Fanconi AnemiaPhase 2/3NCT00352976
TBI Dose De-escalation for Fanconi Anemia
A Phase 2/3 study testing Cyclophosphamide, Fludarabine and Total Body Irradiation in people with Fanconi Anemia, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
This is a single arm, total body irradiation (TBI) trial. All patients will be prescribed TBI 300 cGy with the goal of evaluating secondary endpoints. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fanconi Anemia
- What is being tested?
- Cyclophosphamide, Fludarabine and Total Body Irradiation
- 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
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2006to 9 Oct 2020
- Phase
- Phase 2/3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Meeting the definition of standard risk or high risk Fanconi anemia as defined in the next two sections:
- Standard risk patients must be <18 years of age with a diagnosis of Fanconi anemia with aplastic anemia (AA), myelodysplastic syndrome without excess blasts, or high risk genotype as defined below:
- Aplastic anemia is defined as having at least one of the following when not receiving growth factors or transfusions:
- platelet count <20 * 10^9/L
- ANC <5 * 10^8/L
- Hemoglobin <8 g/dL
Show all 22Show fewer
- Myelodysplastic syndrome (MDS) with multilineage dysplasia with or without chromosomal anomalies
- High risk genotype (e.g. IVS-4 or exon 14 FANCC mutations, or BRCA1 or 2 mutations)
- High risk patients must have one or more of the following high risk features:
- Advanced MDS (≥ 5% blast) or acute leukemia
- Require additional HSCT for graft failure
- History at any time of systemic fungal or gram negative infection
- Severe renal disease with a creatinine clearance <40 mL/min
- Age > 18 years
- Very high risk patients must have Advanced MDS (≥ 5% blast) or acute leukemia after initial hematopoietic stem cell transplant (HSCT)
- Patients must have an appropriate source of stem cells. Patients and donors will be typed for HLA-A, B, C and DRB1 using high resolution molecular typing.
- Adequate major organ function including:
- Cardiac: ejection fraction >45%
- Hepatic: bilirubin, AST or ALT, ALP <5 x normal
- Karnofsky performance status >70% or Lansky >50 (if < 16 years of age)
- Women of child-bearing age must be using adequate birth control and have a negative pregnancy test.
- Written consent.
Who cannot join
- Available HLA-genotypically identical related donor in standard risk patients.
- Active central nervous system (CNS) leukemia at time of study enrollment.
- History of squamous cell carcinoma of the head/neck/cervix within previous 2 years.
- Prior radiation therapy that prevents further total body irradiation (TBI).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
About this study
Official title: Total Body Irradiation Dose De-escalation Study in Patients With Fanconi Anemia Undergoing Alternate Donor Hematopoietic Cell Transplantation
This is a single arm, total body irradiation (TBI) trial. All patients will be prescribed TBI 300 cGy with the goal of evaluating secondary endpoints.
Read the detailed description
Study Treatment: Patients will receive voriconazole (antifungal therapy) by mouth beginning 1 month prior to conditioning therapy, if possible. 1) The subject is to receive total body irradiation (300 cGy) with thymic shielding; it will be given six days before the stem cells are given (day -6). 2) Day -5 through Day -2, subjects will receive a chemotherapy regimen of Fludarabine and Cyclophosphamide via central line (i.e. Hickman or Broviac). Starting Day -3, patients will receive sirolimus therapy with a taper commencing on day +180 and also mycophenolate mofetil (MMF) through day +30 or for 7 days after engraftment, whichever day is later, if no acute graft-versus-host disease (GVHD). 4) If the subject is receiving bone marrow or "peripheral" stem cells (cells collected from the donor's arm via a cell separator), on the day of transplantation, the stem cells taken from the donor will be put into a machine which will separate the lymphocytes (the cells that cause graft-versus-host disease [GVHD]) from the stem cells. If the subject is receiving an umbilical cord blood, the lymphocytes will not be removed because the risk of GVHD is not as high. Otherwise all patients will receive the same treatment. The stem cells are given as an infusion into the subject's existing catheter over 1-2 hours on day 0.5. On the day after transplant (day +1) subjects will be given G-CSF to stimulate the growth of the transplanted cells. 6. While receiving treatment and until the subject's blood counts recover he/she will have daily blood tests, and several bone marrow biopsies and aspirates. After recovery, subjects will be seen once a month for a health assessment and blood tests until at least 3 months after the cells have been infused. Additional blood tests or assessments may be done as medically indicated.
