BMT CTN 0903 (AMC-080): Allogeneic Hematopoietic Cell Transplantation for Hematological Cancers and Myelodysplastic Syndromes in HIV-Infected Individuals

SUMMARY

The main purpose of this study is to learn how well allogeneic transplant treats blood cancers in people with HIV. We invite you to participate in this study because you have HIV and a blood cancer. 

Blood Cancer and Transplant

For people with a blood cancer, the main treatment choices include chemotherapy, radiation therapy, immunotherapy, and a transplant using cells that can make blood.  The blood-making cells are most often collected from bone marrow and the bloodstream.  These cells are called hematopoietic cells and transplant using these kinds of cells is called hematopoietic cell transplant, or HCT.  These treatments may be used alone or used in combination.  For some people with a blood cancer, a HCT transplant may offer the best chance to be free of signs of disease for a long time (long-term remission).

This clinical trial will study how well allogeneic transplant works as a treatment for people who have a blood cancer and HIV.  An allogeneic transplant uses blood-making cells from a family member or an unrelated donor to remove and replace the abnormal blood cells in the subject.

An allogeneic transplant is a common treatment for subjects with a blood cancer that has either returned (relapsed) or does not respond well to other treatments (refractory), or is known to be likely to return (high risk).  The blood cancers we will include in this study are: acute myeloid or lymphocytic leukemia (AML or ALL), myelodysplastic syndrome (MDS), Hodgkin lymphoma and non-Hodgkin lymphoma.

Conditioning Regimen

We will use a combination of chemotherapy and in some cases radiation as a treatment to destroy cancer cells and help donor cells start to grow in your bone marrow.  Depending on the combination used, each treatment (or “conditioning regimen”) can have a different intensity or strength.

  • High intensity treatment uses a combination of chemotherapy that uses strong or higher amounts of drugs and sometimes radiation.  This is also called “myeloablative conditioning”.
  • Reduced intensity treatment uses a combination of chemotherapy, using less strong or lower amounts of drugs and sometimes radiation.  This is also called “reduced intensity conditioning”.

Both kinds of treatments are used by blood and marrow transplant doctors around the world and are not experimental.  You and your doctor will decide which conditioning regimen intensity is the best choice for you.  This study will help us to better understand how to use these treatments in people with HIV who have an allogeneic transplant to treat their blood cancer.

COH Protocol Number : 11065

ClinicalTrials.gov Number : NCT01410344

Principal Investigator : Alvarnas, Joseph M.D.

Sponsor : BMT Clinical Trials Network (CTN)

BRIEF ELIGIBILITY CRITERIA :

Eligible Ages : >=16

Gender : Either

Treatment Intent : Non-Adjuvant treatment

Prior Chemotherapy :

Brain Metastases :

Measurable Disease :