Who is sponsoring NCT00578942?

NCT00578942 is sponsored by David Rizzieri, MD.

What condition does NCT00578942 study?

NCT00578942 studies Lymphoma, Myeloma, Leukemia, Myelodysplasia, Solid Tumors.

What drugs are being tested in NCT00578942?

Interventions: Campath Purged Non-myeloablative ASCT.

What is the status of NCT00578942?

NCT00578942 is currently COMPLETED.

Last reviewed 2016-05-23 · How we verify

Allogeneic Non-myeloablative Stem Cell Transplantation Utilizing Matched Family Member Stem Cells Purged Using Campath-1H

NCT00578942 Phase 2 COMPLETED Results posted

Allogeneic transplantation is used to treat many malignant and non-malignant diseases, though the potential toxicities of the procedure remain high. We and others have shown that a less toxic preparative regimen allows reliable allogeneic engraftment for allogeneic transplantation. The primary purpose of this treatment trial is to follow subjects undergoing allogeneic transplantation for long term outcomes. The regimen used has been tested in our prior phase I / II trial which has completed accrual. The issues of engraftment and rate of graft versus host disease have been answered and our success has led to this regimen being a standard approach for less toxic allogeneic therapy.

Details

Lead sponsor	David Rizzieri, MD
Phase	Phase 2
Status	COMPLETED
Enrolment	48
Start date	2005-05
Completion	2013-04

Conditions

Lymphoma
Myeloma
Leukemia
Myelodysplasia
Solid Tumors

Interventions

Campath Purged Non-myeloablative ASCT

Primary outcomes

Toxicity — 1 year
Acute graft versus host disease (GVHD) was graded according to the consensus criteria and NCI common terminology criteria for adverse events (CTCAE) v2.0 or 3.0 was used for all other toxicities. Recognizing that acute GVHD pathology in the nonablative and donor lymphocyte infusion (DLI) setting may occur late, we tabulated skin, gut and liver toxicity consistent with acute GVHD (aGVHD) at anytime in the year following the infusion as aGVHD. Toxicities were formally recorded for all patients twice weekly for the first 100 days, at each follow up visit, and as needed intercurrently.
Overall Survival (OS) — Up to 12 years; participants were followed for the duration of the study, an average of 8 years
Estimate overall survival rates in subjects treated with a non-myeloablative preparative regimen followed by matched related allogeneic stem cells for allogeneic transplantation.

Countries

United States