- Conditions
- Fanconi Anemia
- Being tested
- Cyclophosphamide, Fludarabine, Total Body Irradiation, Bone Marrow Transplantation, Mycophenolate Mofetil
- Keywords
- Bone Marrow transplant, stem cell transplant, cord blood transplant, total body irradiation, thymic shielding
- Medical subject headings
- Fanconi Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Also called cytoxan
Day -5 through Day -2, subjects will receive chemotherapy of Cyclophosphamide via central line (i.e. Hickman or Broviac),10 mg/kg intravenously (IV)
FludarabineDrug
Also called fludara
Day -5 through Day -2 prior to transplant; subjects will receive chemotherapy of Fludarabine via central line (i.e. Hickman or Broviac),35 mg/m^2 intravenous (IV)
Total Body IrradiationProcedure or surgery
Also called Radiation Therapy, Therapeutic radiation
total body irradiation (300 cGy) with thymic shielding will be given six days before the stem cells are given (day -6). Thymic shielding is done by placing a piece of lead on the chest during the irradiation treatment so that the irradiation beams do not go to the thymus.
Bone Marrow TransplantationProcedure or surgery
Also called Stem Cell transplantation
A target of 5 * 10^6/kg and a minimum of 4 * 10^6 CD34+ cell/kg recipient weight will be collected by apheresis and used for transplant. In most cases this dose will be recovered in a single apheresis; however, a second or rarely third apheresis performed on the following days may be required to achieve the minimum dose.
Also called MMF
Patients will receive MMF therapy beginning on day -3 through day +30 or for 7 days after engraftment, whichever day is later, if no acute graft-versus-host disease (GVHD). Engraftment is defined as 1st day of 3 consecutive days of absolute neutrophil count [ANC] > 0.5 * 10^9/L. MMF will be given at a dose of 15 mg/kg/dose every 8 hours by mouth(to a maximum dose of 1 gram).
SirolimusDrug
Also called Rapamycin
Sirolimus will be administered starting at day -3 with 8mg-12mg mg oral loading dose followed by single dose 4 mg/day with a target serum concentration of 3 to 12 mg/mL by high-performance liquid chromatography (HPLC). Levels are to be monitored 3 times/week in the first 2 weeks, weekly until day +60, and as clinically indicated until day +100 post-transplantation. In the absence of acute GVHD sirolimus may be tapered starting at day +100 and eliminated by day +180 post-transplantation.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with TBI | Experimental | Patients treated with total body irradiation, Fludarabine, Cyclophosphamide, Bone Marrow Transplantation, Mycophenolate Mofetil, and Sirolimus. Receives: Drug: Cyclophosphamide; Drug: Fludarabine; Procedure: Total Body Irradiation; Procedure: Bone Marrow Transplantation; Drug: Mycophenolate Mofetil; Drug: Sirolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participant With Neutrophil Recovery
Number of participant with neutrophil recovery. Neutrophil recovery is defined as absolute neutrophil count ≥500/µL for three consecutive days
Measured: by day 42
Secondary outcomes (17)
Number of Participants Experiencing Grade ≥3 Regimen Related Toxicity
Regimen related toxicities (RRT) include: significant hemorrhagic cystitis, pulmonary hemorrhage, interstitial pneumonitis, GI hemorrhage, renal failure, erythroderma, and severe hepatic veno-occlusive disease
Measured: by day 100
Number of Participants With Secondary Graft Failure at 100 Days
