Chronic Myeloproliferative DisordersPhase 2NCT00544115
Donor Peripheral Stem Cell Transplant in Treating Patients With Advanced Hematologic Cancer or Other Disorders
A Phase 2 study testing busulfan, cyclophosphamide and cyclosporine in people with Chronic Myeloproliferative Disorders and Graft Versus Host Disease, run by City of Hope Medical Center.
Trial summary
RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral stem cell transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Read more about this study
- Who is it for?
- Ages 0 to 120 years
- Conditions the study is for
- Chronic Myeloproliferative Disorders, Graft Versus Host Disease, Leukemia
- What is being tested?
- busulfan, cyclophosphamide and cyclosporine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- No sites listed yet
- Study dates
- 16 Oct 2001to 29 Mar 2027
- 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 0 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of one of the following:
- Acute lymphocytic leukemia (ALL), meeting one of the following criteria:
- In first relapse or beyond
- High-risk ALL, defined by any of the following:
- Hypoploidy (≤ 44 chromosomes)
- Pseudodiploidy with translocations or molecular evidence of t(9;22), 11q23, or t(8;14), excluding B-cell ALL
- Elevated WBC at presentation (WBC > 20,000/mm³ [for patients > 18 years of age]; WBC > 200,000/mm³ [for patients 12-18 years of age])
- Acute myeloid leukemia (AML), meeting one of the following criteria:
- In first complete remission
- Failed to achieve remission
- In first relapse or beyond
- Secondary AML (> 30% blasts in marrow aspirate)
- Should receive induction chemotherapy to obtain remission, if possible, before transplant
- Chronic myelogenous leukemia, meeting one of the following criteria:
- In first or second chronic phase or accelerated phase
- In blast crisis, defined as > 30% promyelocytes plus blasts in the bone marrow
- Myelodysplastic syndromes, including any of the following:
- Refractory anemia with excess blasts (RAEB)
- Chronic myelomonocytic leukemia
- RAEB in transformation
- Refractory non-Hodgkin lymphoma, chronic lymphocytic leukemia, Hodgkin lymphoma, or multiple myeloma
- Received and failed front-line therapy, high-dose therapy and autologous stem cell transplantation, or salvage therapy
- Myeloproliferative disorders/myelofibrosis may be allowed on a case by case basis
- Severe aplastic anemia, paroxysmal nocturnal hemoglobinuria, or any other hematologic disorder requiring transplantation
- Patients > 55 years of age with hematologic diseases treatable by allogeneic stem cell transplantation who are not eligible for IRB 99190 are eligible
- No uncontrolled CNS involvement of disease
- No matched (6/6) related donor available
- HLA-identical unrelated donor available
- HLA-phenotypically identical for HLA-A and HLA-B alleles and identical for DRB1 alleles by DNA typing for both class I and class II antigens
- Allele mismatch for HLA class I (i.e., B 2701 vs B 2702) allowed if no alternative donors
- Allele mismatch for class II (i.e., DRB1 0401 vs 0402) or minor mismatch for class I cross reactive group (CREG) (i.e., A 2 vs A 28) allowed in patients ≤ 35 years of age requiring urgent transplant
PATIENT CHARACTERISTICS:
- Karnofsky performance status 50-100%
- Life expectancy > 8 weeks
- LVEF ≥ 45% at rest
- AST ≤ 2 times normal (unless liver function abnormality is due to underlying disease)
- Total bilirubin < 1.5 times normal (unless liver function abnormality is due to underlying disease)
- Creatinine ≤ 1.5 times normal OR creatinine clearance ≥ 60 mL/min
- DLCO ≥ 40% of predicted (corrected for hemoglobin)
- No coexisting medical problem that would significantly increase the risk of the transplant procedure
- HIV negative
- Not pregnant
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
About this study
Official title: A Phase II Trial of Allogeneic Peripheral Blood Stem Cell Transplantation From Matched Unrelated Donors in Patients With Advanced Hematologic Malignancies and Hematological Disorders
RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral stem cell transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving tacrolimus, methotrexate, cyclosporine, mycophenolate mofetil, and sirolimus before and after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well donor peripheral stem cell transplant works in treating patients with advanced hematologic cancer or other disorders.
