Hematological MalignanciesPhase 2NCT01349101
A Research Study of Bone Marrow Transplantation From Unrelated or Partially Matched Related Donors
A Phase 2 study testing Total Body Irradiation, Cyclophosphamide and Tacrolimus in people with Hematological Malignancies, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial summary
It is hypothesized that engraftment when administering cyclophosphamide post the stem cell infusion will increase, the incidence of graft versus host disease (GVHD) and day 100 mortality will decrease, and the use of cyclophosphamide post stem cell infusion with alternative donors will be as safe and as effective as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematological Malignancies
- What is being tested?
- Total Body Irradiation, Cyclophosphamide and Tacrolimus
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2011to 7 Dec 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient with a hematological or oncological diagnosis in which allogeneic hematopoietic stem cell transplantation (HSCT) is thought to be beneficial.
- Patients without morphological or molecular evidence of disease
- For patients with "indolent diseases," if the patient has evidence of disease the disease burden must be minimal (at least PR) and the disease must be chemoresponsive. Thus for example patients with acute leukemia (not an indolent disease) must be in a morphological CR or CRp.
- For patients with MDS the inclusion criteria is specifically as follows:
- For patients with RA or RARS or isolated 5q- they can proceed to transplant without any treatment.
- For patients with RAEB-1, RCMD+/-RS, or MDS NOS must have stable disease for 6 months (as documented by serial bone marrow examinations) in the absence of any therapy but growth factors or transfusion support. Patients who require treatment to "control their disease" must show chemo-responsiveness
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- For patients with CMML or RAEB-2 they must demonstrate chemo-responsiveness
- Chemo-responsiveness is defined as a blast percentage decrease by at least 5 percentage points and there must be less than 10% blasts after treatment and at the time of transplant, if there are more than 10% blasts at any point during the disease course
- Chemo-responsiveness must also include at least one of the following if applicable:
- A cytogenetic response
- A well-documented decrease in transfusion requirements.
- Patients must have a related donor who is zero, one, two, three, or four antigen mismatched at the HLA-A; B; C; DR loci or an unrelated donor up to a two antigen mismatch. DNA will be retained by the tissue typing laboratory for possible typing for DQ and DP. When multiple related donor options are available donor selection will be determined the same as in the TJU two-step protocols. When multiple unrelated donors are available care will be made to avoid HLA-A and HLA-B mismatches if possible based on data from the Japanese Marrow Donor Registry studies. An HLA antibody screen will be performed on each patient.
- All patients must have adequate organ function:
- Patients with related donors must have an LVEF of >35%. Patients with unrelated donors must have an LVEF >45%. Patients with LVEF ≤50% and all patients with symptoms or history of heart failure or coronary artery disease must have a stress echo or equivalent test and a cardiological evaluation.
- Patients with related donors must have a DLCO >35% of predicted corrected for hemoglobin. Patients with unrelated donors must have a DLCO >45% of predicted corrected for hemoglobin. For related donors if the DLCO is less than 45% the EF must be greater than 45% and vice versa.
- Patients with related donors must have an adequate liver function as defined by a serum bilirubin <3.0, AST and ALT <3.0X upper limit of normal. Patients with unrelated donors must have an adequate liver function as defined by a serum bilirubin <1.8, AST and ALT < 2.5X upper limit of normal. Exceptions may be granted for patients with "benign" liver disorders such as Gilbert's disease.
- Patients with related donors or with unrelated donors must have a creatinine clearance of > 60 ml/min/1.73 m^2.
- Patients with related donors must have a performance status > 60% (TJU Karnofsky14) (Appendix A). Patients with unrelated donors must have a Performance status > 70% (TJU Karnofsky).
- Patients with related donors must have a HCT-CI Score < 6 Points (Appendix B). Patients with unrelated donors must have a HCT-CI Score < 5 Points.
- Patients must be willing to use contraception if they are of childbearing potential.
- Patients must be able to give informed consent or have a care giver who can give consent.
- Patients that are HIV positive will be eligible for the study if they have an undetectable viral load and meet the above criteria for patients with unrelated donors.