Secondary Graft Rejection by day 100
Measured: 100 days
Number of Participants Experiencing Acute Graft-versus-host Disease (GVHD)
Number of participants experiencing acute GVHD (all grades) by day 100
Measured: at 100 days
Number of Participants Experiencing Chronic GVHD
Number of participants experiencing chronic Graft Vs Host Disease by 1 year
Measured: at one year
Number of Participants Experiencing Overall Survival
Number of participants experiencing overall survival by 1 year
Measured: at one year
Number of Participants Experiencing Infections by Day 100
Measured: by day 100
Number of Participants Experiencing Infections by Day 180
Measured: by day 180
Number of Participants Experiencing Infections by Day 365
Measured: by day 365
Average Immunoglobulin G (IgG) Levels as a Measure of Immune Reconstitution After Transplant, by 100 Days
Measured: by 100 days
Average IgG Levels as a Measure of Immune Reconstitution After Transplant, by 180 Days
Measured: by 180 days
Average IgG Levels as a Measure of Immune Reconstitution After Transplant by 365 Days
Measured: by 365 days
Average IgA Levels as a Measure of Immune Reconstitution After Transplant by 100 Days
Measured: by 100 days
Average IgA Levels as a Measure of Immune Reconstitution After Transplant by 180 Days
Measured: by 180 days
Average IgA Levels as a Measure of Immune Reconstitution After Transplant by 365 Days
Measured: by 365 days
Average IgM Levels as a Measure of Immune Reconstitution After Transplant by 100 Days
Measured: by 100 days
Average IgM Levels as a Measure of Immune Reconstitution After Transplant by 180 Days
Measured: by 180 days
Average IgM Levels as a Measure of Immune Reconstitution After Transplant by 365 Days
Measured: by 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2006 (estimated)
- Study start18 May 2006
- Primary completion9 Oct 2020
- Study completion9 Oct 2020
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fanconi AnemiaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margaret L MacMillan, M.D., Principal investigator, University of Minnesota Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00352976
- Sponsor's protocol ID
- MT2006-05
- Other IDs
- 0605M85788
- Status last verified
- Oct 2021
- First submitted
- 14 Jul 2006
- Last updated
- 24 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
MacMillan ML, DeFor TE, Young JA, Dusenbery KE, Blazar BR, Slungaard A, Zierhut H, Weisdorf DJ, Wagner JE. Alternative donor hematopoietic cell transplantation for Fanconi anemia. Blood. 2015 Jun 11;125(24):3798-804. doi: 10.1182/blood-2015-02-626002. Epub 2015 Mar 30.
PubMed 25824692
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Body Irradiation Dose De-escalation Study in Patients With Fanconi Anemia Undergoing Alternate Donor Hematopoietic Cell Transplantation
- ClinicalTrials.gov ID
- NCT00352976
- Acronym / sponsor ID
- MT2006-05
- Conditions
- Fanconi Anemia
- Keywords
- Bone Marrow transplant, stem cell transplant, cord blood transplant, total body irradiation, thymic shielding
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 18 May 2006 (actual)
- Primary completion
- 9 Oct 2020 (actual)
- Study completion
- 9 Oct 2020 (actual)
- First posted
- 17 Jul 2006 (estimated)
- Results
- Posted 24 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single arm, total body irradiation (TBI) trial. All patients will be prescribed TBI 300 cGy with the goal of evaluating secondary endpoints.
