant. The patient may require blood transfusions for
the following 2-4 weeks and sometimes longer.

Patients with progressive ("growing") Hodgkin's disease after the transplant will initially
be taken off their immunosuppressive medications (tacrolimus, corticosteroids). If there is
no response to this maneuver, they will be considered for infusion of additional cells from
their donors, with or without preceding chemotherapy Both these maneuvers may produce a
response ("shrinkage") of the tumor. Patients with persistent but stable (not "growing")
disease may also be treated in a similar fashion. Potential side effects of the infusion of
additional cells include graft-versus-host disease and /or a generalized drop in the blood
counts. Both of these conditions can be serious or life-threatening.

Blood, urine, bone marrow and x-ray examinations will be performed as necessary to monitor
the results of bone marrow transplantation. Patients may require blood and platelet
transfusions. Blood tests will be done daily while hospitalized and several times a week
until the blood counts recover. Bone marrow aspiration and biopsies will be performed prior
to the transplant, when the donated cells show signs of engraftment, and at other times
during the next 1 to 3 years to evaluate the growth of the transplant marrow, to evaluate
possible recurrence of malignancy and recovery of immunity.

This is an investigational study. Up to 50 patients will be treated on this study. If the
initial results are discouraging, the study may be stopped after a minimum of four patients
have been enrolled.

Inclusion Criteria:

1. Patients <65 years of age with histologically confirmed primary refractory or
relapsed Hodgkin's disease. In the event of transplants from unrelated donors, the
upper age limit will be 55 years.

2. Patients who failed or relapsed after an autologous transplant are eligible.

3. Patients should have responsive or stable disease on salvage chemotherapy. Patients
with untreated, smoldering (i.e. not rapidly progressive) relapses are eligible.
Patients who failed or relapsed after an autologous transplant are eligible.

4. Patients must have a serum bilirubin <2.0 mg/dl, serum creatinine <2.0 mg/dl, no
symptomatic cardiac or pulmonary disease and a PS<2. Life expectancy not severely
limited by concomitant illness (>12 weeks). Left ventricular ejection fraction >50%.

5. Patients must have an HLA-compatible donor (one-antigen mismatched related donors are
acceptable) willing to donate marrow or rhG-CSF-mobilized peripheral blood stem cells
. In the event of transplants from unrelated donors, only fully serologically A-, B-
and DR-matched donors (including donors having a single micromismatch by DR/DQ
molecular typing) will be acceptable. HLA-compatible cord blood unit will also be
acceptable for recipient with a body weight of 50 kg or less.

Exclusion Criteria:

1. Patients with documented disease progression on salvage chemotherapy are not

2. Uncontrolled arrhythmia or symptomatic cardiac disease. FEV1, FVC and DLCO less than
50% . Symptomatic pulmonary disease. Evidence of chronic active hepatitis or

3. Active or uncontrolled infection.

Type of Study:


Study Design:

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

Principal Investigator

Paolo Anderlini, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

January 1998

Completion Date:

August 2007

Related Keywords:

  • Hodgkin's Disease
  • Hodgkin's Disease
  • Allogeneic Blood Stem Cell Transplantation
  • Bone Marrow Transplantation
  • Fludarabine
  • Melphalan
  • Hodgkin Disease



U.T. M.D. Anderson Cancer Center Houston, Texas  77030