Allogeneic Blood Stem Cell Transplantation and Adoptive Immunotherapy for Hodgkin's Disease
Allogeneic Stem Cell Transplantation Followed By Adoptive Immunotherapy for Patients With Relapsed and Refractory Hodgkin's Disease
2 other identifiers
interventional
52
1 country
1
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), collected from a matched related (i.e. a sibling) or unrelated donor, or a mismatched related donor, can help to control Hodgkin's disease. The safety of the treatment will also be studied.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2005
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 9, 2006
CompletedFirst Posted
Study publicly available on registry
October 11, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedResults Posted
Study results publicly available
May 9, 2018
CompletedMay 9, 2018
April 1, 2018
11.1 years
October 9, 2006
August 22, 2017
April 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Transplant Related Mortality Rate
Transplant-related mortality defined as death from any cause in the first 100 days post-transplant in patients without active disease.
Transplant to 100 days post transplant
Study Arms (2)
Gemcitabine + Fludarabine + Melphalan
EXPERIMENTALGemcitabine 800 mg/m\^2 intravenous (IV) over 30 minutes for one day; Fludarabine 33 mg/m\^2 IV for 4 days; Melphalan 70 mg/m\^2 IV over 30 minutes for 2 days. Antithymocyte Globulin 2 mg/kg IV for 2 days before stem cell transplantation. If receiving transplant from matched unrelated donor (not blood relative), a mismatched related donor (a blood relative, but not a full match), or receiving a cord blood transplant, infusion of stem cells on Day 0. Tacrolimus 0.03 mg/kg by vein over 24 hours following infusion; beginning Day +7 Filgrastim (G-CSF) injection under skin once daily and Methotrexate 5 mg/m2 by vein on Days +1, +3, +6, and +11.
Fludarabine + Melphalan
EXPERIMENTALFludarabine 33 mg/m\^2 IV for 4 days; Melphalan 70 mg/m\^2 IV over 30 minutes for 2 days. Antithymocyte Globulin 2 mg/kg IV for 2 days before stem cell transplantation. If receiving transplant from matched unrelated donor (not blood relative), a mismatched related donor (a blood relative, but not a full match), or receiving a cord blood transplant, infusion of stem cells on Day 0. Tacrolimus 0.03 mg/kg by vein over 24 hours following infusion; beginning Day +7 Filgrastim (G-CSF) injection under skin once daily and Methotrexate 5 mg/m2 by vein on Days +1, +3, +6, and +11.
Interventions
800 mg/m\^2 IV over 30 minutes on Day -7 (1 day)
33 mg/m\^2 IV over 30 minutes Day -5 to Day -2 (4 days)
70 mg/m\^2 IV over 30 minutes on Day -3 to Day -2 (2 days)
2 mg/kg IV on Day -4 and Day -3 (2 days) before stem cell transplantation. If receiving transplant from matched unrelated donor (not a blood relative), a mismatched related donor (a blood relative, but not a full match), or receiving a cord blood transplant.
Infusion of stem cells on Day 0.
0.03 mg/kg beginning Day -2 by vein over 24 hours; when tolerable change to pill form given once daily for 3-4 months.
Starting 1 week after transplant (Day +7) given as injection under the skin once daily until blood cell levels return to normal.
5 mg/m2 by vein on Days +1, +3, +6, and +11 to decrease risk of GVHD.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Research Operations Team, Office of VP Clinical Research
- Organization
- UT MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Paolo Anderlini, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2006
First Posted
October 11, 2006
Study Start
July 1, 2005
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
May 9, 2018
Results First Posted
May 9, 2018
Record last verified: 2018-04