Low-Intensity Preparation and Allogeneic Transplant in Patients With Cancers of the Blood
Completed · Phase 2
Conditions studied: Myeloma, Plasma-Cell, Lymphoma, Malignant, Myeloproliferative Disorders, Myelodysplastic Syndromes, Waldenstrom's Macroglobulinemia
In brief
The purpose of this study is to determine whether a less-intensive preparative therapy followed by an allogeneic peripheral stem cell transplantation will provide an effective treatment for your disease and whether it will be associated with fewer side effects.
Key facts
- Study ID
- NCT00146055
- Run by
- University of Michigan Rogel Cancer Center
- People needed
- 60
- Starts
- 2000-03-01
- Expected to finish
- 2007-10-01
- Last updated by the study team
- 2012-08-09
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must be a candidate for unrelated donor stem cell transplantation and the donor and recipient must be 5/6 or 6/6 matched. In addition, patients must have one of the following histologically confirmed diagnosis :
- Patients with previously treated AML (M0 - M7 by FAB classification)
- who are in not in complete remission (CR).
- who are in second or later CR.
- who have 5-30% persistent blasts in bone marrow following induction or salvage chemotherapy.
- who have high-risk feature in first complete remission e.g. presence of Philadelphia chromosome or non-core-binding factor type of chromosomal abnormalities.
- Patients with myelodysplastic syndromes and IPS int-1, int-2 or high-risk scores who are transfusion-dependent.
- Patients with chronic myeloid leukemia who are in accelerated, blastic, or or chronic phase
- Patients with acute lymphoblastic leukemia
- who are in first complete remission and have high risk disease [Ph' or t (4; 11) , WBC> 30,000, > 4 weeks to achieve CR].
- who are in second or greater CR.
- who did not achieve a CR following induction or salvage therapy.
- Patients with Hodgkin's or non-Hodgkin's lymphoma who are not curable with conventional chemotherapy and do not have any tumor larger than 5 centimeters in diameter.
- Patients with myeloma or plasma cell neoplasms who are :
- stage III at presentation.
- stage I-II at presentation but were not responding or progressed after first line therapy.
- Patient with chronic lymphocytic leukemia or Waldenström's macroglobulinemia who progressed after first-line therapy.
- Patients with MDS or myeloproliferative disorders who had history of life-threatening complications related to thrombosis, hemorrhagic diathesis or intractable hypercatabolic state (fever cachexia).
You may not qualify if…
- Cardiac disease of symptomatic nature; < 25% ejection fraction.
- Severe renal disease; creatinine > 2.O mg/dl or creatinine clearance < 40 ml/min. (Corrected for age)
- Severe pulmonary disease < 60% normal (FEV1 \& FVC).
- Severe hepatic disease; bilirubin >2.0, and/or transaminase > 3 x normal corrected for age.
- Karnofsky performance status of < 60%.
- Patients with evidence of HIV infection by western blot.
- Any conditions, in the opinion of the transplant team such as substance abuse, or severe personality disorder that would keep the patients from complying with the needs of the protocol and would markedly increase the morbidity and mortality from the procedure.
Where it is running
- The University of Michigan — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.