Hemophagocytic LymphohistiocytosisPhase 2NCT00176865
Stem Cell Transplant for Immunologic or Histiocytic Disorders
A Phase 2 study testing Stem Cell Transplant, Fludarabine and Melphalan in people with Hemophagocytic Lymphohistiocytosis and X-Linked Lymphoproliferative Disorders, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
This study tests the clinical outcomes of a preparative regimen of fludarabine (FLU), anti-thymocyte globulin (ATG)/or Campath, and melphalan; followed by hematopoietic stem cell transplant, and a post transplant regimen of Cyclosporin A (CsA) in patients with immunologic or histiocytic disorders. Read more about this study
- Who is it for?
- Ages Up to 35 years
- Conditions the study is for
- Hemophagocytic Lymphohistiocytosis, X-Linked Lymphoproliferative Disorders, Chediak-Higashi Syndrome
- What is being tested?
- Stem Cell Transplant, Fludarabine and Melphalan
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2002to Aug 2014
- Phase
- Phase 2
- 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 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with immunodeficiencies or histiocytic disorders 0-35 years of age with an acceptable stem cell donor and disease characteristic defined by the following:
- Patients with histocytic disorders (hemophagocytic lymphohistiocytosis of any etiology and refractory Langerhans cell histiocytosis) who do not meet eligibility criteria for a myeloablative transplant procedure
- Patients with immunodeficiency disorders in whom residual immune function may not require a fully myeloablative preparative regimen or patient is ineligible for standard myeloablative preparative regimen (any form of severe combined immunodeficiency [SCID], or other immunodeficiency with T cell defect)
- Patients with immunodeficiency disorders that have had poor outcome with myeloablative stem cell transplants (including, but not limited to, common variable immunodeficiency [CVID], Wiskott Aldrich Syndrome [WAS] if > 5 years of age, ataxia telangiectasia)
- Patients with immunodeficiencies or histocytic disorders that require a second stem cell transplant (SCT) for any reason
Who cannot join
- Karnofsky or Lansky performance score <70
- Glomerular filtration rate (GFR)<30% predicted
- Cardiac function <50% normal by echocardiogram
- Serum creatinine > 2x normal for age/weight
- Pregnant or lactating females
- Active serious infection that has not had an adequate course of therapy pre-SCT. Any patient with acquired immune deficiency syndrome (AIDS) or AIDS-related complex (ARC) or human immunodeficiency virus (HIV) seropositivity
Trial locations and contacts
1 site in 1 country.
United States1 site
Masonic Cancer Center University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Allogeneic Hematopoietic Stem Cell Transplant for Patients With Immunologic or Histiocytic Disorders Using a Non-Myeloablative Preparative Regimen to Achieve Stable Mixed Chimerism
This study tests the clinical outcomes of a preparative regimen of fludarabine (FLU), anti-thymocyte globulin (ATG)/or Campath, and melphalan; followed by hematopoietic stem cell transplant, and a post transplant regimen of Cyclosporin A (CsA) in patients with immunologic or histiocytic disorders. The researchers hypothesize that this regimen will have a positive effect on post transplant engraftment and the incidence of graft-versus-host-disease (GVHD).
Patients will be randomized biologically into one of 3 arms based upon donor availability: (a) human leukocyte antigen (HLA) genotypic matched sibling donor, (b) HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor, (c) two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).
Read the detailed description
Prior to transplantation, subjects will receive Melphalan, Fludarabine and Anti-Thymocyte Globulin (ATG) or Campath. These three drugs are being given to subjects to help the new stem cells take and grow. On the day of transplantation, subjects will receive stem cells transfused via intravenous (IV) catheter.
After stem cell transplantation, subjects will be given Cyclosporin A (CsA) and mycophenolate mofetil (MMF) to reduce the risk of graft-versus-host disease, the complication that occurs when the donor's stem cells react against the patient.
