Hematologic MalignanciesPhase 2NCT01749293
Partially HLA Mismatched (Haploidentical) Allogeneic Bone Marrow Transplantation
A Phase 2 study testing Haploidentical Transplant, Fludarabine and Busulfan in people with Hematologic Malignancies, run by University of Illinois Chicago at 1 site in United States.
Trial summary
Allogeneic stem cell transplantation is a potentially curative treatment for patients with many hematologic malignancies (e.g. leukemia, lymphoma, and myeloma with high risk of relapse). This process requires a suitable donor. The best case scenario involves an Human Leukocyte Antigen (HLA) matched sibling donor. Read more about this study
- Who is it for?
- Ages 10 to 75 years
- Conditions the study is for
- Hematologic Malignancies
- What is being tested?
- Haploidentical Transplant, Fludarabine and Busulfan
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2012to 15 May 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 10 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- First-degree related donor or half-sibling who is at minimum HLA haploidentical
- Lack of fully matched donor (related or unrelated). Patients with a matched unrelated donor may only be enrolled if they require an urgent transplant. Urgency of transplant will judged by PI and co-investigators.
- Eligible diagnoses are listed below:
- Low-grade non-Hodgkin's lymphoma or plasma cell neoplasm that has progressed during multiagent therapy including follicular lymphoma, Marginal zone (or MALT) lymphoma, lymphoplasmacytic lymphoma / Waldenstrom's macroglobulinemia, Hairy cell leukemia, Small lymphocytic lymphoma (SLL) or chronic lymphocytic leukemia (CLL), Prolymphocytic leukemia, Multiple myeloma and Plasma cell leukemia
- Poor-risk SLL or CLL
- Aggressive lymphoma that has failed at least one prior regimen of multiagent chemotherapy, and patient is either ineligible for autologous BMT or autologous BMT is not recommended including Hodgkin lymphoma, high grade Follicular lymphoma, Mantle cell lymphoma, Diffuse large B-cell lymphoma, Burkitt's lymphoma/leukemia, Anaplastic large cell lymphoma, Plasmablastic lymphoma, Peripheral T-cell lymphoma
Show all 26Show fewer
- Relapsed or refractory acute leukemias.
- Poor-risk acute leukemia in first remission:
- Acute myeloid leukemia (AML) with at least one of the following:
- AML arising from myelodysplastic syndrome (MDS) or a myeloproliferative disorder
- Presence of FLT3 internal tandem duplications
- Poor-risk cytogenetics
- Acute lymphoblastic leukemia and/or lymphoma (ALL) with at least one of the following:
- Poor risk cytogenetics
- Primary refractory disease
- Biphenotypic leukemia
- MDS with at least one of the following poor-risk features: i. Poor-risk cytogenetics ii. Int-2 or high IPSS score iii. Treatment-related MDS iv. MDS diagnosed before age 21 years v. Progression on or lack of response to standard hypomethylator therapy vi. Life-threatening cytopenias
- Imatinib-refractory chronic myelogenous leukemia (CML) in accelerated or chronic phase
- Philadelphia chromosome negative myeloproliferative neoplasm
- Chronic myelomonocytic leukemia
- 5. Adequate end-organ function as measured by:
- Left ventricular ejection fraction ≥ 35%
- Bilirubin ≤ 3.0 mg/dL and ALT and AST < 5 x ULN
- FEV1 and FVC > 40% of predicted
- 6. Karnofsky score > 60
- 7. Lack of recipient anti-donor HLA antibody
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois Cancer Center
Chicago, Illinois, 60612
About this study
Official title: Partially HLA Mismatched (Haploidentical) Allogeneic Bone Marrow Transplantation for Patients With Hematologic Malignancies
Allogeneic stem cell transplantation is a potentially curative treatment for patients with many hematologic malignancies (e.g. leukemia, lymphoma, and myeloma with high risk of relapse). This process requires a suitable donor. The best case scenario involves an Human Leukocyte Antigen (HLA) matched sibling donor. However, this type of donor is not always available. Donor registries can provide another source for matched unrelated donors, but this may take valuable time delaying treatment for the transplant recipient. Donor availability remains a significant barrier to the use of allogeneic (from a donor) stem cell transplant. This issue disproportionately affects patients of minority backgrounds. Novel strategies to improve outcomes using alternative donors are desperately needed.
