Hematologic MalignanciesPhase 2NCT02623439
A Study of Haploidentical Bone Marrow Transplant for Patients With Hematologic Malignancies
A Phase 2 study testing Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant in people with Hematologic Malignancies, run by University of California, San Diego at 1 site in United States.
Trial summary
The primary objective is to determine overall survival 180 days after transplantation involving HLA-haploidentical stem cell/bone marrow graft, and post-transplant Cy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hematologic Malignancies
- What is being tested?
- Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2012to 1 Jan 2023
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: Subjects 18-70 years old.
- Donor must be 18 years of age.
- HLA typing will be performed at high resolution. A minimum match of 5 out of 10 is required.
- Patients must have received multi-agent chemotherapy within 3 months of consent date (measured from the start date of chemotherapy).
- Acute Leukemias.
- Acute Lymphoblastic Leukemia in high risk 1st complete response (CR1)
Show all 13Show fewer
- Acute Myelogenous Leukemia in high risk 1st complete response (CR1)
- Acute Leukemias in 2nd or subsequent Complete Response (CR)
- Biphenotypic/Undifferentiated Leukemias in 1st or subsequent Complete Response (CR).
- Burkitt's lymphoma: second or subsequent Complete Response (CR).
- Lymphoma
- Patients with adequate physical function
- Performance status: Karnofsky score 70-100%.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2 Study of Nonmyeloablative Conditioning With Transplantation of Partially Human Leukocyte Antigen (HLA)-Mismatched Bone Marrow and Post-transplant Cyclophosphamide for Patients With Hematologic Malignancies
The primary objective is to determine overall survival 180 days after transplantation involving HLA-haploidentical stem cell/bone marrow graft, and post-transplant Cy.
Read the detailed description
Study Design: This is a single center Phase 2 study of myeloablative (MA) and nonmyeloablative (NMA) conditioning, transplantation of partially HLA-mismatched bone marrow or peripheral blood stem cells and post-transplantation cyclophosphamide (Cy) in patients with hematologic malignancies including:
- Acute lymphoblastic leukemia/lymphoma, acute myelogenous leukemia, and Burkitt's lymphoma in remission.
- Relapsed lymphoma, including marginal zone B cell lymphoma, follicular lymphoma, and chemotherapy-sensitive large-cell or Hodgkin lymphoma.
- Myelodysplastic Syndrome (MDS)
- Blastic plasmacytoid dendritic cell neoplasm
Primary Objective:
The primary objective is to determine overall survival 180 days after transplantation involving Myeloablative and Non myeloablative conditioning, HLA-haploidentical marrow or peripheral blood stem cell grafts, and post-transplant Cyclophosphamide as GVHD prophylaxis.
Secondary Objectives:
Secondary objectives include estimating overall and progression-free survival at 100 days, 180 days, and one year after transplantation, treatment-related mortality, incidence of neutrophil and platelet recovery or engraftment, incidence of graft failure, cumulative incidence of acute and chronic Graft versus Host Disease (GVHD), incidence of infections, and cumulative incidence of relapse/progression. The investigators will also examine the amount of time to transplant (day of unrelated search initiation to day 0).
- Conditions
- Hematologic Malignancies
- Being tested
- Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant
- Keywords
- hematologic malignancies
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplantDrug
Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant
| Study group | Role | What they receive |
|---|---|---|
| cyclophosphamide post BMT | Experimental | Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant Receives: Drug: Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
180 days after transplantation
Measured: Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2015 (estimated)
- Study start21 Sep 2012
- Primary completion12 May 2016
- Study completion1 Jan 2023
Why it stopped: Toxicity
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 California, San DiegoThe 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caitlin Costello, MD, University of California, San Diego
- Investigators
- Caitlin Caitlin, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02623439
- Sponsor's protocol ID
- 120931
- Status last verified
- Oct 2025
- First submitted
- 29 Aug 2013
- Last updated
- 10 Nov 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 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Nonmyeloablative Conditioning With Transplantation of Partially Human Leukocyte Antigen (HLA)-Mismatched Bone Marrow and Post-transplant Cyclophosphamide for Patients With Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT02623439
- Acronym / sponsor ID
- 120931
- Conditions
- Hematologic Malignancies
- Keywords
- hematologic malignancies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Toxicity
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 21 Sep 2012 (actual)
- Primary completion
- 12 May 2016 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 7 Dec 2015 (estimated)
- Results
- Posted 10 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to determine overall survival 180 days after transplantation involving HLA-haploidentical stem cell/bone marrow graft, and post-transplant Cy.
Detailed description
Study Design: This is a single center Phase 2 study of myeloablative (MA) and nonmyeloablative (NMA) conditioning, transplantation of partially HLA-mismatched bone marrow or peripheral blood stem cells and post-transplantation cyclophosphamide (Cy) in patients with hematologic malignancies including:
- Acute lymphoblastic leukemia/lymphoma, acute myelogenous leukemia, and Burkitt's lymphoma in remission.
- Relapsed lymphoma, including marginal zone B cell lymphoma, follicular lymphoma, and chemotherapy-sensitive large-cell or Hodgkin lymphoma.
- Myelodysplastic Syndrome (MDS)
- Blastic plasmacytoid dendritic cell neoplasm
Primary Objective:
The primary objective is to determine overall survival 180 days after transplantation involving Myeloablative and Non myeloablative conditioning, HLA-haploidentical marrow or peripheral blood stem cell grafts, and post-transplant Cyclophosphamide as GVHD prophylaxis.
Secondary Objectives:
Secondary objectives include estimating overall and progression-free survival at 100 days, 180 days, and one year after transplantation, treatment-related mortality, incidence of neutrophil and platelet recovery or engraftment, incidence of graft failure, cumulative incidence of acute and chronic Graft versus Host Disease (GVHD), incidence of infections, and cumulative incidence of relapse/progression. The investigators will also examine the amount of time to transplant (day of unrelated search initiation to day 0).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cyclophosphamide post BMT | Experimental | Drug: Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplantCyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age: Subjects 18-70 years old.
- Donor must be 18 years of age.
- HLA typing will be performed at high resolution. A minimum match of 5 out of 10 is required.
- Patients must have received multi-agent chemotherapy within 3 months of consent date (measured from the start date of chemotherapy).
- Acute Leukemias.
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 |
|---|---|---|
| Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplantCyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant | Drug | cyclophosphamide post BMT |
Primary outcome
Overall Survival
Time frame: Day 180
180 days after transplantation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- 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.
Caitlin Caitlin, MD principal investigator
University of California, San Diego
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 Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant in people with Hematologic Malignancies, run by University of California, San Diego 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 13 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 10 Nov 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 10 Nov 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?
Overall Survival (time frame: Day 180). 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 10 Nov 2025.