Who cannot join
- Patients with related donors who have a combination of Performance status of < 70% (TJU Karnofsky) and an HCT-CI of 4 points or more. Patients with unrelated donors with a combination of Performance status of < 80% (TJU Karnofsky) and an HCT-CI of 4 points or more.
- Patients with active involvement of the central nervous system with malignancy. Patients with a disease with potential for CNS involvement should have documentation of the lack of CNS involvement via lumbar puncture or similar procedure performed within two months of admission or as per TJU standard practice guidelines.
- Patients with a psychiatric disorder that would preclude patients from complying with the protocol even with a caregiver. Patients with a lack of social support that would interfere with the ability to receive appropriate medical care will also be excluded.
- Pregnancy
- Patients with life expectancy of < 6 months for reasons other than their underlying hematological/oncological disorder.
- Patients who have received alemtuzumab within 8 weeks of the transplant admission, or who have recently received horse or rabbit ant-thymocyte globulin and have an ATG level of > 2 μg/ml. Patients on systemic corticosteroids at a dose equivalent of prednisone 7.5mg/day or higher.
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- Patients who cannot receive cyclophosphamide.
- Patients with evidence of another malignancy, exclusive of a skin cancer that requires only local treatment, should not be enrolled on this protocol.
- Patients with refractory disease.
- Patients with clinically significant preformed antibodies to their donors.
- Patients who require supplemental oxygen other than for sleep apnea will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Post Transplant Cyclophosphamide for Unrelated and Related Allogeneic Hematopoietic Stem Cell Transplantation for Hematological Malignancies
It is hypothesized that engraftment when administering cyclophosphamide post the stem cell infusion will increase, the incidence of graft versus host disease (GVHD) and day 100 mortality will decrease, and the use of cyclophosphamide post stem cell infusion with alternative donors will be as safe and as effective as traditional matched transplants.
Read the detailed description
The primary rationale for the development of this research study is to find out if the use of cyclophosphamide after a "blood" stem cell transplant is an effective treatment for patients with blood cancers who require transplant for long-term survival but are without an available matched-sibling donor. Historically, survival rates for patients undergoing partially matched related or unrelated donor transplants (henceforth to be called alternative donor transplants) have been much lower than those observed after matched sibling stem cell transplants. Survival post alternative donor stem cell transplant has also been affected by the requirement to remove or reduce the numbers of donor T cells resulting in higher rates of infection, graft rejection, and relapse. One significant limitation to conventional donor transplants with HLA matched siblings has been that over 50% of patients do not have HLA matched siblings so that increasing the safety of alternative donor transplants could have a significant influence on the number of patients who could safely receive transplants. Because of the historically low overall survival (OS) after alternative donor transplants, it has become a procedure of "last resort" in many centers unwilling to consider it unless all other options are exhausted. There fore several centers including ours have sought to overcome problems using various strategies. The strategy the investigators have proposed for this study (which has been used similarly by other centers) has been to administer cyclophosphamide post the stem cell infusion (traditionally it is given before the stem cell infusion) thereby hopefully destroying the activated T-cells causing graft-versus host disease (GVHD) and allow T cell tolerization and engraftment; but, not the inactivated T cells thereby hopefully preserving the anti-tumor effects of the donor immune system. Thus, the major aim of this study will be to measure the engraftment with this regimen and secondarily to measure incidence of GVHD and day 100 mortality. The goal is to see if in the first 3 months the use of cyclophosphamide post stem cell infusion with alternative donors is as safe and as effective as traditional matched transplants.
- Conditions
- Hematological Malignancies
- Being tested
- Total Body Irradiation, Cyclophosphamide, Tacrolimus, Mycophenolate mofetil, Fludarabine
- Keywords
- hematopoietic stem cell transplantation, HSCT, allogeneic marrow transplantation, cyclophosphamide, graft-versus-host disease, GVHD
- Medical subject headings
- Hematologic Neoplasms, Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Body IrradiationRadiation
Also called TBI, radiotherapy
Myeloablative HSCT Arm: Total body irradiation (TBI) is given in 8 fractions over 4 days (total dose of 12 Gy)
Reduced Intensity HSCT Arm: TBI is given in one fraction (total dose of 2 Gy)
CyclophosphamideDrug
Also called Endoxan, Cytoxan, Neosar, Procytox
Cyclophosphamide is administered on the third day after the hematopoietic stem cell transplantation (HSCT) to help reduce graft-versus-host disease (GVHD). It is given at a dose of 60 mg/kg/d for 2 days on days +3 and +4.