Haploidentical transplants are an alternative which provides a readily available donor in the form of a partially HLA matched family member. This provides for more potential donors and the donors can be selected based on other factors that can play a role in transplant success (e.g. age, gender, KIR alloreactivity). Recent advances in transplant techniques have greatly improved success rates with haploidentical transplants although disease relapse has remained as issue.
This trial aims to provide an alternative transplant option for patients with hematologic malignancies who require bone marrow transplantation but lack an HLA identical donor. The investigational component of this study is the combination of the Fludarabine/ Busulfan/ Total Body Irradiation conditioning regimen and the HLA Haploidentical Transplant with post-transplant Cyclophosphamide.
Read the detailed description
Allogeneic stem cell transplantation is a potentially curative treatment for patients with hematologic malignancies such as leukemia, lymphoma and myeloma who are at high risk of relapse. As well as the potential to deliver high doses of chemotherapy or radiation this procedure affords the benefit of an immunologic weapon against disease in the form of the graft versus tumor effect.
The major variables affecting the outcome of allogeneic transplant include: patient selection (age and comorbidities); disease status at the time of transplantation (remission vs. active disease); type of donor (HLA matched vs. mismatched or related vs. unrelated); type of conditioning regimen; source of stem cells (bone marrow vs. peripheral blood). Recent advances in the field of stem cell transplant have substantially lowered transplant related morbidity and mortality.
The availability of stem cell transplant as a treatment modality is dependent upon the availability of a suitable donor. Best outcomes are thought to occur in HLA matched sibling donors. The chance of a sibling being HLA matched is approximately 25%. Despite the development of large worldwide donor registries the likelihood of finding an HLA matched unrelated donor is 60-70% at best and drops to 10% in some ethnic minorities. In addition the process of identifying, confirming and harvesting an unrelated donor is cumbersome and time consuming at a time when the patient must proceed immediately to transplant (time from initiation of search to identification of an unrelated donor identification takes a median of 49 days). Therefore the development of alternative sources of hematopoietic stem cells is an area of immense interest to many investigators.
Alternative sources include cord blood and HLA haploidentical donors. Cord blood has been an attractive source permitting immediate availability and possibly a lower rate of graft versus host disease (GVHD). However delay in engraftment, particularly after myeloablative conditioning, remains a significant disadvantage. Haploidentical transplants carry some of the same advantages with virtually all patients having immediate access to a suitable and willing donor in the form of a partially HLA matched family member. Furthermore the number of potential donors allows for donor selection based upon factors such as age, gender, KIR alloreactivity. Finally the donor is readily available for future cellular therapies such as donor lymphocyte infusion.
Early attempts at haploidentical transplantation were hampered by high rates of graft failure and severe graft versus host disease. Recent advances in graft versus host disease prophylaxis with post transplant high dose cyclophosphamide (Cy) have overcome these barriers to a large degree. Published studies have shown that HLA-haploidentical bone marrow transplant (BMT) after non-myeloablative conditioning and using 2 doses of post-transplantation Cy followed by tacrolimus and mycophenolate mofetil (MMF) is a well-tolerated procedure. However, the major cause of treatment failure in this high-risk population was early relapse. As conditioning intensity has been clearly linked to rates of relapse in multiple diseases, it is postulated that utilizing conditioning with higher anti-tumor potential will lead to a lower relapse rate.
Given the advances in GVHD prophylaxis with post-transplantation Cy, reduced intensity conditioning with Fludarabine, Busulfan and total body irradiation combined with high-dose post-transplantation Cy is the platform for this study. The toxicities of this reduced intensity conditioning regimen are not expected to differ substantially from previous data incorporating post-transplantation Cy. However, this regimen may have higher anti-tumor potential resulting in a decreased relapse rate.