Read the detailed description
OBJECTIVES:
Primary
- To evaluate hematopoietic recovery, using neutrophil and platelet engraftment as the primary criterion, in patients with advanced hematologic malignancies or other disorders undergoing allogeneic peripheral blood stem cell (PBSC) transplantation from matched unrelated donors.
- To evaluate the incidence of acute and chronic graft-versus-host-disease (GVHD) in patients undergoing allogeneic PBSC transplantation from matched unrelated donors.
Secondary
- To evaluate the impact of HLA class I and class II allele-matching on the incidence of GVHD and on the survival outcome of these patients.
- To evaluate overall survival, disease-free survival, and relapse in these patients.
OUTLINE: Patients are stratified according to type of conditioning regimen (myeloablative vs reduced-intensity myeloablative). Patients are assigned to a conditioning regimen according to diagnosis, age, disease status, prior radiotherapy, and prior autologous stem cell transplantation.
- Conditioning regimen:
- Regimen I: Patients undergo total body irradiation (TBI) on days -7 to -4 and receive cyclophosphamide IV on days -3 and -2. Alternatively, patients may receive cyclophosphamide on days -7 and -6 and undergo TBI on days -4 to -1.
- Regimen II: Patients receive busulfan IV over 2 hours once on day -8 and then every 6 hours on days -7 to -4. Patients also receive cyclophosphamide IV on days -3 and -2.
- Regimen III: Patients undergo TBI on days -7 to -4 and receive etoposide IV on day -3.
- Regimen IV: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3 and melphalan IV on day -2.
- Regimen V: Patients receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo TBI on day 0.
- Regimen VI: Patients receive busulfan IV over 3 hours and fludarabine phosphate IV over 30 minutes on days -5 to -2.
- Allogeneic peripheral blood stem cell (PBSC) transplantation: All patients undergo allogeneic PBSC transplantation on day 0.
- Graft-versus-host disease (GVHD) prophylaxis: Patients receive one of the following GVHD prophylaxis regimens:
- Regimen A: Patients receive tacrolimus IV or orally on days -1 to 180 and methotrexate IV on days 1, 3, 6, and 11.
- Regimen B: Patients receive cyclosporine IV or orally twice daily on days -1 to 180, mycophenolate mofetil IV over 2 hours or orally twice daily on days 0-27, and methotrexate IV on days 1, 3, and 6.
- Regimen C: Patients receive tacrolimus IV continuously or orally, and oral sirolimus beginning on day -3. Patients also receive methotrexate IV on days 1, 3, and 6.
After completion of study therapy, patients are followed periodically.
- Conditions
- Chronic Myeloproliferative Disorders, Graft Versus Host Disease, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes
- Being tested
- busulfan, cyclophosphamide, cyclosporine, etoposide, fludarabine phosphate
- Keywords
- graft versus host disease, recurrent adult acute lymphoblastic leukemia, recurrent childhood acute lymphoblastic leukemia, untreated adult acute lymphoblastic leukemia, untreated childhood acute lymphoblastic leukemia, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, refractory anemia with excess blasts in transformation, refractory anemia with excess blasts, atypical chronic myeloid leukemia, chronic myelomonocytic leukemia, juvenile myelomonocytic leukemia, myelodysplastic/myeloproliferative disease, unclassifiable, recurrent adult acute myeloid leukemia, recurrent childhood acute myeloid leukemia, adult acute myeloid leukemia in remission, childhood acute myeloid leukemia in remission, secondary acute myeloid leukemia, adult acute myeloid leukemia with 11q23 (MLL) abnormalities
- Medical subject headings
- Myeloproliferative Disorders, Graft vs Host Disease, Leukemia, Lymphoma, Multiple Myeloma, Neoplasms, Plasma Cell, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
busulfanDrug
cyclophosphamideDrug
cyclosporineDrug
etoposideDrug
melphalanDrug
methotrexateDrug
sirolimusDrug
tacrolimusDrug
allogeneic hematopoietic stem cell transplantationProcedure or surgery
peripheral blood stem cell transplantationProcedure or surgery
total-body irradiationRadiation
| Study group | Role | What they receive |
|---|---|---|
| Regimen I | Active comparator | Patients undergo total body irradiation (TBI) on days -7 to -4 and receive cyclophosphamide IV on days -3 and -2. Alternatively, patients may receive cyclophosphamide on days -7 and -6 and undergo TBI on days -4 to -1. Receives: Drug: cyclophosphamide; Drug: cyclosporine; Drug: methotrexate; Drug: mycophenolate mofetil; Drug: sirolimus; Drug: tacrolimus; Procedure: allogeneic hematopoietic stem cell transplantation; Procedure: peripheral blood stem cell transplantation; Radiation: total-body irradiation |
