Allogeneic Stem Cell Transplantation Followed By Adoptive Immunotherapy for Patients With Relapsed and Refractory Hodgkin's Disease
N/A
65 Years
Both
Hodgkin's Disease
Trial Information
Allogeneic Stem Cell Transplantation Followed By Adoptive Immunotherapy for Patients With Relapsed and Refractory Hodgkin's Disease
The main drugs used in this study are fludarabine, melphalan and gemcitabine. Fludarabine
is a drug designed to weaken the immune defenses in order to allow the body to accept
donors' cells. Melphalan is a chemotherapy drug that weakens the immune system but also
kills cancer cells present in the body. Gemcitabine is a chemotherapy drug that kills cancer
cells present in the body.
If you are found to be eligible to take part in this study, you will have a plastic tube
(catheter) inserted into a vein under the collarbone. Drugs, blood products, and stem cells
will be given and taken through this tube.
Gemcitabine will be given by vein or through the catheter for one day. Fludarabine will be
given through the catheter once a day for 4 days. You will also receive melphalan once
daily for 2 days. If you are receiving a transplant from a matched unrelated donor (not a
blood relative), a mismatched related donor (a blood relative, but not a full match), you
will also receive antithymocyte globulin (ATG) once a day for 2 days. ATG is given to
decrease the risk of graft-versus-host disease. Tacrolimus will also be given to all
patients to decrease the risk of (or treat) graft-versus-host disease. All participants are
expected to need blood transfusions as part of this treatment.
Beginning 2 days before the transplant, tacrolimus will be given through the catheter over
24 hours. This will be changed to pills once you can tolerate swallowing pills. If no
active cancer is detected and there is no graft-versus-host disease, you will then swallow 1
or more tacrolimus pills a day for only about 3-4 months, instead of the usual period of 6
months. This is done to boost the donor immune system against the cancer.
On the transplant day ("Day 0"), the stem cells or bone marrow collected from the donor will
be infused through the catheter ("transplant"). You will receive a mixture of stem cells and
immune cells. Drugs such as corticosteroids, acetaminophen (Tylenol), and/or Benadryl will
be given through the catheter, before the infusion, to decrease the chance of allergic
reactions. Starting on Day 7 after the transplant, filgrastim (G-CSF) will be given as an
injection under the skin or through a needle to increase the growth of white blood cells.
Methotrexate, a chemotherapy drug, will be given in small doses through the catheter on Days
1,3,6, 11 after the transplant to decrease the risk of graft-versus-host disease (GVHD).
If you have persistent but stable (not "growing") disease after transplant, you will have
your immunosuppressive medications (tacrolimus, corticosteroids) stopped even before 4
months. If there is no response, you will receive an infusion of additional cells from your
donor. If you have progressive ("growing") Hodgkin's disease after the transplant, you will
be taken off study, and other treatment options may be explored.
Blood, bone marrow, and x-ray examinations will be performed periodically to monitor the
results of the bone marrow transplantation. Blood tests will usually require up to 3-4
tablespoons of blood. These examinations will be done before the transplant, before you are
released to go back home (about 100 days after the transplant), and then as deemed necessary
by your physician. Blood tests will be done daily while you are hospitalized and several
times a week until your blood counts recover.
This is an investigational study. All of the drugs used in this study are FDA-approved and
commercially available. Up to 70 patients will take part in this study. All will be
enrolled at MD Anderson.
Inclusion Criteria:
1. Patients < 65 years of age with histologically confirmed refractory or relapsed
Hodgkin's disease (including patients who fail or relapse after autologous SCT). This
upper age limit will apply to transplants from both matched related and unrelated
donors.
2. Patients should have any of the following disease status: a. responsive or stable
disease on salvage chemotherapy or radiation therapy. b. untreated, smoldering (i.e.
not rapidly progressive) relapses.
3. Patients must have a serum bilirubin equal to or hyperbilirubinemia related to Gilbert's disease allowed), serum transaminase (ALT)
equal to or mg/dl (provided they also have a glomerular filtration rate of at least 55 ml/min),
no symptomatic cardiac or pulmonary disease and a performance status equal to or
/= 40%, FEV1, FVC and DLCO >/= 50%
predicted.
4. Patients must have an HLA-compatible related or unrelated 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
matched unrelated donors, a high-resolution allele match for HLA-A, -B, -C, -DRB1 ("8
of 8 match") is required.
5. Women of childbearing potential must have a negative serum pregnancy test within two
weeks of study entry and should be advised to avoid becoming pregnant. Men should be
advised to not father a child while on treatment. Both women of childbearing
potential and men must agree to practice effective methods of contraception.
6. Patients must be capable and willing to sign informed consent.
Exclusion Criteria:
1. Patients with documented disease progression on salvage chemotherapy.
2. Nursing or pregnant females. Should a woman become pregnant or suspect she is
pregnant while participating in the study, she should inform her treating physician
immediately.
3. Severe concomitant medical or psychiatric illness.
4. Uncontrolled arrhythmia or symptomatic cardiac or pulmonary disease.
5. Chronic active hepatitis or cirrhosis.
6. Active or uncontrolled infection.
7. Radiation therapy involving chest (axilla excluded), mediastinum, or abdomen (i.e.,
small or large bowel) completed within 10 weeks of transplant admission. Radiation
therapy shortly before the start of the preparative regimen is allowed.
8. Prior or concurrent malignancies (including myelodysplasia) except resected basal
cell carcinoma or treated carcinoma in-situ. Cancer treated with curative intent < 5
years previously will not be allowed unless approved by the Protocol Chair. Cancer
treated with curative intent > 5 years previously will be allowed.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Transplant Related Mortality
Outcome Time Frame:
Transplant to 100 days post transplant
Safety Issue:
Yes
Principal Investigator
Paolo Anderlini, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2005-0015
NCT ID:
NCT00385788
Start Date:
July 2005
Completion Date:
Related Keywords:
- Hodgkin's Disease
- Hodgkin's Disease
- Stem Cell Transplantation
- Antithymocyte Globulin
- Gemcitabine
- Gemzar
- Fludarabine
- Fludarabine Phosphate
- Melphalan
- Allogeneic stem cell transplantation
- AST
- SCT
- ATG
- Thymoglobulin
- Hodgkin Disease
Name | Location |
|---|---|
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
