NCT00612716

Brief Summary

RATIONALE: Giving chemotherapy, such as cyclophosphamide and busulfan, and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells from bone marrow or umbilical cord blood may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving methotrexate and cyclosporine after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well a donor stem cell transplant works in treating patients with previously treated lymphoma, multiple myeloma, or chronic lymphocytic leukemia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_2 leukemia

Timeline
Completed

Started Oct 1999

Longer than P75 for phase_2 leukemia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 6, 1999

Completed
8.4 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 12, 2008

Completed
11.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2019

Completed
12 months until next milestone

Results Posted

Study results publicly available

December 9, 2020

Completed
Last Updated

December 9, 2020

Status Verified

November 1, 2020

Enrollment Period

20.1 years

First QC Date

February 9, 2008

Results QC Date

November 12, 2020

Last Update Submit

November 12, 2020

Conditions

LeukemiaLymphomaMultiple Myeloma and Plasma Cell Neoplasm

Keywords

stage I multiple myelomastage II multiple myelomastage III multiple myelomarefractory multiple myelomarecurrent adult Hodgkin lymphomarecurrent/refractory childhood Hodgkin lymphomarefractory chronic lymphocytic leukemiastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiarecurrent adult grade III lymphomatoid granulomatosisadult nasal type extranodal NK/T-cell lymphomaWaldenstrom macroglobulinemiarecurrent adult Burkitt lymphomastage I adult Burkitt lymphomastage II adult Burkitt lymphomastage III adult Burkitt lymphomastage IV adult Burkitt lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult immunoblastic large cell lymphomastage I adult immunoblastic large cell lymphomastage II adult immunoblastic large cell lymphomastage III adult immunoblastic large cell lymphomastage IV adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomastage I adult lymphoblastic lymphomastage II adult lymphoblastic lymphomastage III adult lymphoblastic lymphomastage IV adult lymphoblastic lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomarecurrent marginal zone lymphomasplenic marginal zone lymphomarecurrent small lymphocytic lymphomarecurrent childhood anaplastic large cell lymphomarecurrent childhood grade III lymphomatoid granulomatosischildhood diffuse large cell lymphomachildhood immunoblastic large cell lymphomarecurrent childhood large cell lymphomarecurrent childhood lymphoblastic lymphomachildhood nasal type extranodal NK/T-cell lymphomaBurkitt lymphomarecurrent childhood small noncleaved cell lymphomastage I childhood small noncleaved cell lymphomastage II childhood small noncleaved cell lymphomastage III childhood small noncleaved cell lymphomastage IV childhood small noncleaved cell lymphoma

Outcome Measures

Primary Outcomes (8)

  • Number of Participants With Engraftment Failure

    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.

    3 Months

  • Number of Participants With Neutrophil Engraftment

    Time to 1st 3 consecutive days with absolute neutrophil count (ANC) \> 5 x 10\^8/L and percentage of patients with neutrophil recovery by day 42 (Cumulative incidence).

    Day 42

  • Number of Participants With Platelet Engraftment

    Time to platelets \> 20,000 (first of 3 consecutive days) with no platelet transfusions for seven days and percentage of patients with platelet engraftment \>50,000 by day 100.

    Day 180

  • Number of Participants With Grade 3-4 Acute Graft-versus-host Disease

    Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host.

    Day 100

  • Number of Participants With Persistence Disease

    the return of disease after its apparent recovery/cessation.

    3 Years

  • Number of Participants With Relapse of Malignancy

    the return of disease after its apparent recovery/cessation.

    3 Years

  • Number of Participants With 1 Year Overall Survival

    The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate. Overall survival will be defined as time from date enrollment to date of death or censored at the date of last documented contact for patients still alive.

    1 year

  • Number of Participants With 2 Year Overall Survival

    The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate. Overall survival will be defined as time from date enrollment to date of death or censored at the date of last documented contact for patients still alive.

    2 year

Secondary Outcomes (1)

  • Number of Participants With of Chronic GVHD.

    1 Year

Study Arms (1)

Allogeneic Transplantation

EXPERIMENTAL

Patients receiving total body irradiation, stem cell infusion (allogeneic)transplantation using unrelated or partially matched allogeneic marrow or cord blood donors, busulfan, and cyclophosphamide.

Drug: busulfanDrug: cyclophosphamideBiological: Stem cell infusionRadiation: Total body irradiation

Interventions

busulfanDRUG

For those not eligible for total body irradiation: busulfan 4 mg/kg/day orally (1 mg/kg orally every 6 hrs) on Days -9 through -6.

Also known as: Busulfex
Allogeneic Transplantation
cyclophosphamideDRUG

Cyclophosphamide 60 mg/kg/day on days -7 and -6. For patients not eligible for total body irradiation: cytoxan 50 mg/kg intravenously (IV) on days -5 through -2.

Also known as: Cytoxan
Allogeneic Transplantation
Stem cell infusionBIOLOGICAL

Infused on Day 0

Also known as: umbilical cord blood transplantation, hematopoietic stem cell transplantation, allogeneic transplantation, bone marrow transplantation
Allogeneic Transplantation
Total body irradiationRADIATION

165 cGy morning and evening on days -4 through -1.

Also known as: TBI
Allogeneic Transplantation

Eligibility Criteria

AgeUp to 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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).
  • +10 more criteria

You may not qualify if:

  • No available histocompatible related donor; 2nd bone marrow transplant (BMT), HIV-1 positive; active uncontrolled infection; or resistant malignancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

LeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellHodgkin DiseaseRecurrenceLeukemia, Lymphocytic, Chronic, B-CellLymphoma, Extranodal NK-T-CellWaldenstrom MacroglobulinemiaBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, FollicularLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLymphoma, Large-Cell, AnaplasticDendritic Cell Sarcoma, Interdigitating

Interventions

BusulfanCyclophosphamideCord Blood Stem Cell TransplantationHematopoietic Stem Cell TransplantationTransplantation, HomologousBone Marrow TransplantationWhole-Body Irradiation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, B-CellLeukemia, LymphoidChronic DiseaseLymphoma, T-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellHistiocytic Disorders, MalignantHistiocytosis

Intervention Hierarchy (Ancestors)

Butylene GlycolsGlycolsAlcoholsOrganic ChemicalsMesylatesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsSulfonic AcidsSulfur AcidsSulfur CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, OperativeTissue TransplantationRadiotherapyInvestigative Techniques

Results Point of Contact

Title
Dr. Daniel J.Weisdorf, M.D
Organization
Masonic Cancer Center, University of Minnesota
weisd001@umn.edu
612 624-3101

Study Officials

  • Daniel J. Weisdorf, MD

    Masonic Cancer Center, University of Minnesota

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

February 9, 2008

First Posted

February 12, 2008

Study Start

October 6, 1999

Primary Completion

November 15, 2019

Study Completion

December 15, 2019

Last Updated

December 9, 2020

Results First Posted

December 9, 2020

Record last verified: 2020-11

Locations

US(1)