TacrolimusDrug
Also called FK-506, Fujimycin
Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).
Also called CellCept, MMF
Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).
FludarabineDrug
Also called fludarabine phosphate, Fludara
Started the fifth day before the transplant. Given for four days at 30 mg/m2/d.
BusulfanDrug
Also called Myleran, Busulfex IV
Started the fourth day before the transplant. Given for two days at 3.2 mg/kg.
Hematopoietic stem cell transplantationGenetic
Also called HSCT
Allogeneic marrow transplantation given after the last dose of total body irradiation (TBI)
| Study group | Role | What they receive |
|---|---|---|
| Myeloablative HSCT | Experimental | Myeloablative Hematopoietic Stem Cell Transplantation (HSCT): Patients will receive myeloablative transplants or nonmyeloablative transplants depending on their disease type. Receives: Radiation: Total Body Irradiation; Drug: Cyclophosphamide; Drug: Tacrolimus; Drug: Mycophenolate mofetil; Genetic: Hematopoietic stem cell transplantation |
| Reduced Intensity HSCT | Experimental | Reduced Intensity Hematopoietic Stem Cell Transplantation (HSCT): Patients who have received a previous transplant, patients who have received dose limiting radiation, and patients with a DLCO <45% will receive the reduced intensity conditioning regimen. Receives: Radiation: Total Body Irradiation; Drug: Cyclophosphamide; Drug: Tacrolimus; Drug: Mycophenolate mofetil; Drug: Fludarabine; Drug: Busulfan; Genetic: Hematopoietic stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Engraftment Using Cyclophosphamide Post-Transplant
Successful Hematopoietic engraftment will be assessed by determining the incidence of participants who achieve both of the following criteria within the 100 days post-transplant:
ANC >/= 0.5x10e9/L for at least 3 days. Platelet engraftment >20,000 with no transfusions X 7 days. The incidence will be calculated as the number of participants who meet both engraftment criteria. Results will be presented as a proportion/percentage/probability not as an incidence rate.
Measured: Through 100 days post-transplant
Secondary outcomes (3)
Cumulative Incidence of Grade III-IV GVHD
The cumulative incidence of Grade III-IV graft-versus-host disease (GVHD) within 100 days post-transplant will be estimated; goal is less than 10%. The cumulative incidence represents the probability that a participant experiences Grade III-IV GVHD by day 100. Results will be reported as proportion/percentage/probability.
Measured: Through 100 days post-transplant
Incidence of GVHD Unresponsive to Corticosteroids and Photopheresis
This outcome will estimate the cumulative incidence (probability) of graft-versus-host disease (GVHD) that is considered unresponsive to corticosteroids and photopheresis within 100 days after treatment; goal is less than 15%. The cumulative incidence will be calculated as the number of participants meeting these criteria. Results will be reported as a proportion/percentage.
Measured: Through 100 days post-treatment
Transplant-Related Mortality
The cumulative incidence of transplant related mortality (TRM) by day 100 post-transplant will be estimated. Assess day 100 transplant-related mortality; goal is less than 15%. TRM is defined as death that results from medical treatment rather than from the underlying disease itself. The cumulative incidence reflects the probability of TRM by day 100. The result will be reported as a proportion/percentage/probability, not an incidence rate.