| Regimen II | Active comparator | Patients receive busulfan IV over 2 hours once on day -8 and then every 6 hours on days -7 to -4. Patients also receive cyclophosphamide IV on days -3 and -2. Receives: Drug: busulfan; Drug: cyclophosphamide; Drug: cyclosporine; Drug: methotrexate; Drug: mycophenolate mofetil; Drug: sirolimus; Drug: tacrolimus; Procedure: allogeneic hematopoietic stem cell transplantation; Procedure: peripheral blood stem cell transplantation |
| Regimen III | Active comparator | Patients undergo TBI on days -7 to -4 and receive etoposide IV on day -3. Receives: Drug: cyclosporine; Drug: etoposide; Drug: methotrexate; Drug: mycophenolate mofetil; Drug: sirolimus; Drug: tacrolimus; Procedure: allogeneic hematopoietic stem cell transplantation; Procedure: peripheral blood stem cell transplantation; Radiation: total-body irradiation |
| Regimen IV | Active comparator | Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3 and melphalan IV on day -2. Receives: Drug: cyclosporine; Drug: fludarabine phosphate; Drug: melphalan; Drug: methotrexate; Drug: mycophenolate mofetil; Drug: sirolimus; Drug: tacrolimus; Procedure: allogeneic hematopoietic stem cell transplantation; Procedure: peripheral blood stem cell transplantation |
| Regimen V | Active comparator | Patients receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo TBI on day 0. Receives: Drug: cyclosporine; Drug: fludarabine phosphate; Drug: methotrexate; Drug: mycophenolate mofetil; Drug: sirolimus; Drug: tacrolimus; Procedure: allogeneic hematopoietic stem cell transplantation; Procedure: peripheral blood stem cell transplantation; Radiation: total-body irradiation |
| Regimen VI | Active comparator | Patients receive busulfan IV over 3 hours and fludarabine phosphate IV over 30 minutes on days -5 to -2. Receives: Drug: busulfan; Drug: cyclosporine; Drug: fludarabine phosphate; Drug: methotrexate; Drug: mycophenolate mofetil; Drug: sirolimus; Drug: tacrolimus; Procedure: allogeneic hematopoietic stem cell transplantation; Procedure: peripheral blood stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutrophil Engraftment - The Days Till ANC Recovery
The primary engraftment endpoint, neutrophil engraftment, is defined as the first of three consecutive days on which the absolute neutrophil count is > 500/µL. The duration and extent of neutrophil engraftment is the time from transplant to neutrophil engraftment.
Measured: Up to 180 days post transplant
Secondary outcomes (1)
Two-year Overall Survival
Overall survival (OS) was measured from peripheral stem cell infusion to death from any cause. It was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula. Participants were followed up to 2 years after transplant and Kaplan-Meier survival analysis was used to generate the two-year Overall Survival estimate presented.
Measured: Up to 2 years post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2007 (estimated)
- Study start16 Oct 2001
- Primary completion13 Mar 2007
- Study completion29 Mar 2027 (estimated)
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 Chronic Myeloproliferative DisordersStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Auayporn P. Nademanee, MD, Study chair, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00544115
- Sponsor's protocol ID
- 01089
- Other IDs
- P30CA033572, CHNMC-01089, 01089, CDR0000566376
- Status last verified
- May 2026
- First submitted
- 13 Oct 2007
- Last updated
- 2 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Allogeneic Peripheral Blood Stem Cell Transplantation From Matched Unrelated Donors in Patients With Advanced Hematologic Malignancies and Hematological Disorders
- ClinicalTrials.gov ID
- NCT00544115
- Acronym / sponsor ID
- 01089
- Conditions
- Chronic Myeloproliferative Disorders, Graft Versus Host Disease, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes
- Keywords
- graft versus host disease, recurrent adult acute lymphoblastic leukemia, recurrent childhood acute lymphoblastic leukemia, untreated adult acute lymphoblastic leukemia, untreated childhood acute lymphoblastic leukemia, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 260 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 16 Oct 2001 (actual)
- Primary completion
- 13 Mar 2007 (actual)
- Study completion
- 29 Mar 2027 (estimated)
- First posted
- 16 Oct 2007 (estimated)
- Results
- Posted 10 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral stem cell transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving tacrolimus, methotrexate, cyclosporine, mycophenolate mofetil, and sirolimus before and after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well donor peripheral stem cell transplant works in treating patients with advanced hematologic cancer or other disorders.