- Conditions
- Hemophagocytic Lymphohistiocytosis, X-Linked Lymphoproliferative Disorders, Chediak-Higashi Syndrome, Griscelli Syndrome, Immunologic Deficiency Syndromes, Langerhans-Cell Histiocytosis
- Being tested
- Stem Cell Transplant, Fludarabine, Melphalan, Anti-thymocyte globulin (ATG), Campath 1H
- Keywords
- Stem cell transplant, immunodeficiency, donor lymphocyte infusion
- Medical subject headings
- Lymphohistiocytosis, Hemophagocytic, Lymphoproliferative Disorders, Chediak-Higashi Syndrome, Immunologic Deficiency Syndromes, Histiocytosis, Langerhans-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stem Cell TransplantProcedure or surgery
Also called hematopoietic stem cell transplant
IV on Day 0
FludarabineDrug
Also called Fludara
30mg/m^2 IV Day -7 through Day -3
MelphalanDrug
Also called Alkeran
140 mg/m^2 IV Day -1
Anti-thymocyte globulin (ATG)Drug
Also called ATGAM
30 mg/kg IV Day -5 through Day -1
Campath 1HDrug
Also called Alemtuzumab
0.2 mg/kg IV X 5 days (used as an alternative to Anti-thymocyte globulin (ATG) if unable to tolerate ATG) Day -10 through Day -6
Cyclosporin ADrug
2.5 mg/kg IV every 12 hours (adults) or every 8 hours (children <40 kg) maintaining a level of >200mg/L Day -3 until Day +180 when, if no GVHD, the dose will be tapered 10% per week beginning on day 181
Also called CellCept
15 mg/kg IV or orally bid and discontinued on Day +45 unless GVHD is present
Intravenous immunoglobulin (IVIG)Drug
500 mg/kg IV weekly beginning on Day +7 until Day +100
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Matched sibling donor | Active comparator | Stem Cell Transplant: human leukocyte antigen (HLA) genotypic matched sibling donor and pre-treatment with fludarabine, melphalan, anti-thymocyte globulin or Campath 1H and post-treatment with Cyclosporin A, mycophenolate mofetil and Intravenous immunoglobulin (IVIG) Receives: Procedure: Stem Cell Transplant; Drug: Fludarabine; Drug: Melphalan; Drug: Anti-thymocyte globulin (ATG); Drug: Campath 1H; Drug: Cyclosporin A; Drug: Mycophenolate mofetil; Drug: Intravenous immunoglobulin (IVIG) |
| Arm 2 - Matched unrelated donor | Active comparator | Stem Cell Transplant: HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor and pre-treatment with fludarabine, melphalan, anti-thymocyte globulin or Campath 1H and post-treatment with Cyclosporin A, mycophenolate mofetil and Intravenous immunoglobulin (IVIG) Receives: Procedure: Stem Cell Transplant; Drug: Fludarabine; Drug: Melphalan; Drug: Anti-thymocyte globulin (ATG); Drug: Campath 1H; Drug: Cyclosporin A; Drug: Mycophenolate mofetil; Drug: Intravenous immunoglobulin (IVIG) |
| Arm 3 - Mismatched double cord donors | Active comparator | Stem Cell Transplant: two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord) and pre-treatment with fludarabine, melphalan, anti-thymocyte globulin or Campath 1H and post-treatment with Cyclosporin A, mycophenolate mofetil and Intravenous immunoglobulin (IVIG) Receives: Procedure: Stem Cell Transplant; Drug: Fludarabine; Drug: Melphalan; Drug: Anti-thymocyte globulin (ATG); Drug: Campath 1H; Drug: Cyclosporin A; Drug: Mycophenolate mofetil; Drug: Intravenous immunoglobulin (IVIG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Mixed Chimerism
>10% Donor Cells at Day 100
Measured: Day 100
Secondary outcomes (9)
Percentage of Donor Chimerism at 100 Days
The percent of recipient bone marrow and blood cells that are of donor origin.
Measured: Day 100
Percentage of Donor Chimerism at 180 Days
The percent of recipient bone marrow and blood cells that are of donor origin.
Measured: Day 180
Percentage of Donor Chimerism at 365 Days
The percent of recipient bone marrow and blood cells that are of donor origin.
Measured: Day 365
Incidence of Grade 2-4 Acute Graft Versus Host Disease (aGVHD)
Acute graft versus host disease (aGVHD) is a reaction occurring within the first 100 days after transplant where the T- cells of the donor graft attacks the recipient's (host's) skin, GI tract, liver and other organs. The severity of aGVHD is graded on a scale of 1 - 4 with the highest number representing the most severe disease.
Measured: Day 100
Incidence of Grade 3-4 Acute Graft Versus Host Disease (aGVHD)
Acute graft versus host disease (aGVHD) is a reaction occurring within the first 100 days after transplant where the T- cells of the donor graft attacks the recipient's (host's) skin, GI tract, liver and other organs. The severity of aGVHD is graded on a scale of 1 - 4 with the highest number representing the most severe disease.
Measured: Day 100
Incidence of Chronic Graft Versus Host Disease (cGVHD)
Chronic graft versus host disease (cGVHD) is a reaction which typically develops 3 to 6 months after transplant where the T- cells of the donor graft attacks the recipient's (host's) skin, GI tract, liver and other organs.