- Conditions
- Hematologic Malignancies
- Being tested
- Haploidentical Transplant, Fludarabine, Busulfan, Total Body Irradiation, Cyclophosphamide
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Haploidentical TransplantProcedure or surgery
Also called Mismatched allogeneic bone marrow transplant
Subjects will be dosed with pre-transplant Fludarabine (180mg/m2)and Busulfan total AUC 2400 μmol*min/L or 6.4mg/kg. Subjects will then undergo total body irradiation 2Gy. Subjects will undergo haploidentical allogeneic bone marrow transplant, followed by Cyclophosphamide, Tacrolimus and MMF based GVHD prophylaxis.
FludarabineDrug
Also called Fludara
Subjects in this trial will receive Fludarabine 30 mg/m2 IV QD, adjusted for CrCl from Days -8 through -3.
BusulfanDrug
Also called Busulfex, Myleran
Subjects in this trial will receive Busulfan total AUC 2400 μmol*min/L or 6.4mg/kg in 4 doses with seizure prophylaxis from Days -6 through -3.
Total Body IrradiationRadiation
Subjects in this trial will receive total body irradiation (2Gy fractionated) from Day -2 or -1.
CyclophosphamideDrug
Also called Endoxan, Cytoxan, Neosar, Procytox
Subjects in this trial will receive Cyclophosphamide 50 mg/kg IV QD on Days 3 and 4 post-transplant.
| Study group | Role | What they receive |
|---|---|---|
| Haploidentical Transplant | Experimental | All subjects will be dosed with pre-transplant Fludarabine (180mg/m2)and Busulfan total AUC 2400 μmol*min/L or 6.4mg/kg. Subjects will then undergo total body irradiation 2Gy. Subjects will undergo haploidentical allogeneic bone marrow transplant, followed by Cyclophosphamide, Tacrolimus and MMF based GVHD prophylaxis. Receives: Procedure: Haploidentical Transplant; Drug: Fludarabine; Drug: Busulfan; Radiation: Total Body Irradiation; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Engrafted and the Number of Participants That Had Full Donor Chimerism at Day 60
To estimate the number of participants that had engraftment rates and the number of participants that had full donor chimerism at Day 60 in patients undergoing an HLA haploidentical stem cell transplant with post transplant high dose cyclophosphamide.
Measured: Up to Day 60 post-transplant.
Secondary outcomes (2)
Number of Participants That Had an Overall Survival Rate
To estimate the number of participants that had an overall survival (OS) rate
Measured: Up to one year post-transplant.
Number of Participants That Had an Event Free Survival Rate
To estimate the number of participants who had an event free survival rate
Measured: Up to 1 year post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2012 (estimated)
- Study start30 Aug 2012
- Primary completion15 May 2014
- Study completion15 May 2014
Why it stopped: The protocol design is being reconfigured in order to open a new study.
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 Hematologic MalignanciesStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pritesh Patel, MD, University of Illinois Chicago
- Investigators
- Pritesh Patel, MD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01749293
- Sponsor's protocol ID
- 2012-0170
- Status last verified
- Feb 2020
- First submitted
- 20 Nov 2012
- Last updated
- 25 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partially HLA Mismatched (Haploidentical) Allogeneic Bone Marrow Transplantation for Patients With Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT01749293
- Acronym / sponsor ID
- 2012-0170
- Conditions
- Hematologic Malignancies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The protocol design is being reconfigured in order to open a new study.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 30 Aug 2012 (actual)
- Primary completion
- 15 May 2014 (actual)
- Study completion
- 15 May 2014 (actual)
- First posted
- 13 Dec 2012 (estimated)
- Results
- Posted 25 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Allogeneic stem cell transplantation is a potentially curative treatment for patients with many hematologic malignancies (e.g. leukemia, lymphoma, and myeloma with high risk of relapse). This process requires a suitable donor. The best case scenario involves an Human Leukocyte Antigen (HLA) matched sibling donor. However, this type of donor is not always available. Donor registries can provide another source for matched unrelated donors, but this may take valuable time delaying treatment for the transplant recipient. Donor availability remains a significant barrier to the use of allogeneic (from a donor) stem cell transplant. This issue disproportionately affects patients of minority backgrounds. Novel strategies to improve outcomes using alternative donors are desperately needed.
