Status:
COMPLETED
Allogeneic Blood Stem Cell Transplantation and Adoptive Immunotherapy for Hodgkin's Disease
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Hodgkin's Disease
Eligibility:
All Genders
Up to 65 years
Phase:
PHASE2
Brief Summary
The goal of this clinical research study is to learn if fludarabine, melphalan and gemcitabine followed by transplantation of stem cells (blood-forming cells) as well as immune cells (lymphocytes), co...
Detailed Description
Central Venous Catheter: If you choose to take part in this study, the chemotherapy, some of the other drugs in this study, and the stem cell transplant and immune cells will be given by vein through...
Eligibility Criteria
Inclusion
- 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.
- 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.
- Patients must have a serum bilirubin equal to or \</=2.0 mg/dl (isolated hyperbilirubinemia related to Gilbert's disease allowed), serum transaminase (ALT) equal to or \</= 3 times the upper limit of the normal range, serum creatinine \<2.0 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 \</=2. Left ventricular ejection fraction \>/= 40%, forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and corrected diffusing capacity of lung for carbon monoxide (DLCO) \>/= 50% predicted.
- 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.
- 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.
- Patients must be capable and willing to sign informed consent.
Exclusion
- Patients with documented disease progression on salvage chemotherapy.
- 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.
- Severe concomitant medical or psychiatric illness.
- Uncontrolled arrhythmia or symptomatic cardiac or pulmonary disease.
- Chronic active hepatitis or cirrhosis.
- Active or uncontrolled infection.
- 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.
- 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.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00385788
Start Date
July 1 2005
End Date
August 1 2016
Last Update
May 9 2018
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030