A Phase II Study of Reduced Intensity Allogeneic Transplantation for Refractory Hodgkin Lymphoma
16 Years
65 Years
Both
Lymphoma
Trial Information
A Phase II Study of Reduced Intensity Allogeneic Transplantation for Refractory Hodgkin Lymphoma
OBJECTIVES:
- To document the toxicity and feasibility of reduced-intensity conditioning regimen
comprising carmustine, etoposide, cytarabine, melphalan, and alemtuzumab followed by
allogeneic hematopoietic stem cell transplantation in patients with primary refractory
or relapsed Hodgkin lymphoma.
- To document the survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
- Conditioning regimen: Patients receive BEAM chemotherapy comprising carmustine IV over
2 hours on day -6, etoposide IV over ≥ 1 hour on days -5 to -2, cytarabine IV over 15
minutes twice daily on days -5 to -2, and melphalan IV on day -1. Patients also receive
alemtuzumab IV on days -5 to -1.
- Allogeneic hematopoietic stem cell transplantation (HSCT): Patients undergo allogeneic
HSCT on day 0.
- Graft-versus-host disease (GVHD) prophylaxis: Patients receive cyclosporine IV (or
orally once tolerable) beginning on day -1 and continuing until day 60, followed by a
taper in the absence of GVHD.
- Donor lymphocyte infusion (DLI): Patients with mixed chimerism or stable residual
disease at 6 months after HSCT or disease progression or relapse at any time after HSCT
may receive DLI in the absence of GVHD.
After completion of study treatment, patients are followed periodically for 3 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Confirmed diagnosis of Hodgkin lymphoma, meeting 1 of the following criteria:
- Refractory to initial multi-agent induction therapy and achieved less than a
complete response to one line of salvage chemotherapy
- In first relapse and achieved less than a partial response to one line of
salvage chemotherapy
- No progressive disease
- Must have an HLA-matched (≥ 9/10) sibling or unrelated donor available
PATIENT CHARACTERISTICS:
- WHO performance status 0-1
- Creatinine clearance ≥ 50 mL/min
- 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 2-3 months after
completion of study treatment
- No HIV positivity
- No other malignancy within the past 5 years, except for nonmelanoma skin cancer or
stage 0 (in situ) cervical carcinoma
- No concurrent serious medical condition that would preclude an allograft
- No symptomatic respiratory compromise
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:
Progression-free survival at 3 years
Safety Issue:
No
Principal Investigator
Karl Peggs, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University College London (UCL) Cancer Institute
Authority:
Unspecified
Study ID:
CDR0000640493
NCT ID:
NCT00908180
Start Date:
July 2009
Completion Date:
Related Keywords:
- Lymphoma
- recurrent adult Hodgkin lymphoma
- Hodgkin Disease
- Lymphoma
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