Detailed description
Study Treatment: Patients will receive voriconazole (antifungal therapy) by mouth beginning 1 month prior to conditioning therapy, if possible. 1) The subject is to receive total body irradiation (300 cGy) with thymic shielding; it will be given six days before the stem cells are given (day -6). 2) Day -5 through Day -2, subjects will receive a chemotherapy regimen of Fludarabine and Cyclophosphamide via central line (i.e. Hickman or Broviac). Starting Day -3, patients will receive sirolimus therapy with a taper commencing on day +180 and also mycophenolate mofetil (MMF) through day +30 or for 7 days after engraftment, whichever day is later, if no acute graft-versus-host disease (GVHD). 4) If the subject is receiving bone marrow or "peripheral" stem cells (cells collected from the donor's arm via a cell separator), on the day of transplantation, the stem cells taken from the donor will be put into a machine which will separate the lymphocytes (the cells that cause graft-versus-host disease [GVHD]) from the stem cells. If the subject is receiving an umbilical cord blood, the lymphocytes will not be removed because the risk of GVHD is not as high. Otherwise all patients will receive the same treatment. The stem cells are given as an infusion into the subject's existing catheter over 1-2 hours on day 0.5. On the day after transplant (day +1) subjects will be given G-CSF to stimulate the growth of the transplanted cells. 6. While receiving treatment and until the subject's blood counts recover he/she will have daily blood tests, and several bone marrow biopsies and aspirates. After recovery, subjects will be seen once a month for a health assessment and blood tests until at least 3 months after the cells have been infused. Additional blood tests or assessments may be done as medically indicated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with TBI | Experimental | Drug: Cyclophosphamide, Drug: Fludarabine, Procedure: Total Body Irradiation, Procedure: Bone Marrow Transplantation, Drug: Mycophenolate Mofetil, Drug: SirolimusPatients treated with total body irradiation, Fludarabine, Cyclophosphamide, Bone Marrow Transplantation, Mycophenolate Mofetil, and Sirolimus. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (22 listed)
- Meeting the definition of standard risk or high risk Fanconi anemia as defined in the next two sections:
- Standard risk patients must be <18 years of age with a diagnosis of Fanconi anemia with aplastic anemia (AA), myelodysplastic syndrome without excess blasts, or high risk genotype as defined below:
- High risk patients must have one or more of the following high risk features:
- Very high risk patients must have Advanced MDS (≥ 5% blast) or acute leukemia after initial hematopoietic stem cell transplant (HSCT)
- Patients must have an appropriate source of stem cells. Patients and donors will be typed for HLA-A, B, C and DRB1 using high resolution molecular typing.
Key exclusion criteria (4 listed)
- Available HLA-genotypically identical related donor in standard risk patients.
- Active central nervous system (CNS) leukemia at time of study enrollment.
- History of squamous cell carcinoma of the head/neck/cervix within previous 2 years.
- Prior radiation therapy that prevents further total body irradiation (TBI).
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 |
|---|---|---|
| CyclophosphamideAlso: cytoxanDay -5 through Day -2, subjects will receive chemotherapy of Cyclophosphamide via central line (i.e. Hickman or Broviac),10 mg/kg intravenously (IV) | Drug | Treatment with TBI |
| FludarabineAlso: fludaraDay -5 through Day -2 prior to transplant; subjects will receive chemotherapy of Fludarabine via central line (i.e. Hickman or Broviac),35 mg/m^2 intravenous (IV) | Drug | Treatment with TBI |
| Total Body IrradiationAlso: Radiation Therapy, Therapeutic radiationtotal body irradiation (300 cGy) with thymic shielding will be given six days before the stem cells are given (day -6). Thymic shielding is done by placing a piece of lead on the chest during the irradiation treatment so that the irradiation beams do not go to the thymus. | Procedure or surgery | Treatment with TBI |