Detailed description
OBJECTIVES:
Primary
- To evaluate hematopoietic recovery, using neutrophil and platelet engraftment as the primary criterion, in patients with advanced hematologic malignancies or other disorders undergoing allogeneic peripheral blood stem cell (PBSC) transplantation from matched unrelated donors.
- To evaluate the incidence of acute and chronic graft-versus-host-disease (GVHD) in patients undergoing allogeneic PBSC transplantation from matched unrelated donors.
Secondary
- To evaluate the impact of HLA class I and class II allele-matching on the incidence of GVHD and on the survival outcome of these patients.
- To evaluate overall survival, disease-free survival, and relapse in these patients.
OUTLINE: Patients are stratified according to type of conditioning regimen (myeloablative vs reduced-intensity myeloablative). Patients are assigned to a conditioning regimen according to diagnosis, age, disease status, prior radiotherapy, and prior autologous stem cell transplantation.
- Conditioning regimen:
- Regimen I: Patients undergo total body irradiation (TBI) on days -7 to -4 and receive cyclophosphamide IV on days -3 and -2. Alternatively, patients may receive cyclophosphamide on days -7 and -6 and undergo TBI on days -4 to -1.
- Regimen II: Patients receive busulfan IV over 2 hours once on day -8 and then every 6 hours on days -7 to -4. Patients also receive cyclophosphamide IV on days -3 and -2.
- Regimen III: Patients undergo TBI on days -7 to -4 and receive etoposide IV on day -3.
- Regimen IV: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3 and melphalan IV on day -2.
- Regimen V: Patients receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo TBI on day 0.
- Regimen VI: Patients receive busulfan IV over 3 hours and fludarabine phosphate IV over 30 minutes on days -5 to -2.
- Allogeneic peripheral blood stem cell (PBSC) transplantation: All patients undergo allogeneic PBSC transplantation on day 0.
- Graft-versus-host disease (GVHD) prophylaxis: Patients receive one of the following GVHD prophylaxis regimens:
- Regimen A: Patients receive tacrolimus IV or orally on days -1 to 180 and methotrexate IV on days 1, 3, 6, and 11.
- Regimen B: Patients receive cyclosporine IV or orally twice daily on days -1 to 180, mycophenolate mofetil IV over 2 hours or orally twice daily on days 0-27, and methotrexate IV on days 1, 3, and 6.
- Regimen C: Patients receive tacrolimus IV continuously or orally, and oral sirolimus beginning on day -3. Patients also receive methotrexate IV on days 1, 3, and 6.