Haploidentical transplants are an alternative which provides a readily available donor in the form of a partially HLA matched family member. This provides for more potential donors and the donors can be selected based on other factors that can play a role in transplant success (e.g. age, gender, KIR alloreactivity). Recent advances in transplant techniques have greatly improved success rates with haploidentical transplants although disease relapse has remained as issue.
This trial aims to provide an alternative transplant option for patients with hematologic malignancies who require bone marrow transplantation but lack an HLA identical donor. The investigational component of this study is the combination of the Fludarabine/ Busulfan/ Total Body Irradiation conditioning regimen and the HLA Haploidentical Transplant with post-transplant Cyclophosphamide.
Detailed description
Allogeneic stem cell transplantation is a potentially curative treatment for patients with hematologic malignancies such as leukemia, lymphoma and myeloma who are at high risk of relapse. As well as the potential to deliver high doses of chemotherapy or radiation this procedure affords the benefit of an immunologic weapon against disease in the form of the graft versus tumor effect.
The major variables affecting the outcome of allogeneic transplant include: patient selection (age and comorbidities); disease status at the time of transplantation (remission vs. active disease); type of donor (HLA matched vs. mismatched or related vs. unrelated); type of conditioning regimen; source of stem cells (bone marrow vs. peripheral blood). Recent advances in the field of stem cell transplant have substantially lowered transplant related morbidity and mortality.
The availability of stem cell transplant as a treatment modality is dependent upon the availability of a suitable donor. Best outcomes are thought to occur in HLA matched sibling donors. The chance of a sibling being HLA matched is approximately 25%. Despite the development of large worldwide donor registries the likelihood of finding an HLA matched unrelated donor is 60-70% at best and drops to 10% in some ethnic minorities. In addition the process of identifying, confirming and harvesting an unrelated donor is cumbersome and time consuming at a time when the patient must proceed immediately to transplant (time from initiation of search to identification of an unrelated donor identification takes a median of 49 days). Therefore the development of alternative sources of hematopoietic stem cells is an area of immense interest to many investigators.
Alternative sources include cord blood and HLA haploidentical donors. Cord blood has been an attractive source permitting immediate availability and possibly a lower rate of graft versus host disease (GVHD). However delay in engraftment, particularly after myeloablative conditioning, remains a significant disadvantage. Haploidentical transplants carry some of the same advantages with virtually all patients having immediate access to a suitable and willing donor in the form of a partially HLA matched family member. Furthermore the number of potential donors allows for donor selection based upon factors such as age, gender, KIR alloreactivity. Finally the donor is readily available for future cellular therapies such as donor lymphocyte infusion.
Early attempts at haploidentical transplantation were hampered by high rates of graft failure and severe graft versus host disease. Recent advances in graft versus host disease prophylaxis with post transplant high dose cyclophosphamide (Cy) have overcome these barriers to a large degree. Published studies have shown that HLA-haploidentical bone marrow transplant (BMT) after non-myeloablative conditioning and using 2 doses of post-transplantation Cy followed by tacrolimus and mycophenolate mofetil (MMF) is a well-tolerated procedure. However, the major cause of treatment failure in this high-risk population was early relapse. As conditioning intensity has been clearly linked to rates of relapse in multiple diseases, it is postulated that utilizing conditioning with higher anti-tumor potential will lead to a lower relapse rate.
