Brief Title
Low-Intensity Preparation and Allogeneic Transplant in Patients With Cancers of the Blood
Official Title
Low-Intensity Preparative Regimen and Allogeneic Peripheral Blood Stem Cell Transplantation From Unrelated Donor in Patients With Hematologic Malignancy
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 disease and whether it will be associated with fewer side effects.
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 approach. Chemotherapeutic drugs and radiation are given in higher doses to
increase their effectiveness. High-dose chemotherapy and radiation therapy generally affect
cells that are dividing. They are used to treat cancer because cancer cells divide more often
than most other cells. High-dose treatment severely damages the patient's bone marrow so that
the patient no longer is able to produce needed blood cells. Peripheral stem cell
transplantation allows stem cells that were damaged by treatment to be replaced with healthy
stem cells that can produce the blood cells the patient needs. Patients experience a number
of complications after transplantation. Some are temporary and relatively minor; yet others
can be life threatening. Many doctors consider high-dose chemotherapy, by itself or with
radiation, and bone marrow or stem cell transplantation as the best available treatment
option for diseases under specific circumstances. However, this study will explore whether a
less-intensive preparative therapy before the peripheral stem cell transplantation will prove
to be safer, have less side effects, and be an effective treatment for certain diseases.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
- To evaluate the toxicity of low-intensity regimen for allogeneic stem cell transplantation from an unrelated donor.
Condition
Myeloma, Plasma-Cell
Intervention
Reduced intensity conditioning with allogeneic transplant
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
60
Start Date
March 2000
Completion Date
October 2007
Primary Completion Date
November 2004
Eligibility Criteria
Inclusion Criteria:
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 :
1. 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.
2. Patients with myelodysplastic syndromes and IPS int-1, int-2 or high-risk scores who
are transfusion-dependent.
3. Patients with chronic myeloid leukemia who are in accelerated, blastic, or or chronic
phase
4. 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.
5. 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.
6. 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.
7. Patient with chronic lymphocytic leukemia or Waldenström's macroglobulinemia who
progressed after first-line therapy.
8. 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 Criteria:
1. Cardiac disease of symptomatic nature; < 25% ejection fraction.
2. Severe renal disease; creatinine > 2.O mg/dl or creatinine clearance < 40 ml/min.
(Corrected for age)
3. Severe pulmonary disease < 60% normal (FEV1 & FVC).
4. Severe hepatic disease; bilirubin >2.0, and/or transaminase > 3 x normal corrected for
age.
5. Karnofsky performance status of < 60%.
6. Patients with evidence of HIV infection by western blot.
7. 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.
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
John E. Levine, MS MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00146055
Organization ID
UMCC 9970
Responsible Party
Sponsor
Study Sponsor
University of Michigan Rogel Cancer Center
Study Sponsor
John E. Levine, MS MD, Principal Investigator, The Univeristy of Michigan
Verification Date
August 2012