A Phase II Study of Reduced Intensity Sibling Allogeneic Transplantation for Relapsed, Chemosensitive, PET-positive Hodgkin Lymphoma
16 Years
65 Years
Both
Lymphoma
Trial Information
A Phase II Study of Reduced Intensity Sibling Allogeneic Transplantation for Relapsed, Chemosensitive, PET-positive Hodgkin Lymphoma
OBJECTIVES:
- To document the toxicity, feasibility, and survival after reduced-intensity
conditioning followed by allogeneic hematopoietic stem cell transplantation from a
matched sibling donor in patients with relapsed, chemosensitive Hodgkin lymphoma.
OUTLINE: This is a multicenter study.
- Reduced-intensity conditioning: Patients receive fludarabine phosphate IV on days -7 to
-3, melphalan IV over 30 minutes on day -2, and alemtuzumab IV on day -1.
- Transplantation: Patients undergo donor stem cell infusion on day 0.
- Graft-vs-host disease (GVHD) prophylaxis: Patients receive cyclosporine IV or orally on
days -1 to 60, followed by a taper until 3 months post-transplantation, in the absence
of GVHD.
- Donor-lymphocyte infusion (DLI): DLI is used for the eradication of mixed chimerism and
for the management of residual or relapsed disease. If necessary, patients undergo DLI
every 3 months until the desired endpoint is achieved or GVHD develops.
After completion of study therapy, patients are followed up every 3 months for 3 years.
This study is peer reviewed and funded or endorsed by Cancer Research UK.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Confirmed diagnosis of Hodgkin lymphoma, meeting all of the following criteria:
- Achieved partial or complete remission (using standard criteria) after salvage
chemotherapy
- Relapsed after first remission with residual fludeoxyglucose F 18-avid lesions
- Available HLA-matched sibling donor
PATIENT CHARACTERISTICS:
- WHO performance status 0-1
- Creatinine clearance ≥ 50 mL/min (measured by EDTA clearance or 24-hour urine
collection)
- Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2 times ULN
- LVEF ≥ 40%
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 2 months (or 3
months for women) after completion of study therapy
- No other malignancy within the past 5 years except for nonmelanoma skin tumors or
stage 0 (in situ) cervical carcinoma
- No HIV positivity
- No symptomatic respiratory compromise
- No concurrent serious medical condition that would preclude transplantation
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior high-dose therapy or allograft
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
3-year progression-free survival
Safety Issue:
No
Principal Investigator
Karl Peggs, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University College London (UCL) Cancer Institute
Authority:
Unspecified
Study ID:
CDR0000640500
NCT ID:
NCT00907036
Start Date:
July 2009
Completion Date:
Related Keywords:
- Lymphoma
- recurrent adult Hodgkin lymphoma
- Hodgkin Disease
- Lymphoma
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