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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

Fred Hutchinson Cancer Center (FHCC) logo

Fred Hutchinson Cancer Center (FHCC)

Status

Completed

Conditions

Stage I Childhood Anaplastic Large Cell Lymphoma
AIDS-related Peripheral/Systemic Lymphoma
Stage III Mantle Cell Lymphoma
Polycythemia Vera
Stage IV Marginal Zone Lymphoma
Stage IB Mycosis Fungoides/Sezary Syndrome
Cutaneous B-cell Non-Hodgkin Lymphoma
Childhood Burkitt Lymphoma
T-cell Large Granular Lymphocyte Leukemia
Chronic Neutrophilic Leukemia
Noncontiguous Stage II Grade 1 Follicular Lymphoma
Stage II Adult T-cell Leukemia/Lymphoma
Noncontiguous Stage II Mantle Cell Lymphoma
Childhood Myelodysplastic Syndromes
Stage III Grade 3 Follicular Lymphoma
Stage II Childhood Lymphoblastic Lymphoma
Post-transplant Lymphoproliferative Disorder
Progressive Hairy Cell Leukemia, Initial Treatment
AIDS-related Diffuse Mixed Cell Lymphoma
Small Intestine Lymphoma
Stage I Multiple Myeloma
Contiguous Stage II Adult Lymphoblastic Lymphoma
Contiguous Stage II Adult Immunoblastic Large Cell Lymphoma
Angioimmunoblastic T-cell Lymphoma
Stage III Adult Diffuse Mixed Cell Lymphoma
Noncontiguous Stage II Small Lymphocytic Lymphoma
Chronic Myelomonocytic Leukemia
Childhood Chronic Myelogenous Leukemia
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Waldenström Macroglobulinemia
Stage III Adult Diffuse Large Cell Lymphoma
Stage IVA Mycosis Fungoides/Sezary Syndrome
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Stage III Adult Burkitt Lymphoma
Stage II Childhood Large Cell Lymphoma
Stage III Adult Diffuse Small Cleaved Cell Lymphoma
AIDS-related Primary CNS Lymphoma
Stage III Multiple Myeloma
Stage III Marginal Zone Lymphoma
Hepatosplenic T-cell Lymphoma
Stage II Cutaneous T-cell Non-Hodgkin Lymphoma
Childhood Immunoblastic Large Cell Lymphoma
Contiguous Stage II Grade 1 Follicular Lymphoma
Stage I Childhood Lymphoblastic Lymphoma
Stage I Grade 2 Follicular Lymphoma
Stage IV Adult Diffuse Mixed Cell Lymphoma
Stage IV Adult T-cell Leukemia/Lymphoma
Aggressive NK-cell Leukemia
Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma
Primary Central Nervous System Lymphoma
Stage IV Childhood Anaplastic Large Cell Lymphoma
Stage I Cutaneous T-cell Non-Hodgkin Lymphoma
Stage IV Adult Hodgkin Lymphoma
Stage I Adult Hodgkin Lymphoma
Stage II Childhood Anaplastic Large Cell Lymphoma
Stage III Small Lymphocytic Lymphoma
Stage I Grade 1 Follicular Lymphoma
Contiguous Stage II Grade 3 Follicular Lymphoma
Stage IIIA Mycosis Fungoides/Sezary Syndrome
Noncutaneous Extranodal Lymphoma
Stage IV Adult Diffuse Large Cell Lymphoma
Stage II Childhood Hodgkin Lymphoma
Unspecified Adult Solid Tumor, Protocol Specific
Stage IV Adult Immunoblastic Large Cell Lymphoma
Stage III Cutaneous T-cell Non-Hodgkin Lymphoma
Noncontiguous Stage II Grade 2 Follicular Lymphoma
Contiguous Stage II Adult Diffuse Large Cell Lymphoma
Stage III Adult T-cell Leukemia/Lymphoma
Stage II Chronic Lymphocytic Leukemia
Stage III Childhood Lymphoblastic Lymphoma
Secondary Myelodysplastic Syndromes
Stage IVB Mycosis Fungoides/Sezary Syndrome
Stage IV Adult Burkitt Lymphoma
Childhood Diffuse Large Cell Lymphoma
Stage IV Chronic Lymphocytic Leukemia
Stage I Adult Immunoblastic Large Cell Lymphoma
Acute Undifferentiated Leukemia
Peripheral T-cell Lymphoma
Stage II Multiple Myeloma
Stage IV Childhood Lymphoblastic Lymphoma
Stage IV Small Lymphocytic Lymphoma
Stage I Marginal Zone Lymphoma
Stage IV Adult Diffuse Small Cleaved Cell Lymphoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
AIDS-related Diffuse Large Cell Lymphoma
Splenic Marginal Zone Lymphoma
Chronic Eosinophilic Leukemia
Noncontiguous Stage II Marginal Zone Lymphoma
Adult Acute Myeloid Leukemia in Remission
Stage I Small Lymphocytic Lymphoma
Stage I Childhood Large Cell Lymphoma
Contiguous Stage II Adult Burkitt Lymphoma
Adult Grade III Lymphomatoid Granulomatosis
Stage IA Mycosis Fungoides/Sezary Syndrome
Stage IV Childhood Small Noncleaved Cell Lymphoma
Stage III Childhood Hodgkin Lymphoma
Stage IV Adult Lymphoblastic Lymphoma
Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma
Stage IV Childhood Hodgkin Lymphoma
Blastic Phase Chronic Myelogenous Leukemia
