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

NCT00146055 | Completed Phase 2

• 1 other identifier: UMCC 9970
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Myeloma, Plasma-Cell; Lymphoma, Malignant; Myeloproliferative Disorders; Myelodysplastic Syndromes; Waldenstrom's Macroglobulinemia

Outcome Measures

Primary Outcomes (3)

• - 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.

Interventions

Reduced intensity conditioning with allogeneic transplant PROCEDURE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

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.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Lymphoma; Myeloproliferative Disorders; Myelodysplastic Syndromes; Waldenstrom Macroglobulinemia

Interventions

Transplantation, Homologous

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Lymphatic Diseases; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Officials

• John E. Levine, MS MD

  The Univeristy of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 5, 2005
• Study Start: March 1, 2000
• Primary Completion: November 1, 2004
• Study Completion: October 1, 2007
• Last Updated: August 9, 2012

Record last verified: 2012-08

Locations

US (1)