NCT00112593 · REGISTRY CONDITION SEARCH

Fludarabine and Total-Body Irradiation Followed By Donor Stem Cell Transplant and Cyclosporine and Mycophenolate Mofetil in Treating HIV-Positive Patients With or Without Cancer

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

Phase: NA
Status at capture: COMPLETED
Registry last update: 2017-05-24

This clinical trial studies the side effects and best dose of giving fludarabine and total-body irradiation (TBI) together followed by a donor stem cell transplant and cyclosporine and mycophenolate mofetil in treating human immunodeficiency virus (HIV)-positive patients with or without cancer. Giving low doses of chemotherapy, such as fludarabine, and TBI before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer or abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells 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 cyclosporine (CSP) and mycophenolate mofetil (MMF) after the transplant may stop this from happening.

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

→

baseline

Baseline characteristics

→

outcome · POSTED

Death From Regimen Toxicity or Opportunistic Infection

→

outcome · POSTED

Death From GVHD

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outcome · POSTED

Successful Induction of Mixed Hematopoietic Chimerism as Assessed by the Percentage of Peripheral Blood T Cells That Are of Donor Origin

→

outcome · POSTED

Overall Survival

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outcome · POSTED

Progression of HIV

→

outcome · POSTED

Reconstitution of HIV-specific Immunity

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→

Who could take part

eligibility Criteria: Inclusion Criteria: * Patients with hematologic malignancy, lymphoma or other HIV-associated malignancy are eligible provided these criteria are met: * The malignancy is in complete remission or very good partial remission, defined as a significant reduction of disease with therapy and no evidence for continued tumor growth in the case of lymphoma or solid tumors * Highly active antiretroviral therapy (HAART) is initiated within one month of hematopoietic cell transplant * Viral load has decreased by \>= 1.5 logs or viral load \< 5000 copies/ml plasma on HAART therapy * CD4 count is allowed to be \> 100 cells/ul * HIV infected patients without malignancy who have failed HAART are eligible provided that these criteria are met: * They have been treated with more than one regimen of HAART for a total of at least 6 months duration * The viral load is \< 50 copies/ml plasma * The CD4 count \< 100 cells/ul * DONOR: Human leukocyte antigen (HLA) genotypically/phenotypically identical donor; if more than one HLA-identical sibling is available, priority will be given to donors matched for cytomegalovirus (CMV) status, ABO titer, and sex * Peripheral blood stem cells will be collected from donors greater than 12 years of age * Bone marrow will be collected from donors less than 12 years of age * DONOR: HLA phenotypically identical unrelated donor; match grades allowed: * Match grade 1: Matched at allele level for HLA-A, B, C, DRB1, and DQB1 * Match grade 2.1: Single allele disparity for HLA-A, B, C, DRB1, and DQB1 Exclusion Criteria: * Positive serology for toxoplasma gondii on treatment or with evidence of active infection * Patients with other disease or organ dysfunction that would limit survival to less than 30 days * Patients with medical history of noncompliance with HAART or medical therapy * DONOR: Donors for whom medical or psychologic reasons would make donor procedure intolerable * DONOR: Marrow donors who have increased anesthetic risk * DONOR: Donors who are HIV positive * DONOR: Age \> 75 years
healthy Volunteers: false
maximum Age: 75 Years
sex: ALL
std Ages: CHILD
ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD.
intervention Names
Drug: fludarabine phosphate
Radiation: total-body irradiation
Procedure: peripheral blood stem cell transplantation
Drug: cyclosporine
Drug: mycophenolate mofetil
Other: laboratory biomarker analysis
label
Treatment (allogeneic hematopoietic stem cell transplantation)
type
EXPERIMENTAL

interventions

arm Group Labels
Treatment (allogeneic hematopoietic stem cell transplantation)
description
Given IV
name
fludarabine phosphate
other Names
2-F-ara-AMP
Beneflur
Fludara
type
DRUG
arm Group Labels
Treatment (allogeneic hematopoietic stem cell transplantation)
description
Undergo TBI
name
total-body irradiation
other Names
TBI
type
RADIATION
arm Group Labels
Treatment (allogeneic hematopoietic stem cell transplantation)
description
Undergo allogeneic bone marrow or peripheral blood stem cell transplantation
name
peripheral blood stem cell transplantation
other Names
PBPC transplantation
PBSC transplantation
peripheral blood progenitor cell transplantation
transplantation, peripheral blood stem cell
type
PROCEDURE
arm Group Labels
Treatment (allogeneic hematopoietic stem cell transplantation)
description
Given IV or PO
name
cyclosporine
other Names
ciclosporin
cyclosporin
cyclosporin A
CYSP
Sandimmune
type
DRUG
arm Group Labels
Treatment (allogeneic hematopoietic stem cell transplantation)
description
Given IV or PO
name
mycophenolate mofetil
other Names
Cellcept
MMF
type
DRUG
arm Group Labels
Treatment (allogeneic hematopoietic stem cell transplantation)
description
Correlative studies
name
laboratory biomarker analysis
type
OTHER