Stage III Chronic Lymphocytic Leukemia
HIV-associated Hodgkin Lymphoma
Primary Systemic Amyloidosis
Essential Thrombocythemia
Stage I Adult Diffuse Mixed Cell Lymphoma
Stage III Adult Immunoblastic Large Cell Lymphoma
Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma
AIDS-related Lymphoblastic Lymphoma
Stage I Adult Burkitt Lymphoma
Stage III Adult Hodgkin Lymphoma
Contiguous Stage II Adult Diffuse Mixed Cell Lymphoma
AIDS-related Small Noncleaved Cell Lymphoma
Juvenile Myelomonocytic Leukemia
Stage I Adult Lymphoblastic Lymphoma
Stage III Adult Lymphoblastic Lymphoma
Accelerated Phase Chronic Myelogenous Leukemia
Nodal Marginal Zone B-cell Lymphoma
Stage I Adult Diffuse Small Cleaved Cell Lymphoma
Noncontiguous Stage II Adult Lymphoblastic Lymphoma
Stage I Childhood Hodgkin Lymphoma
Contiguous Stage II Marginal Zone Lymphoma
Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma
Noncontiguous Stage II Adult Burkitt Lymphoma
Chronic Phase Chronic Myelogenous Leukemia
AIDS-related Diffuse Small Cleaved Cell Lymphoma
Adult Nasal Type Extranodal NK/T-cell Lymphoma
Stage I Grade 3 Follicular Lymphoma
Stage IIIB Mycosis Fungoides/Sezary Syndrome
Stage III Grade 1 Follicular Lymphoma
Stage III Grade 2 Follicular Lymphoma
Stage I Mantle Cell Lymphoma
Stage IV Grade 2 Follicular Lymphoma
Stage IIB Mycosis Fungoides/Sezary Syndrome
Contiguous Stage II Mantle Cell Lymphoma
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Stage I Chronic Lymphocytic Leukemia
Stage 0 Chronic Lymphocytic Leukemia
Previously Treated Myelodysplastic Syndromes
Anaplastic Large Cell Lymphoma
Isolated Plasmacytoma of Bone
Childhood Grade III Lymphomatoid Granulomatosis
Testicular Lymphoma
Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma
Stage IV Grade 3 Follicular Lymphoma
Stage II Adult Hodgkin Lymphoma
Prolymphocytic Leukemia
Intraocular Lymphoma
Adult Acute Myeloid Leukemia With Del(5q)
Childhood Nasal Type Extranodal NK/T-cell Lymphoma
Stage III Childhood Large Cell Lymphoma
Contiguous Stage II Small Lymphocytic Lymphoma
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Meningeal Chronic Myelogenous Leukemia
Childhood Acute Myeloid Leukemia in Remission
Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma
Adult Acute Lymphoblastic Leukemia in Remission
Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
Stage III Childhood Anaplastic Large Cell Lymphoma
Childhood Acute Lymphoblastic Leukemia in Remission
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Stage IV Childhood Large Cell Lymphoma
Stage II Childhood Small Noncleaved Cell Lymphoma
Myeloid/NK-cell Acute Leukemia
Contiguous Stage II Grade 2 Follicular Lymphoma
Stage III Childhood Small Noncleaved Cell Lymphoma
Stage I Adult T-cell Leukemia/Lymphoma
Noncontiguous Stage II Grade 3 Follicular Lymphoma
Stage IV Mantle Cell Lymphoma
Extramedullary Plasmacytoma
Stage I Adult Diffuse Large Cell Lymphoma
Mast Cell Leukemia
Primary Myelofibrosis
AIDS-related Immunoblastic Large Cell Lymphoma
Secondary Acute Myeloid Leukemia
HIV Infection
Stage I Childhood Small Noncleaved Cell Lymphoma
Stage IIA Mycosis Fungoides/Sezary Syndrome
Unspecified Childhood Solid Tumor, Protocol Specific
Stage IV Grade 1 Follicular Lymphoma

Treatments

Radiation: total-body irradiation
Drug: cyclosporine
Other: laboratory biomarker analysis
Procedure: peripheral blood stem cell transplantation
Drug: mycophenolate mofetil
Drug: fludarabine phosphate

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00112593
NCI-2010-00802 (Registry Identifier)
P30CA015704 (U.S. NIH Grant/Contract)
1410.00 (Other Identifier)
P01CA018029 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

5 patients

Sex

All

Ages

Under 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

5 participants in 1 patient group

Treatment (allogeneic hematopoietic stem cell transplantation)
Experimental group
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.
Treatment:
Drug: mycophenolate mofetil
Drug: fludarabine phosphate
Other: laboratory biomarker analysis
Procedure: peripheral blood stem cell transplantation
Drug: cyclosporine
Radiation: total-body irradiation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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