Stem Cell Transplant for Hematological Malignancy

• Status: Terminated
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to develop a standard of care treatment using allogeneic stem cells for patients with cancers of the blood.

The protocol was revised to reflect that this study is considered "treatment guidelines", rather than a research study.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Masonic Cancer Center, University of Minnesota
• Treatments: Busulfan; Cyclophosphamide

Criteria

Inclusion Criteria:

• Donor will be <75 years of age and in good health.

• Recipients will be < or = 55 years, will have normal organ function (excluding bone marrow) and will have a Karnofsky activity assessment > or = 90%.

• Recipients with related or unrelated donor matched at the HLA A, B, DRB1 loci, or mismatched related or unrelated (if < 35 years old) at a single HLA A, B, DRB1 locus.

• Recipients will be eligible in one of the following disease categories

• Chronic myelogenous leukemia in accelerated phase or in post blast crisis second or greater chronic phase; or in chronic phase but intolerant of or resistant to tyrosine kinase inhibitors.

• Acute myelocytic leukemia in first or greater remission, or first, second or third relapse.

• Acute lymphocytic leukemia in the 2nd or greater bone marrow remission.

• High risk children will be transplanted in first remission if they meet criteria

• Myelodysplastic syndrome.

• Myeloproliferative Diseases - (i.e. myelofibrosis, chronic myelomonocytic leukemia (CMML))

• Juvenile myelomonocytic leukemia

• Chronic lymphocytic leukemia

• Advanced non-Hodgkin's (NHL).

• Advanced Hodgkin's disease beyond PR2 (> CR3, > PR3).

• Multiple Myeloma after initial therapy.

• Donors and recipients signed informed consent

Exclusion Criteria

donors and recipients should meet the following test criteria.

• required for donors:

• anti-HIV, Hepatitis B, surface antigen, anti-HCV, CMV, HSV, EBV serologies, pre-priming.

• CBC, platelet count each day of apheresis, day 0 (or 1 or 2 as needed)

• required for recipients:

• anti-HIV, Hepatitis B, surface antigen, anti-HCV, CMV, HSV, EBV serologies, pre-transplant.