Measured: 100 days post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2011 (estimated)
- Study start10 Feb 2011
- Primary completion31 Oct 2022
- Study completion7 Dec 2022
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 Hematological MalignanciesStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John L Wagner, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01349101
- Sponsor's protocol ID
- 11D.51
- Other IDs
- 2010-54, JT 2137
- Status last verified
- Nov 2025
- First submitted
- 26 Apr 2011
- Last updated
- 15 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Transplant Cyclophosphamide for Unrelated and Related Allogeneic Hematopoietic Stem Cell Transplantation for Hematological Malignancies
- ClinicalTrials.gov ID
- NCT01349101
- Acronym / sponsor ID
- 11D.51
- Conditions
- Hematological Malignancies
- Keywords
- hematopoietic stem cell transplantation, HSCT, allogeneic marrow transplantation, cyclophosphamide, graft-versus-host disease, GVHD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 10 Feb 2011 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 7 Dec 2022 (actual)
- First posted
- 6 May 2011 (estimated)
- Results
- Posted 15 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is hypothesized that engraftment when administering cyclophosphamide post the stem cell infusion will increase, the incidence of graft versus host disease (GVHD) and day 100 mortality will decrease, and the use of cyclophosphamide post stem cell infusion with alternative donors will be as safe and as effective as traditional matched transplants.
Detailed description
The primary rationale for the development of this research study is to find out if the use of cyclophosphamide after a "blood" stem cell transplant is an effective treatment for patients with blood cancers who require transplant for long-term survival but are without an available matched-sibling donor. Historically, survival rates for patients undergoing partially matched related or unrelated donor transplants (henceforth to be called alternative donor transplants) have been much lower than those observed after matched sibling stem cell transplants. Survival post alternative donor stem cell transplant has also been affected by the requirement to remove or reduce the numbers of donor T cells resulting in higher rates of infection, graft rejection, and relapse. One significant limitation to conventional donor transplants with HLA matched siblings has been that over 50% of patients do not have HLA matched siblings so that increasing the safety of alternative donor transplants could have a significant influence on the number of patients who could safely receive transplants. Because of the historically low overall survival (OS) after alternative donor transplants, it has become a procedure of "last resort" in many centers unwilling to consider it unless all other options are exhausted. There fore several centers including ours have sought to overcome problems using various strategies. The strategy the investigators have proposed for this study (which has been used similarly by other centers) has been to administer cyclophosphamide post the stem cell infusion (traditionally it is given before the stem cell infusion) thereby hopefully destroying the activated T-cells causing graft-versus host disease (GVHD) and allow T cell tolerization and engraftment; but, not the inactivated T cells thereby hopefully preserving the anti-tumor effects of the donor immune system. Thus, the major aim of this study will be to measure the engraftment with this regimen and secondarily to measure incidence of GVHD and day 100 mortality. The goal is to see if in the first 3 months the use of cyclophosphamide post stem cell infusion with alternative donors is as safe and as effective as traditional matched transplants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myeloablative HSCT | Experimental | Radiation: Total Body Irradiation, Drug: Cyclophosphamide, Drug: Tacrolimus, Drug: Mycophenolate mofetil, Genetic: Hematopoietic stem cell transplantationMyeloablative Hematopoietic Stem Cell Transplantation (HSCT): Patients will receive myeloablative transplants or nonmyeloablative transplants depending on their disease type. |
| Reduced Intensity HSCT | Experimental | Radiation: Total Body Irradiation, Drug: Cyclophosphamide, Drug: Tacrolimus, Drug: Mycophenolate mofetil, Drug: Fludarabine, Drug: Busulfan, Genetic: Hematopoietic stem cell transplantationReduced Intensity Hematopoietic Stem Cell Transplantation (HSCT): Patients who have received a previous transplant, patients who have received dose limiting radiation, and patients with a DLCO <45% will receive the reduced intensity conditioning regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Any patient with a hematological or oncological diagnosis in which allogeneic hematopoietic stem cell transplantation (HSCT) is thought to be beneficial.
- For patients with MDS the inclusion criteria is specifically as follows:
- Patients must have a related donor who is zero, one, two, three, or four antigen mismatched at the HLA-A; B; C; DR loci or an unrelated donor up to a two antigen mismatch. DNA will be retained by the tissue typing laboratory for possible typing for DQ and DP. When multiple related donor options are available donor selection will be determined the same as in the TJU two-step protocols. When multiple unrelated donors are available care will be made to avoid HLA-A and HLA-B mismatches if possible based on data from the Japanese Marrow Donor Registry studies. An HLA antibody screen will be performed on each patient.
