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Unrelated or Partially Matched Allogeneic Donor Stem Cells for Lymphoma, Myeloma, and Chronic Lymphocytic Leukemia


Phase 2
N/A
55 Years
Open (Enrolling)
Both
Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm

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Trial Information

Unrelated or Partially Matched Allogeneic Donor Stem Cells for Lymphoma, Myeloma, and Chronic Lymphocytic Leukemia


OBJECTIVES:

- Determine if allogeneic stem cell transplantation using unrelated matched or related
haploidentical donor bone marrow or unrelated matched cord blood results in timely,
complete, and durable engraftment in patients with previously treated lymphoma,
multiple myeloma, or chronic lymphocytic leukemia.

- Determine the incidence and grade of acute and chronic graft-versus-host disease in
patients treated with this regimen.

- Determine if the augmented graft-versus-tumor effect accompanying unrelated or
partially matched donor allogeneic transplant reduces the incidence of relapse in these
patients.

OUTLINE:

- Preparative regimen: Patients receive cyclophosphamide IV over 2 hours on days -7 and
-6 and undergo total-body irradiation (TBI) twice daily on days -4 to -1. Patients who
are unable to undergo TBI receive busulfan IV or orally 4 times daily on days -9 to -6
and cyclophosphamide IV over 2 hours on days -5 to -2.

- Stem cell transplantation: All patients undergo unrelated matched bone marrow or
umbilical cord blood transplantation or partially matched related allogeneic bone
marrow transplantation on day 0.

- Graft-versus-host disease (GVHD) prophylaxis: Patients receive GVHD prophylaxis
comprising methotrexate and cyclosporine. Patients may be enrolled in other protocols
directed towards GVHD prophylaxis.


Inclusion Criteria:



- 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 be <55 years, 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, Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
<2 x normal.

- Pulmonary function test and Carbon Monoxide Diffusing Capacity (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 (5) 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 Response (CR) or Partial Response (PR)
including purine antagonist (i.e. fludarabine).

- Recent chemotherapy responsiveness

- Advanced non-Hodgkin's lymphoma(NHL).

- 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. CHOP).

- Mantle zone lymphoma after any progression following initial therapy (>CR1,
> PR1). At least one prior therapy of intermediate intensity (e.g. CHOP).

- Intermediate grade lymphoma (>PR2). Response duration <1 year from prior
therapy.

- High-grade Non-Hodgkin's Lymphoma (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.

- 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 bone marrow transplant (BMT), HIV-1
positive; active uncontrolled infection; or resistant malignancy.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Engraftment failure

Outcome Description:

Graft failure is defined as not accepting donated cells. The donated cells do not make the new white blood cells, red blood cells and platelets.

Outcome Time Frame:

3 Months

Safety Issue:

No

Principal Investigator

Daniel J. Weisdorf, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota

Authority:

United States: Food and Drug Administration

Study ID:

1999LS060

NCT ID:

NCT00612716

Start Date:

October 1999

Completion Date:

January 2016

Related Keywords:

  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • refractory multiple myeloma
  • recurrent adult Hodgkin lymphoma
  • recurrent/refractory childhood Hodgkin lymphoma
  • refractory chronic lymphocytic leukemia
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • recurrent adult grade III lymphomatoid granulomatosis
  • adult nasal type extranodal NK/T-cell lymphoma
  • Waldenstrom macroglobulinemia
  • recurrent adult Burkitt lymphoma
  • stage I adult Burkitt lymphoma
  • stage II adult Burkitt lymphoma
  • stage III adult Burkitt lymphoma
  • stage IV adult Burkitt lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • stage I adult immunoblastic large cell lymphoma
  • stage II adult immunoblastic large cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • stage I adult lymphoblastic lymphoma
  • stage II adult lymphoblastic lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage IV adult lymphoblastic lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent mantle cell lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • recurrent marginal zone lymphoma
  • splenic marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • recurrent childhood anaplastic large cell lymphoma
  • recurrent childhood grade III lymphomatoid granulomatosis
  • childhood diffuse large cell lymphoma
  • childhood immunoblastic large cell lymphoma
  • recurrent childhood large cell lymphoma
  • recurrent childhood lymphoblastic lymphoma
  • childhood nasal type extranodal NK/T-cell lymphoma
  • Burkitt lymphoma
  • recurrent childhood small noncleaved cell lymphoma
  • stage I childhood small noncleaved cell lymphoma
  • stage II childhood small noncleaved cell lymphoma
  • stage III childhood small noncleaved cell lymphoma
  • stage IV childhood small noncleaved cell lymphoma
  • Neoplasms
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Lymphoma, Large-Cell, Immunoblastic
  • Lymphoma, Non-Hodgkin

Name

Location

Masonic Cancer Center, University of MinnesotaMinneapolis, Minnesota  55455