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Low-Intensity Preparation and Allogeneic Transplant in Patients With Cancers of the Blood

Primary Purpose

Myeloma, Plasma-Cell, Lymphoma, Malignant, Myeloproliferative Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Reduced intensity conditioning with allogeneic transplant
Sponsored by
University of Michigan Rogel Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myeloma, Plasma-Cell

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 : 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 Criteria: 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.

Sites / Locations

  • The University of Michigan

Outcomes

Primary Outcome Measures

- To evaluate the toxicity of low-intensity regimen for allogeneic stem cell transplantation from an unrelated donor.
- To evaluate the engraftment, and chimerism.
- To estimate the rate of acute GVHD, relapse and survival.

Secondary Outcome Measures

Full Information

First Posted
September 1, 2005
Last Updated
August 7, 2012
Sponsor
University of Michigan Rogel Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00146055
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
March 2000 (undefined)
Primary Completion Date
November 2004 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Michigan Rogel Cancer Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myeloma, Plasma-Cell, Lymphoma, Malignant, Myeloproliferative Disorders, Myelodysplastic Syndromes, Waldenstrom's Macroglobulinemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Reduced intensity conditioning with allogeneic transplant
Primary Outcome Measure Information:
Title
- To evaluate the toxicity of low-intensity regimen for allogeneic stem cell transplantation from an unrelated donor.
Title
- To evaluate the engraftment, and chimerism.
Title
- To estimate the rate of acute GVHD, relapse and survival.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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 : 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 Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John E. Levine, MS MD
Organizational Affiliation
The Univeristy of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Low-Intensity Preparation and Allogeneic Transplant in Patients With Cancers of the Blood

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