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Accelerated Phase Chronic Myelogenous LeukemiaNCT00112593

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

A study testing fludarabine phosphate, total-body irradiation and peripheral blood stem cell transplantation in people with Accelerated Phase Chronic Myelogenous Leukemia and Acute Undifferentiated Leukemia, run by Fred Hutchinson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 75 years
What is being tested?
fludarabine phosphate, total-body irradiation and peripheral blood stem cell transplantation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
Nov 1999to Nov 2014
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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:
Show all 15Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: Allogeneic Hematopoietic Stem Cell Transplantation for Induction of Mixed Hematopoietic Chimerism in Patients Infected With Human Immunodeficiency Virus-1 Using a Non-Marrow Ablative Conditioning Regimen Containing Total Body Irradiation in Combination With Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate Mofetil

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Keywords
HIV, Lymphoma, Leukemia
Medical subject headings
Leukemia, Myeloid, Accelerated Phase, Leukemia, Biphenotypic, Acute, Congenital Abnormalities, Lymphoma, Extranodal NK-T-Cell, Leukemia, Large Granular Lymphocytic, Lymphoma, Large-Cell, Anaplastic, Immunoblastic Lymphadenopathy, Blast Crisis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fludarabine phosphateDrug

    Also called 2-F-ara-AMP, Beneflur, Fludara

    Given IV

  • total-body irradiationRadiation

    Also called TBI

    Undergo TBI

  • peripheral blood stem cell transplantationProcedure or surgery

    Also called PBPC transplantation, PBSC transplantation, peripheral blood progenitor cell transplantation, transplantation, peripheral blood stem cell

    Undergo allogeneic bone marrow or peripheral blood stem cell transplantation

  • cyclosporineDrug

    Also called ciclosporin, cyclosporin, cyclosporin A, CYSP

    Given IV or PO

  • mycophenolate mofetilDrug

    Also called Cellcept, MMF

    Given IV or PO

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00112593
Study groupRoleWhat they receive
Treatment (allogeneic hematopoietic stem cell transplantation)ExperimentalCONDITIONING 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.
Receives: Drug: fludarabine phosphate; Radiation: total-body irradiation; Procedure: peripheral blood stem cell transplantation; Drug: cyclosporine; Drug: mycophenolate mofetil; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Death From Regimen Toxicity or Opportunistic Infection

    Measured: Within the first 100 days

  2. Death From GVHD

    Measured: Within the first 360 days

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

    Determined by a DNA-based assay that compares the profile of amplified fragment length polymorphisms (ampFLP) of the patient and donor.

    Measured: Up to day 80

Secondary outcomes (3)

  1. Overall Survival

    Kaplan-Meier estimate assessed at 1 year.

    Measured: Up to 1 year

  2. Progression of HIV

    Count of participants with HIV progression.

    Measured: Within 1 year

  3. Reconstitution of HIV-specific Immunity

    Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2005 (estimated)
  2. Study startNov 1999
  3. Primary completionNov 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00112593
Sponsor's protocol ID
1410.00
Other IDs
NCI-2010-00802, 1410.00, P30CA015704, P01CA018029
Status last verified
Apr 2017
First submitted
2 Jun 2005
Last updated
24 May 2017
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 18698002

Questions about this trial

What is this clinical trial studying?

A study testing fludarabine phosphate, total-body irradiation and peripheral blood stem cell transplantation in people with Accelerated Phase Chronic Myelogenous Leukemia and Acute Undifferentiated Leukemia, run by Fred Hutchinson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Death From Regimen Toxicity or Opportunistic Infection (time frame: Within the first 100 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00112593, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2017; AzTrials last refreshed its copy on 8 Nov 2026.

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