Measured: 6 months and 1 year
Number of Subjects Alive at 100 Days
Measured: Day 100
Number of Subjects Alive at One Year
Measured: Day 365
Compare Quality of Life (QOL)
Measured: Pretransplant, 1 year, 2 years and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startAug 2002
- Primary completionAug 2012
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hemophagocytic LymphohistiocytosisStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angela Smith, MD, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00176865
- Sponsor's protocol ID
- MT2002-12
- Other IDs
- 0207M29448
- Status last verified
- Dec 2017
- First submitted
- 12 Sep 2005
- Last updated
- 28 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Hematopoietic Stem Cell Transplant for Patients With Immunologic or Histiocytic Disorders Using a Non-Myeloablative Preparative Regimen to Achieve Stable Mixed Chimerism
- ClinicalTrials.gov ID
- NCT00176865
- Acronym / sponsor ID
- MT2002-12
- Conditions
- Hemophagocytic Lymphohistiocytosis, X-Linked Lymphoproliferative Disorders, Chediak-Higashi Syndrome, Griscelli Syndrome, Immunologic Deficiency Syndromes, Langerhans-Cell Histiocytosis
- Keywords
- Stem cell transplant, immunodeficiency, donor lymphocyte infusion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- Aug 2002
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Posted 14 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study tests the clinical outcomes of a preparative regimen of fludarabine (FLU), anti-thymocyte globulin (ATG)/or Campath, and melphalan; followed by hematopoietic stem cell transplant, and a post transplant regimen of Cyclosporin A (CsA) in patients with immunologic or histiocytic disorders. The researchers hypothesize that this regimen will have a positive effect on post transplant engraftment and the incidence of graft-versus-host-disease (GVHD).
Patients will be randomized biologically into one of 3 arms based upon donor availability: (a) human leukocyte antigen (HLA) genotypic matched sibling donor, (b) HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor, (c) two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).
Detailed description
Prior to transplantation, subjects will receive Melphalan, Fludarabine and Anti-Thymocyte Globulin (ATG) or Campath. These three drugs are being given to subjects to help the new stem cells take and grow. On the day of transplantation, subjects will receive stem cells transfused via intravenous (IV) catheter.
After stem cell transplantation, subjects will be given Cyclosporin A (CsA) and mycophenolate mofetil (MMF) to reduce the risk of graft-versus-host disease, the complication that occurs when the donor's stem cells react against the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Matched sibling donor | Active comparator | Procedure: Stem Cell Transplant, Drug: Fludarabine, Drug: Melphalan, Drug: Anti-thymocyte globulin (ATG), Drug: Campath 1H, Drug: Cyclosporin A, Drug: Mycophenolate mofetil, Drug: Intravenous immunoglobulin (IVIG)Stem Cell Transplant: human leukocyte antigen (HLA) genotypic matched sibling donor and pre-treatment with fludarabine, melphalan, anti-thymocyte globulin or Campath 1H and post-treatment with Cyclosporin A, mycophenolate mofetil and Intravenous immunoglobulin (IVIG) |
| Arm 2 - Matched unrelated donor | Active comparator | Procedure: Stem Cell Transplant, Drug: Fludarabine, Drug: Melphalan, Drug: Anti-thymocyte globulin (ATG), Drug: Campath 1H, Drug: Cyclosporin A, Drug: Mycophenolate mofetil, Drug: Intravenous immunoglobulin (IVIG)Stem Cell Transplant: HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor and pre-treatment with fludarabine, melphalan, anti-thymocyte globulin or Campath 1H and post-treatment with Cyclosporin A, mycophenolate mofetil and Intravenous immunoglobulin (IVIG) |
| Arm 3 - Mismatched double cord donors | Active comparator | Procedure: Stem Cell Transplant, Drug: Fludarabine, Drug: Melphalan, Drug: Anti-thymocyte globulin (ATG), Drug: Campath 1H, Drug: Cyclosporin A, Drug: Mycophenolate mofetil, Drug: Intravenous immunoglobulin (IVIG)Stem Cell Transplant: two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord) and pre-treatment with fludarabine, melphalan, anti-thymocyte globulin or Campath 1H and post-treatment with Cyclosporin A, mycophenolate mofetil and Intravenous immunoglobulin (IVIG) |
Who may qualify
- Ages
- Up to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients with immunodeficiencies or histiocytic disorders 0-35 years of age with an acceptable stem cell donor and disease characteristic defined by the following:
