Donor Peripheral Blood Stem Cell or Bone Marrow Transplant in Treating Patients With Lymphoma, Multiple Myeloma, or Chronic Lymphocytic Leukemia

Status: Active

Description

This clinical trial studies donor peripheral blood stem cell or bone marrow transplant in treating patients with lymphoma, multiple myeloma, or chronic lymphocytic leukemia. Giving chemotherapy, such as cyclophosphamide and busulfan, and total-body irradiation (TBI) before a donor peripheral blood stem cell (PBSC) or bone marrow transplant (BMT) helps stop the growth of cancer cells. It may also stop the patient’s immune system from rejecting the donor’s stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient’s bone marrow make stem cells, red blood cells, white blood cells, and platelets.

Eligibility Criteria

Inclusion Criteria

  • DONOR: Donors will be < 55 years of age and in good health as approved by the National Marrow Donor Program (NMDP) donor and collection centers; related donors will be < 70 years of age
  • Recipients will have satisfactory organ function (excluding bone marrow) and will have a Karnofsky activity assessment > 90% and will have:
  • Creatinine =< 2.0 mg/dl
  • Bilirubin, aspartate aminotransferase (AST), alkaline phosphatase (ALK) =< 2 x normal
  • Pulmonary function test and diffusion capacity of carbon monoxide (DLCO) > 50% of normal
  • Multi gated acquisition scan (MUGA) > 45% injection fraction
  • Recipients with unrelated donor matched at the HLA A, B, DRBI loci, or if < 35 years mismatched at a single HLA A or B, or DRBI locus
  • Umbilical cord blood used as an unrelated stem cell source will provide > 2.0 x 10^7 cells/kg and will be matched at 4 - 6 of 6 HLA A, B, and DRBI loci; cord blood grafts may include a single or pair of cord units depending on the cell dose
  • Partially matched related donors will be at least haploidentical (matched at >= 3 of 6 HLA A, B, DRB1 loci)
  • Recipients will fall under one of the following disease categories:
  • Chronic lymphocytic leukemia (must have all three): Rai Stage III/IV; progression after previous complete remission (CR) or partial remission (PR) including purine antagonist (i.e. fludarabine); recent chemotherapy responsiveness
  • Advanced non-Hodgkin lymphoma (NHL): A) low-grade NHL (Working Formulation A, B, C) following progression after initial therapy if asymptomatic at diagnosis (>= CR2, >= PR2; response duration < 1 year from last therapy) or if no CR was achieved (> PR1); at least one prior therapy of intermediate intensity (e.g. cyclophosphamide, doxorubicin, vincristine, prednisone [CHOP]); B) mantle zone lymphoma after any progression following initial therapy (> CR1, > PR1); at least one prior therapy of intermediate intensity (e.g. CHOP); C) intermediate grade lymphoma (> PR2); response duration < 1 year from prior therapy; D) high-grade NHL (IWF H, I, J) after initial therapy if >= stage III at diagnosis; after any progression even if localized (stage I, II) at diagnosis with prior response duration < 1 year; E) recent chemotherapy responsiveness after treatment with >= 3 intermediate intensity regimens
  • Advanced Hodgkin's disease beyond PR2 (>= CR3, >= PR3): recent chemotherapy responsiveness
  • Multiple Myeloma (> CR2, > PR2) or after initial therapy if no prior PR: recent chemotherapy responsiveness
  • Recipients will sign informed consent approved by the Committee on the Use of Human Subjects at the University of Minnesota

Exclusion Criteria

  • No available histocompatible related donor
  • 2nd BMT, human immunodeficiency virus (HIV)-1 positive
  • Active uncontrolled infection
  • Resistant malignancy

Locations & Contacts

Minnesota

Minneapolis
University of Minnesota / Masonic Cancer Center
Status: Active
Contact: Daniel Jordan Weisdorf
Phone: 612-624-0123
Email: weisd001@umn.edu

Trial Objectives and Outline

OBJECTIVES:

I. Can allogeneic transplantation using unrelated or partially matched allogeneic marrow or cord blood donors result in timely, complete and durable engraftment in recipients with advanced lymphoproliferative malignancies?

II. What is the incidence and grade of acute and of chronic graft-vs-host disease (GVHD) observed following such allogeneic transplant?

III. Can the augmented graft versus tumor effect accompanying unrelated or partially matched donor allogeneic transplant reduce the incidence of relapse for these high risk malignancies?

OUTLINE:

PREPARATIVE REGIMEN: Patients receive cyclophosphamide intravenously (IV) over 2 hours on days -7 and -6 and undergo TBI* on days -4 to -1.

NOTE: *Patients not eligible to undergo TBI receive busulfan orally (PO) or IV every 6 hours on days -9 to -6 and cyclophosphamide IV over 2 hours on days -5 to -2.

TRANSPLANTATION: Patients undergo allogeneic PBSC transplant (PBSCT) or BMT on day 0.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
University of Minnesota / Masonic Cancer Center

Principal Investigator
Daniel Jordan Weisdorf

Trial IDs

Primary ID MT1999-14
Secondary IDs NCI-2010-02157, 1999LS060
Clinicaltrials.gov ID NCT00612716