Stem Cell (Modified Bone Marrow) Transplantation in HIV-Infected Patients With Blood Cancer

Plain-language summary

This study examined transplantation of donor stem cells genetically modified with a retroviral vector in patients with blood cancers who were normally excluded from transplant because of HIV infection. The aim was both to treat the malignancy and to make the transplanted cells resistant to HIV. It was carried out as a Phase 1 study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 1

Status

Completed

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Intervention

GCSF Mobilized Allogeneic PBSC Cultured w/Cytokines; Transduced w/RV

Start date

9/1/1999

Estimated completion

11/1/2001

Countries

United States

Related genes

Locations

• Bethesda, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

PATIENTS:

Patients with hematologic malignancies curable by allogeneic BMT not currently considered for transplant because of HIV positivity.

Chronic myelogenous leukemia (CML): chronic phase.

Acute lymphoblastic leukemia (ALL), all patients in complete or partial remission.

Acute myelogenous leukemia (AML): AML in first complete or partial remission. (Exceptions: AML with good risk karyotypes: AML M3t, AML M4Eo, AML t. All AML in second or subsequent complete remission.)

Myelodysplastic syndromes: refractory anemia (failing ATG and/or CSA) to early transformation to acute leukemia. Chronic myelomonocytic leukemia and myeloproliferative disease.

Chronic lymphocytic leukemia (CLL) and prolymphocytic leukemia, in complete or partial remission, Mantle cell lymphoma, relapsed Hodgkin's and non-Hodgkin's lymphoma.

Multiple myeloma in remission following chemotherapy.

No major organ dysfunction precluding transplantation.

DLCO greater than 40 percent predicted.

Left ventricular ejection fraction greater than 30 percent.

ECOG performance status of 0 to 2.

DONOR:

HLA identical sibling donor.

Fit to receive G-CSF and give peripheral blood stem cells (normal blood count, normotensive, no history of stroke, no history of severe heart disease).

Informed consent given.

DONOR AND PATIENT:

Must not be pregnant or lactating.

Must be between 18 and 80 years of age.

Must not have ECOG performance status of 3 or more. Must not have psychiatric disorder or mental deficiency of the patient or the donor sufficiently severe as to make compliance with the BMT treatment unlikely, and making informed consent impossible.

Must not have a major anticipated illness or organ failure incompatible with survival from BMT as determined by your NIH physician (including encephalopathy, cardiomyopathy, and hepatitis.)

Must not have DLCO less than 40 percent predicted.

Must not have glomerular filtration rate less than 40.

Must not have serum bilirubin greater than 4 mg/dl, transaminases greater than 4x upper limit of normal.

Donor must be HIV negative. Donors who are positive for HBV, HCV or HTLV will be used at the discretion of the investigator.

Must not have other malignant diseases liable to relapse or progress within 5 years.

Donor must be fit to receive G-CSF and undergo apheresis. (Uncontrolled hypertension, history of congestive heart failure or unstable angina, thrombocytopenia).