| Bone Marrow TransplantationAlso: Stem Cell transplantationA target of 5 * 10^6/kg and a minimum of 4 * 10^6 CD34+ cell/kg recipient weight will be collected by apheresis and used for transplant. In most cases this dose will be recovered in a single apheresis; however, a second or rarely third apheresis performed on the following days may be required to achieve the minimum dose. | Procedure or surgery | Treatment with TBI |
| Mycophenolate MofetilAlso: MMFPatients will receive MMF therapy beginning on day -3 through day +30 or for 7 days after engraftment, whichever day is later, if no acute graft-versus-host disease (GVHD). Engraftment is defined as 1st day of 3 consecutive days of absolute neutrophil count [ANC] > 0.5 * 10^9/L. MMF will be given at a dose of 15 mg/kg/dose every 8 hours by mouth(to a maximum dose of 1 gram). | Drug | Treatment with TBI |
| SirolimusAlso: RapamycinSirolimus will be administered starting at day -3 with 8mg-12mg mg oral loading dose followed by single dose 4 mg/day with a target serum concentration of 3 to 12 mg/mL by high-performance liquid chromatography (HPLC). Levels are to be monitored 3 times/week in the first 2 weeks, weekly until day +60, and as clinically indicated until day +100 post-transplantation. In the absence of acute GVHD sirolimus may be tapered starting at day +100 and eliminated by day +180 post-transplantation. | Drug | Treatment with TBI |
Primary outcome
Number of Participant With Neutrophil Recovery
Time frame: by day 42
Number of participant with neutrophil recovery. Neutrophil recovery is defined as absolute neutrophil count ≥500/µL for three consecutive days
17 secondary outcomes
Number of Participants Experiencing Grade ≥3 Regimen Related Toxicity
Time frame: by day 100
Number of Participants With Secondary Graft Failure at 100 Days
Time frame: 100 days
Number of Participants Experiencing Acute Graft-versus-host Disease (GVHD)
Time frame: at 100 days
Number of Participants Experiencing Chronic GVHD
Time frame: at one year
Number of Participants Experiencing Overall Survival
Time frame: at one year
Number of Participants Experiencing Infections by Day 100
Time frame: by day 100
Number of Participants Experiencing Infections by Day 180
Time frame: by day 180
Number of Participants Experiencing Infections by Day 365
Time frame: by day 365
Average Immunoglobulin G (IgG) Levels as a Measure of Immune Reconstitution After Transplant, by 100 Days
Time frame: by 100 days
Average IgG Levels as a Measure of Immune Reconstitution After Transplant, by 180 Days
Time frame: by 180 days
Average IgG Levels as a Measure of Immune Reconstitution After Transplant by 365 Days
Time frame: by 365 days
Average IgA Levels as a Measure of Immune Reconstitution After Transplant by 100 Days
Time frame: by 100 days
Average IgA Levels as a Measure of Immune Reconstitution After Transplant by 180 Days
Time frame: by 180 days
Average IgA Levels as a Measure of Immune Reconstitution After Transplant by 365 Days
Time frame: by 365 days
Average IgM Levels as a Measure of Immune Reconstitution After Transplant by 100 Days
Time frame: by 100 days
Average IgM Levels as a Measure of Immune Reconstitution After Transplant by 180 Days
Time frame: by 180 days
Average IgM Levels as a Measure of Immune Reconstitution After Transplant by 365 Days
Time frame: by 365 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25824692MacMillan ML, DeFor TE, Young JA, Dusenbery KE, Blazar BR, Slungaard A, Zierhut H, Weisdorf DJ, Wagner JE. Alternative donor hematopoietic cell transplantation for Fanconi anemia. Blood. 2015 Jun 11;125(24):3798-804. doi: 10.1182/blood-2015-02-626002. Epub 2015 Mar 30.
- Trial 4 listed in the article corresponds to this clinical trial.Link provided by the sponsor.
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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.
Margaret L MacMillan, M.D. principal investigator
University of Minnesota Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cyclophosphamide, Fludarabine and Total Body Irradiation in people with Fanconi Anemia, 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 22 inclusion and 4 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 Nov 2021. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 24 Nov 2021). 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 Participant With Neutrophil Recovery (time frame: by day 42). 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 NCT00352976, 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 Nov 2021; AzTrials last refreshed its copy on 6 Nov 2026.