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 5
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

measure
Death From Regimen Toxicity or Opportunistic Infection
time Frame
Within the first 100 days
measure
Death From GVHD
time Frame
Within the first 360 days
description
Determined by a DNA-based assay that compares the profile of amplified fragment length polymorphisms (ampFLP) of the patient and donor.
measure
Successful Induction of Mixed Hematopoietic Chimerism as Assessed by the Percentage of Peripheral Blood T Cells That Are of Donor Origin
time Frame
Up to day 80

secondary Outcomes

description
Kaplan-Meier estimate assessed at 1 year.
measure
Overall Survival
time Frame
Up to 1 year
description
Count of participants with HIV progression.
measure
Progression of HIV
time Frame
Within 1 year
measure
Reconstitution of HIV-specific Immunity
time Frame
Up to 1 year

Full study description

brief Summary: This clinical trial studies the side effects and best dose of giving fludarabine and total-body irradiation (TBI) together followed by a donor stem cell transplant and cyclosporine and mycophenolate mofetil in treating human immunodeficiency virus (HIV)-positive patients with or without cancer. Giving low doses of chemotherapy, such as fludarabine, and TBI before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer or abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells 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 cyclosporine (CSP) and mycophenolate mofetil (MMF) after the transplant may stop this from happening.
detailed Description: PRIMARY OBJECTIVES: I. To determine the safety of treating high-risk HIV1-infected patients with 200 centigray (cGy) TBI plus post-transplant MMF/CSP. II. To determine whether 200 cGy TBI plus post-transplant MMF/CSP results in stable mixed donor lymphocyte chimerism (5-95% donor cluster of differentiation \[CD\]3) in high-risk human immunodeficiency virus (HIV)-1 infected patients. SECONDARY OBJECTIVES: I. To define the kinetics of immune reconstitution following a non-lethal conditioning regimen in HIV1-infected patients. II. To determine the effect of a non-lethal conditioning regimen on viral load. OUTLINE: CONDITIONING REGIMEN: Patients receive fludarabine intravenously (IV) over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or orally (PO) 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of graft-vs-host disease (GVHD). Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD. After completion of study treatment, patients are followed up for at least 1 year.

Source references

references

citation
Woolfrey AE, Malhotra U, Harrington RD, McNevin J, Manley TJ, Riddell SR, Coombs RW, Appelbaum FR, Corey L, Storb R. Generation of HIV-1-specific CD8+ cell responses following allogeneic hematopoietic cell transplantation. Blood. 2008 Oct 15;112(8):3484-7. doi: 10.1182/blood-2008-05-157511. Epub 2008 Aug 12.
pmid
18698002
type
DERIVED

Source notices and limitations

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source string sha256
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source url
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release id
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edge id
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requested nct id
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primary nct id
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source kind
ctgov_condition_query
source url
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source record id
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source file sha256
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payload
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id
nct-edge-e6beb1dbad0f44d228cc
link basis
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nct id
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occurrences
context exact
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query cond
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release id
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source kind
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source record id
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source file sha256
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payload sha256
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payload
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id
nct-edge-eb848b0813780e94e8df
link basis
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nct id
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occurrences
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query disease state id
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source url
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release id
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requested nct id
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primary nct id
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source kind
ctgov_condition_query
source url
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source record id
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source file sha256
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payload
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id
nct-edge-ecf8cdb169090c7815d4
link basis
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nct id
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occurrences
context exact
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query disease state id
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source file
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release id
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edge id
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requested nct id
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primary nct id
NCT00112593
source kind
ctgov_condition_query
source url
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source record id
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id
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link basis
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nct id
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occurrences
context exact
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query cond
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source file
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Preserved source evidence · Not medical advice