Carmustine, Etoposide, Cytarabine, Melphalan, and Alemtuzumab Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma
|ClinicalTrials.gov Identifier: NCT00908180|
Recruitment Status : Unknown
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was: Not yet recruiting
First Posted : May 25, 2009
Last Update Posted : August 2, 2013
RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. Monoclonal antibodies, such as alemtuzumab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine before and after the transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them (called graft-versus-tumor effect). Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may boost this effect.
PURPOSE: This phase II trial is studying the side effects of giving carmustine together with etoposide, cytarabine, melphalan, and alemtuzumab followed by donor stem cell transplant and to see how well it works in treating patients with relapsed or refractory Hodgkin lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: alemtuzumab Biological: donor lymphocytes Drug: carmustine Drug: cyclosporine Drug: cytarabine Drug: etoposide Drug: melphalan Procedure: allogeneic hematopoietic stem cell transplantation||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||47 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Reduced Intensity Allogeneic Transplantation for Refractory Hodgkin Lymphoma|
|Study Start Date :||July 2009|
|Estimated Primary Completion Date :||July 2014|
- Progression-free survival at 3 years
- Donor engraftment rates, including chimerism at 3 and 6 months
- Non-relapse mortality at 100 days, 1 year, and 2 years post-transplant
- Incidence of grade II-IV toxicity as assessed by NCI CTCAE v3.0
- Incidence, severity, and timing of acute and chronic graft-versus-host disease
- Response rates
- Relapse rates
- Response to donor lymphocyte infusions
- Overall survival
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00908180
|Principal Investigator:||Karl Peggs, MD||University College London (UCL) Cancer Institute|