Status:
COMPLETED
Low-Intensity Preparation and Allogeneic Transplant in Patients With Cancers of the Blood
Lead Sponsor:
University of Michigan Rogel Cancer Center
Conditions:
Myeloma, Plasma-Cell
Lymphoma, Malignant
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
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 disea...
Detailed Description
Combinations of high-dose chemotherapy and radiation therapy (preparative regimen) followed with allogeneic bone marrow or stem cell transplantation from an unrelated donor is a current treatment appr...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2000
Trial Type :
INTERVENTIONAL
End Date :
October 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00146055
Start Date
March 1 2000
End Date
October 1 2007
Last Update
August 9 2012
Active Locations (1)
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1
The University of Michigan
Ann Arbor, Michigan, United States, 48109