Given the advances in GVHD prophylaxis with post-transplantation Cy, reduced intensity conditioning with Fludarabine, Busulfan and total body irradiation combined with high-dose post-transplantation Cy is the platform for this study. The toxicities of this reduced intensity conditioning regimen are not expected to differ substantially from previous data incorporating post-transplantation Cy. However, this regimen may have higher anti-tumor potential resulting in a decreased relapse rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Haploidentical Transplant | Experimental | Procedure: Haploidentical Transplant, Drug: Fludarabine, Drug: Busulfan, Radiation: Total Body Irradiation, Drug: CyclophosphamideAll subjects will be dosed with pre-transplant Fludarabine (180mg/m2)and Busulfan total AUC 2400 μmol*min/L or 6.4mg/kg. Subjects will then undergo total body irradiation 2Gy. Subjects will undergo haploidentical allogeneic bone marrow transplant, followed by Cyclophosphamide, Tacrolimus and MMF based GVHD prophylaxis. |
Who may qualify
- Ages
- 10 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (26 listed)
- First-degree related donor or half-sibling who is at minimum HLA haploidentical
- Lack of fully matched donor (related or unrelated). Patients with a matched unrelated donor may only be enrolled if they require an urgent transplant. Urgency of transplant will judged by PI and co-investigators.
- Eligible diagnoses are listed below:
- Left ventricular ejection fraction ≥ 35%
- Bilirubin ≤ 3.0 mg/dL and ALT and AST < 5 x ULN
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Haploidentical TransplantAlso: Mismatched allogeneic bone marrow transplantSubjects will be dosed with pre-transplant Fludarabine (180mg/m2)and Busulfan total AUC 2400 μmol*min/L or 6.4mg/kg. Subjects will then undergo total body irradiation 2Gy. Subjects will undergo haploidentical allogeneic bone marrow transplant, followed by Cyclophosphamide, Tacrolimus and MMF based GVHD prophylaxis. | Procedure or surgery | Haploidentical Transplant |
| FludarabineAlso: FludaraSubjects in this trial will receive Fludarabine 30 mg/m2 IV QD, adjusted for CrCl from Days -8 through -3. | Drug | Haploidentical Transplant |
| BusulfanAlso: Busulfex, MyleranSubjects in this trial will receive Busulfan total AUC 2400 μmol*min/L or 6.4mg/kg in 4 doses with seizure prophylaxis from Days -6 through -3. | Drug | Haploidentical Transplant |
| Total Body IrradiationSubjects in this trial will receive total body irradiation (2Gy fractionated) from Day -2 or -1. | Radiation | Haploidentical Transplant |
| CyclophosphamideAlso: Endoxan, Cytoxan, Neosar, ProcytoxSubjects in this trial will receive Cyclophosphamide 50 mg/kg IV QD on Days 3 and 4 post-transplant. | Drug | Haploidentical Transplant |
Primary outcome
Number of Participants That Engrafted and the Number of Participants That Had Full Donor Chimerism at Day 60
Time frame: Up to Day 60 post-transplant.
To estimate the number of participants that had engraftment rates and the number of participants that had full donor chimerism at Day 60 in patients undergoing an HLA haploidentical stem cell transplant with post transplant high dose cyclophosphamide.
2 secondary outcomes
Number of Participants That Had an Overall Survival Rate
Time frame: Up to one year post-transplant.
Number of Participants That Had an Event Free Survival Rate
Time frame: Up to 1 year post-transplant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- 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.
Pritesh Patel, MD principal investigator
University of Illinois Chicago
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 Haploidentical Transplant, Fludarabine and Busulfan in people with Hematologic Malignancies, run by University of Illinois Chicago 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 26 inclusion and 0 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: stopped early, as of the sponsor's last update on 25 Feb 2020. 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 25 Feb 2020). 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 Participants That Engrafted and the Number of Participants That Had Full Donor Chimerism at Day 60 (time frame: Up to Day 60 post-transplant.). 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 25 Feb 2020; AzTrials last refreshed its copy on 3 Nov 2026.