After completion of study therapy, patients are followed periodically.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Regimen I | Active comparator | Drug: cyclophosphamide, Drug: cyclosporine, Drug: methotrexate, Drug: mycophenolate mofetil, Drug: sirolimus, Drug: tacrolimus, Procedure: allogeneic hematopoietic stem cell transplantation, Procedure: peripheral blood stem cell transplantation, Radiation: total-body irradiationPatients undergo total body irradiation (TBI) on days -7 to -4 and receive cyclophosphamide IV on days -3 and -2. Alternatively, patients may receive cyclophosphamide on days -7 and -6 and undergo TBI on days -4 to -1. |
| Regimen II | Active comparator | Drug: busulfan, Drug: cyclophosphamide, Drug: cyclosporine, Drug: methotrexate, Drug: mycophenolate mofetil, Drug: sirolimus, Drug: tacrolimus, Procedure: allogeneic hematopoietic stem cell transplantation, Procedure: peripheral blood stem cell transplantationPatients receive busulfan IV over 2 hours once on day -8 and then every 6 hours on days -7 to -4. Patients also receive cyclophosphamide IV on days -3 and -2. |
| Regimen III | Active comparator | Drug: cyclosporine, Drug: etoposide, Drug: methotrexate, Drug: mycophenolate mofetil, Drug: sirolimus, Drug: tacrolimus, Procedure: allogeneic hematopoietic stem cell transplantation, Procedure: peripheral blood stem cell transplantation, Radiation: total-body irradiationPatients undergo TBI on days -7 to -4 and receive etoposide IV on day -3. |
| Regimen IV | Active comparator | Drug: cyclosporine, Drug: fludarabine phosphate, Drug: melphalan, Drug: methotrexate, Drug: mycophenolate mofetil, Drug: sirolimus, Drug: tacrolimus, Procedure: allogeneic hematopoietic stem cell transplantation, Procedure: peripheral blood stem cell transplantationPatients receive fludarabine phosphate IV over 30 minutes on days -7 to -3 and melphalan IV on day -2. |
| Regimen V | Active comparator | Drug: cyclosporine, Drug: fludarabine phosphate, Drug: methotrexate, Drug: mycophenolate mofetil, Drug: sirolimus, Drug: tacrolimus, Procedure: allogeneic hematopoietic stem cell transplantation, Procedure: peripheral blood stem cell transplantation, Radiation: total-body irradiationPatients receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo TBI on day 0. |
| Regimen VI | Active comparator | Drug: busulfan, Drug: cyclosporine, Drug: fludarabine phosphate, Drug: methotrexate, Drug: mycophenolate mofetil, Drug: sirolimus, Drug: tacrolimus, Procedure: allogeneic hematopoietic stem cell transplantation, Procedure: peripheral blood stem cell transplantationPatients receive busulfan IV over 3 hours and fludarabine phosphate IV over 30 minutes on days -5 to -2. |
Who may qualify
- Ages
- 0 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| busulfan | Drug | Regimen II, Regimen VI |
| cyclophosphamide | Drug | Regimen I, Regimen II |
| cyclosporine | Drug | Regimen I, Regimen II, Regimen III, Regimen IV, Regimen V, Regimen VI |
| etoposide | Drug | Regimen III |
| fludarabine phosphate | Drug | Regimen IV, Regimen V, Regimen VI |
| melphalan | Drug | Regimen IV |
| methotrexate | Drug | Regimen I, Regimen II, Regimen III, Regimen IV, Regimen V, Regimen VI |
| mycophenolate mofetil | Drug | Regimen I, Regimen II, Regimen III, Regimen IV, Regimen V, Regimen VI |
| sirolimus | Drug | Regimen I, Regimen II, Regimen III, Regimen IV, Regimen V, Regimen VI |
| tacrolimus | Drug | Regimen I, Regimen II, Regimen III, Regimen IV, Regimen V, Regimen VI |
| allogeneic hematopoietic stem cell transplantation | Procedure or surgery | Regimen I, Regimen II, Regimen III, Regimen IV, Regimen V, Regimen VI |
| peripheral blood stem cell transplantation | Procedure or surgery | Regimen I, Regimen II, Regimen III, Regimen IV, Regimen V, Regimen VI |
| total-body irradiation | Radiation | Regimen I, Regimen III, Regimen V |
Primary outcome
Neutrophil Engraftment - The Days Till ANC Recovery
Time frame: Up to 180 days post transplant
The primary engraftment endpoint, neutrophil engraftment, is defined as the first of three consecutive days on which the absolute neutrophil count is > 500/µL. The duration and extent of neutrophil engraftment is the time from transplant to neutrophil engraftment.
1 secondary outcome
Two-year Overall Survival
Time frame: Up to 2 years post transplant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- 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.
Auayporn P. Nademanee, MD study chair
City of Hope Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing busulfan, cyclophosphamide and cyclosporine in people with Chronic Myeloproliferative Disorders and Graft Versus Host Disease, run by City of Hope Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: under way, not looking for participants, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 10 May 2023). 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?
Neutrophil Engraftment - The Days Till ANC Recovery (time frame: Up to 180 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 2 Jun 2026.