CompletedPhase 1/2

Stem Cell Transplant for Patients With Blood Malignancy Using Donors and Less Toxic Chemotherapy With CAMPATH 1H

United States40 participantsStarted 2000-06

Plain-language summary

1. To assess the treatment related mortality of allogeneic stem cell transplantation with non-myeloablative therapy incorporating the lymphodepleting MAb CAMPATH-1H, in patients with hematological diseases and renal cell carcinoma not eligible for conventional (myeloablative) therapy. 2. To assess the time to engraftment and incidence of graft failure in patients receiving this transplant regimen. 3. To assess the safety, pharmacokinetics and immunologic activity of CAMPATH-1H when used as part of a subablative conditioning regimen.

Who can participate

Age range70 Years

SexALL

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Inclusion criteria

✓. Diagnosis of myelodysplastic disorders, Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Multiple Myeloma, Plasma Cell Dyscrasia, Lymphoproliferative disorders (Non-Hodgkin Lymphoma, Hairy Cell Leukemia, Chronic Lymphocytic Leukemia and Hodgkins Disease) or Renal Cell Carcinoma.
✓. Conditions that increase treatment related mortality (need one or more to be eligible):
✓. Greater to or equal to 50 years of age.
✓. EF of less than 45%
✓. DLCO less than 50% of FEV1 50-75% of predicted value.
✓. Diabetes Mellitus
✓. Renal Insufficiency (but creatine clearance not less than 25ml/min).
✓. Prior recent history of systemic fungal infection.

Exclusion criteria

✕. Patient is pregnant, lactating or unwilling to use contraceptives
✕

Trial details

NCT IDNCT00048412

SponsorBaylor College of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2004-11-12

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