NCT00612716 · REGISTRY CONDITION SEARCH

Donor Stem Cell Transplant in Treating Patients With Previously Treated Lymphoma, Multiple Myeloma, or Chronic Lymphocytic Leukemia

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2020-12-09

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Engraftment Failure

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outcome · POSTED

Number of Participants With Neutrophil Engraftment

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outcome · POSTED

Number of Participants With Platelet Engraftment

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outcome · POSTED

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

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outcome · POSTED

Number of Participants With Persistence Disease

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outcome · POSTED

Number of Participants With Relapse of Malignancy

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outcome · POSTED

Number of Participants With 1 Year Overall Survival

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outcome · POSTED

Number of Participants With 2 Year Overall Survival

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outcome · POSTED

Number of Participants With of Chronic GVHD.

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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.
healthy Volunteers: false
maximum Age: 55 Years
sex: ALL
std Ages: CHILD
ADULT

Treatment arms and interventions

arm Groups

description
Patients receiving total body irradiation, stem cell infusion (allogeneic)transplantation using unrelated or partially matched allogeneic marrow or cord blood donors, busulfan, and cyclophosphamide.
intervention Names
Drug: busulfan
Drug: cyclophosphamide
Biological: Stem cell infusion
Radiation: Total body irradiation
label
Allogeneic Transplantation
type
EXPERIMENTAL

interventions

arm Group Labels
Allogeneic Transplantation
description
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.
name
busulfan
other Names
Busulfex
type
DRUG
arm Group Labels
Allogeneic Transplantation
description
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.
name
cyclophosphamide
other Names
Cytoxan
type
DRUG
arm Group Labels
Allogeneic Transplantation
description
Infused on Day 0
name
Stem cell infusion
other Names
umbilical cord blood transplantation
hematopoietic stem cell transplantation
allogeneic transplantation
bone marrow transplantation
type
BIOLOGICAL
arm Group Labels
Allogeneic Transplantation
description
165 cGy morning and evening on days -4 through -1.
name
Total body irradiation
other Names
TBI
type
RADIATION

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 6
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

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.
measure
Number of Participants With Engraftment Failure
time Frame
3 Months
description
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).
measure
Number of Participants With Neutrophil Engraftment
time Frame
Day 42
description
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.
measure
Number of Participants With Platelet Engraftment
time Frame
Day 180
description
Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host.
measure
Number of Participants With Grade 3-4 Acute Graft-versus-host Disease
time Frame
Day 100
description
the return of disease after its apparent recovery/cessation.
measure
Number of Participants With Persistence Disease
time Frame
3 Years
description
the return of disease after its apparent recovery/cessation.
measure
Number of Participants With Relapse of Malignancy
time Frame
3 Years
description
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.
measure
Number of Participants With 1 Year Overall Survival
time Frame
1 year
description
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.
measure
Number of Participants With 2 Year Overall Survival
time Frame
2 year

secondary Outcomes

description
Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host.
measure
Number of Participants With of Chronic GVHD.
time Frame
1 Year

Full study description

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.
detailed Description: 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.

Source references

Source notices and limitations

Discovery and provenance

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query disease state id
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source url
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Preserved source evidence · Not medical advice