- All patients must have adequate organ function:
Key exclusion criteria (11 listed)
- Patients with related donors who have a combination of Performance status of < 70% (TJU Karnofsky) and an HCT-CI of 4 points or more. Patients with unrelated donors with a combination of Performance status of < 80% (TJU Karnofsky) and an HCT-CI of 4 points or more.
- Patients with active involvement of the central nervous system with malignancy. Patients with a disease with potential for CNS involvement should have documentation of the lack of CNS involvement via lumbar puncture or similar procedure performed within two months of admission or as per TJU standard practice guidelines.
- Patients with a psychiatric disorder that would preclude patients from complying with the protocol even with a caregiver. Patients with a lack of social support that would interfere with the ability to receive appropriate medical care will also be excluded.
- Pregnancy
- Patients with life expectancy of < 6 months for reasons other than their underlying hematological/oncological disorder.
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 |
|---|---|---|
| Total Body IrradiationAlso: TBI, radiotherapyMyeloablative HSCT Arm: Total body irradiation (TBI) is given in 8 fractions over 4 days (total dose of 12 Gy) Reduced Intensity HSCT Arm: TBI is given in one fraction (total dose of 2 Gy) | Radiation | Myeloablative HSCT, Reduced Intensity HSCT |
| CyclophosphamideAlso: Endoxan, Cytoxan, Neosar, ProcytoxCyclophosphamide is administered on the third day after the hematopoietic stem cell transplantation (HSCT) to help reduce graft-versus-host disease (GVHD). It is given at a dose of 60 mg/kg/d for 2 days on days +3 and +4. | Drug | Myeloablative HSCT, Reduced Intensity HSCT |
| TacrolimusAlso: FK-506, FujimycinStarted the fifth day after the transplant to help prevent graft-versus-host disease (GVHD). | Drug | Myeloablative HSCT, Reduced Intensity HSCT |
| Mycophenolate mofetilAlso: CellCept, MMFStarted the fifth day after the transplant to help prevent graft-versus-host disease (GVHD). | Drug | Myeloablative HSCT, Reduced Intensity HSCT |
| FludarabineAlso: fludarabine phosphate, FludaraStarted the fifth day before the transplant. Given for four days at 30 mg/m2/d. | Drug | Reduced Intensity HSCT |
| BusulfanAlso: Myleran, Busulfex IVStarted the fourth day before the transplant. Given for two days at 3.2 mg/kg. | Drug | Reduced Intensity HSCT |
| Hematopoietic stem cell transplantationAlso: HSCTAllogeneic marrow transplantation given after the last dose of total body irradiation (TBI) | Genetic | Myeloablative HSCT, Reduced Intensity HSCT |
Primary outcome
Successful Engraftment Using Cyclophosphamide Post-Transplant
Time frame: Through 100 days post-transplant
Successful Hematopoietic engraftment will be assessed by determining the incidence of participants who achieve both of the following criteria within the 100 days post-transplant: ANC >/= 0.5x10e9/L for at least 3 days. Platelet engraftment >20,000 with no transfusions X 7 days. The incidence will be calculated as the number of participants who meet both engraftment criteria. Results will be presented as a proportion/percentage/probability not as an incidence rate.
3 secondary outcomes
Cumulative Incidence of Grade III-IV GVHD
Time frame: Through 100 days post-transplant
Incidence of GVHD Unresponsive to Corticosteroids and Photopheresis
Time frame: Through 100 days post-treatment
Transplant-Related Mortality
Time frame: 100 days post-transplant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Thomas Jefferson University HospitalsLink 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.
John L Wagner, MD principal investigator
Thomas Jefferson University
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 Total Body Irradiation, Cyclophosphamide and Tacrolimus in people with Hematological Malignancies, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University 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 11 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 15 Dec 2025. 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 15 Dec 2025). 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?
Successful Engraftment Using Cyclophosphamide Post-Transplant (time frame: Through 100 days 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 15 Dec 2025.