- Patients with histocytic disorders (hemophagocytic lymphohistiocytosis of any etiology and refractory Langerhans cell histiocytosis) who do not meet eligibility criteria for a myeloablative transplant procedure
- Patients with immunodeficiency disorders in whom residual immune function may not require a fully myeloablative preparative regimen or patient is ineligible for standard myeloablative preparative regimen (any form of severe combined immunodeficiency [SCID], or other immunodeficiency with T cell defect)
- Patients with immunodeficiency disorders that have had poor outcome with myeloablative stem cell transplants (including, but not limited to, common variable immunodeficiency [CVID], Wiskott Aldrich Syndrome [WAS] if > 5 years of age, ataxia telangiectasia)
- Patients with immunodeficiencies or histocytic disorders that require a second stem cell transplant (SCT) for any reason
Key exclusion criteria (6 listed)
- Karnofsky or Lansky performance score <70
- Glomerular filtration rate (GFR)<30% predicted
- Cardiac function <50% normal by echocardiogram
- Serum creatinine > 2x normal for age/weight
- Pregnant or lactating females
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stem Cell TransplantAlso: hematopoietic stem cell transplantIV on Day 0 | Procedure or surgery | Arm 1 - Matched sibling donor, Arm 2 - Matched unrelated donor, Arm 3 - Mismatched double cord donors |
| FludarabineAlso: Fludara30mg/m^2 IV Day -7 through Day -3 | Drug | Arm 1 - Matched sibling donor, Arm 2 - Matched unrelated donor, Arm 3 - Mismatched double cord donors |
| MelphalanAlso: Alkeran140 mg/m^2 IV Day -1 | Drug | Arm 1 - Matched sibling donor, Arm 2 - Matched unrelated donor, Arm 3 - Mismatched double cord donors |
| Anti-thymocyte globulin (ATG)Also: ATGAM30 mg/kg IV Day -5 through Day -1 | Drug | Arm 1 - Matched sibling donor, Arm 2 - Matched unrelated donor, Arm 3 - Mismatched double cord donors |
| Campath 1HAlso: Alemtuzumab0.2 mg/kg IV X 5 days (used as an alternative to Anti-thymocyte globulin (ATG) if unable to tolerate ATG) Day -10 through Day -6 | Drug | Arm 1 - Matched sibling donor, Arm 2 - Matched unrelated donor, Arm 3 - Mismatched double cord donors |
| Cyclosporin A2.5 mg/kg IV every 12 hours (adults) or every 8 hours (children <40 kg) maintaining a level of >200mg/L Day -3 until Day +180 when, if no GVHD, the dose will be tapered 10% per week beginning on day 181 | Drug | Arm 1 - Matched sibling donor, Arm 2 - Matched unrelated donor, Arm 3 - Mismatched double cord donors |
| Mycophenolate mofetilAlso: CellCept15 mg/kg IV or orally bid and discontinued on Day +45 unless GVHD is present | Drug | Arm 1 - Matched sibling donor, Arm 2 - Matched unrelated donor, Arm 3 - Mismatched double cord donors |
| Intravenous immunoglobulin (IVIG)500 mg/kg IV weekly beginning on Day +7 until Day +100 | Drug | Arm 1 - Matched sibling donor, Arm 2 - Matched unrelated donor, Arm 3 - Mismatched double cord donors |
Primary outcome
Number of Subjects With Mixed Chimerism
Time frame: Day 100
>10% Donor Cells at Day 100
9 secondary outcomes
Percentage of Donor Chimerism at 100 Days
Time frame: Day 100
Percentage of Donor Chimerism at 180 Days
Time frame: Day 180
Percentage of Donor Chimerism at 365 Days
Time frame: Day 365
Incidence of Grade 2-4 Acute Graft Versus Host Disease (aGVHD)
Time frame: Day 100
Incidence of Grade 3-4 Acute Graft Versus Host Disease (aGVHD)
Time frame: Day 100
Incidence of Chronic Graft Versus Host Disease (cGVHD)
Time frame: 6 months and 1 year
Number of Subjects Alive at 100 Days
Time frame: Day 100
Number of Subjects Alive at One Year
Time frame: Day 365
Compare Quality of Life (QOL)
Time frame: Pretransplant, 1 year, 2 years and 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela Smith, MD principal investigator
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stem Cell Transplant, Fludarabine and Melphalan in people with Hemophagocytic Lymphohistiocytosis and X-Linked Lymphoproliferative Disorders, run by Masonic Cancer Center, University of Minnesota 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 5 inclusion and 6 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 28 Dec 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Apr 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?
Number of Subjects With Mixed Chimerism (time frame: Day 100). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Dec 2017.