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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000640500 | Registry Identifier | PDQ (Physician Data Query) | |
| EUDRACT-2008-004956-60 | |||
| EU-20928 | |||
| UCL/08/0122 |
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RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Also, 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 fludarabine phosphate, melphalan, and alemtuzumab followed by donor stem cell transplant in treating patients with relapsed Hodgkin lymphoma.
OBJECTIVES:
OUTLINE: This is a multicenter study.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alemtuzumab | Biological | |||
| donor lymphocytes | Biological | |||
| cyclosporine | Drug | |||
| fludarabine phosphate | Drug | |||
| melphalan | Drug | |||
| allogeneic hematopoietic stem cell transplantation | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year progression-free survival |
| Measure | Description | Time Frame |
|---|---|---|
| Donor engraftment rates, including chimerism at 3 and 6 months | ||
| Non-relapse mortality at 100 days and at 1 and 2 years post-transplant | ||
| Incidence of grade II-IV toxicity as assessed by NCI CTCAE v3.0 |
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DISEASE CHARACTERISTICS:
Confirmed diagnosis of Hodgkin lymphoma, meeting all of the following criteria:
Available HLA-matched sibling donor
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Karl Peggs, MD | University College London (UCL) Cancer Institute | Principal Investigator |
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| Incidence, severity, and timing of graft-vs-host disease |
| Response rates |
| Relapse rates |
| Response to donor lymphocyte infusions |
| Overall survival |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000074323 | Alemtuzumab |
| D016572 | Cyclosporine |
| C042382 | fludarabine phosphate |
| D008558 | Melphalan |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
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