Allogeneic Blood Stem Cell Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00423709
Recruitment Status : Completed
First Posted : January 18, 2007
Last Update Posted : January 24, 2012
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
  1. To determine the feasibility and toxicity of employing allogeneic peripheral blood stem cell transplantation after intensive but non-myeloablative chemotherapy in patients with relapsed Hodgkin's disease (HD).
  2. To determine the engraftment kinetics and degree of chimerism that can be achieved with this strategy.
  3. To assess the antitumor activity of this approach in high-risk HD patients and the possible presence of a graft-vs-HD effect.

Condition or disease Intervention/treatment Phase
Hodgkin's Disease Procedure: Allogeneic Blood Stem Cell Transplantation Drug: Fludarabine Drug: Melphalan Not Applicable

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of Allogeneic Blood Stem Cell Transplantation With Purine Analog-Based Conditioning For Patients With Advanced Hodgkin's Disease
Study Start Date : January 1998
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hodgkin Disease
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00423709

United States, Texas
U.T. M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Paolo Anderlini, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00423709     History of Changes
Other Study ID Numbers: DM97-259
First Posted: January 18, 2007    Key Record Dates
Last Update Posted: January 24, 2012
Last Verified: January 2012

Keywords provided by M.D. Anderson Cancer Center:
Hodgkin's Disease
Allogeneic Blood Stem Cell Transplantation
Bone Marrow Transplantation

Additional relevant MeSH terms:
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Fludarabine phosphate
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists